Compounds > raltegravir potassium
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raltegravir potassium

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Description

Raltegravir Potassium: A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID23668479
CHEMBL ID518520
SCHEMBL ID15939218
MeSH IDM000604085

Synonyms (66)

Synonym
AC-2062
AB01274746-01
871038-72-1
isentress (tn)
D07133 ,
raltegravir potassium (jan/usan)
mk-518
isentress
raltegravir potassium
n-[1-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxo-pyrimidin-2-yl]-1-methyl-ethyl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
mk-0518 potassium
raltegravir monopotassium salt
raltegravir potassium salt
mk0518 potassium
CHEMBL518520
potassium 4-((4-fluorobenzyl)carbamoyl)-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-1,6-dihydropyrimidin-5-olate
43y000u234 ,
unii-43y000u234
n-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-4-pyrimidinecarboxamide monopotassium salt
raltegravir potassium [usan:jan]
4-pyrimidinecarboxamide, n-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-, monopotassium salt
BCPP000092
FT-0649661
raltegravir potassium [who-dd]
dutrebis component raltegravir potassium
potassium 4-[(4-fluorobenzyl)carbamoyl]-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-1,6-dihydropyrimidin-5-olate
raltegravir potassium [usp-rs]
raltegravir monopotassium salt [mi]
raltegravir potassium [jan]
raltegravir potassium [ep monograph]
raltegravir potassium [usan]
raltegravir potassium [orange book]
raltegravir potassium [mart.]
raltegravir potassium component of dutrebis
raltegravir potassium [usp monograph]
AKOS015896594
CS-3263
raltegravir (potassium)
HY-10353A
IFUKBHBISRAZTF-UHFFFAOYSA-M
Q-201657
SCHEMBL15939218
potassium 4-((4-fluorobenzyl)carbamoyl)-1-methyl-2-(2-(5-methyl-1,3,4-oxadiazole-2-carboxamido)propan-2-yl)-6-oxo-1,6-dihydropyrimidin-5-olate
potassium;4-[(4-fluorophenyl)methylcarbamoyl]-1-methyl-2-[2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl]-6-oxopyrimidin-5-olate
raltegravir (potassium salt)
mfcd12031642
potassium, raltegravir
mk 0518 potassium salt
bdbm50480673
isentress hd
potassium 4-{[(4-fluorophenyl)methyl]carbamoyl}-1-methyl-2-{2-[(5-methyl-1,3,4-oxadiazol-2-yl)formamido]propan-2-yl}-6-oxo-1,6-dihydropyrimidin-5-olate
raltegravir ( k salt) api
871038-72-1 (potassium)
AS-19171
BCP01757
AMY3328
CCG-269568
Q27258678
potassium 4-[{[(4-fluorophenyl)methyl]imino}(hydroxy)methyl]-1-methyl-2-{2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl}-6-oxo-1,6-dihydropyrimidin-5-olate
DTXSID501007339
BR164314
raltegravir potassium- bio-x
raltegravir potassium (ep monograph)
raltegravir potassium (usp monograph)
raltegravir potassium (mart.)
raltegravir potassium (usp-rs)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Four patients discontinued due to adverse experiences, three (2%) of the 133 patients across all raltegravir groups and one (2%) of the 45 patients on placebo."( Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial.
Chen, J; Gatell, JM; Gonzalez, CJ; Grinsztejn, B; Harvey, CM; Isaacs, RD; Katlama, C; Lazzarin, A; Nguyen, BY; Vittecoq, D, 2007)		0.34
" Significantly fewer drug-related clinical adverse events occurred in patients on raltegravir (n=124 [44."( Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial.
Barnard, RJ; Berger, DS; DeJesus, E; DiNubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Madruga, JV; Miller, MD; Nguyen, BY; Pollard, RB; Rodgers, AJ; Sklar, P; Williams-Diaz, A; Xu, X; Zhao, J, 2009)		0.35
" There were no grade 3 or 4 adverse events related to raltegravir."( Efficacy and safety of switching from enfuvirtide to raltegravir in patients with virological suppression.
Caum, C; Clotet, B; Domingo, P; Ferrer, E; Imaz, A; Llibre, JM; Martin-Iguacel, R; Moltó, J; Podzamczer, D; Santos, JR, )		0.13
" There were few discontinuations of raltegravir (4%) due to adverse events."( Long-term efficacy and safety of the HIV integrase inhibitor raltegravir in patients with limited treatment options in a Phase II study.
Danovich, RM; Eron, JJ; Gatell, JM; Gonzalez, CJ; Grinsztejn, B; Harvey, CM; Isaacs, RD; Katlama, C; Lazzarin, A; Meibohm, AR; Nguyen, BY; Strohmaier, KM; Vittecoq, D; Wan, H; Zhao, J, 2010)		0.36
" All adverse events were of mild or moderate intensity."( Pharmacokinetics and safety of twice-daily atazanavir 300 mg and raltegravir 400 mg in healthy individuals.
Bertz, R; Breidinger, S; Butterton, J; Comisar, W; Panebianco, D; Persson, A; Stonier, M; Zhang, J; Zhu, L, 2010)		0.36
" Atazanavir and raltegravir alone and coadministered appeared safe and well-tolerated."( Pharmacokinetics and safety of twice-daily atazanavir 300 mg and raltegravir 400 mg in healthy individuals.
Bertz, R; Breidinger, S; Butterton, J; Comisar, W; Panebianco, D; Persson, A; Stonier, M; Zhang, J; Zhu, L, 2010)		0.36
"In STARTMRK, drug-related adverse events (AEs) occurred less frequently with raltegravir than efavirenz."( Long-term safety from the raltegravir clinical development program.
Brown, DD; Leavitt, RY; Lehman, HP; Lievano, F; Mast, TC; Nguyen, BY; Sklar, P; Teppler, H; Wan, H; Xu, X, 2011)		0.37
" The incidence of drug-related adverse events was similar in raltegravir recipients with and without hepatitis coinfection in both STARTMRK (50 vs."( Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection.
Harvey, C; Leavitt, R; Nguyen, BY; Rockstroh, J; Sklar, P; Strohmaier, K; Teppler, H; Zhao, J, 2012)		0.38
" Safety criteria were: occurrence of any adverse event, unexpected blood test abnormalities and increased consumption of coagulation factors."( Safety and effectiveness of raltegravir in patients with haemophilia and anti-HIV multidrug resistance.
Fusco, F; Gringeri, A; Mago, D; Mangiafico, L; Perja, M; Riva, S, 2012)		0.38
" Three patients allocated elvitegravir had serious adverse events related to study drugs compared with seven assigned raltegravir; two and eight patients died, respectively."( Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study.
Andrade-Villanueva, J; Cheng, AK; Chuck, SL; Clotet, B; Clumeck, N; Lamarca, A; Liu, YP; Margot, N; Molina, JM; Zhong, L, 2012)		0.38
" The occurrence of treatment-related, moderate/severe adverse events was similar between treatment groups through 48 weeks of treatment."( Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naïve subjects: the progress study, 48-week results.
Fredrick, LM; Gathe, J; Lawal, A; Nilius, AM; Podsadecki, TJ; Pulido, F; Reynes, J; Soto-Malave, R; Tian, M, )		0.13
" There were no serious adverse events (AEs) in either arm."( A switch in therapy to a reverse transcriptase inhibitor sparing combination of lopinavir/ritonavir and raltegravir in virologically suppressed HIV-infected patients: a pilot randomized trial to assess efficacy and safety profile: the KITE study.
Del Rio, C; Easley, KA; Eaton, ME; Lennox, JL; Ofotokun, I; Sanford, SE; Shenvi, N; Sheth, AN; White, K, 2012)		0.38
" There were no serious adverse events and no discontinuations due to adverse events over 48 weeks; HIV RNA remained undetectable."( A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults.
Beileiter, K; Bloch, M; Boyd, MA; Carey, D; Cooper, DA; Emery, S; MacRae, K; Pett, SL; Ray, JE; Wand, H, 2012)		0.38
" Few drug-related adverse events were reported after week 48."( Sustained efficacy and safety of raltegravir after 5 years of combination antiretroviral therapy as initial treatment of HIV-1 infection: final results of a randomized, controlled, phase II study (Protocol 004).
Bhanja, S; Gotuzzo, E; Lu, C; Markowitz, M; Morales-Ramirez, JO; Nguyen, BY; Prada, G; Ratanasuwan, W; Smith, G; Strohmaier, KM; Teppler, H, 2012)		0.38
" Proximal myopathy may be an uncommon but significant side effect of raltegravir exposure."( Skeletal muscle toxicity associated with raltegravir-based combination antiretroviral therapy in HIV-infected adults.
Amin, J; Bloch, M; Carr, A; Lee, FJ; Marriott, D; Pett, SL, 2013)		0.39
" Drug-related clinical adverse events were reported by 8% of men, 18% of women, 14% of blacks, and 9% of nonblacks."( Safety, tolerability, and efficacy of raltegravir in a diverse cohort of HIV-infected patients: 48-week results from the REALMRK Study.
Bekker, LG; Campo, RE; Cheng, B; Eron, JJ; Jackson, BE; Kumar, P; Lu, C; Marquez, F; Mounzer, K; Nguyen, BY; Robertson, M; Rockstroh, JK; Rodgers, A; Sklar, P; Squires, KE; Strohmaier, KM; Thompson, M; Wenning, LA, 2013)		0.39
"Overall, 71 of 281 raltegravir recipients (25%) and 98 of 282 efavirenz recipients (35%) discontinued the study; discontinuations due to adverse events occurred in 14 (5%) and 28 (10%) patients in the respective groups."( Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK.
DeJesus, E; DiNubile, MJ; Leavitt, R; Lennox, JL; Miller, M; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Yazdanpanah, Y, 2013)		0.39
" Over the entire study, fewer patients experienced neuropsychiatric and drug-related adverse events in the raltegravir group than in the efavirenz group."( Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: final 5-year results from STARTMRK.
DeJesus, E; DiNubile, MJ; Leavitt, R; Lennox, JL; Miller, M; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Yazdanpanah, Y, 2013)		0.39
" However, data on the long-term exposure to these therapeutic options are needed, and a handful of case reports are emerging, reporting rare but potentially life-threatening adverse hepatic events in patients with hepatitis co-infection or taking other hepatotoxic drugs."( Hepatoxicity of new antiretrovirals: a systematic review.
Lacombe, K; Surgers, L, 2013)		0.39
" The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group."( Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials.
Barnard, RJ; Clotet, B; Cooper, DA; Eron, JJ; Gatell, JM; Kumar, PN; Lazzarin, A; Lennox, JL; Loutfy, MR; Markowitz, M; Nguyen, BY; Rockstroh, JK; Schechter, M; Steigbigel, RT; Strohmaier, KM; Teppler, H; Wan, H; Yeni, P, 2013)		0.39
" Adverse event (AE) and treatment-related AE incidence was 91."( Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study.
Bicudo, EL; Cassoli, LM; da Eira, M; de Andrade Neto, JL; Furtado, J; Leite, OH; Lewi, DS; Lima, MP; Lopes, MI; Machado, AA; Madruga, JV; Miranda, AF; Netto, EM; Pedro, Rde J; Portsmouth, S; Santini-Oliveira, M; Santos, BR; Tupinambas, U; Wajsbrot, DB, 2013)		0.39
" We assessed adherence (compared between groups and with nonstudy controls) and clinical and adverse events at weeks 1, 2 and 4, and efficacy at week 12."( Raltegravir-emtricitabine-tenofovir as HIV nonoccupational post-exposure prophylaxis in men who have sex with men: safety, tolerability and adherence.
Carr, A; Ingersoll, A; McAllister, J; McNulty, A; Read, P; Tong, WW, 2014)		0.4
" Safety data through weeks 24 and 48, and grade ≥ 3 or serious adverse events (AEs) were assessed."( Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years.
Acosta, EP; Alvero, C; Fenton, T; Frenkel, LM; Graham, B; Handelsman, E; Homony, B; Nachman, S; Spector, SA; Teppler, H; Wenning, L; Wiznia, A; Worrell, C; Xu, X; Zheng, N, 2014)		0.4
"The Raltegravir Switch for Toxicity or Adverse Events (RASTA) Study is a 2-arm randomized pilot study exploring the safety and efficacy at 48 weeks of a treatment switch to raltegravir associated with tenofovir/emtricitabine or abacavir/lamivudine in patients with regimens with optimal virological control."( Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RAST
Cauda, R; Ciccarelli, N; Colafigli, M; D'Avino, A; D'Ettorre, G; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Fortuna, S; Mondi, A; Murri, R; Paoletti, F; Sidella, L; Vullo, V, 2014)		0.4
"5%) regimen discontinuations occurred: 2 were for low-level viremia virological failure (both in arm A, at weeks 24 and 48) and 3 were for adverse events (neurological disturbances and skin rash in arm B; proximal tubulopathy in arm A)."( Safety and efficacy of treatment switch to raltegravir plus tenofovir/emtricitabine or abacavir/lamivudine in patients with optimal virological control: 48-week results from a randomized pilot study (Raltegravir Switch for Toxicity or Adverse Events, RAST
Cauda, R; Ciccarelli, N; Colafigli, M; D'Avino, A; D'Ettorre, G; De Luca, A; Di Giambenedetto, S; Fabbiani, M; Fortuna, S; Mondi, A; Murri, R; Paoletti, F; Sidella, L; Vullo, V, 2014)		0.4
"Using data from HIV clinical cohorts at Johns Hopkins University and the University of North Carolina at Chapel Hill, we evaluated factors associated with liver enzyme elevations (LEEs) and calculated adverse event incidence rates for patients initiated on raltegravir-containing regimens prior to 1 January 2010."( Hepatic safety and tolerability of raltegravir among HIV patients coinfected with hepatitis B and/or C.
Eron, JJ; Hurt, CB; Moore, RD; Napravnik, S, 2014)		0.4
" With appropriate monitoring, raltegravir-based therapy is safe in hepatitis-coinfected patients."( Hepatic safety and tolerability of raltegravir among HIV patients coinfected with hepatitis B and/or C.
Eron, JJ; Hurt, CB; Moore, RD; Napravnik, S, 2014)		0.4
"Growing evidence associates the non-nucleoside reverse transcriptase inhibitor efavirenz with several adverse events."( Lack of mitochondrial toxicity of darunavir, raltegravir and rilpivirine in neurons and hepatocytes: a comparison with efavirenz.
Alegre, F; Apostolova, N; Blas-García, A; Esplugues, JV; Funes, HA; Martínez, E; Polo, M, 2014)		0.4
"Darunavir, rilpivirine and raltegravir do not induce toxic effects on Hep3B cells and primary rat neurons, which suggests a safer hepatic and neurological profile than that of efavirenz."( Lack of mitochondrial toxicity of darunavir, raltegravir and rilpivirine in neurons and hepatocytes: a comparison with efavirenz.
Alegre, F; Apostolova, N; Blas-García, A; Esplugues, JV; Funes, HA; Martínez, E; Polo, M, 2014)		0.4
" Bayesian fixed-effect network meta-analysis models adjusting for the type of nucleoside reverse transcriptase inhibitor backbone (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC] or abacavir/lamivudine [ABC/3TC]) were used to evaluate week 48 efficacy (HIV-RNA suppression to <50 copies/mL and change in CD4+ cells/µL) and safety (lipid changes, adverse events, and discontinuations due to adverse events) of DTG relative to all other treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014)		0.4
" Dolutegravir had better or equivalent changes in total cholesterol, LDL, triglycerides, and lower odds of adverse events and discontinuation due to adverse events compared to all treatments."( 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1-infected patients: a systematic review and network meta-analysis.
Camejo, RR; Cuffe, R; Gilchrist, KA; Lim, JW; Nichols, G; Patel, DA; Pulgar, S; Snedecor, SJ; Stephens, J; Sudharshan, L; Tang, WY, 2014)		0.4
" Overall, 12 (31%) patients stopped dual therapy: 7 patients because of adverse events, mostly clinical myositis (n = 3)."( Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study.
Batard, ML; Bernard-Henry, C; Cheneau, C; De Mautort, E; Fafi-Kremer, S; Gantner, P; Koeppel, C; Muret, P; Partisani, M; Priester, M; Rey, D; Sueur, C, 2014)		0.4
" Skeletal muscle toxicity is not an unusual adverse event in subjects receiving raltegravir, but it is usually represented by a mild-to-moderate increase in CK concentration, while clinical symptoms of myopathy are very uncommon."( Skeletal muscle toxicity in HIV-1-infected patients treated with a raltegravir-containing antiretroviral therapy: a cohort study.
Appolloni, L; Borderi, M; Calza, L; Colangeli, V; Danese, I; Girometti, N; Manfredi, R; Puggioli, C; Vandi, G; Viale, P, 2014)		0.4
" The concomitant use of ATT including rifabutin and an ART (RAL + ABC/3TC) regimen was safe since one patient was noted to have a RAL-related adverse event (AE) (an allergic reaction) and caused the patient to discontinue therapy."( [The efficacy and safety of a therapy regimen including raltegravir and a fixed dose combination of lamivudine and abacavir in previously rifabutin-treated patients with tuberculosis and HIV infection].
Deulina, MO; Ivanova, ES; Kanestri, VG; Kravchenko, AV; Pokrovsky, VV; Popova, AA; Yakovlev, AA; Zimina, VN, 2014)		0.4
"3%) adverse events (AEs) were of mild or moderate severity with few grade 3/4 events, discontinuations, or temporary discontinuations/dose reductions due to AEs or serious AEs."( The maraviroc expanded access program - safety and efficacy data from an open-label study.
Craig, C; Heera, J; Lazzarin, A; Molina, JM; Mukwaya, G; Reynes, J; Sierra-Madero, JG; Valluri, S; van der Ryst, E, )		0.13
" Safety data through Weeks 24 and 48 and Grade ≥3 or serious adverse events (AEs) were assessed."( Pharmacokinetics and 48-Week Safety and Efficacy of Raltegravir for Oral Suspension in Human Immunodeficiency Virus Type-1-Infected Children 4 Weeks to 2 Years of Age.
Acosta, EP; Alvero, C; Fenton, T; Frenkel, LM; Graham, B; Handelsman, E; Homony, B; Nachman, S; Rizk, ML; Spector, SA; Teppler, H; Wiznia, A; Worrell, C; Xu, X, 2015)		0.42
"When treating HIV-infected patients with hemophilia, adverse drug reactions and interactions and the effect of treatment on bleeding disorders must be considered."( Efficacy and safety of antiretroviral regimens including raltegravir to treat HIV-infected patients with hemophilia.
Gu, S; Lu, H; Sun, H; Wang, J; Xiao, H; Xue, Y, 2016)		0.43
" The standard raltegravir dose seems safe and effective in preventing mother-to-child transmission in late pregnancy presenters with unknown or unsuppressed viral load, or in multidrug resistance."( Critical Review: Review of the Efficacy, Safety, and Pharmacokinetics of Raltegravir in Pregnancy.
Maliakkal, A; Tseng, A; Walmsley, S, 2016)		0.43
"Switch to atazanavir/raltegravir was safe and well tolerated allowing optimal drugs' plasma exposure."( Efficacy, safety and pharmacokinetics of atazanavir (200mg twice daily) plus raltegravir (400mg twice daily) dual regimen in the clinical setting.
Bonora, S; Bramato, C; Calcagno, A; Cenderello, G; D'Avolio, A; Di Perri, G; Marinaro, L; Orofino, G; Pirriatore, V; Ripamonti, D; Rizzi, M; Rusconi, S; Salassa, B; Trentini, L, 2017)		0.46
" Outcomes of interest were viral suppression, mortality, AIDS-defining illnesses or WHO stage 3-4 disease, discontinuations, discontinuations due to adverse events, and serious adverse events."( Comparative efficacy and safety of second-line antiretroviral therapy for treatment of HIV/AIDS: a systematic review and network meta-analysis.
Ayers, D; Calmy, A; Chan, K; Cooper, DA; Doherty, M; Ford, N; Kanters, S; Mills, EJ; Nsanzimana, S; Paton, NI; Popoff, E; Socias, ME; Vitoria, M; Wiens, MO, 2017)		0.46
" Expert opinion: Despite the arrival of new integrase strand transfer inhibitors (INSTIs) with advantages in terms of dosing convenience (elvitegravir, ELV) and higher genetic barrier (dolutegravir, DTG), RAL has stood the test of time and its overall favourable safety profile, without significant appearance of unexpected adverse events, vouch for its relevance in the antiretroviral armamentarium."( A safety evaluation of raltegravir for the treatment of HIV.
Arribas, JR; de Miguel, R; Montejano, R; Stella-Ascariz, N, 2018)		0.48
" INSTIs have also been demonstrated as safe and tolerable."( Dolutegravir Neuropsychiatric Adverse Events: Specific Drug Effect or Class Effect.
Yombi, JC, )		0.13
" There were few serious clinical or laboratory safety events noted, with two patients having a drug-related adverse event (skin rash), which led one patient to discontinue the study treatment."( Safety and efficacy at 240 weeks of different raltegravir formulations in children with HIV-1: a phase 1/2 open label, non-randomised, multicentre trial.
Alvero, C; Browning, RS; Fenton, T; Frenkel, LM; Graham, BL; Hazra, R; Homony, B; Nachman, S; Rodgers, AJ; Teppler, H; Wiznia, AA, 2018)		0.48
"To analyse the frequency and causes of treatment discontinuation in patients who were treated with an integrase strand transfer inhibitor (INSTI), with a focus on neuropsychiatric adverse events (NPAEs)."( Integrase strand transfer inhibitors and neuropsychiatric adverse events in a large prospective cohort.
Allavena, C; Bani-Sadr, F; Bregigeon, S; Cabié, A; Cuzin, L; Ferry, T; Katlama, C; Lourenco, J; Pugliese, P; Rey, D; Reynes, J, 2019)		0.51
"The aim of the study was to assess the rates of discontinuation of integrase inhibitor regimens because of any neuropsychiatric adverse event (NPAE) and the factors associated with discontinuation."( Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort.
Abdulghani, N; Ambrosioni, J; Casabona, J; Curran, A; Domingo, P; Force, L; Homar, F; Llibre, JM; Miró, JM; Montoliu, A; Peraire, J; Riera, M; Tiraboschi, J, 2019)		0.51
" Every discontinuation because of adverse events (AEs) was double-checked directly with treating physicians."( Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort.
Abdulghani, N; Ambrosioni, J; Casabona, J; Curran, A; Domingo, P; Force, L; Homar, F; Llibre, JM; Miró, JM; Montoliu, A; Peraire, J; Riera, M; Tiraboschi, J, 2019)		0.51
" The rate of discontinuations because of NPAEs was low, but was significantly higher for dolutegravir than for elvitegravir/cobicistat, with significant differences among centres, suggesting that greater predisposition to believe that a given adverse event is caused by a given drug of some treating physicians might play a role in the discordance seen between cohorts."( Discontinuation of dolutegravir, elvitegravir/cobicistat and raltegravir because of toxicity in a prospective cohort.
Abdulghani, N; Ambrosioni, J; Casabona, J; Curran, A; Domingo, P; Force, L; Homar, F; Llibre, JM; Miró, JM; Montoliu, A; Peraire, J; Riera, M; Tiraboschi, J, 2019)		0.51
"In absence of HIV infection, or concomitant treatment, short-term exposure to T20 or RAL in healthy adult volunteers did not lead to any indicative changes in toxicity markers thus presuming the safe profile of both drugs."( Metabolic, mitochondrial, renal and hepatic safety of enfuvirtide and raltegravir antiretroviral administration: Randomized crossover clinical trial in healthy volunteers.
Arnaiz, JA; Barroso, S; Blanco, JL; Carné, X; Garrabou, G; Gatell, JM; González-Segura, À; Larousse, M; Lazzari, E; Llopis, J; Loncà, M; Mallolas, J; Manriquez, M; Martínez, E; Miró, O; Morén, C; Riba, N; Santana, G, 2019)		0.51
" Raltegravir is well-known for its low frequency of adverse effects."( An HIV-infected Patient with No Serious Adverse Events after Overdosing on Raltegravir.
Hosoda, T; Naito, T; Uehara, Y, 2020)		0.56
"Population modeling and simulations can be used to facilitate the conduct of phase I studies to develop safe and effective dosing regimens in neonates."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
"P1110 is an international, multicenter trial to determine safe and effective raltegravir doses in neonates at risk for HIV infection."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
" The chosen neonatal raltegravir dosing regimen was safe and well tolerated in full-term neonates during treatment over the first 6 weeks of life and follow-up to age 24 weeks."( Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Acosta, EP; Bryson, Y; Cababasay, M; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, B; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" There are concerns of increasing adverse effects from HIV medications, such as integrase strand transfer inhibitors, as a result of changes in pharmacodynamic and pharmacokinetic parameters within the older population."( Clinical Safety Considerations of Integrase Strand Transfer Inhibitors in the Older Population Living with HIV.
Gavioli, EM; Vider, E, 2021)		0.62
" We also assessed antiretroviral therapy safety, analyzing treatment discontinuation for adverse events."( Brief Report: Efficacy and Safety of Efavirenz, Raltegravir, and Dolutegravir in HIV-1/TB Coinfection. A Multicenter Retrospective Cohort Study in France.
Brun, A; de Castro, N; Hamet, G; Joly, V; Kherabi, Y; Méchaï, F; Molina, JM; Sellier, PO; Yazdanpanah, Y, 2022)		0.72
" Rate of treatment discontinuation for drug-related adverse events was 10."( Brief Report: Efficacy and Safety of Efavirenz, Raltegravir, and Dolutegravir in HIV-1/TB Coinfection. A Multicenter Retrospective Cohort Study in France.
Brun, A; de Castro, N; Hamet, G; Joly, V; Kherabi, Y; Méchaï, F; Molina, JM; Sellier, PO; Yazdanpanah, Y, 2022)		0.72
"Exposure to some InSTIs, even at subtherapeutic concentrations, can induce adverse effects in hESCs and pregnant mice."( Second-Generation Human Immunodeficiency Virus Integrase Inhibitors Induce Differentiation Dysregulation and Exert Toxic Effects in Human Embryonic Stem Cell and Mouse Models.
Ajaykumar, A; Côté, HCF; Gadawska, I; Hsieh, AYY; Martineau, L; Mohan, H; Patel, R; Piret, JM; Serghides, L; Sherwood, C; Smith, MR, 2022)		0.72
"Previous clinical data have shown that raltegravir-based antiretroviral therapy (ART) with fewer drug-drug interactions (DDIs) and adverse events (AEs) is a good regimen in patients with HIV infection who need cancer chemotherapy."( Safety and efficacy of pharmacotherapy containing INSTIs and chemotherapy drugs in people living with HIV and concomitant colorectal cancer.
Chen, T; Gui, F; Tan, J; Wei, G; Yang, J; Zhao, Y, 2022)		0.72
" Outcomes included efficacy/effectiveness (CD4 counts and viral load) and/or safety outcomes (mortality, grade 3/4 adverse events and treatment discontinuation) through 6 months or more post-treatment initiation."( Effectiveness and safety of dolutegravir and raltegravir for treating children and adolescents living with HIV: a systematic review.
Castro, H; Collins, IJ; Jesson, J; Judd, A; Leroy, V; Milanzi, E; O'Rourke, J; Penazzato, M; Renaud, F; Townsend, CL; Vicari, M, 2022)		0.72
" Across all studies assessing dolutegravir or raltegravir, grade 3/4 adverse events (clinical and/or laboratory) were reported in 0-50% of subjects, few resulted in discontinuation, few were drug related and no deaths were attributed to either drug."( Effectiveness and safety of dolutegravir and raltegravir for treating children and adolescents living with HIV: a systematic review.
Castro, H; Collins, IJ; Jesson, J; Judd, A; Leroy, V; Milanzi, E; O'Rourke, J; Penazzato, M; Renaud, F; Townsend, CL; Vicari, M, 2022)		0.72
"These reassuring findings suggest that dolutegravir and raltegravir are effective and safe as preferred regimens in children and adolescents living with HIV."( Effectiveness and safety of dolutegravir and raltegravir for treating children and adolescents living with HIV: a systematic review.
Castro, H; Collins, IJ; Jesson, J; Judd, A; Leroy, V; Milanzi, E; O'Rourke, J; Penazzato, M; Renaud, F; Townsend, CL; Vicari, M, 2022)		0.72
" We assessed discontinuations and adverse events (AEs) that were considered related to the initial INSTI in the first year following initiation among treatment-naïve people living with HIV (PLWH)."( Treatment-related early discontinuations and adverse events among newly diagnosed people living with HIV initiating integrase inhibitors in a real-world setting.
Castano, J; DeJesus, E; Hinestrosa, F; Nguyen, V; Patel, K; Rolle, CP, 2023)		0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Patients were monitored for safety, pharmacokinetic parameters, and antiretroviral effect."( Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals.
Cooper, DA; Gilde, LR; Isaacs, R; Kovacs, CM; Liporace, R; Markowitz, M; Morales-Ramirez, JO; Nguyen, BY; Schwartz, R; Steigbigel, RT; Teppler, H; Wenning, L; Zhao, J, 2006)		0.33
"750) or apparent half-life (P = ."( Lack of a pharmacokinetic effect of raltegravir on midazolam: in vitro/in vivo correlation.
DeNoia, EP; Ghosh, K; Gottesdiener, KM; Hanley, WD; Iwamoto, M; Kassahun, K; Lu, P; Mangin, E; Petry, AS; Rhoton, A; Stone, JA; Troyer, MD; Wagner, JA; Wenning, LA, 2008)		0.35
" Two pharmacokinetic studies were performed in healthy subjects: study 1 examined the effect of administration of 600-mg rifampin once daily on the pharmacokinetics of a single dose of 400-mg raltegravir, and study 2 examined the effect of 600-mg rifampin once daily on the pharmacokinetics of 800-mg raltegravir twice daily compared to 400-mg raltegravir twice daily without rifampin."( Effect of rifampin, a potent inducer of drug-metabolizing enzymes, on the pharmacokinetics of raltegravir.
Berg, JK; Brainard, DM; Chodakewitz, JA; Ghosh, K; Gottesdiener, KM; Hanley, WD; Iwamoto, M; Jin, B; Mangin, E; Marbury, TC; Petry, AS; Stone, JA; Wagner, JA; Wenning, LA, 2009)		0.35
" * As both these drugs are likely to be used in combination, this study evaluated the pharmacokinetic interaction between them."( Assessment of the pharmacokinetics of co-administered maraviroc and raltegravir.
Andrews, E; Crownover, P; Damle, B; Fang, J; Glue, P; Tressler, R, 2010)		0.36
"To assess the two-way pharmacokinetic interaction between maraviroc and raltegravir."( Assessment of the pharmacokinetics of co-administered maraviroc and raltegravir.
Andrews, E; Crownover, P; Damle, B; Fang, J; Glue, P; Tressler, R, 2010)		0.36
" Test/reference ratios and 95% confidence intervals (CIs) were determined for pharmacokinetic parameters."( Assessment of the pharmacokinetics of co-administered maraviroc and raltegravir.
Andrews, E; Crownover, P; Damle, B; Fang, J; Glue, P; Tressler, R, 2010)		0.36
"Nucleoside-sparing combination antiretroviral therapy (cART) regimens might be an attractive therapeutic option for HIV type-1 (HIV-1)-infected patients; however, the pharmacokinetic profiles of such regimens are frequently unknown."( The effects of a nucleoside-sparing antiretroviral regimen on the pharmacokinetics of ritonavir-boosted darunavir in HIV type-1-infected patients.
Back, D; Dickinson, L; Erlwein, OW; Garvey, L; Latch, N; Mackie, NE; McClure, MO; Scullard, G; Walsh, J; Winston, A, 2010)		0.36
"Fourteen HIV-1-infected patients (age 21-55 years, 64% male) on stable cART with plasma HIV RNA <50 copies/ml entered this Phase I pharmacokinetic study."( The effects of a nucleoside-sparing antiretroviral regimen on the pharmacokinetics of ritonavir-boosted darunavir in HIV type-1-infected patients.
Back, D; Dickinson, L; Erlwein, OW; Garvey, L; Latch, N; Mackie, NE; McClure, MO; Scullard, G; Walsh, J; Winston, A, 2010)		0.36
" Subjects underwent two intensive pharmacokinetic visits in the fasted state separated by a 5- to 12-day washout period."( Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers.
Anderson, PL; Brundage, R; Bumpass, JB; Bushman, L; Kiser, JJ; Mawhinney, S; Meditz, AL; Predhomme, JA; Ray, M; Rower, J, 2010)		0.36
" A pharmacokinetic study was performed in 22 HIV-infected adults treated with 400 mg RAL plus 300 mg ATV 300 twice a day."( Exposure-related effects of atazanavir on the pharmacokinetics of raltegravir in HIV-1-infected patients.
Baldelli, S; Cattaneo, D; Clementi, E; Conti, F; Cozzi, V; Ripamonti, D, 2010)		0.36
" However, in the presence of raltegravir, ezetimibe AUC0-24 and Ctrough were significantly lower (>20%) and ezetimibe glucuronide Cmax was higher."( Pharmacokinetics and safety of the co-administration of the antiretroviral raltegravir and the lipid-lowering drug ezetimibe in healthy volunteers.
Armenis, K; Back, D; Boffito, M; Bonora, S; D'Avolio, A; Gazzard, B; Jackson, A; Moyle, G; Taylor, J; Watson, V, 2011)		0.37
" The aim of this study was to assess the safety and pharmacokinetic (PK) profile of raltegravir and ribavirin when dosed separately and together."( Pharmacokinetic and safety profile of raltegravir and ribavirin, when dosed separately and together, in healthy volunteers.
Ashby, J; Back, D; D'Avolio, A; Dickinson, L; Erlwein, OW; Garvey, L; Lamba, H; Latch, N; Legg, K; McClure, MO; Weston, R; Winston, A, 2011)		0.37
" Persistently high intracellular concentrations of raltegravir may explain sustained efficacy despite high pharmacokinetic variability."( Pharmacokinetic modeling of plasma and intracellular concentrations of raltegravir in healthy volunteers.
Flexner, C; Goh, BC; Lee, E; Lee, L; Li, J; Seng, KY; Soon, GH; Wang, L; Yong, EL, 2011)		0.37
" Pharmacokinetic evaluations were performed during two consecutive visits."( Inter- and intra-patient variability of raltegravir pharmacokinetics in HIV-1-infected subjects.
Baldelli, S; Cattaneo, D; Clementi, E; Cozzi, V; Fucile, S; Galli, M; Gervasoni, C; Landonio, S; Meraviglia, P; Pellegrini, M, 2012)		0.38
"The pharmacokinetic evaluation was repeated after an average of 52 ± 68 days."( Inter- and intra-patient variability of raltegravir pharmacokinetics in HIV-1-infected subjects.
Baldelli, S; Cattaneo, D; Clementi, E; Cozzi, V; Fucile, S; Galli, M; Gervasoni, C; Landonio, S; Meraviglia, P; Pellegrini, M, 2012)		0.38
" More comprehensive in vivo pharmacokinetic data are required to justify the potential use of these agents as safe and effective options during pregnancy."( Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the fetal compartment (placenta and amniotic fluid).
Back, DJ; Else, LJ; Khoo, SH; Taylor, S, 2011)		0.37
" Intensive pharmacokinetic analyses were performed, and HIV RNA was monitored."( Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy.
Ananworanich, J; Avihingsanon, A; Burger, DM; Gorowara, M; Hill, A; Kerr, SJ; Khongpetch, C; Ruxrungtham, K; Uanithirat, A; van Heesch, N, 2012)		0.38
"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)		0.38
" ATV and RAL demonstrated considerable pharmacokinetic variability."( A randomized study of pharmacokinetics, efficacy, and safety of 2 raltegravir plus atazanavir strategies in ART-treated adults.
Beileiter, K; Bloch, M; Boyd, MA; Carey, D; Cooper, DA; Emery, S; MacRae, K; Pett, SL; Ray, JE; Wand, H, 2012)		0.38
" Pharmacokinetic sampling of raltegravir was performed up to 12 h after intake on an empty stomach."( Effect of ginkgo biloba on the pharmacokinetics of raltegravir in healthy volunteers.
Blonk, M; Burger, D; Colbers, A; Poirters, A; Schouwenberg, B, 2012)		0.38
" In the in vivo study, we found that patients given RAL by chewing the tablets presented pharmacokinetic profiles characterized by significantly higher RAL absorption than did patients receiving the drug by swallowing."( Comparison of the in vivo pharmacokinetics and in vitro dissolution of raltegravir in HIV patients receiving the drug by swallowing or by chewing.
Baldelli, S; Cattaneo, D; Cerea, M; Clementi, E; Cozzi, V; Fucile, S; Galli, M; Gazzaniga, A; Gervasoni, C; Landonio, S; Meraviglia, P; Rizzardini, G; Simioni, E, 2012)		0.38
" Drug concentrations at two trough values of 12 and 24 h after dosing (C(12) and C(24)), area under the concentration-curve values (AUC), maximum drug concentration (C(max)), and the time at which this concentration occurred (T(max)) in plasma were estimated with noncompartmental pharmacokinetic methods and compared to data from a subset of white subjects randomized to the RAL twice a day (plus TDF/FTC) arm of the QDMRK study, a phase III study of the safety and efficacy of once daily versus twice daily RAL in treatment naive patients."( Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study.
Blevins, S; Dumond, JB; Eron, JJ; Floris-Moore, M; Hudgens, MG; Kashuba, AD; Massengale, K; Pittard, D; Ragan, D; Richardson, A; Walsh, K; Wang, R; Wohl, DA, 2013)		0.39
"We performed a within-subject open-labeled pharmacokinetic and pharmacodynamic study in 12 HIV-seronegative subjects stabilized on at least 3 weeks of buprenorphine/naloxone therapy."( Pharmacokinetic interactions between buprenorphine/naloxone and raltegravir in subjects receiving chronic buprenorphine/naloxone treatment.
Andrews, L; Chodkowski, D; Douglas Bruce, R; Fang, WB; Friedland, GH; Moody, DE; Morrison, J; Parsons, TL, 2013)		0.39
"The addition of raltegravir to stabilized patients receiving buprenorphine/naloxone does not significantly affect buprenorphine/naloxone or raltegravir pharmacokinetic or pharmacodynamic parameters."( Pharmacokinetic interactions between buprenorphine/naloxone and raltegravir in subjects receiving chronic buprenorphine/naloxone treatment.
Andrews, L; Chodkowski, D; Douglas Bruce, R; Fang, WB; Friedland, GH; Moody, DE; Morrison, J; Parsons, TL, 2013)		0.39
"A qd regimen of raltegravir 800 mg, atazanavir 600 mg and lamivudine or emtricitabine resulted in favourable pharmacokinetic profiles and good short-term safety and efficacy data."( Pharmacokinetics of the combination raltegravir/atazanavir in HIV-1-infected patients.
Burger, DM; Colbers, EP; Jansen, A; Richter, C; Rockstroh, JK; van der Ven, AJ; van Luin, M; Wasmuth, JC, 2013)		0.39
" However, data on the pharmacokinetic (PK) profiles of these regimens are limited."( Pharmacokinetic study of dual therapy with raltegravir 400 mg twice daily and Darunavir/Ritonavir 800/100 mg once daily in HIV-1-infected patients.
Blanco, JL; Brunet, M; Calvo, M; Gatell, JM; González, A; Hidalgo, S; Laguno, M; Loncà, M; Mallolas, J; Martínez, E; Martínez-Rebollar, M; Muñoz, A; Pérez, I, 2013)		0.39
" The geometric mean values for DRV were AUC0-24 68,730 ng·h·mL [95% confidence interval (CI): 58,970-86,480], Ctrough 1330 ng/mL (95% CI: 1110-1760; IC-50 for wild-type and resistant HIV-1 strains was 55 and 550 ng/mL, respectively), Cmax 7630 ng/mL (95% CI: 6740-9000), and t1/2 10."( Pharmacokinetic study of dual therapy with raltegravir 400 mg twice daily and Darunavir/Ritonavir 800/100 mg once daily in HIV-1-infected patients.
Blanco, JL; Brunet, M; Calvo, M; Gatell, JM; González, A; Hidalgo, S; Laguno, M; Loncà, M; Mallolas, J; Martínez, E; Martínez-Rebollar, M; Muñoz, A; Pérez, I, 2013)		0.39
"This was a non-randomized, Phase I, parallel-assignment, open-label pharmacokinetic study in HIV/HCV-coinfected patients with Child-Pugh grade C hepatic cirrhosis."( Raltegravir pharmacokinetics in HIV/HCV-coinfected patients with advanced liver cirrhosis (Child-Pugh C).
Aguilar, M; Casado, JL; Dronda, F; Fumero, E; Hernández-Novoa, B; Madrid-Elena, N; Moltó, J; Moreno, A; Moreno, S; Pérez-Elías, MJ; Quereda, C, 2014)		0.4
"Dose selection for each cohort (I: 12 to <19 years; II: 6 to <12 years; and III: 2 to <6 years) was based on review of short-term safety (4 weeks) and intensive pharmacokinetic evaluation."( Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years.
Acosta, EP; Alvero, C; Fenton, T; Frenkel, LM; Graham, B; Handelsman, E; Homony, B; Nachman, S; Spector, SA; Teppler, H; Wenning, L; Wiznia, A; Worrell, C; Xu, X; Zheng, N, 2014)		0.4
"The targeted pharmacokinetic parameters (AUC0-12h and C12h) were achieved for each cohort, allowing dose selection for 2 formulations."( Pharmacokinetics, safety, and 48-week efficacy of oral raltegravir in HIV-1-infected children aged 2 through 18 years.
Acosta, EP; Alvero, C; Fenton, T; Frenkel, LM; Graham, B; Handelsman, E; Homony, B; Nachman, S; Spector, SA; Teppler, H; Wenning, L; Wiznia, A; Worrell, C; Xu, X; Zheng, N, 2014)		0.4
" We evaluated the effect of rifapentine on the pharmacokinetic properties of raltegravir."( Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers.
Egelund, EF; Engle, M; Gelfond, JA; Kiser, M; Mac Kenzie, W; Peloquin, CA; Prihoda, TJ; Weiner, M, 2014)		0.4
"In 16 subjects who completed the study, coadministration of raltegravir with rifapentine (900 mg once weekly; Period 2) compared with raltegravir alone resulted in the geometric mean of the raltegravir AUC from 0 to 12 h (AUC0-12) being increased by 71%; the peak concentration increased by 89% and the trough concentration decreased by 12%."( Pharmacokinetic interaction of rifapentine and raltegravir in healthy volunteers.
Egelund, EF; Engle, M; Gelfond, JA; Kiser, M; Mac Kenzie, W; Peloquin, CA; Prihoda, TJ; Weiner, M, 2014)		0.4
" With the final dose, plasma was collected for pharmacokinetic analysis at 9 timepoints over 12 hours, and CSF collected 4 hours post dose."( Genetic and non-genetic determinants of raltegravir penetration into cerebrospinal fluid: a single arm pharmacokinetic study.
Acosta, EP; Erdem, H; Haas, DW; Johnson, DH; Richardson, D; Sutherland, D, 2013)		0.39
"We sought to determine the pharmacokinetic disposition of raltegravir in the blood and seminal plasma of HIV-infected men."( Pharmacokinetics of raltegravir in the semen of HIV-infected men.
Antoniou, T; Brunetta, J; Halpenny, R; la Porte, C; Loutfy, MR; Smith, G, 2014)		0.4
"We conducted a pharmacokinetic study using a staggered sampling approach."( Pharmacokinetics of raltegravir in the semen of HIV-infected men.
Antoniou, T; Brunetta, J; Halpenny, R; la Porte, C; Loutfy, MR; Smith, G, 2014)		0.4
" We documented previously that HIV patients taking RAL at 400 mg bid by chewing the tablets had significantly higher drug absorption and reduced pharmacokinetic variability than patients taking the drug by swallowing the tablets."( Comparison of the pharmacokinetics of raltegravir given at 2 doses of 400 mg by swallowing versus one dose of 800 mg by chewing in healthy volunteers: a randomized, open-label, 2-period, single-dose, crossover phase 1 study.
Baldelli, S; Capetti, A; Cattaneo, D; Clementi, E; Cossu, MV; Fucile, S; Galli, M; Gervasoni, C; Impagnatiello, C; Landonio, S; Meraviglia, P; Resnati, C; Riva, A; Rizzardini, G, 2015)		0.42
"RAL at 800 mg once daily by chewing the tablets may represent a novel therapeutic option for the treatment of HIV being associated with higher drug absorption, reduced pharmacokinetic variability, and potentially better compliance compared with patients swallowing the 400-mg bid intact tablets."( Comparison of the pharmacokinetics of raltegravir given at 2 doses of 400 mg by swallowing versus one dose of 800 mg by chewing in healthy volunteers: a randomized, open-label, 2-period, single-dose, crossover phase 1 study.
Baldelli, S; Capetti, A; Cattaneo, D; Clementi, E; Cossu, MV; Fucile, S; Galli, M; Gervasoni, C; Impagnatiello, C; Landonio, S; Meraviglia, P; Resnati, C; Riva, A; Rizzardini, G, 2015)		0.42
"The end-stage LIVER disease and RALtegravir-Agence Nationale de Recherche sur le Sida et les hépatites (LIVERAL-ANRS) 148 study aimed to evaluate the safety, efficacy, and pharmacokinetic parameters of raltegravir (RAL) in human immunodeficiency virus (HIV)-infected patients with end-stage liver disease (ESLD) (substudy 1) and to assess the lack of pharmacokinetic interaction between RAL and the immunosuppressive regimen introduced after liver transplant (substudy 2)."( Pharmacokinetic study of raltegravir in HIV-infected patients with end-stage liver disease: the LIVERAL-ANRS 148 study.
Aboulker, JP; Barau, C; Braun, J; Duclos-Vallée, JC; Fournier, I; Haim-Boukobza, S; Miailhes, P; Molina, JM; Taburet, AM; Teicher, E; Vincent, C; Vittecoq, D, 2014)		0.4
" No pharmacokinetic interaction was observed between cyclosporine, mycophenolic acid, and RAL."( Pharmacokinetic study of raltegravir in HIV-infected patients with end-stage liver disease: the LIVERAL-ANRS 148 study.
Aboulker, JP; Barau, C; Braun, J; Duclos-Vallée, JC; Fournier, I; Haim-Boukobza, S; Miailhes, P; Molina, JM; Taburet, AM; Teicher, E; Vincent, C; Vittecoq, D, 2014)		0.4
" Twenty-two mother-infant pairs were enrolled; evaluable pharmacokinetic data were available from 19 mother-infant pairs."( Raltegravir pharmacokinetics in neonates following maternal dosing.
Acosta, EP; Bryson, YJ; Cababasay, MP; Clarke, DF; Handelsman, E; Mirochnick, M; Mofenson, LM; Persaud, D; Rizk, ML; Spector, SA; Teppler, H; Wang, J; Welebob, C, 2014)		0.4
" In vitro plasma protein binding, metabolic stability, intravenous blood-brain barrier (BBB) permeability and oral pharmacokinetic studies were performed."( Pregnancy influences the plasma pharmacokinetics but not the cerebrospinal fluid pharmacokinetics of raltegravir: a preclinical investigation.
Chaudhary, S; Edunuri, R; Khan, FR; Mahat, MY; Nidhyanandan, S; Thippeswamy, BS, 2014)		0.4
" Pharmacokinetic sampling was performed on days 5, 33 and 38."( Effect of intermittent rifampicin on the pharmacokinetics and safety of raltegravir.
Back, DJ; Chaponda, M; Chiong, J; Chrdle, A; Egan, D; Else, L; Khoo, SH; Reynolds, HE, 2015)		0.42
" Raltegravir Cmax and AUC0-12 were both significantly higher in the presence of rifampicin when dosed at 800 mg twice daily (76% and 84%, respectively), but this dose was well tolerated."( Effect of intermittent rifampicin on the pharmacokinetics and safety of raltegravir.
Back, DJ; Chaponda, M; Chiong, J; Chrdle, A; Egan, D; Else, L; Khoo, SH; Reynolds, HE, 2015)		0.42
" Here we summarize P1066 pharmacokinetic (PK) data and a population PK model for the pediatric chewable tablet and oral granules."( Population pharmacokinetic analysis of raltegravir pediatric formulations in HIV-infected children 4 weeks to 18 years of age.
Acosta, EP; Bennetto-Hood, C; Du, L; Fry, C; Graham, B; Homony, B; Nachman, S; Rizk, ML; Smith, B; Teppler, H; Wenning, L; Wiznia, A; Worrell, C, 2015)		0.42
" The objective of this study was to assess the pharmacokinetic (PK) profile in older HIV-infected subjects (>60 years) switching combination antiretroviral therapy (cART) to a raltegravir (RAL) containing regimen."( The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
Back, D; Barber, T; Boffito, M; Dickinson, L; Else, L; Jackson, A; Mora-Peris, B; Vera, JH; Winston, A, )		0.13
"2 years, n = 38) based on population pharmacokinetic analysis."( The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age.
Back, D; Barber, T; Boffito, M; Dickinson, L; Else, L; Jackson, A; Mora-Peris, B; Vera, JH; Winston, A, )		0.13
" Intensive steady-state 12- and 24-hour pharmacokinetic blood sampling was performed."( Pharmacokinetic Drug-Drug Interaction Study Between Raltegravir and Atorvastatin 20 mg in Healthy Volunteers.
Blonk, M; Burger, D; Colbers, A; Schouwenberg, B; van Beek, M, 2015)		0.42
" Steady-state pharmacokinetic profiles were obtained in the third trimester and postpartum along with cord and maternal delivery concentrations."( Raltegravir in HIV-1-Infected Pregnant Women: Pharmacokinetics, Safety, and Efficacy.
Blonk, MI; Burger, DM; Colbers, AP; Giaquinto, C; Gingelmaier, A; Haberl, AE; Hawkins, DA; Hidalgo-Tenorio, C; Ivanovic, J; Kabeya, K; Moltó, J; Taylor, GP; van der Ende, ME; Weizsäcker, K, 2015)		0.42
"Three cohorts of women were enrolled sequentially in a single-site, open-label pharmacokinetic study of oral raltegravir 400 mg twice daily: HIV-negative premenopausal, HIV-infected premenopausal and HIV-infected post-menopausal women."( Effect of HIV infection and menopause status on raltegravir pharmacokinetics in the blood and genital tract.
Cottrell, ML; Jones, A; Kashuba, AD; Patterson, KB; Prince, HM; Wang, R; White, N, 2015)		0.42
" All cohorts contributed to steady-state pharmacokinetic profiles."( Effect of HIV infection and menopause status on raltegravir pharmacokinetics in the blood and genital tract.
Cottrell, ML; Jones, A; Kashuba, AD; Patterson, KB; Prince, HM; Wang, R; White, N, 2015)		0.42
" This review aims to provide an overview of its role in the management of HIV-1 infection, highlighting its key pharmacokinetic and pharmacodynamic properties."( Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients.
Bonora, S; Calcagno, A; D'Avolio, A, 2015)		0.42
" For its weak genetic barrier to resistance and erratic pharmacokinetic profile, it should be administered twice daily and with fully active companion antiretrovirals."( Pharmacokinetic and pharmacodynamic evaluation of raltegravir and experience from clinical trials in HIV-positive patients.
Bonora, S; Calcagno, A; D'Avolio, A, 2015)		0.42
" Pharmacokinetic sampling was performed over 12-hour periods, 4 weeks after initiation of RAL together with RIF (period 1), 4 weeks after RIF discontinuation (period 2), and after the RAL dose reduction in arm 2 (period 3)."( Pharmacokinetics of Raltegravir in HIV-Infected Patients on Rifampicin-Based Antitubercular Therapy.
Assuied, A; De Castro, N; Fagard, C; Grinsztejn, B; Grondin, C; Molina, JM; Pilotto, JH; Sauvageon, H; Taburet, AM; Veloso, V, 2015)		0.42
" We investigated the two-way pharmacokinetic drug-drug interaction and tolerability of concomitant administration of the SSRI citalopram and the HIV-1 integrase inhibitor raltegravir in healthy volunteers."( Pharmacokinetic drug-drug interaction study between raltegravir and citalopram.
Blonk, MI; Burger, DM; Colbers, AP; Hoogtanders, KE; Langemeijer, CC; Schouwenberg, BJ; van Schaik, RH, 2016)		0.43
" Intensive steady-state pharmacokinetic blood sampling was performed."( Pharmacokinetic drug-drug interaction study between raltegravir and citalopram.
Blonk, MI; Burger, DM; Colbers, AP; Hoogtanders, KE; Langemeijer, CC; Schouwenberg, BJ; van Schaik, RH, 2016)		0.43
" Plasma concentrations were measured as therapeutic drug monitoring while a subset of patients underwent intensive 12-hour pharmacokinetic evaluation."( Raltegravir Plus Nevirapine as Maintenance Antiretroviral Therapy in HIV-Positive Patients: Safety, Efficacy and Pharmacokinetics.
Bonora, S; Calcagno, A; Calza, L; Capetti, A; Cenderello, G; D'Avolio, A; Di Perri, G; Guaraldi, G; Lanzafame, M; Marinaro, L; Montrucchio, C; Tettoni, MC; Trentini, L, 2016)		0.43
" Median trough raltegravir and nevirapine concentrations were 83 ng/ml (32-227) and 5460 ng/ml (4037-7221); intensive 12-hours pharmacokinetic parameters (n=7) were similar to published data."( Raltegravir Plus Nevirapine as Maintenance Antiretroviral Therapy in HIV-Positive Patients: Safety, Efficacy and Pharmacokinetics.
Bonora, S; Calcagno, A; Calza, L; Capetti, A; Cenderello, G; D'Avolio, A; Di Perri, G; Guaraldi, G; Lanzafame, M; Marinaro, L; Montrucchio, C; Tettoni, MC; Trentini, L, 2016)		0.43
" Raltegravir pharmacokinetic parameters remained unchanged whether administered on or off anti-HCV therapy."( Raltegravir Pharmacokinetics in Patients on Asunaprevir-Daclatasvir.
Barrail-Tran, A; Cheret, A; Furlan, V; Molina, JM; Piroth, L; Rosa, I; Rosenthal, E; Taburet, AM; Vincent, C, 2015)		0.42
" For the success of these strategies, pharmacokinetic (PK) data defining the optimal concentration of the drug needed for protection in relevant mucosal exposure sites is essential."( Mucosal tissue pharmacokinetics of the integrase inhibitor raltegravir in a humanized mouse model: Implications for HIV pre-exposure prophylaxis.
Akkina, R; Kashuba, AD; Remling-Mulder, L; Sykes, C; Veselinovic, M; Yang, KH, 2016)		0.43
" Pharmacokinetic analyses were performed using WinNonLin and NONMEM."( Phenotyping of UGT1A1 Activity Using Raltegravir Predicts Pharmacokinetics and Toxicity of Irinotecan in FOLFIRI.
Cheong, PF; Fan, L; Goh, BC; Hee, KH; Lee, LS; Lee, SC; Sapari, NS; Seng, KY; Soh, TI; Soo, R; Soong, R; Wang, LZ; Wong, A; Yong, WP, 2016)		0.43
"EVG is currently available as a single tablet regimen and requires cobisistat, a pharmacokinetic booster and CYP3A inhibitor to allow QD dosing."( How recent findings on the pharmacokinetics and pharmacodynamics of integrase inhibitors can inform clinical use.
Boffito, M; Chirwa, M; Elliot, E, 2017)		0.46
" The methods have been successfully applied in a maternal-fetal pharmacokinetic study."( Determination of raltegravir and raltegravir glucuronide in human plasma and urine by LC-MS/MS with application in a maternal-fetal pharmacokinetic study.
Duarte, G; Lanchote, VL; Marques, MP; Moreira, FL, 2020)		0.56
" Intensive RAL pharmacokinetic sampling was conducted 5 to 8 days after antiretroviral therapy was initiated; a fourth antiretroviral agent was then added."( Pharmacokinetics and safety of a raltegravir-containing regimen in HIV-infected children aged 2-12 years on rifampicin for tuberculosis.
Acosta, EP; Bradford, S; Cotton, MF; Denson, K; Hesseling, A; Hovind, L; Krogstad, P; Marillo, L; Masenya, M; Mathiba, SR; Meyers, T; Moye, J; Samson, P; Sise, T; Teppler, H; Townley, E, 2019)		0.51
"Giving 12 mg/kg twice daily of the chewable RAL formulation achieved pharmacokinetic targets safely in HIV-infected children receiving RIF for TB."( Pharmacokinetics and safety of a raltegravir-containing regimen in HIV-infected children aged 2-12 years on rifampicin for tuberculosis.
Acosta, EP; Bradford, S; Cotton, MF; Denson, K; Hesseling, A; Hovind, L; Krogstad, P; Marillo, L; Masenya, M; Mathiba, SR; Meyers, T; Moye, J; Samson, P; Sise, T; Teppler, H; Townley, E, 2019)		0.51
"3) were applied to determine pharmacokinetic parameters and assess demographic covariates and relationships with SNPs (SLCO3A1, SLCO1B1, NR1I2, NR1I3, CYP3A5*3, CYP3A4*22, ABCC2, ABCC10, ABCG2 and SCL47A1)."( Population pharmacokinetics and pharmacogenetics of ritonavir-boosted darunavir in the presence of raltegravir or tenofovir disoproxil fumarate/emtricitabine in HIV-infected adults and the relationship with virological response: a sub-study of the NEAT001
Boffito, M; Bonora, S; Cursley, A; D'Avolio, A; Di Perri, G; Dickinson, L; Fäetkenheuer, G; Gurjar, R; Molina, JM; Owen, A; Pozniak, A; Raffi, F; Richert, L; Stöhr, W; Vandekerckhove, L, 2020)		0.56
"Adequate pharmacokinetic and safety data in neonates are lacking for most antiretroviral agents."( Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Acosta, EP; Bryson, Y; Cababasay, M; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, B; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" The geometric mean protocol exposure targets for AUC, Ctrough, and Cmax were met or slightly exceeded in all infants."( Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Acosta, EP; Bryson, Y; Cababasay, M; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, B; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" We found that 12 mg/kg twice daily raltegravir chewable tablets (administered after crushing) safely achieved pharmacokinetic targets in children living with HIV aged 4 weeks to <2 years receiving concurrent rifampin to treat TB."( Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis.
Acosta, EP; Bradford, S; Brown, E; Denson, K; Fairlie, L; Graham, B; Hovind, L; Krogstad, P; Mathiba, SR; Meyers, T; Moye, J; Samson, P; Sise, T; Slade, G; Teppler, H; Townley, E; Winckler, JL, 2021)		0.62
" This study aimed to develop and evaluate maternal-fetal physiologically based pharmacokinetic models for two antiretroviral drugs, dolutegravir and raltegravir."( Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2020)		0.56
" Our aims were to characterize raltegravir elimination kinetics in low birth weight (LBW) neonates after maternal dosing and to develop a pharmacokinetic model to predict raltegravir plasma concentrations for term and preterm neonates."( Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.
Acosta, EP; Bryson, Y; Cababasay, MP; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, E; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" An integrated maternal-neonatal pharmacokinetic model was developed to predict neonatal raltegravir plasma concentrations."( Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.
Acosta, EP; Bryson, Y; Cababasay, MP; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, E; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" The median (range) raltegravir elimination half-life was 24."( Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.
Acosta, EP; Bryson, Y; Cababasay, MP; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, E; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
" Our objective was to develop and evaluate a novel, physiologically based pharmacokinetic modeling workflow for predicting perinatal and postnatal disposition of commonly used antiretroviral drugs administered prenatally to pregnant women living with human immunodeficiency virus."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021)		0.62
"Neonatal physiologically based pharmacokinetic models generally captured the initial plasma concentrations after delivery but underestimated concentrations in the terminal phase."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021)		0.62
"These findings demonstrate the general feasibility of applying physiologically based pharmacokinetic models to predict washout concentrations of transplacentally acquired drugs in newborns."( Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Best, BM; Burckart, GJ; Cressey, TR; Dallmann, A; Green, DJ; Liu, XI; Mirochnick, M; Momper, JD; Rakhmanina, NY; van den Anker, JN, 2021)		0.62
" Pharmacokinetic parameter values were calculated on the basis of plasma and urine data using noncompartmental methods."( Total, Unbound, Renal, and Hepatic Clearances of Raltegravir and the Formation and Elimination Clearances of Raltegravir Glucuronide in Pregnant Women.
Duarte, G; Lanchote, VL; Marques, MP; Melli, PPDS; Moreira, FL; Paz, TA; Rocha, A; Thomaz, ML, 2023)		0.91
" Peer-reviewed publications were included if they met all criteria: adults (≥ 18 years of age) living with or without HIV; report any pharmacokinetic parameter or plasma concentration of at least one of the following ARVs: tenofovir alafenamide fumarate (TAF); doravirine (DOR), rilpivirine (RIL) and etravirine (ETR); darunavir (DRV), tipranavir (TPV) and fostemsavir (FTR); dolutegravir (DTG), raltegravir (RAL), bictegravir (BIC) and elvitegravir (EVG); maraviroc (MVC); ibalizumab (IBA); cobicistat (COBI)."( Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.
Cardoso, SW; Castro, T; Estrela, R; Grinsztejn, B; Oliveira, VG; Toledo, T; Torres, TS; Veloso, VG, 2023)		0.91
"Among 97 studies included, 20 reported pharmacokinetic evaluation in older individuals (age ≥ 50 years)."( Pharmacokinetics of Antiretroviral Drugs in Older People Living with HIV: A Systematic Review.
Cardoso, SW; Castro, T; Estrela, R; Grinsztejn, B; Oliveira, VG; Toledo, T; Torres, TS; Veloso, VG, 2023)		0.91

Compound-Compound Interactions

ExcerptReferenceRelevance
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008)		0.35
"A new drug combination regimen, consisting of raltegravir, emtricitabine and tenofovir disoproxil fumarate (TDF), is described for the treatment of HIV-1 infection."( A new drug combination therapy for treatment-naive patients with HIV-1 infection, consisting of raltegravir, emtricitabine and tenofovir disoproxil fumarate.
De Clercq, E, 2009)		0.35
"To review all currently published drug-drug interaction studies with the HIV-integrase inhibitor raltegravir."( Drug-drug interactions with raltegravir.
Burger, DM, 2009)		0.35
"A total of 14 drug-drug interaction studies were found."( Drug-drug interactions with raltegravir.
Burger, DM, 2009)		0.35
"Raltegravir is not without drug-drug interactions but due to the lack of an effect on CYP450 or UGT by raltegravir and the broad therapeutic range of raltegravir itself, this agent can safely combined with almost all tested agents."( Drug-drug interactions with raltegravir.
Burger, DM, 2009)		0.35
"To evaluate the potential drug-drug interaction between raltegravir and pravastatin."( Drug-drug interactions between raltegravir and pravastatin in healthy volunteers.
Burger, DM; Colbers, A; da Silva, HG; Hoitsma, A; Schouwenberg, B; van Ewijk-Beneken Kolmer, EW; van Luin, M; Verweij-van Wissen, CP, 2010)		0.36
" Differences in drug-drug interaction potential may represent an important differentiating feature when choosing between these regimen types."( Predictors of clinically significant drug-drug interactions among patients treated with nonnucleoside reverse transcriptase inhibitor-, protease inhibitor-, and raltegravir-based antiretroviral regimens.
Abdelsayed, S; Miller, CD; Patel, N; Veve, M, 2011)		0.37
"To identify risk factors for clinically significant drug-drug interactions (CSDDIs) among patients on NNRTI-, PI-, and raltegravir-based antiretroviral regimens; compare CSDDI risks between these regimen types; and develop a clinical prediction tool for antiretroviral CSDDIs."( Predictors of clinically significant drug-drug interactions among patients treated with nonnucleoside reverse transcriptase inhibitor-, protease inhibitor-, and raltegravir-based antiretroviral regimens.
Abdelsayed, S; Miller, CD; Patel, N; Veve, M, 2011)		0.37
" The CSDDIs were defined as either (1) a drug combination that is contraindicated or accompanied by strong precautions per DHHS antiretroviral guidelines or (2) a drug combination that necessitates a medication dose adjustment."( Predictors of clinically significant drug-drug interactions among patients treated with nonnucleoside reverse transcriptase inhibitor-, protease inhibitor-, and raltegravir-based antiretroviral regimens.
Abdelsayed, S; Miller, CD; Patel, N; Veve, M, 2011)		0.37
"Eligible patients with HIV-1 RNA (vRNA) levels >5000 copies/mL and without baseline resistance to efavirenz, tenofovir, or emtricitabine were randomized in a double-blind, noninferiority study to receive raltegravir or efavirenz, each combined with tenofovir/emtricitabine."( Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK.
Dejesus, E; Dinubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Xu, X; Zhao, J, 2011)		0.37
"When combined with tenofovir/emtricitabine in treatment-naive patients, raltegravir produced durable viral suppression and immune restoration that was at least equivalent to efavirenz through 156 weeks of therapy."( Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK.
Dejesus, E; Dinubile, MJ; Lazzarin, A; Leavitt, R; Lennox, JL; Nguyen, BY; Rockstroh, JK; Rodgers, AJ; Saag, MS; Sklar, P; Teppler, H; Walker, ML; Wan, H; Xu, X; Zhao, J, 2011)		0.37
" Mean plasma concentration-time profiles for atazanavir, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), darunavir (DRV, administered with ritonavir [RTV]), and drospirenone/ethinylestradiol were similar following co-administration of GSK2248761."( Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor.
de Serres, M; Gould, E; Johnson, M; Kim, J; Lou, Y; Mayers, D; Pietropaolo, K; Piscitelli, S; White, S; Zhou, XJ, 2012)		0.38
" Drug-drug interactions have been demonstrated between boceprevir, an HCV protease inhibitor, and frequently prescribed antiretroviral drugs, such as efavirenz and boosted HIV protease inhibitors."( Lack of a clinically significant drug-drug interaction in healthy volunteers between the hepatitis C virus protease inhibitor boceprevir and the HIV integrase inhibitor raltegravir.
Blonk, MI; Burger, DM; Colbers, AP; de Kanter, CT; Schouwenberg, BJ, 2013)		0.39
"Raltegravir (RAL) is a human immunodeficiency virus type 1 (HIV-1) integrase inhibitor approved to treat HIV infection in adults in combination with other antiretrovirals."( Raltegravir has a low propensity to cause clinical drug interactions through inhibition of major drug transporters: an in vitro evaluation.
Chan, GH; Chu, X; Hafey, M; Houle, R; Rhee, EG; Rizk, ML, 2014)		0.4
" When treating HIV-infected patients with a selective serotonin reuptake inhibitor (SSRI), potential drug-drug interactions with antiretroviral agents have to be taken into account."( Pharmacokinetic drug-drug interaction study between raltegravir and citalopram.
Blonk, MI; Burger, DM; Colbers, AP; Hoogtanders, KE; Langemeijer, CC; Schouwenberg, BJ; van Schaik, RH, 2016)		0.43
" Subjects received the following treatments: citalopram 20 mg once daily for 2 weeks followed by the combination with raltegravir 400 mg twice daily for 5 days and after a washout period raltegravir 400 mg twice daily for 5 days."( Pharmacokinetic drug-drug interaction study between raltegravir and citalopram.
Blonk, MI; Burger, DM; Colbers, AP; Hoogtanders, KE; Langemeijer, CC; Schouwenberg, BJ; van Schaik, RH, 2016)		0.43
" The 3D regimen of 150/100 mg daily paritaprevir/ritonavir, 25 mg daily ombitasvir, and 400 mg twice-daily dasabuvir was administered alone or in combination with 200 mg daily of emtricitabine and 300 mg daily of tenofovir disoproxil fumarate (tenofovir DF), 25 mg daily of rilpivirine, or 400 mg of raltegravir twice daily."( Evaluation of Drug-Drug Interactions between Direct-Acting Anti-Hepatitis C Virus Combination Regimens and the HIV-1 Antiretroviral Agents Raltegravir, Tenofovir, Emtricitabine, Efavirenz, and Rilpivirine.
Awni, W; Dunbar, M; Dutta, S; Khatri, A; Menon, R; Podsadecki, T; Trinh, R, 2016)		0.43
"To determine the prevalence and types of clinically significant drug-drug interactions (CSDI) in the drug regimens of HIV-infected patients receiving antiretroviral treatment."( [Predictive factors of clinically significant drug-drug interactions among regimens based on protease inhibitors, non-nucleoside reverse transcriptase inhibitors and raltegravir].
Agud, JL; Cervero, M; Jusdado, JJ; Pastor, S; Torres, R, 2016)		0.43
"To determine the prevalence and types of clinically significant drug-drug interactions (CSDI) in the drug regimens of HIV-infected patients receiving antiretroviral treatment."( [Predictive factors of clinically significant drug-drug interactions among regimens based on protease inhibitors, non-nucleoside reverse transcriptase inhibitors and raltegravir].
Agud, JL; Cervero, M; Jusdado, JJ; Pastor, S; Torres, R, 2016)		0.43
"In general, DTG 50 mg given once daily combined with an active background drug is a better choice in terms of both efficacy and safety."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016)		0.43
"Elbasvir or grazoprevir co-administered with raltegravir or dolutegravir resulted in no clinically meaningful drug-drug interactions and was generally well tolerated."( Assessment of drug interaction potential between the HCV direct-acting antiviral agents elbasvir/grazoprevir and the HIV integrase inhibitors raltegravir and dolutegravir.
Butterton, JR; Caro, L; Fandozzi, C; Feng, HP; Fraser, I; Guo, Z; Huang, X; Iwamoto, M; Jumes, P; Ma, J; Mangin, E; Marshall, WL; Panebianco, D; Ross, LL; Talaty, J; Yeh, WW, 2019)		0.51
"The predictive performance of the PBPK model to simulate dolutegravir and raltegravir pharmacokinetics and to reproduce the strength of induction was verified using clinical drug-drug interaction studies (steady-state induction) and switch studies (residual induction)."( Management of Drug Interactions with Inducers: Onset and Disappearance of Induction on Cytochrome P450 3A4 and Uridine Diphosphate Glucuronosyltransferase 1A1 Substrates.
Battegay, M; Berton, M; Bettonte, S; Marzolini, C; Stader, F, 2023)		0.91

Bioavailability

ExcerptReferenceRelevance
"MK-0518 is a novel HIV-1 integrase strand transfer inhibitor with potent in vitro activity against HIV-1 (95% inhibitory concentration [IC95] = 33 nM in 50% human serum) and good bioavailability in uninfected subjects."( Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals.
Cooper, DA; Gilde, LR; Isaacs, R; Kovacs, CM; Liporace, R; Markowitz, M; Morales-Ramirez, JO; Nguyen, BY; Schwartz, R; Steigbigel, RT; Teppler, H; Wenning, L; Zhao, J, 2006)		0.33
" A highly potent and orally bioavailable compound (compound 9) was identified and selected for development."( Tricyclic HIV integrase inhibitors: potent and orally bioavailable C5-aza analogs.
Cai, R; Chen, X; Jabri, S; Jin, H; Kim, CU; Lansdown, R; Metobo, S; Mish, M; Pastor, R; Pyun, P; Tsiang, M; Wright, M, 2008)		0.35
" Raltegravir plasma concentration increases with omeprazole coadministration in healthy subjects; this is likely secondary to an increase in bioavailability attributable to increased gastric pH."( Effects of omeprazole on plasma levels of raltegravir.
Azrolan, N; Breidinger, SA; Chodakewitz, JA; Farmer, HF; Hanley, WD; Harvey, CM; Isaacs, RD; Iwamoto, M; Jin, B; Moreau, AR; Nguyen, BY; Rhodes, RR; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2009)		0.35
" A pediatric formulation of raltegravir with less variable pharmacokinetics and greater bioavailability was US Food and Drug Administration (US FDA)-approved in December 2011."( Pharmacology of HIV integrase inhibitors.
Adams, JL; Greener, BN; Kashuba, AD, 2012)		0.38
" These transporters might play a role in the restriction of raltegravir permeability across the blood-brain, blood-testicular, and blood-intestinal barriers, potentially contributing to its low tissue concentrations and/or low oral bioavailability observed in the clinic setting."( Raltegravir permeability across blood-tissue barriers and the potential role of drug efflux transporters.
Bendayan, R; De Rosa, MF; Hoque, MT; Kis, O, 2015)		0.42
" In several Phase I pharmacokinetic studies, one Dutrebis (150 mg lamivudine/300 mg raltegravir) fixed-dose combination tablet showed a higher bioavailability but comparable lamivudine and 400 mg raltegravir poloxamer exposures."( Dutrebis (lamivudine and raltegravir) for use in combination with other antiretroviral products for the treatment of HIV-1 infection.
Bañón, S; Casado, JL, 2015)		0.42
" The new raltegravir 600-mg formulation had a higher relative bioavailability compared with the 400-mg tablets."( Single- and Multiple-Dose Pharmacokinetics of Once-Daily Formulations of Raltegravir.
Kesisoglou, F; Krishna, R; Larson, P; Pop, R; Rizk, ML; Schulz, V, 2018)		0.48
" Proficient bioavailability coupled with no predicted in silico toxicity rendered them as prospective alternatives for designing and development of novel combinatorial therapy formulations for improving existing treatment regimes to combat COVID-19."( Computational drug re-purposing targeting the spike glycoprotein of SARS-CoV-2 as an effective strategy to neutralize COVID-19.
Banerjee, DI; Darji, SA; Lipsa Rath, S; Toor, HG, 2021)		0.62
" The antiviral drugs Raltegravir, Indinavir, Tipranavir, Dolutegravir, and Etravirine also exhibited good bioavailability and drug-likeness properties."( Raltegravir, Indinavir, Tipranavir, Dolutegravir, and Etravirine against main protease and RNA-dependent RNA polymerase of SARS-CoV-2: A molecular docking and drug repurposing approach.
Al-Dhabi, NA; Arunagirinathan, N; Ignacimuthu, S; Indu, P; Rameshkumar, MR; Valan Arasu, M, 2020)		0.56
"Commercialization of most promising active pharmaceutical ingredients (APIs) is impeded either by poor bioavailability or challenging physical properties leading to costly manufacture."( Templated Reactive Crystallization of Active Pharmaceutical Ingredient in Hydrogel Microparticles Enabling Robust Drug Product Processing.
Doyle, PS; Khan, SA; Manghnani, PN; Schenck, L, 2023)		0.91

Dosage Studied

ExcerptRelevanceReference
" Raltegravir is generally well tolerated at doses of up to 1,600 mg/day given for up to 10 days and exhibits a pharmacokinetic profile supportive of twice-daily dosing with multiple doses of 100 mg and greater achieving trough levels >33 nM."( Safety, tolerability, and pharmacokinetics of raltegravir after single and multiple doses in healthy subjects.
De Smet, M; Gottesdiener, KM; Iwamoto, M; Kost, JT; Laethem, M; Lasseter, KC; Merschman, SA; Petry, AS; Ramael, S; Stone, JA; Strohmaier, KM; Wagner, JA; Wenning, LA, 2008)		0.35
" The metabolic fate and excretion balance of compound A (+) and MK-0518 were investigated in rats and dogs following intravenous and oral dosing using a combination of (19)F-NMR-monitored enzyme hydrolysis and solid-phase extraction chromatography and NMR spectroscopy (SPEC-NMR)."( Studies of metabolism and disposition of potent human immunodeficiency virus (HIV) integrase inhibitors using 19F-NMR spectroscopy.
Fiore, F; Laufer, R; Monteagudo, E; Nizi, E; Pesci, S; Petrocchi, A; Rowley, M; Summa, V; Taliani, M, 2007)		0.34
" In clinical trials, raltegravir has been shown to be a potent drug with a pharmacokinetic profile that supports a twice-daily dosing schedule."( Raltegravir (MK-0518): an integrase inhibitor for the treatment of HIV-1.
Evering, TH; Markowitz, M, 2007)		0.34
" Pharmacokinetic profiles were also determined in HIV-1-infected patients dosed with raltegravir monotherapy versus raltegravir in combination with TDF and lamivudine."( Lack of a significant drug interaction between raltegravir and tenofovir.
Breidinger, SA; Chen, J; Friedman, EJ; Gottesdiener, KM; Iwamoto, M; Kost, JT; Lasseter, KC; Stek, JE; Stone, JA; Teppler, H; Wagner, JA; Wenning, LA, 2008)		0.35
" It is dosed twice daily with or without food."( Raltegravir: the first in a new class of integrase inhibitors for the treatment of HIV.
Khanlou, H; Sayana, S, 2008)		0.35
"This article reviews the pharmacology, pharmacokinetics, pharmacodynamics, efficacy, tolerability, resistance profile, drug interactions, and dosing and administration of raltegravir."( Raltegravir: the first HIV integrase inhibitor.
Cocohoba, J; Dong, BJ, 2008)		0.35
"Multicenter, double-blind, randomized study of raltegravir (100, 200, 400, or 600 mg twice a day) vs efavirenz (600 mg every day), both with tenofovir/lamivudine (TDF/3TC), for 48 weeks, after which raltegravir arms were combined and all dosed at 400 mg twice a day."( Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection.
Campbell, H; Crumpacker, CS; Danovich, RM; Gotuzzo, E; Isaacs, RD; Kovacs, C; Markowitz, M; Mendo, F; Morales-Ramirez, JO; Nguyen, BY; Prada, G; Ratanasuwan, W; Strohmaier, KM; Teppler, H; Wan, H, 2009)		0.35
" Our results suggest minimal raltegravir removal by hemodialysis with no specific raltegravir dosage adjustments required in HIV-infected patients undergoing hemodialysis."( Minimal removal of raltegravir by hemodialysis in HIV-infected patients with end-stage renal disease.
Bonal, J; Bouarich, H; Cedeño, S; Clotet, B; Moltó, J; Sanz-Moreno, J; Valle, M, 2010)		0.36
" The primary outcome was the ratio of plasma raltegravir C(tau), or concentration at the end of the dosing interval, for arm B (24 h) versus arm A (12 h)."( Pharmacokinetics and pharmacogenomics of once-daily raltegravir and atazanavir in healthy volunteers.
Calmy, A; Decosterd, L; di Iulio, J; Fayet, A; Jelliffe, R; Kanani, M; Lee, JS; Margol, A; Neely, M; von Schoen-Angerer, T, 2010)		0.36
" Studies are needed to determine the clinical relevance of this interaction, whether it remains after multiple dosing to steady state, whether it is mitigated by temporal separation, and whether raltegravir interacts with divalent cation-containing vitamins, supplements, or foods."( Effect of antacids on the pharmacokinetics of raltegravir in human immunodeficiency virus-seronegative volunteers.
Anderson, PL; Brundage, R; Bumpass, JB; Bushman, L; Kiser, JJ; Mawhinney, S; Meditz, AL; Predhomme, JA; Ray, M; Rower, J, 2010)		0.36
" No significant differences were seen when comparing raltegravir twice daily or once daily in this context, although once-daily dosing tended to perform less well."( Simplification from protease inhibitors to once- or twice-daily raltegravir: the ODIS trial.
Barreiro, P; Blanco, F; Gonzalez-Lahoz, J; Jimenez-Nacher, I; Maida, I; Mena, A; Morello, J; Rodríguez-Novoa, S; Soriano, V; Vispo, E, )		0.13
" The aim of this study was to assess the safety and pharmacokinetic (PK) profile of raltegravir and ribavirin when dosed separately and together."( Pharmacokinetic and safety profile of raltegravir and ribavirin, when dosed separately and together, in healthy volunteers.
Ashby, J; Back, D; D'Avolio, A; Dickinson, L; Erlwein, OW; Garvey, L; Lamba, H; Latch, N; Legg, K; McClure, MO; Weston, R; Winston, A, 2011)		0.37
" Plasma and peripheral blood mononuclear cells were simultaneously collected during a 12 h dosing interval after drug intake."( Cell disposition of raltegravir and newer antiretrovirals in HIV-infected patients: high inter-individual variability in raltegravir cellular penetration.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Cruchon, S; Decosterd, LA; Fayet Mello, A; Franc, C; Guignard, N; Telenti, A, 2011)		0.37
" Both concentrations fluctuate in parallel, with C(cell)/C(tot) ratios remaining fairly constant for each patient without a significant time-related trend over the dosing interval."( Cell disposition of raltegravir and newer antiretrovirals in HIV-infected patients: high inter-individual variability in raltegravir cellular penetration.
Biollaz, J; Buclin, T; Cavassini, M; Colombo, S; Cruchon, S; Decosterd, LA; Fayet Mello, A; Franc, C; Guignard, N; Telenti, A, 2011)		0.37
" On the basis of pharmacokinetic data suggesting efficacy of once-daily raltegravir and because adherence is often improved with once-daily dosing, we aimed to compare these dosing schedules."( Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial.
Andrade-Villanueva, J; Arribas, JR; Bekker, LG; Campbell, H; DiNubile, MJ; Eron, JJ; Gatell-Artigas, JM; Hazuda, D; Isaacs, R; Katlama, C; Leavitt, R; Miller, MD; Nelson, M; Nguyen, BY; Ramalho-Madruga, JV; Reynes, J; Rizk, ML; Robertson, MN; Rockstroh, JK; Rodgers, AJ; Sklar, P; Wenning, L; Young, B; Zhao, J, 2011)		0.37
" Notably, this interaction was independent of the dosage of darunavir and not due to effects of raltegravir on the pharmacokinetics of ritonavir."( Co-administration of raltegravir reduces daily darunavir exposure in HIV-1 infected patients.
Baldelli, S; Boreggio, G; Cattaneo, D; Clementi, E; Cozzi, V; Fucile, S; Gervasoni, C; Landonio, S; Meraviglia, P; Rizzardini, G, 2012)		0.38
"The need to adjust the dosage of raltegravir in HIV-infected patients who are also receiving etravirine is unclear."( Raltegravir dosage adjustment in HIV-infected patients receiving etravirine.
Do, VT; Fulco, PP; Higginson, RT, 2011)		0.37
" Minor, clinically nonsignificant effects on the pharmacokinetics of raltegravir coadministered with lersivirine were observed at steady state for raltegravir, with estimated mean changes of -15%, -29%, and +25% in the area under the concentration-time profile from time zero to the end of the dosing interval (AUC(tau)), maximum plasma concentration (C(max)), and concentration observed 12 h postdose (C(12)), respectively."( Pharmacokinetic effects of coadministration of lersivirine with raltegravir or maraviroc in healthy subjects.
Banerjee, S; Davis, J; Labadie, RR; Langdon, G; Layton, G; Ndongo, MN; Vourvahis, M, 2012)		0.38
" Nineteen adults on raltegravir at 400 mg twice daily (BID) with HIV RNA loads of <50 copies/ml were randomized to receive 400 mg once daily (QD) or 800 mg QD for 2 weeks, followed by the other dosing for 2 weeks."( Pharmacokinetics of and short-term virologic response to low-dose 400-milligram once-daily raltegravir maintenance therapy.
Ananworanich, J; Avihingsanon, A; Burger, DM; Gorowara, M; Hill, A; Kerr, SJ; Khongpetch, C; Ruxrungtham, K; Uanithirat, A; van Heesch, N, 2012)		0.38
"Current product labels for maraviroc and raltegravir provide no dosing guidance for patients with end-stage liver disease and worsening renal function."( Impaired maraviroc and raltegravir clearance in a human immunodeficiency virus-infected patient with end-stage liver disease and renal impairment: a management dilemma.
Boyd, SD; McLaughlin, M; Morse, CG; Pau, AK; Penzak, SR, 2012)		0.38
" Raltegravir must be dosed twice daily, as once daily raltegravir displays decreased virologic efficacy compared to twice daily dosing."( Role of raltegravir in HIV-1 management.
Bookstaver, PB; Bryant, JE; Millisor, VE; Rokas, KE; Shamroe, CL; Sutton, SS; Weissman, SB, 2012)		0.38
" The development of resistance and the need for a once-daily dosing option has led to the development of new INSTIs, including elvitegravir and dolutegravir."( Update on raltegravir and the development of new integrase strand transfer inhibitors.
Bookstaver, PB; Rokas, KE; Shamroe, CL; Weissman, SB, 2012)		0.38
" Once daily dosing of raltegravir is virologically inferior to raltegravir taken twice daily."( The use of HIV-1 integrase inhibitors in antiretroviral naive patients.
Lennox, JL, 2012)		0.38
" These data better characterized integrase inhibitor pharmacokinetics, assessed dosing regimens, and investigated previously undescribed drug-drug interactions."( Pharmacology of HIV integrase inhibitors.
Adams, JL; Greener, BN; Kashuba, AD, 2012)		0.38
" Pharmacokinetic data in special populations (pregnancy, pediatrics) to optimize dosing are still required."( Pharmacology of HIV integrase inhibitors.
Adams, JL; Greener, BN; Kashuba, AD, 2012)		0.38
" Drug concentrations at two trough values of 12 and 24 h after dosing (C(12) and C(24)), area under the concentration-curve values (AUC), maximum drug concentration (C(max)), and the time at which this concentration occurred (T(max)) in plasma were estimated with noncompartmental pharmacokinetic methods and compared to data from a subset of white subjects randomized to the RAL twice a day (plus TDF/FTC) arm of the QDMRK study, a phase III study of the safety and efficacy of once daily versus twice daily RAL in treatment naive patients."( Raltegravir pharmacokinetics in treatment-naive patients is not influenced by race: results from the raltegravir early therapy in African-Americans living with HIV (REAL) study.
Blevins, S; Dumond, JB; Eron, JJ; Floris-Moore, M; Hudgens, MG; Kashuba, AD; Massengale, K; Pittard, D; Ragan, D; Richardson, A; Walsh, K; Wang, R; Wohl, DA, 2013)		0.39
" Dolutegravir had a good, similar safety profile with each dosing regimen."( Safety and efficacy of dolutegravir in treatment-experienced subjects with raltegravir-resistant HIV type 1 infection: 24-week results of the VIKING Study.
Ait-Khaled, M; Clotet, B; Durant, J; Eron, JJ; Fujiwara, T; Huang, J; Katlama, C; Kumar, P; Lazzarin, A; Min, S; Poizot-Martin, I; Richmond, G; Soriano, V; Vavro, C; Yeo, J, 2013)		0.39
" However, it has the limitations of twice-daily dosing and a relatively modest genetic barrier to the development of resistance."( Next-generation integrase inhibitors : where to after raltegravir?
Karmon, SL; Markowitz, M, 2013)		0.39
" Structure-activity studies evolved a tricyclic series of carbamoyl pyridines that demonstrated properties indicative of once-daily dosing and superior potency against resistant viral strains."( Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744).
Akiyama, T; Foster, SA; Fuji, M; Fujiwara, T; Garvey, EP; Jeffrey, J; Johns, BA; Johnson, MN; Kawasuji, T; Kiyama, R; Kobayashi, M; Murai, H; Sato, A; Seki, T; Taishi, T; Tanimoto, N; Taoda, Y; Temelkoff, DP; Weatherhead, JG; Yoshida, H; Yoshinaga, T, 2013)		0.39
" Once-daily dosing without requirement for a pharmacokinetic booster makes dolutegravir-based therapy an attractive treatment option for HIV-1-infected treatment-naive patients."( Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial.
Albrecht, H; Almond, S; Baril, JG; Belonosova, E; Brennan, C; Domingo, P; Gatell, JM; Jaeger, H; Min, S; Quiros-Roldan, E; Raffi, F, 2013)		0.39
" Raltegravir is an important new option for the treatment of children and adolescents with HIV-1 infection, and the introduction of a new chewable formulation (allowing dosage flexibility) extends its benefits to the treatment of younger children."( Raltegravir: a review of its use in the management of HIV-1 infection in children and adolescents.
Perry, CM, 2014)		0.4
" Its key advantages include safety, tolerability and fewer drug interactions but it has some important limitations such as a lower barrier to resistance and a twice-daily dosing schedule."( Raltegravir as antiretroviral therapy in HIV/AIDS.
Sharma, M; Walmsley, SL, 2014)		0.4
" However, its standard twice-daily (BID) dosing schedule makes it less convenient than once-daily (QD) options."( Once-daily raltegravir moving ahead.
Fernández-Montero, JV, )		0.13
" Once-a-day dolutegravir dosing also does not require a pharmacokinetic booster like elvitegravir which minimizes the drug-drug interaction potential of dolutegravir."( Dolutegravir for the treatment of adult patients with HIV-1 infection.
Abraham, T; Saad, N; Wu, G, 2014)		0.4
"Pill burden, dosing frequency, and concerns about safety and tolerability are important obstacles to maintaining adequate medication adherence."( Switching from twice-daily raltegravir plus tenofovir disoproxil fumarate/emtricitabine to once-daily elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate in virologically suppressed, HIV-1-infected subjects: 48 weeks data.
Brinson, C; Cao, H; Cheng, A; Crofoot, G; Ebrahimi, R; Garner, W; Kulkarni, R; Mills, A; Ortiz, R; Rashbaum, B; Szwarcberg, J; Towner, W; Ward, D, )		0.13
" Finally, raltegravir concentrations in plasma, gut contents, small intestine and large intestine were determined after oral dosing to Wistar rats 1 and 4 h post-dose."( A multisystem investigation of raltegravir association with intestinal tissue: implications for pre-exposure prophylaxis and eradication.
Curley, P; Moss, DM; Owen, A; Shone, A; Siccardi, M, 2014)		0.4
" Most patients (70%) received a 400 mg ATV dosing per day, once (26%) or twice daily (44%)."( Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study.
Batard, ML; Bernard-Henry, C; Cheneau, C; De Mautort, E; Fafi-Kremer, S; Gantner, P; Koeppel, C; Muret, P; Partisani, M; Priester, M; Rey, D; Sueur, C, 2014)		0.4
"Previous studies of raltegravir and rifampicin have not studied the interaction when rifampicin is dosed intermittently."( Effect of intermittent rifampicin on the pharmacokinetics and safety of raltegravir.
Back, DJ; Chaponda, M; Chiong, J; Chrdle, A; Egan, D; Else, L; Khoo, SH; Reynolds, HE, 2015)		0.42
" Raltegravir trough plasma concentration (C12) was significantly lower in the presence of rifampicin when dosed at 400 mg twice daily (40%), which was not observed with 800 mg twice daily dosing."( Effect of intermittent rifampicin on the pharmacokinetics and safety of raltegravir.
Back, DJ; Chaponda, M; Chiong, J; Chrdle, A; Egan, D; Else, L; Khoo, SH; Reynolds, HE, 2015)		0.42
" New treatment options show high efficacy and safety and include single-tablet coformulations for once-daily dosing to improve convenience."( HIV: new drugs, new guidelines.
Geretti, AM; Tsakiroglou, M, 2014)		0.4
"Developing new antiretroviral therapies for HIV-1 infection with potential for less frequent dosing represents an important goal within drug discovery."( Discovery of MK-8970: an acetal carbonate prodrug of raltegravir with enhanced colonic absorption.
Balsells, J; Bennet, A; Bennett, DJ; Ceglia, SS; Chessen, G; Clas, SD; Coleman, PJ; Dang, Q; de Lera Ruiz, M; Di Marco, CN; Grobler, J; Hafey, M; Higgins, J; John, C; Kim, SH; Li, J; Manser, K; Nissley, B; Nofsinger, R; Sanchez, RI; Sanders, JM; Smith, R; Templeton, A; Wai, JS; Walji, AM; Wang, J; Wu, Y, 2015)		0.42
" However, q24h regimens were not noninferior to q12h dosing in a clinical trial."( Pharmacokinetic determinants of virological response to raltegravir in the in vitro pharmacodynamic hollow-fiber infection model system.
Adams, JR; Baluya, DL; Brown, AN; Drusano, GL, 2015)		0.42
" Once-daily dosing seems effective where adherence is good."( Five years' real-life experience with raltegravir in a large HIV centre.
Ashton, K; Lin, N; Torkington, A; Ustianowski, A; van Halsema, C; Whitfield, T, 2016)		0.43
" The ANOVA rank-sum test was used to evaluate between-group differences in steady state raltegravir exposure (area under the concentration-time curve over the 12-h dosing interval [AUC0-12 h])."( Effect of HIV infection and menopause status on raltegravir pharmacokinetics in the blood and genital tract.
Cottrell, ML; Jones, A; Kashuba, AD; Patterson, KB; Prince, HM; Wang, R; White, N, 2015)		0.42
" Integrase strand transfer inhibitors cause a rapid drop in viral load, exhibit very low drug interactions (except elvitegravir/cobicistat), and have low pill burden and convenient dosing frequency."( Efficacy and Tolerability of Integrase Inhibitors in Antiretroviral-Naive Patients.
Abrescia, N; Busto, A; D'Abbraccio, M; De Marco, M; Figoni, M; Maddaloni, A, )		0.13
"8) at week 96, independently of the dosing regimen and of the raltegravir concentrations."( Does Once-Daily Raltegravir Have Any Role in the Antiretroviral Treatment?
Ben-Marzouk-Hidalgo, OJ; Chacón-Mora, N; Gutierrez-Valencia, A; Lopez-Cortes, LF; Ruiz-Valderas, R; Torres-Cornejo, A; Viciana, P, 2015)		0.42
"The first-generation integrase inhibitors (INIs) raltegravir (RAL) and elvitegravir (EVG) have shown efficacy against HIV infection, but they have the limitations of once-more daily dosing and extensive cross-resistance."( Dolutegravir(DTG, S/GSK1349572) combined with other ARTs is superior to RAL- or EFV-based regimens for treatment of HIV-1 infection: a meta-analysis of randomized controlled trials.
Chen, H; Guo, W; Huang, J; Jiang, J; Liang, B; Liang, H; Liao, Y; Su, J; Xu, X; Ye, L; Zang, N, 2016)		0.43
" The CCR5-antagonist maraviroc (MVC), the non-nucleoside reverse transcriptase inhibitors (NNRTIs) etravirine (ETV) and rilpivirine (RPV), as well as the integrase strand transfer inhibitor (INSTI) raltegravir (RAL), have all been evaluated using both oral and non-oral dosing regimens, demonstrating a need for dynamic and sensitive bioanalytical tools for drug quantification in plasma and tissue."( Development and validation of a liquid chromatographic-tandem mass spectrometric method for the multiplexed quantification of etravirine, maraviroc, raltegravir, and rilpivirine in human plasma and tissue.
Marzinke, MA; Parsons, TL, 2016)		0.43
" A hyperinsulinaemic euglycaemic clamp was performed prior to and following each 2-week dosing phase."( An open-label, randomized study of the impact on insulin sensitivity, lipid profile and vascular inflammation by treatment with lopinavir/ritonavir or raltegravir in HIV-negative male volunteers.
Boffito, M; Jackson, A; Milinkovic, A; Moyle, G; Randell, P, 2017)		0.46
" This case demonstrates delayed raltegravir elimination in a neonate born at 33 weeks gestational age and a need for less frequent raltegravir dosing than is used in older infants and children."( Therapeutic drug monitoring guided raltegravir dosing for prevention of vertical transmission in a premature neonate born to a woman living with perinatally acquired HIV.
Brophy, J; Dayneka, N; Kreutzwiser, D; Lemire, B; Samson, L; Sheehan, N; Wong, A, 2017)		0.46
"A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method with ultraviolet detection has been developed for quantification of darunavir and raltegravir in their pharmaceutical dosage form."( A rapid validated UV-HPLC method for the simultaneous determination of the antiretroviral compounds darunavir and raltegravir in their dosage form.
Estan-Cerezo, G; García-Monsalve, A; Navarro-Ruiz, A; Rodríguez-Lucena, FJ; Soriano-Irigaray, L, 2017)		0.46
"Determination of the darunavir and raltegravir in their dosage form was done with a maximum deviation of 4%."( A rapid validated UV-HPLC method for the simultaneous determination of the antiretroviral compounds darunavir and raltegravir in their dosage form.
Estan-Cerezo, G; García-Monsalve, A; Navarro-Ruiz, A; Rodríguez-Lucena, FJ; Soriano-Irigaray, L, 2017)		0.46
" Once absorbed, both 3 × 400-mg and 2 × 600-mg dosage forms of raltegravir exhibited similar systemic pharmacokinetics; in dictating bioavailability, differences were from increased absorption that was the result of improved in vivo disintegration/dissolution."( Single- and Multiple-Dose Pharmacokinetics of Once-Daily Formulations of Raltegravir.
Kesisoglou, F; Krishna, R; Larson, P; Pop, R; Rizk, ML; Schulz, V, 2018)		0.48
" Expert opinion: Despite the arrival of new integrase strand transfer inhibitors (INSTIs) with advantages in terms of dosing convenience (elvitegravir, ELV) and higher genetic barrier (dolutegravir, DTG), RAL has stood the test of time and its overall favourable safety profile, without significant appearance of unexpected adverse events, vouch for its relevance in the antiretroviral armamentarium."( A safety evaluation of raltegravir for the treatment of HIV.
Arribas, JR; de Miguel, R; Montejano, R; Stella-Ascariz, N, 2018)		0.48
" This could be due to the choice of antiretroviral agent used in this study, the need for a combination of agents, as used in treating HIV infection, the short treatment period or dosing regimen, or the lack of a role of HERV expression in MS once the disease is established."( A phase II baseline versus treatment study to determine the efficacy of raltegravir (Isentress) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI: The INSPIRE study.
Adiutori, R; Altmann, D; Bianchi, L; Christensen, T; Giovannoni, G; Gold, J; Holden, D; MacManus, D; Marta, M; Meier, UC; Miller, D; Schmierer, K; Turner, B; Yousry, T, 2018)		0.48
" His dosing schedule of raltegravir was changed from BID (a 400 mg tablet, twice) to QD (2x600 mg tablet, once)."( A case of under-dosing after raltegravir formulation change in an elderly patient treated for HIV.
Higashino, S; Kobayashi, S; Kuroda, S; Momo, K; Yasu, T, 2019)		0.51
" To establish an appropriate dosing regimen, an integrated maternal-neonatal pharmacokinetics model was built to predict raltegravir plasma concentrations in neonates with in utero raltegravir exposure."( Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing.
Acosta, EP; Chain, A; Clarke, D; Kerbusch, T; Lommerse, J; Merdjan, H; Mirochnick, M; Nachman, S; Teppler, H; Wenning, L; Witjes, H, 2019)		0.51
" We found that standard dosing strategies in preclinical species closely mimicked tissue concentrations in humans for some, but not all, ARVs."( Antiretroviral Penetration across Three Preclinical Animal Models and Humans in Eight Putative HIV Viral Reservoirs.
Adamson, L; Akkina, R; Blake, K; Burgunder, EM; Devanathan, AS; Garcia, JV; Kashuba, ADM; Kovarova, M; Luciw, P; Pirone, JR; Remling-Mulder, L; Rosen, EP; Schauer, AP; Srinivas, N; Sykes, C; White, NR, 2019)		0.51
"Population modeling and simulations can be used to facilitate the conduct of phase I studies to develop safe and effective dosing regimens in neonates."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
" The combined database was used for population pharmacokinetic modeling and simulations to select a daily dosing regimen for investigation in a second cohort of neonates."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
" Monte Carlo simulations were run to evaluate potential daily dosing regimens from birth to 6 weeks of age, allowing for selection of a regimen to be evaluated in a subsequent cohort of neonates receiving chronic raltegravir dosing."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
"An adaptive design incorporating population pharmacokinetic modeling and simulations was used to select a developmentally appropriate neonatal raltegravir dosing regimen in the first 6 weeks of life."( Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110.
Acosta, EP; Capparelli, E; Chain, A; Clarke, DF; Lommerse, J; Mirochnick, M; Smith, B; Teppler, H, 2019)		0.51
"Raltegravir can be safely administered to full-term infants using the daily dosing regimen studied."( Raltegravir (RAL) in Neonates: Dosing, Pharmacokinetics (PK), and Safety in HIV-1-Exposed Neonates at Risk of Infection (IMPAACT P1110).
Acosta, EP; Bryson, Y; Cababasay, M; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, B; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
"HIV treatment of neonates requires identifying appropriate antiretroviral dosing regimens."( Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.
Acosta, EP; Bryson, Y; Cababasay, MP; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, E; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
"Modeling suggests that prematurity reduces raltegravir clearance and a modified raltegravir dosing regimen will be necessary to avoid elevated plasma raltegravir concentrations."( Impact of Low Birth Weight and Prematurity on Neonatal Raltegravir Pharmacokinetics: Impaact P1097.
Acosta, EP; Bryson, Y; Cababasay, MP; Calabrese, K; Chain, A; Clarke, DF; Graham, B; Hazra, R; Lommerse, J; Mirochnick, M; Popson, S; Smith, E; Spector, SA; Teppler, H; Wang, J, 2020)		0.56
"Non-bioequivalent plasma concentration profiles among different dosage forms of the salt of raltegravir, a poorly soluble acidic drug, were investigated using biorelevant in vitro testing combined with the commercial in silico software, Simcyp®."( Simulation of oral absorption from non-bioequivalent dosage forms of the salt of raltegravir, a poorly soluble acidic drug, using a physiologically based biopharmaceutical modeling (PBBM) approach.
Dressman, J; Komasaka, T, 2021)		0.62
" Dosing with raltegravir alone provided modest ex vivo HIV protection with higher drug levels in rectal tissue and vaginal tissue than in plasma on and off PrEP."( Pharmacokinetic/pharmacodynamic investigation of raltegravir with or without lamivudine in the context of HIV-1 pre-exposure prophylaxis (PrEP).
Amara, A; Boffito, M; Challenger, E; Dickinson, L; Egan, D; Else, L; Fox, J; Herrera, C; Khoo, S; Lee, M; Lwanga, J; Mantori, S; Penchala, SD; Shattock, R, 2021)		0.62
" Tuberculosis is a common coinfection in Mexico that requires rifampin-based anti-tuberculosis therapy, which requires increasing DTG to double dosing (50 mg BID)."( Dolutegravir in Mexico for special populations: A cost analysis perspective.
Cristhian, R; Cristina, H; Del Angel, J; Isidoro, P; Marco, B; Reyes, A; Sigfrido, R, 2021)		0.62
"This patient-focused process produced health literate instructions for preparing and administering an antiretroviral for neonatal use with complex dosing requirements."( A Health Literate Patient-focused Approach to the Redesign of the Raltegravir (ISENTRESS) Pediatric Kit and Instructions for Use.
Homony, B; Mills, A; Miteva, YR; Myers, L; Raudenbush, C; Seeley, S; Straus, WL; Teppler, H; Vossen, DA, 2022)		0.72
"This study was aimed at assessing the adherence and incorrect drug intake associated with changes in the dosing schedule of raltegravir, the first integrase strand transfer inhibitor, from 400 mg twice a day (BID) to 600 mg × 2 tablets once a day (QD) in human immunodeficiency virus (HIV)-infected patients."( Effects of raltegravir formulation change on medication adherence and medication errors.
Higashino, S; Kuroda, S; Momo, K; Yasu, T, 2022)		0.72
" HCWs reported challenges with caregivers understanding dosing instructions, measuring with a syringe, swirling and not shaking the medicine, discarding unused medication and following the changes in the dosing schedule and amount when RAL was initiated a few days after birth."( Optimising neonatal antiretroviral therapy using raltegravir: a qualitative analysis of healthcare workers' and caregivers' perspectives.
Andifasi, P; Denoeud-Ndam, L; Gombakomba, G; Hrapcak, S; Jakazi, C; Katirayi, L; Maphosa, T; Mungati, M; Murandu, M; Mushavi, A; Rivadeneira, E; Stecker, C; Thorsen, V; Tiwari, P; Weber, R, 2022)		0.72
" Adequate training and sufficient instruction and support for caregivers would help to ensure that RAL granules are prepared, dosed and administered correctly."( Optimising neonatal antiretroviral therapy using raltegravir: a qualitative analysis of healthcare workers' and caregivers' perspectives.
Andifasi, P; Denoeud-Ndam, L; Gombakomba, G; Hrapcak, S; Jakazi, C; Katirayi, L; Maphosa, T; Mungati, M; Murandu, M; Mushavi, A; Rivadeneira, E; Stecker, C; Thorsen, V; Tiwari, P; Weber, R, 2022)		0.72
"Our simulations support the common practice of maintaining the adjusted dosage of a drug for another 2 weeks after stopping an inducer."( Management of Drug Interactions with Inducers: Onset and Disappearance of Induction on Cytochrome P450 3A4 and Uridine Diphosphate Glucuronosyltransferase 1A1 Substrates.
Battegay, M; Berton, M; Bettonte, S; Marzolini, C; Stader, F, 2023)		0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (2)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Translocator proteinRattus norvegicus (Norway rat)IC50 (µMol)0.13000.00010.63934.8100AID516402
Integrase Human immunodeficiency virus 1IC50 (µMol)0.04940.00051.544310.0000AID428231; AID516402; AID586237
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (99)

Assay IDTitleYearJournalArticle
AID586237Inhibition of strand transfer activity of Human immunodeficiency virus 1 Integrase using [3H]labeled target DNA as substrate after 45 mins by scintillation counting2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID516402Inhibition of HIV1 integrase 3'-strand transfer2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
Design of a series of bicyclic HIV-1 integrase inhibitors. Part 1: selection of the scaffold.
AID364216Terminal half life in po dosed rhesus monkey2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586483Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155H/D232N mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID1365353Cytotoxic activity against mock-infected human MT4 cellls assessed as reduction in cell viability by MTT assay2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
1-Hydroxypyrido[2,3-d]pyrimidin-2(1H)-ones as novel selective HIV integrase inhibitors obtained via privileged substructure-based compound libraries.
AID586356Ratio of EC50 for Human immunodeficiency virus 1 3B harboring integrase T124A,Q148K,Q148R,N17S/Q148K,E92Q/M154I,G140C/Q148K,G140S/Q148R,Q148K/G163R,V151I/N155H, N155H/I204T,T124A/V151I/N155H,G140C/Q148K/G163R mutant infected in human MT2 cells to EC50 for2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586379Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase I151L mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364206Oral bioavailability in po dosed dog2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID759978Antiviral activity against pseudo Human immunodeficiency virus infected in HEK293T cells after 2 days in presence of human serum albumin2013Journal of medicinal chemistry, Jul-25, Volume: 56, Issue:14
Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744).
AID586378Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364240Plasma concentration in dog at 10 mg/kg, po after 12 hrs2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586364Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E92V mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586371Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Y143C mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364207Oral bioavailability in po dosed rhesus monkey2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID428231Inhibition of HIV1 recombinant integrase strand transfer activity treated after enzyme assembly and washing2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
N-(4-Fluorobenzyl)-3-hydroxy-9,9-dimethyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrazino[1,2-a]pyrimidine-2-carboxamides a novel class of potent HIV-1 integrase inhibitors.
AID586372Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Y143H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586473Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138K/Q148K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586357Ratio of EC50 for Human immunodeficiency virus 1 3B harboring integrase T124A,Q148K,Q148R,E138K/Q148K,E138K/Q148R,G140S/Q148R,V151I/N155H,N155H/I204T,N17S/Q148K/G163R,T124A/V151I/N155H,E138K/Q148K/G163R,G140C/Q148K/G163R,E92Q/E138K/Q148K/M154I mutant infe2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586273Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase G59E, T124A,Q148K, Q148R,N155H, N155H/I204T mutant infected in human MT2 cells assessed as inhibition of virus-induced effect selected on day 42 after 12 passages by PCR2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586239Antiviral activity against Human immunodeficiency virus 1 Bal infected in human PBMC assessed as incorporation of [methly-3H]dTTP to viral DNA after 7 days by reverse transcriptase activity2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364178Antiviral activity against HIV1 3B in human MT4 cells in presence of 50% normal human serum2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID1365352Antiviral activity against HIV2 ROD 3B infected in human MT4 cells assessed as inhibition of viral-induced cytopathic effect by MTT assay2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
1-Hydroxypyrido[2,3-d]pyrimidin-2(1H)-ones as novel selective HIV integrase inhibitors obtained via privileged substructure-based compound libraries.
AID586246Antiviral activity against Human immunodeficiency virus 1 Bal infected in human PBMC assessed as incorporation of [methly-3H]dTTP to viral DNA after 7 days by reverse transcriptase activity in presence of 20% human serum albumin2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586376Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Q148H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID668361Antiviral activity against HIV infected in human TZM-bl cells at 10 uM after 48 hrs by measuring luciferase activity by luminometer analysis2012European journal of medicinal chemistry, Aug, Volume: 54Design, synthesis and antiviral activity of novel pyridazines.
AID586380Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase S153F mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586471Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138A/Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364214Terminal half life in po dosed Sprague-Dawley rat2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586480Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Q148R/N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586274Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase T124A, Q148K,Q148R, N155H, E92Q/M154I,Q148K/G163R, N155H/I204T mutant infected in human MT2 cells assessed as inhibition of virus-induced effect selected on day 56 after 16 p2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586382Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase M154I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID428232Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of viral spread in presence of 10% heat inactivated fetal bovine serum2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
N-(4-Fluorobenzyl)-3-hydroxy-9,9-dimethyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrazino[1,2-a]pyrimidine-2-carboxamides a novel class of potent HIV-1 integrase inhibitors.
AID586466Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase L74M/N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficien2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586388Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66K/L74M mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficienc2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586373Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Y143R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586481Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155H/G163K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364219AUC in rhesus monkey at 10 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586365Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase L101I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586479Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Y143H/N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586359Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66A mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364212Cmax in dog at 2 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586482Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155H/G163R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586355Ratio of EC50 for Human immunodeficiency virus 1 3B harboring integrase T124A, Q148K,Q148R, N155H, E92Q/M154I,Q148K/G163R, N155H/I204T mutant infected in human MT2 cells to EC50 for wild type Human immunodeficiency virus 1 3B infected in human MT2 cells2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364211Cmax in po dosed Sprague-Dawley rat2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID364205Oral bioavailability in po dosed Sprague-Dawley rat2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586387Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66I/E92Q mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficienc2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586361Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586363Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E92Q mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586362Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E92I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID759977Antiviral activity against Human immunodeficiency virus harboring integrase Q148K mutant infected in human HeLa cells expressing CD4 after 2 days by beta galactosidase assay relative to wild type HIV2013Journal of medicinal chemistry, Jul-25, Volume: 56, Issue:14
Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744).
AID586468Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T97A/N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficien2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID1365358Selectivity index, ratio of CC50 for cytotoxic activity against mock-infected human MT4 cells to EC50 for antiviral activity against HIV2 ROD 3B infected in human MT4 cells2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
1-Hydroxypyrido[2,3-d]pyrimidin-2(1H)-ones as novel selective HIV integrase inhibitors obtained via privileged substructure-based compound libraries.
AID364215Terminal half life in dog at 10 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586485Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase L101I/T124A/S153F mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunod2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586467Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E92Q/N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficien2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586469Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase L101I/S153F mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586368Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T124A mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586370Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G140S mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586383Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586484Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase V72I/F121Y/T125K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunode2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586475Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G140C/Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364220AUC in dog at 2 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID645268Antiviral activity against HIV1 harboring VSV glycoprotein-G co-transfected with luciferase gene infected in human TZM-bl cells assessed as inhibition of viral replication after 48 hrs by microplate luminometer based luciferase assay2012European journal of medicinal chemistry, Apr, Volume: 50Hydroxyl may not be indispensable for raltegravir: Design, synthesis and SAR Studies of raltegravir derivatives as HIV-1 inhibitors.
AID1365351Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of viral-induced cytopathic effect by MTT assay2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
1-Hydroxypyrido[2,3-d]pyrimidin-2(1H)-ones as novel selective HIV integrase inhibitors obtained via privileged substructure-based compound libraries.
AID586476Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G140S/Q148H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586367Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase F121Y mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586264Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase T124A mutant gene infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect selected after 14 passages measured after 2 to 3 days by PCR2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586386Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66I/L74M mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficienc2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364209Cmax in dog at 10 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID428233Antiviral activity against HIV1 3B infected in human MT4 cells assessed as inhibition of viral spread in presence of 50% normal human serum2009Bioorganic & medicinal chemistry letters, Aug-01, Volume: 19, Issue:15
N-(4-Fluorobenzyl)-3-hydroxy-9,9-dimethyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrazino[1,2-a]pyrimidine-2-carboxamides a novel class of potent HIV-1 integrase inhibitors.
AID516403Antiviral activity against HIV1 NL4-3 infected in human Hut78 cells assessed as inhibition of viral replication in presence of 10 % fetal bovine serum2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
Design of a series of bicyclic HIV-1 integrase inhibitors. Part 1: selection of the scaffold.
AID586478Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G140S/Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586369Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586377Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Q148K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586470Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase F121Y/T125K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586272Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase T124A,Q148K,N155H/I204T mutant infected in human MT2 cells assessed as inhibition of virus-induced effect selected on day 28 after 8 passages by PCR2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID516678Antiviral activity against HIV1 NL4-3 infected in human Hut78 cells assessed as inhibition of viral replication in 50 % normal human serum2010Bioorganic & medicinal chemistry letters, Oct-01, Volume: 20, Issue:19
Design of a series of bicyclic HIV-1 integrase inhibitors. Part 1: selection of the scaffold.
AID586374Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase P145S mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586384Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155S mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586245Antiviral activity against Human immunodeficiency virus 1 Bal infected in human PBMC assessed as incorporation of [methly-3H]dTTP to viral DNA after 7 days by reverse transcriptase activity in presence of 20% human serum albumin relative to control2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586487Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase V72I/F121Y/T125K/I151V mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human im2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586375Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase Q146R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586263Antiviral activity against Human immunodeficiency virus 1 3B infected in human MT2 cells assessed as inhibition of virus induced cytopathic effect measured after 2 to 3 days by PCR2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586477Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G140S/Q148K mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID645267Antiviral activity against HIV1 harboring VSV glycoprotein-G co-transfected with luciferase gene infected in human TZM-bl cells assessed as inhibition of viral replication at 10 uM after 48 hrs by microplate luminometer based luciferase assay2012European journal of medicinal chemistry, Apr, Volume: 50Hydroxyl may not be indispensable for raltegravir: Design, synthesis and SAR Studies of raltegravir derivatives as HIV-1 inhibitors.
AID1365354Selectivity index, ratio of CC50 for cytotoxic activity against mock-infected human MT4 cells to EC50 for antiviral activity against HIV1 3B infected in human MT4 cells2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
1-Hydroxypyrido[2,3-d]pyrimidin-2(1H)-ones as novel selective HIV integrase inhibitors obtained via privileged substructure-based compound libraries.
AID586474Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138K/Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364241Plasma concentration in dog at 2 mg/kg, po after 12 hrs2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
AID586385Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase N155T mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID759979Antiviral activity against pseudo Human immunodeficiency virus infected in HEK293T cells after 2 days2013Journal of medicinal chemistry, Jul-25, Volume: 56, Issue:14
Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744).
AID586276Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase T124A,Q148K,Q148R,E138K/Q148K,E138K/Q148R,G140S/Q148R,V151I/N155H,N155H/I204T,N17S/Q148K/G163R,T124A/V151I/N155H,E138K/Q148K/G163R,G140C/Q148K/G163R,E92Q/E138K/Q148K/M154I mu2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586366Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase G118S mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586360Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase T66I mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vir2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586472Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138K/Q148H mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficie2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586381Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase S153Y mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunodeficiency vi2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID759974Ratio of IC50 for pseudo Human immunodeficiency virus to IC50 for pseudo Human immunodeficiency virus in presence of human serum albumin2013Journal of medicinal chemistry, Jul-25, Volume: 56, Issue:14
Carbamoyl pyridone HIV-1 integrase inhibitors 3. A diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744).
AID586275Antiviral activity against Human immunodeficiency virus 1 3B harboring integrase T124A,Q148K,Q148R,N17S/Q148K,E92Q/M154I,G140C/Q148K,G140S/Q148R,Q148K/G163R,V151I/N155H, N155H/I204T,T124A/V151I/N155H,G140C/Q148K/G163R mutant infected in human MT2 cells as2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID586486Antiviral activity against Human immunodeficiency virus 1 NL432 harboring integrase E138A/S147G/Q148R mutant infected in human MT4 cells assessed as inhibition of virus-induced cytopathic effect after 2 to 3 days by PCR relative to wild type Human immunod2011Antimicrobial agents and chemotherapy, Feb, Volume: 55, Issue:2
In Vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor.
AID364217AUC in Sprague-Dawley rat at 3 mg/kg, po2008Journal of medicinal chemistry, Sep-25, Volume: 51, Issue:18
Discovery of raltegravir, a potent, selective orally bioavailable HIV-integrase inhibitor for the treatment of HIV-AIDS infection.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,183)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's198 (16.74)29.6817
2010's824 (69.65)24.3611
2020's161 (13.61)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials243 (19.63%)5.53%
Reviews120 (9.69%)6.00%
Case Studies125 (10.10%)4.05%
Observational38 (3.07%)0.25%
Other712 (57.51%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (243)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase IV, Open-Label Study to Characterize the First-Dose and Multiple-Dose Pharmacokinetics of Raltegravir in the Gastrointestinal Tract of Healthy Male Volunteers [NCT01325051]Phase 115 participants (Actual)Interventional2011-04-30Completed
Measurement of Plasma and Intracellular Concentrations of Raltegravir in Patients Infected With Human Immunodeficiency Virus [NCT01214486]12 participants (Actual)Interventional2010-10-01Completed
Plasma and Intracellular Pharmacokinetics of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects [NCT01047995]Phase 126 participants (Actual)Interventional2009-06-30Completed
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™ [NCT00369941]Phase 3566 participants (Actual)Interventional2006-08-31Completed
A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients [NCT01318096]60 participants (Anticipated)Interventional2011-03-31Not yet recruiting
A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells [NCT01173510]Phase 40 participants (Actual)Interventional2010-08-23Withdrawn(stopped due to This study was not feasible due to facility budget and contractual issues.)
An Open-label, Randomised Pilot Study Comparing the Efficacy, Safety and Tolerability of Raltegravir With Protease Inhibitor-based Therapy in Treatment-naïve, HIV/Hepatitis C Co-infected Injecting Drug Users Receiving Methadone [NCT01105611]Phase 440 participants (Anticipated)Interventional2010-08-31Recruiting
Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH [NCT01114425]Phase 3149 participants (Actual)Interventional2010-11-01Completed
A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC278 25 mg q.d. and Raltegravir 400 mg b.i.d. [NCT01288755]Phase 124 participants (Actual)Interventional2011-02-28Completed
Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function [NCT01294761]59 participants (Actual)Interventional2011-02-28Completed
An Open Pilot Study to Evaluate the Efficacy and Safety, Tolerability of Raltegravir（RAL）in Treatment-experienced HIV-1 Infected Adult Chinese Patients [NCT01201239]Phase 450 participants (Anticipated)Interventional2010-09-30Not yet recruiting
A Phase IV, Open-label Three-arm Study Investigating the Impact of a Combination of Tenofovir Disoproxil Fumarate/Emtricitabine With Raltegravir or Dolutegravir or Elvitegravir/Cobicistat on Renal Tubular Function and Renal Transporters in HIV-1 Antiretro [NCT02351908]Phase 460 participants (Actual)Interventional2015-03-31Completed
Pilot Study of the Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection [NCT01343225]Phase 440 participants (Anticipated)Interventional2011-05-31Not yet recruiting
Evaluation of the Pharmacokinetic Properties and the Tolerance of Raltegravir During the Third Trimester of Pregnancy [NCT02099474]Phase 283 participants (Actual)Interventional2014-06-30Completed
Pharmacokinetics of Low Dose Raltegravir [NCT01159132]Phase 224 participants (Actual)Interventional2010-04-30Completed
Multicenter, Open, Pilot Clinical Trial Aimed to Compare the Efficacy of RAL1200 QD vs DRV-cb 800-150 QD Both in Combination With TAF/FTC in Patients With HIV Infection and CD4 Count Under 200 Cells/microL [NCT03842488]Phase 475 participants (Anticipated)Interventional2019-04-30Not yet recruiting
Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) [NCT01352715]Phase 3515 participants (Actual)Interventional2012-03-13Completed
Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression. [NCT02284035]Phase 375 participants (Anticipated)Interventional2015-01-31Recruiting
QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient [NCT03195452]Phase 2100 participants (Actual)Interventional2017-11-08Completed
Randomized Study Comparing Switching to Raltegravir-based Antiretroviral Versus Maintaining Any Other Antiretroviral Therapy in HIV Monoinfected Patients Impact on Fatty Liver and Liver Fibrosis Assessed by Noninvasive Diagnostic Methods [NCT02210715]Phase 431 participants (Actual)Interventional2015-03-31Completed
Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program [NCT03394196]152 participants (Actual)Interventional2018-07-04Terminated(stopped due to COVID-19 and Funding)
A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas [NCT02302950]254 participants (Actual)Observational2014-09-30Active, not recruiting
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients [NCT00100048]Phase 2206 participants (Actual)Interventional2005-01-31Completed
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289]1,578 participants (Actual)Observational2003-06-09Completed
Research In Viral Eradication of HIV Reservoirs [NCT02336074]Phase 260 participants (Actual)Interventional2015-11-27Completed
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily (800 mg and 400 mg, Respectively) Compared With Standard Dosing (400 mg and 200 mg/12 h) in Patients With HIV Infection [NCT01121809]Phase 416 participants (Actual)Interventional2010-04-30Completed
An Open, Prospective Study to Compare the Safety and Efficacy of Raltegravir vs. Atazanavir / Ritonavir, Both in Combination With Tenofovir DF and Emtricitabine, in the Treatment of HIV-infection in ART Naive Subjects With HCV Co-infection. [NCT01225705]Phase 40 participants (Actual)Interventional2010-10-31Withdrawn(stopped due to no pts recruited)
Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir [NCT01288417]Phase 124 participants (Actual)Interventional2011-08-31Completed
Effect on Liver Fat, Adipose Tissue and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Once Daily Raltegravir in HIV+ Patients With Body Mass Index Over 25 kg/m2 and With at Least One Metabolic Syndrome Component [NCT03374358]Phase 445 participants (Actual)Interventional2018-01-10Completed
Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus [NCT01291459]Phase 240 participants (Anticipated)Interventional2011-09-30Active, not recruiting
A Phase I, Open Label, Single Sequence, Drug Interaction Study Evaluating Plasma GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects. [NCT01101893]Phase 115 participants (Actual)Interventional2010-04-30Completed
A Randomized Prospective Open Label Study of Switching to Raltegravir Based ART Compared to Maintaining Ritonavir Boosted PI-based ART on Liver Fibrosis Progression in HIV-HCV Coinfected Patients [NCT01231685]Phase 29 participants (Actual)Interventional2011-12-31Completed
Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART. [NCT01258439]Phase 425 participants (Actual)Interventional2010-11-30Completed
Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment [NCT01164605]30 participants (Anticipated)Interventional2010-10-31Recruiting
The Time to Protection and Adherence Requirements of Raltegravir With or Without Lamivudine in Protection From HIV Infection [NCT03205566]Phase 438 participants (Actual)Interventional2017-09-19Completed
Phase I, Open Label, Unicentric Study of Multiple-dose Pharmacokinetics of Raltegravir in Patients Infected With Human Immunodeficiency Virus and Hepatitis C Virus With and Without Advanced (Child-Pugh C) Hepatic Cirrhosis. [NCT01289951]Phase 110 participants (Actual)Interventional2010-12-31Completed
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study [NCT03732625]Phase 450 participants (Anticipated)Interventional2019-05-31Not yet recruiting
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals [NCT01293123]2 participants (Actual)Interventional2011-12-31Terminated(stopped due to Did not meet enrollment goals)
A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients [NCT00762892]Phase 433 participants (Actual)Interventional2009-01-31Completed
Effect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot Study [NCT02655471]Early Phase 110 participants (Actual)Interventional2017-07-01Completed
Open Label Phase 4, 48 Week Pilot Study of the Antiviral Efficacy and Tolerability of the Combination of Isentress™ and ReyatazTM When Substituted for Current Antiviral Regimen in Patients With Viral Suppression But Who Are Experiencing Adverse Events Rel [NCT00751153]Phase 440 participants (Anticipated)Interventional2008-03-31Recruiting
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
HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy in Spain [NCT00685191]Phase 415 participants (Actual)Interventional2008-06-30Completed
The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir. [NCT04258475]Phase 412 participants (Anticipated)Interventional2020-12-09Recruiting
A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa [NCT02150993]Phase 2/Phase 3210 participants (Actual)Interventional2016-01-26Completed
Phase I, Drug-drug Interaction Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500 When Administered Orally, in Combination With Raltegravir or Darunavir [NCT02489487]Phase 124 participants (Actual)Interventional2014-09-30Completed
Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance [NCT00105157]Phase 2179 participants (Actual)Interventional2005-03-31Completed
An Open Label Fixed Sequence Phase I Study to Investigate the Effect of BI 201335 Mediated UGT1A1 Inhibition on the Multiple Oral Dose Pharmacokinetics of Raltegravir (Isentress®) in Healthy Male and Female Volunteers [NCT02182375]Phase 124 participants (Actual)Interventional2010-01-31Completed
A Pilot Study of Pharmacokinetics, Tolerance and Efficacy of Raltegravir Combined to Two Fully Active Molecules Among Nucleosi(ti)de Analogs and Enfuvirtide Before and After Liver Transplant in HIV Infected Patients With End Stage Liver Disease (ANRS 148 [NCT01022476]Phase 1/Phase 214 participants (Actual)Interventional2010-05-31Completed
A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen [NCT00738569]30 participants (Actual)Interventional2008-07-31Completed
A Pilot Study to Assess the Safety, Efficacy, and PK Profile of a Switch in Antiretroviral Therapy to a RTI Sparing Combination of LPV/r and RAL in Virologically Suppressed HIV-infected Patients [NCT00700115]Phase 460 participants (Actual)Interventional2008-06-30Completed
IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS [NCT00935480]Phase 317 participants (Actual)Interventional2010-10-31Completed
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
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults [NCT00977756]168 participants (Actual)Observational2002-08-31Completed
Open Label, Randomized Trial of TDF/FTC+Raltegravir Vs. TDF/FTC+Efavirenz in HIV-1-Infected Women: Differential Effects on Viral Suppression/Reservoir, & Immune Parameters in Different Compartments, Including Gut & Genital Tract [NCT00984152]Phase 30 participants (Actual)Interventional2011-06-30Withdrawn(stopped due to Decision not to go forth with study.)
A Phase IV, Open-Label, Single-Sequence Pilot Study to Characterize the Pharmacokinetics of a 400mg Oral Dose of Raltegravir in the Cervicovaginal Fluids of HIV-Infected Women [NCT00774683]1 participants (Actual)Observational2008-08-31Completed
Pilot Study Of The Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy [NCT00807443]Phase 210 participants (Actual)Interventional2009-09-30Completed
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study A [NCT00443703]Phase 3352 participants (Actual)Interventional2007-05-31Terminated(stopped due to primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study B [NCT00443729]Phase 3355 participants (Actual)Interventional2007-05-31Terminated(stopped due to Primary efficacy analysis at Week 24 did not demonstrate non-inferiority of raltegravir versus lopinavir (+) ritonavir)
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis [NCT01087840]Phase 4120 participants (Actual)Interventional2010-07-31Completed
Pilot Study of Raltegravir, an Integrase Inhibitor, in Human T-Cell Lymphotrophic Virus-1(HTLV-1) Associated Myelopathy, Tropical Spastic Paraparesis (HAM/TSP) [NCT01867320]Early Phase 119 participants (Actual)Interventional2013-09-05Completed
A Randomised Open-label Study Comparing the Safety and Efficacy of Ritonavir Boosted Lopinavir and 2-3N(t)RTI Backbone Versus Ritonavir Boosted Lopinavir and Raltegravir in Participants Virologically Failing First-line NNRTI/2N(t)RTI Therapy [NCT00931463]Phase 4558 participants (Actual)Interventional2009-09-30Completed
Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS) [NCT00941083]Phase 4240 participants (Anticipated)Interventional2009-01-31Recruiting
A Prospective Longitudinal Pilot Study to Measure the Effect of Intensification With Raltegravir +/- a Protease Inhibitor (PI) or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) on HIV-1 Levels in the Gut [NCT00884793]8 participants (Actual)Interventional2008-09-30Completed
First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study [NCT00660972]Phase 140 participants (Actual)Interventional2008-05-31Completed
A Randomised Controlled Trial to Evaluate Options for Second-line Therapy in Patients Failing a First-line 2NRTI + NNRTI Regimen in Africa [NCT00988039]Phase 31,277 participants (Actual)Interventional2010-03-31Completed
Investigating the Source of HIV-1 Viremia in Patients on Antiretroviral Therapy Through Intensification With MK-0518 [NCT00618371]10 participants (Actual)Interventional2007-10-31Completed
A Randomised, Open-label, Cross-over Study to Examine the Pharmacokinetics and Short-term Safety and Efficacy of Two Dosing Strategies of Raltegravir Plus Atazanavir in HIV-infected Patients [NCT00874523]Phase 326 participants (Actual)Interventional2009-07-31Completed
SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavi/r IN Race/Gender HIV+ Patients Randomized to Therapeutic Drug Monitoring or Standard of Care [NCT00440271]Phase 333 participants (Actual)Interventional2007-02-28Terminated
Patient Preference, Sleep Quality, and Anxiety/Depression: Comparison of Raltegravir and Efavirenz [NCT00944957]60 participants (Anticipated)Interventional2009-11-30Recruiting
A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Raltegravir (Isentress, [NCT00485264]Phase 1/Phase 2153 participants (Actual)Interventional2007-09-17Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients [NCT00293254]Phase 3351 participants (Actual)Interventional2006-02-28Completed
Comparison of Concentration-time Course of Plasma and Intracellular Raltegravir in Healthy Volunteers. [NCT01027182]Phase 16 participants (Actual)Interventional2009-12-31Completed
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients [NCT00293267]Phase 3352 participants (Actual)Interventional2006-02-28Completed
A Phase III Open-Label Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of MK0518/Raltegravir in a Diverse Cohort of HIV-Infected Patients [NCT00764946]Phase 3209 participants (Actual)Interventional2008-10-31Completed
Nucleoside-Sparing Combination Therapy With Lopinavir/Ritonavir (LPV/r) + Raltegravir (RAL) vs. Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC) in Antiretroviral-Naïve Patients [NCT00752856]Phase 251 participants (Actual)Interventional2008-08-26Completed
The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA) [NCT00665717]Phase 124 participants (Actual)Interventional2008-05-31Completed
A Pilot, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Raltegravir Versus NRTIs as a Backbone in HIV-Infected Patients Switched From a Stable Boosted PI Regimen [NCT00749580]46 participants (Actual)Interventional2008-11-30Completed
CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection [NCT00667433]Phase 138 participants (Actual)Interventional2008-06-30Completed
Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women [NCT00745368]28 participants (Actual)Interventional2008-09-30Completed
Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers [NCT00772720]Phase 114 participants (Anticipated)Interventional2010-03-31Recruiting
Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Raltegravir And UK-453,061 In Healthy Subjects [NCT00784420]Phase 118 participants (Actual)Interventional2008-09-30Completed
Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression [NCT00787774]20 participants (Anticipated)Interventional2008-11-30Recruiting
A Randomized, Open-Label, Six-Period, Drug Interaction Study to Assess Steady-State Plasma Amprenavir (APV) and Raltegravir (RTG) Pharmacokinetics Following Administration of RTG 400 mg BID for 14 Days Alone and in Combination With 14 Days of Either Fosam [NCT00802074]45 participants (Actual)Interventional2008-12-31Completed
A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects [NCT00830804]Phase 2113 participants (Actual)Interventional2009-04-30Completed
A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily [NCT00711009]Phase 3206 participants (Actual)Interventional2008-07-31Completed
Safety and Efficacy of Lopinavir/Ritonavir in Combination With Raltegravir in HIV-infected Patients [NCT00752037]Phase 430 participants (Actual)Interventional2008-09-30Completed
Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers [NCT00772551]Phase 126 participants (Actual)Interventional2008-06-30Completed
An Open Label Phase 4 Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects [NCT00666705]Phase 418 participants (Actual)Interventional2008-02-29Completed
Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir [NCT00781287]Phase 410 participants (Actual)Interventional2009-02-28Terminated(stopped due to Enrollment too slow.)
Phase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Based Antiretroviral Therapy in Women With Fat Accumulation [NCT00656175]Phase 239 participants (Actual)Interventional2008-09-30Completed
Decay Kinetics of HIV With the Integrase Inhibitor Raltegravir [NCT00863668]0 participants (Actual)Interventional2009-03-31Withdrawn
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics [NCT00666055]11 participants (Actual)Observational2008-03-31Completed
Pharmacokinetic and Safety Pilotstudy of RAltegravir and Atazanavir in a Once DAily Dose Regimen in HIV-1 Infected Patients (PRADA) [NCT00943540]Phase 220 participants (Anticipated)Interventional2009-07-31Completed
Steady-State Plasma Amprenavir (APV) and Raltegravir (RTG) Pharmacokinetics After Fosamprenavir (FPV) and Raltegravir (RTG) Are Each Administered Alone Versus in Combination With or Without Ritonavir (RTV) Boosting in Healthy Adult Subjects [NCT00614991]44 participants (Actual)Interventional2008-01-31Completed
The Optimized Treatment That Includes or Omits NRTIs Trial: A Randomized Strategy Study for HIV-1-Infected Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen [NCT00537394]Phase 3517 participants (Actual)Interventional2008-01-31Completed
The Effect of Rifapentine on Plasma Concentrations of Raltegravir [NCT00809718]Phase 127 participants (Actual)Interventional2009-02-28Completed
Pilot Study to Assess the Role of Immune Activation and Apoptosis as a Marker for Treatment Intensification With Raltegravir in Hiv-infected Patients on Antiretroviral Therapy With Long-term Viral Suppression and Unfavourable Immunologic Response (Discord [NCT00773708]Phase 457 participants (Actual)Interventional2009-03-31Completed
A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment [NCT00768989]Phase 2167 participants (Actual)Interventional2008-11-30Terminated(stopped due to Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.)
The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment [NCT00811954]Phase 31,814 participants (Actual)Interventional2009-05-31Completed
Changes in Liver Steatosis After Switching From Efavirenz to Raltegravir Among HIV/HCV-Coinfected Patients Receiving Two Nucleoside Analogs Plus Efavirenz: The Steral Study [NCT01900015]Phase 445 participants (Actual)Interventional2014-02-03Completed
Effect of Antacids on the Pharmacokinetics of Raltegravir in Healthy Volunteers [NCT00944307]Phase 117 participants (Actual)Interventional2009-07-31Completed
"Systematic Adherence Intervention Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study." [NCT02025868]Phase 2201 participants (Actual)Interventional2013-03-31Active, not recruiting
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV In [NCT00745823]Phase 3775 participants (Actual)Interventional2008-09-30Terminated(stopped due to Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily)
Effect of Integrase Inhibitor (MK-0518) on Decay of Low Level Viral Replication in HIV Reservoirs in Infected Individuals Who Initiated Conventional Antiretroviral Therapy During the Chronic Phase of Infection [NCT00520897]Phase 224 participants (Actual)Interventional2007-04-30Completed
Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) [NCT03954327]Phase 237 participants (Actual)Interventional2021-03-01Active, not recruiting
Pharmacokinetic Study of CPT-11, Raltegravir and Midazolam With Characterisation of UGT1A1 Genotype [NCT00808184]Phase 425 participants (Actual)Interventional2010-04-30Completed
Raltegravir Use in the Swiss HIV Cohort Study (SHCS) - Evaluation of Efficacy, Safety, Plasma Levels and Evolution of Resistance [NCT00904644]200 participants (Actual)Observational2008-04-30Completed
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM) [NCT01033760]Phase 390 participants (Actual)Interventional2010-04-30Completed
A Pilot Study With Randomized Controlled Open-label Design to Compare Drug-drug Interaction, Antiretroviral Efficacy and Tolerability of Raltegravir Versus Nevirapine as Anchor Drug in Combination Therapy for Treatment-naive HIV+ Chinese Injection Drug Us [NCT01042652]60 participants (Anticipated)Interventional2011-02-28Recruiting
A Phase 4, Single Arm, Open Label, Pilot Study of Maraviroc (Celsentri) in Combination With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients. [NCT01013987]Phase 460 participants (Anticipated)Interventional2010-02-28Recruiting
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
An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001) [NCT01066962]Phase 3800 participants (Actual)Interventional2010-08-31Completed
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
Switching HIV-positive Women on Tenofovir/Emtricitabine Plus Boosted Atazanavir to RALtegravir Plus Boosted ATazanavir: A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density [NCT01902186]Phase 44 participants (Actual)Interventional2014-09-30Terminated(stopped due to Low enrollment)
A Phase 3, Randomized, Double Blinded, Placebo Controlled Study of Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery [NCT00562510]Phase 320 participants (Actual)Interventional2008-08-31Terminated(stopped due to recruitment lower than estimated)
Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL). [NCT01978782]Phase 124 participants (Actual)Interventional2014-01-31Completed
An Open-Label, Sequential, 3-Period Study to Evaluate Pharmacokinetics of Coadministered Raltegravir (Isentress) and Lopinavir-Ritonavir (Kaletra) in Healthy Adults [NCT00564772]Phase 415 participants (Actual)Interventional2007-11-30Completed
Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection [NCT01154673]Phase 2/Phase 332 participants (Actual)Interventional2011-11-30Completed
Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C [NCT01147107]Phase 480 participants (Actual)Interventional2014-02-28Completed
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection [NCT02219672]Phase 318 participants (Anticipated)Interventional2014-07-31Recruiting
Modeling Intracellular and Extracellular Raltegravir (RAL) Pharmacokinetics in the Female Genital Tract and Blood After a Twice Daily 400mg Dose Over the Course of a Menstrual Cycle [NCT01327482]10 participants (Actual)Interventional2011-10-31Completed
Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis [NCT02273765]Phase 3460 participants (Actual)Interventional2015-09-11Completed
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazan [NCT01332227]Phase 4132 participants (Actual)Interventional2011-10-31Completed
A Phase 1, Open-Label Study, Investigating First-Dose and Steady-State Pharmacokinetics of Raltegravir in the Genital Tract of HIV Uninfected Women [NCT00746499]Phase 17 participants (Actual)Interventional2008-09-30Completed
Clinical Trial Assessing Once Daily Raltegravir Administration (800 mg QD) in HIV-1-Infected Patients Receiving Unboosted Atazanavir (400 mg QD)- Based Antiretroviral Therapy [NCT00718536]Phase 415 participants (Actual)Interventional2008-08-31Completed
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
Phase II Open-label Randomized Multicenter Trial to Compare the Efficacy and Safety of Two Different Doses of Raltegravir and Efavirenz, All in Combination With Tenofovir and Lamivudine, in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuber [NCT00822315]Phase 2155 participants (Actual)Interventional2009-07-31Completed
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine. [NCT00808002]Phase 330 participants (Actual)Interventional2009-02-28Completed
Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Subs [NCT00851799]334 participants (Actual)Observational2009-06-30Completed
Virologic Outcomes of Changing Enfuvirtide to Raltegravir in HIV-1 Patients Well Controlled on an Enfuvirtide Based Regimen [NCT00529243]Phase 352 participants (Actual)Interventional2007-09-30Completed
A Double-Blind, Randomized, Pilot Study to Measure the Effect of Treatment Intensification With a Potent Integrase Inhibitor, Raltegravir (MK-0518), on the Level of Persistent Plasma Viremia Below 50 Copies/ml in Subjects on Protease Inhibitor- or Non-Nuc [NCT00515827]Phase 253 participants (Actual)Interventional2007-11-30Completed
Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients [NCT00677300]Phase 485 participants (Actual)Interventional2009-01-31Completed
A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretrov [NCT01227824]Phase 3828 participants (Actual)Interventional2010-10-19Completed
The Influence of Raltegravir (MK-0518) on the Pharmacokinetics of Single-dose Lamotrigine in Healthy Male Subjects (GRANOLA) [NCT00618241]Phase 124 participants (Actual)Interventional2008-02-29Completed
A Pilot Randomized, Open-Label Study Comparing the Safety and Efficacy of a Raltegravir Based NRTI Sparing Regimen [NCT00814879]60 participants (Actual)Interventional2009-05-31Completed
A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1 [NCT00594646]Phase 4100 participants (Actual)Interventional2008-02-29Completed
Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL). [NCT01420523]Phase 248 participants (Actual)Interventional2011-12-31Terminated
A Single Arm, 3 Phase Study to Determine the Effect of Intermittent Dosing of Rifampicin on the Pharmacokinetics of Raltegravir in Healthy Volunteers [NCT01424826]Phase 118 participants (Actual)Interventional2012-01-31Completed
Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV [NCT00995241]Phase 45 participants (Actual)Interventional2009-11-30Completed
Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression [NCT00554398]Phase 369 participants (Actual)Interventional2007-11-30Completed
Evaluation of the Use of Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection in Pregnant Women Presenting With Detectable Viral Load After 32 Weeks of Gestation: a Pilot Study [NCT01854762]Phase 2/Phase 340 participants (Anticipated)Interventional2015-03-31Recruiting
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options [NCT00377065]0 participants Expanded AccessApproved for marketing
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Maraviroc Therapy [NCT00870363]Phase 444 participants (Actual)Interventional2009-04-30Completed
Treating HIV-infected Elite Controllers as a Model of HIV Remission [NCT01025427]Phase 416 participants (Actual)Interventional2009-12-31Completed
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir When Given With Raltegravir in Healthy Adult Volunteers [NCT01531647]Phase 120 participants (Actual)Interventional2012-01-31Completed
A Prospective, Open-Label, Double-Arm, Crossover, Single-Center Pilot Study to Evaluate the Addition of Raltegravir to Established Suppressive Antiretroviral Therapy While Monitoring Changes in Markers of Immune Activation Among HIV-1 Infected Individuals [NCT01245101]Phase 415 participants (Actual)Interventional2010-11-30Terminated(stopped due to Poor enrollment.)
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects [NCT00518297]Phase 122 participants (Actual)Interventional2007-08-31Completed
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, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve [NCT01231516]Phase 3724 participants (Actual)Interventional2010-10-26Completed
Collection of Data on the Management of HIV-1 Patients Treated With Antiretroviral Combination Therapy Including the HIV Integrase Inhibitor Raltegravir [NCT01048671]482 participants (Actual)Observational2010-01-31Completed
Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors. A 24-week Open-label, Proof-of-concept Pilot Clinical Trial. [NCT01480713]Phase 341 participants (Actual)Interventional2012-05-31Completed
Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission: A Phase I/II Proof of Concept Study [NCT02140255]Phase 1/Phase 2905 participants (Anticipated)Interventional2015-01-23Recruiting
A Phase I, 2-panel, Open-label, Randomized, Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Antiretroviral Agents, Efavirenz and Raltegravir, at Steady State [NCT01241773]Phase 148 participants (Actual)Interventional2010-10-31Completed
The Influence of GINkGo Biloba on the Pharmacokinetics of the UGT Substrate raltEgraviR (GINGER) [NCT01246804]Phase 118 participants (Actual)Interventional2010-11-30Completed
Effectiveness of Raltegravir-Based Antiretroviral Therapy in HIV-HCV Coinfected Liver Transplant Recipients: Retrospective Analysis in a Prospective National Cohort Study (RAL-LT-HIV) [NCT02995824]271 participants (Actual)Observational2002-01-31Completed
A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy [NCT00632970]Phase 46 participants (Actual)Interventional2008-02-29Terminated(stopped due to no patients completed)
Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid [NCT00729924]Phase 2/Phase 340 participants (Actual)Interventional2008-08-31Completed
Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen [NCT00751530]442 participants (Actual)Observational2008-03-01Completed
Randomised Double-blind Placebo Controlled Study to Measure the Effect of Antiretroviral Therapy (ART) Intensification With Raltegravir and/or Hyper-immune Bovine Colostrum on CD4+ T Cell Count in ART Treated, HIV-1 Infected Individuals With Suboptimal CD [NCT00772590]Phase 475 participants (Actual)Interventional2009-03-31Completed
Multicenter, Randomized, Non-comparative, Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression [NCT00976404]Phase 228 participants (Actual)Interventional2009-11-30Completed
An Open-Label, 3-Period, Fixed-Sequence Study to Evaluate the Effect of Famotidine and Omeprazole on MK0518 Pharmacokinetics in HIV-Infected Patients on a Stable MK0518-Containing Regimen [NCT01000818]Phase 118 participants (Actual)Interventional2008-06-30Completed
Dual Therapy With Raltegravir 400 mg BID and Darunavir/Ritonavir 800/100 mg QD in HIV Infected Patients Failing to Nucleoside Reverse Transcriptase Inhibitors Based Regimens [NCT01258374]15 participants (Actual)Observational2010-05-31Completed
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy [NCT01285050]Phase 420 participants (Actual)Interventional2011-01-31Completed
Bone and Body Comp: A Sub Study of the SECOND-LINE Study [NCT01513122]Phase 4210 participants (Actual)Interventional2010-02-28Completed
An Open-label, Randomized, 48-Week Study to Assess the Safety, Tolerability and Activity of Raltegravir When Replacing the Ritonavir-boosted PI Component of HAART in HIV-Infected Individuals With Viral Load Suppression on a Ritonavir-Boosted PI Containing [NCT00528892]Phase 3282 participants (Actual)Interventional2008-01-31Completed
A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine [NCT00931801]Phase 443 participants (Actual)Interventional2009-12-31Completed
Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO [NCT00460382]Phase 2103 participants (Actual)Interventional2007-05-31Completed
An Open Label Study of the Impact on Insulin Sensitivity, Lipid Profile and Vascular Inflammation by Treatment With Lopinavir / Ritonavir (400 / 100 mg Twice Daily) or Raltegravir 400 mg Twice Daily in HIV Negative Male Volunteers. [NCT00531999]Phase 118 participants (Actual)Interventional2007-10-31Completed
Effects of Losartan and Antiretroviral Regimen Containing Raltegravir in Fibrosis Inflammation [NCT01529749]Phase 448 participants (Actual)Interventional2012-02-29Completed
A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects [NCT00525733]40 participants (Actual)Interventional2007-10-31Completed
Raltegravir Substitution for Enfuvirtide in Patients Suffering From Injection Site Reactions (ISRs): The Raleve Pilot Study [NCT00523237]14 participants (Actual)Interventional2007-10-31Completed
An Open Label Study to Examine the Characteristics of HIV Decay Following Introduction of Combination Antiretroviral Therapy Including Raltegravir During Primary and Chronic HIV Infection [NCT00641641]16 participants (Actual)Interventional2008-03-31Completed
Switch to Maraviroc and Integrase Strand Transfer Inhibitor Combination Therapy (a Triple Class-Sparing Regimen) for the Treatment of HIV-1-Infected Patients on Suppressive Antiretroviral Regimens [NCT01896921]Phase 37 participants (Actual)Interventional2013-09-30Completed
Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen [NCT01978743]10 participants (Actual)Interventional2014-01-31Completed
A Randomized, Controlled Trial Assessing the Effects of Raltegravir Intensification on Endothelial Function in Treated HIV Infection [NCT00843713]Phase 456 participants (Actual)Interventional2009-01-31Completed
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study [NCT01450189]46 participants (Actual)Interventional2011-10-31Completed
Changes in Lipid Profiles and Safety of Raltegravir Based Antiretroviral Therapy in HIV-1-infected Patients With Hyperlipidemia While on Current Standard Therapy [NCT00887653]Phase 320 participants (Actual)Interventional2009-05-31Completed
A Phase IV, Open-Label Study to Compare Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Men and Women [NCT02218320]20 participants (Actual)Observational2014-10-31Completed
"Study of the Effect of Atorvastatin for Reducing Inflaming (Aging-related Complication) in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen" [NCT02577042]Phase 442 participants (Actual)Interventional2015-10-15Completed
Phase II Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load [NCT01620736]Phase 20 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to The clinical trial did not receive any funding.)
Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) [NCT05751031]1,200 participants (Anticipated)Observational2023-02-20Recruiting
A Pilot Study of the Safety, Acceptability, Behavior Impact, and HIV Seroincidence Among High Risk Men Who Have Sex With Men With Access to Isentress 400 mg BID + Truvada Once Daily for Peri-exposure Chemoprophylaxis for HIV Infection Chemoprophylaxis for [NCT01697046]Phase 365 participants (Anticipated)Interventional2012-11-30Not yet recruiting
Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) [NCT03311945]Phase 349 participants (Anticipated)Interventional2018-05-03Recruiting
Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin (AVIATOR). [NCT01779687]Phase 124 participants (Actual)Interventional2013-03-31Completed
A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers [NCT01784302]Phase 115 participants (Actual)Interventional2014-04-30Completed
Reduction of Early mortALITY in HIV-infected African Adults and Children Starting Antiretroviral Therapy: a Randomised Controlled Trial [NCT01825031]Phase 31,805 participants (Actual)Interventional2013-06-30Completed
A Pilot Randomized, Open Label Study to Evaluate Efficacy and Safety of the Combination of RAL+ATV/r in Comparison With TDF/FTC+ATV/r in HIV Infected Patients, Who Failed an Initial NNRTI Containing Regimen [NCT01829802]Phase 450 participants (Anticipated)Interventional2014-05-31Active, not recruiting
A Non-interventional Cohort Study for the Assessment of the Efficacy of RALTEGRAVIR 400 mg Administered Twice Daily in Combination With Other Antiretroviral Drugs to Treat Infection With the Human Immunodeficiency Virus 1 (HIV-1) in Adults and Aging Patie [NCT01213316]451 participants (Actual)Observational2010-10-31Completed
A Phase II Baseline Versus Treatment Study to Determine the Efficacy of Raltegravir (Isentress) in Preventing Progression of Relapsing Remitting Multiple Sclerosis as Determined by Gadolinium-enhanced MRI [NCT01767701]Phase 223 participants (Actual)Interventional2013-04-30Completed
An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age [NCT01335620]Phase 419 participants (Actual)Interventional2011-04-30Completed
A Randomised Controlled Clinical Trial of the Efficacy of HAART Intensification With Raltegravir in HIV Virally Suppressed Patients With Cognitive Impairment [NCT01448486]Phase 46 participants (Actual)Interventional2011-10-31Terminated(stopped due to Funding withdrawn based on unacceptably slow recruitment rate.)
ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients [NCT01605890]Phase 230 participants (Actual)Interventional2012-07-31Completed
Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-Infected and TB Co-Infected Infants and Children [NCT01751568]Phase 1/Phase 240 participants (Actual)Interventional2014-11-12Completed
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density [NCT00939874]Phase 452 participants (Actual)Interventional2009-10-31Completed
Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers [NCT05648201]Phase 436 participants (Anticipated)Interventional2023-03-01Recruiting
Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma [NCT01000285]Phase 1/Phase 218 participants (Actual)Interventional2010-09-30Completed
A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers [NCT00982553]Phase 114 participants (Actual)Interventional2009-09-30Completed
A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads [NCT01044771]20 participants (Actual)Interventional2010-01-31Completed
A Phase III, Open-label, Single Centre, Single-arm, Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Raltegravir [NCT01195467]Phase 340 participants (Actual)Interventional2010-10-31Completed
Phase IV, Randomized, Open Label, Crossover, Intervention Trial to Investigate the Effect of the Switch of Lopinavir/Ritonavir to Raltegravir on Endothelial Function, Chronic Inflammation, Immune Activation and HIV Replication <50 Copies/ml [NCT01453933]Phase 424 participants (Anticipated)Interventional2012-01-31Recruiting
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR) [NCT02247687]Phase 34 participants (Actual)Interventional2014-12-31Terminated(stopped due to Low recruitment of participants for the study)
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir [NCT01576731]Phase 4240 participants (Actual)Interventional2012-07-31Completed
Raltegravir Pharmacokinetics and Safety in Neonates [NCT01828073]40 participants (Actual)Observational2011-05-19Completed
A Study to Evaluate the Influence of Metal Cation-Containing Antacids on MK-0518 Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen [NCT02473367]Phase 120 participants (Actual)Interventional2015-06-23Completed
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in [NCT02131233]Phase 3802 participants (Actual)Interventional2014-05-23Completed
One Arm, Open Label, Interventional, Non-comparative Study to Assess Changes in Lipids and Lipoproteins in HIV Infected Women With Hyperlipidemia After Switch From Boosted Protease Inhibitor to Raltegravir [NCT02097108]Phase 211 participants (Actual)Interventional2014-05-31Completed
A Study to Evaluate the Effect of Metal Cation-Containing Antacids on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Stable Raltegravir-Containing Regimen [NCT01622673]Phase 127 participants (Actual)Interventional2012-06-30Completed
Investigation of Faldaprevir Effect on Steady State Pharmacokinetics of Raltegravir in Healthy Male and Female Volunteers (an Open-label Trial With Two Periods in a Fixed Sequence) [NCT01785160]Phase 125 participants (Actual)Interventional2013-02-28Completed
Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE) [NCT01641367]Phase 4545 participants (Actual)Interventional2013-02-22Completed
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME [NCT03029689]Phase 360 participants (Actual)Interventional2017-07-28Completed
Pharmacokinetics Distribution of Raltegravir Using Radiolabeling in HIV-infected Patients by PET/MR: a Pilot Study. [NCT03174977]Early Phase 110 participants (Anticipated)Interventional2018-04-01Recruiting
An Open-label Single Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-0518 1200 mg (600 mg Tablet × 2) in Healthy Japanese Male Participants [NCT03667547]Phase 412 participants (Actual)Interventional2018-09-27Completed
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs [NCT03537404]Phase 136 participants (Actual)Interventional2017-04-24Completed
Phase 3b, Single Arm, Simplification Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk [NCT03333083]Phase 350 participants (Anticipated)Interventional2018-05-03Recruiting
Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK- [NCT02116660]Phase 211 participants (Actual)Interventional2014-09-03Terminated(stopped due to This study was terminated early due to poor recruitment.)
Population Pharmacokinetics of Antiretroviral in Children [NCT03194165]65 participants (Actual)Observational2017-06-16Completed
Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response [NCT00631449]Phase 430 participants (Actual)Interventional2008-02-29Completed
A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects [NCT00654147]Phase 244 participants (Actual)Interventional2008-04-30Completed
Raltegravir and Maraviroc in Combination for the Treatment of Antiretroviral Naïve HIV-1 Infected Patients [NCT01204905]7 participants (Actual)Interventional2010-09-30Completed
A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Childre [NCT01717287]Phase 232 participants (Actual)Interventional2012-11-16Completed
A Study to Evaluate the Effect of Staggered Dosing of a Magnesium/Aluminum Antacid on Raltegravir Pharmacokinetics in HIV-Infected Subjects on a Raltegravir-Containing Regimen [NCT01930045]Phase 118 participants (Actual)Interventional2013-10-01Completed
National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency [NCT01453192]Phase 327 participants (Actual)Interventional2011-12-31Completed
A Two Way Cross Over Pharmacokinetic (PK) Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers [NCT01841593]Phase 119 participants (Actual)Interventional2013-04-30Completed
10493 - MK-0518 Intensification and HDAC Inhibition in Depletion of Resting CD4+ T Cell HIV Infection [NCT00614458]Phase 26 participants (Actual)Interventional2007-04-30Terminated(stopped due to Due to insufficient funds)
A Pilot Project of Virologic, Pharmacologic and Immunologic Correlates of Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution Following Raltegravir Therapy [NCT00661960]25 participants (Actual)Interventional2008-03-31Completed
Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis [NCT00734344]18 participants (Actual)Interventional2008-09-30Completed
A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Neonates at Risk of Acquiring HIV-1 Infection [NCT01780831]Phase 152 participants (Actual)Interventional2014-01-28Completed
A Single Arm Study to Assess the Sustained Virological Suppression and Improvement of Treatment-emerged Adverse Events of Switching to Raltegravir in Stable HIV-infected Patients on Ritonavir-boosted Protease Inhibitor Regimen [NCT01679964]Phase 4107 participants (Actual)Interventional2012-07-31Completed
Pilot Study of Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients [NCT00672932]18 participants (Actual)Interventional2008-04-30Completed
A Randomized Controlled Pilot Trial Comparing Continued Antiretroviral Therapy With Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) With Switch to Tenofovir/Emtricitabine/Raltegravir (TDF/FTC/RAL) on Changes in Endothelial Function and Markers of Bone Met [NCT01270802]Phase 430 participants (Actual)Interventional2011-04-30Completed
A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV) [NCT01214759]Phase 4103 participants (Actual)Interventional2011-05-31Completed
A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Raltegravir (Isentress) and Buprenorphine [NCT00858962]12 participants (Actual)Interventional2009-03-31Completed
A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Expe [NCT00708162]Phase 3724 participants (Actual)Interventional2008-07-31Completed
An Open Label, Randomized, Parallel Design Estimation Pilot Study to Compare the Efficacy and Safety of Raltegravir-based Versus Efavirenz-based Combination Therapy in Treatment-naïve Patients With HIV-1 Infection [NCT01989910]Phase 4107 participants (Actual)Interventional2013-09-30Completed
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose [NCT01384734]Phase 2254 participants (Actual)Interventional2011-07-26Completed
A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifampin-Based Tuberculosis Treatment Versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen With Rifabutin-Based Tuberculosis Treatment W [NCT01601626]Phase 271 participants (Actual)Interventional2013-07-13Terminated(stopped due to The study was stopped early due to feasibility concerns.)
Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for W [NCT02302547]Phase 3224 participants (Actual)Interventional2014-12-31Completed
A Pilot Study of Raltegravir and Cisplatin in Squamous Cell Carcinoma of the Head and Neck [NCT01275183]Early Phase 15 participants (Actual)Interventional2010-12-31Completed
A Phase IV Randomized Trial to Evaluate the Virologic Response and Pharmacokinetics of Two Different Potent Regimens in HIV Infected Women Initiating Triple Antiretroviral Regimens Between 20 and 36 Weeks of Pregnancy for the Prevention of Mother-to-Child [NCT01618305]Phase 4408 participants (Actual)Interventional2013-09-05Completed
Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study [NCT02212379]Phase 2170 participants (Actual)Interventional2015-01-31Completed
A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regi [NCT04513626]Phase 2150 participants (Anticipated)Interventional2020-09-15Recruiting
Switch From an NNRTI or PI-based Regimen to a RAltegravir-based Regimen in Virologically Suppressed HIV-infected Patients: Effects on Platelet Reactivity, Platelet-monocyte Aggregation and the Inflammatory anD Thrombotic State of Monocytes [NCT02383355]Phase 440 participants (Actual)Interventional2015-03-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Plasma Concentration for Contraceptives
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
NCT00042289 (26) [back to overview]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) 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]Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: 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: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
NCT00042289 (26) [back to overview]Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
NCT00042289 (26) [back to overview]PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With CAEs
NCT00100048 (26) [back to overview]Number of Patients That Discontinued With LAEs
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs)
NCT00100048 (26) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Number of Patients With Drug-related CAEs
NCT00100048 (26) [back to overview]Number of Patients With Drug-related LAEs
NCT00100048 (26) [back to overview]Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
NCT00100048 (26) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs)
NCT00100048 (26) [back to overview]Change From Baseline in CD4 (T-helper) Cell Count at Week 240
NCT00100048 (26) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00100048 (26) [back to overview]Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 96
NCT00100048 (26) [back to overview]Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48
NCT00100048 (26) [back to overview]Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
NCT00100048 (26) [back to overview]Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
NCT00100048 (26) [back to overview]Number of Patients With Serious CAEs (Cohort I and II Combined)
NCT00100048 (26) [back to overview]Change From Baseline in Plasma HIV RNA at Week 240
NCT00100048 (26) [back to overview]Number of Patients With Serious LAEs
NCT00100048 (26) [back to overview]Number of Patients With Serious Drug-related LAEs
NCT00105157 (47) [back to overview]Number of Patients With Serious Drug-related CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious Drug-related CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious Drug-related CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related LAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related LAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related LAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With LAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Died by 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Died by 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Died by 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Drug-related CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With CAEs at 96 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
NCT00105157 (47) [back to overview]Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
NCT00105157 (47) [back to overview]Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies
NCT00105157 (47) [back to overview]Change From Baseline in CD4 Cell Count at Week 24
NCT00105157 (47) [back to overview]Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies
NCT00105157 (47) [back to overview]Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
NCT00105157 (47) [back to overview]Number of Patients With Serious Drug-related LAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Serious LAEs at 168 Weeks
NCT00105157 (47) [back to overview]Number of Patients With Virologic Responses at Week 168 in Combined Substudies
NCT00105157 (47) [back to overview]Number of Patients With Virologic Responses at Week 24
NCT00293254 (17) [back to overview]Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
NCT00293254 (17) [back to overview]Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
NCT00293254 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
NCT00293254 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
NCT00293254 (17) [back to overview]Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
NCT00293254 (17) [back to overview]Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)
NCT00293254 (17) [back to overview]Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
NCT00293254 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
NCT00293254 (17) [back to overview]Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
NCT00293254 (17) [back to overview]Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
NCT00293254 (17) [back to overview]Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
NCT00293254 (17) [back to overview]Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
NCT00293254 (17) [back to overview]Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
NCT00293254 (17) [back to overview]Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
NCT00293254 (17) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
NCT00293254 (17) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
NCT00293254 (17) [back to overview]Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16
NCT00293267 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL
NCT00293267 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL
NCT00293267 (17) [back to overview]Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)
NCT00293267 (17) [back to overview]Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)
NCT00293267 (17) [back to overview]Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48
NCT00293267 (17) [back to overview]Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16
NCT00293267 (17) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
NCT00293267 (17) [back to overview]Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48
NCT00293267 (17) [back to overview]Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16
NCT00293267 (17) [back to overview]Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48
NCT00293267 (17) [back to overview]Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16
NCT00293267 (17) [back to overview]Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL
NCT00293267 (17) [back to overview]Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL
NCT00293267 (17) [back to overview]Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)
NCT00293267 (17) [back to overview]Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)
NCT00293267 (17) [back to overview]Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response
NCT00293267 (17) [back to overview]Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Serious CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 96
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 48
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 240
NCT00369941 (73) [back to overview]Number of Participants That Died by Week 156
NCT00369941 (73) [back to overview]Number of Participants That Discontinued With CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants Discontinued With Drug-related LAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
NCT00369941 (73) [back to overview]Number of Participants Discontinued With LAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
NCT00369941 (73) [back to overview]Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 240
NCT00369941 (73) [back to overview]Change From Baseline in CD4 Cell Count at Week 156
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 96
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 48
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 240
NCT00369941 (73) [back to overview]Number of Participants With Serious Drug-related CAEs at Week 156
NCT00369941 (73) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
NCT00443703 (23) [back to overview]Number of Patients That Discontinued Due to CAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients That Discontinued Due to Drug Related CAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients That Discontinued Due to LAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients That Discontinued With Drug Related LAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Drug-related CAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Serious CAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Serious Drug-related CAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Number of Patients With Serious LAEs Through 24 Weeks
NCT00443703 (23) [back to overview]Median Percent Change From Baseline in Serum Triglyceride at Week 12
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
NCT00443703 (23) [back to overview]Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
NCT00443703 (23) [back to overview]Median Percent Change From Baseline in Serum Triglyceride at Week 24
NCT00443703 (23) [back to overview]Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
NCT00443703 (23) [back to overview]Number of Patients That Died by 24 Week Last Patient Last Visit
NCT00443729 (21) [back to overview]Median Percent Change From Baseline in Serum Triglyceride at Week 12
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
NCT00443729 (21) [back to overview]Number of Patients That Discontinued Due to LAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
NCT00443729 (21) [back to overview]Median Percent Change From Baseline in Serum Triglyceride at Week 24
NCT00443729 (21) [back to overview]Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
NCT00443729 (21) [back to overview]Number of Patients That Died by 24 Week Last Patient Last Visit
NCT00443729 (21) [back to overview]Number of Patients With Serious LAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Serious Drug-related CAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients That Discontinued Due to CAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Serious CAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Drug-related LAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Number of Patients With Drug-related CAEs Through 24 Weeks
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24
NCT00443729 (21) [back to overview]Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
NCT00485264 (13) [back to overview]Change of CD4 Percent From Baseline
NCT00485264 (13) [back to overview]Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL
NCT00485264 (13) [back to overview]Change of CD4 Count From Baseline
NCT00485264 (13) [back to overview]PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)
NCT00485264 (13) [back to overview]PK Parameter: Maximum Plasma Concentration (Cmax)
NCT00485264 (13) [back to overview]PK Parameter: Concentration at 12 Hours Postdose (C12h)
NCT00485264 (13) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)
NCT00485264 (13) [back to overview]Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
NCT00485264 (13) [back to overview]Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)
NCT00485264 (13) [back to overview]Number of Participants Who Died
NCT00485264 (13) [back to overview]Number of Participants Who Died
NCT00485264 (13) [back to overview]Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication
NCT00485264 (13) [back to overview]Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication
NCT00515827 (9) [back to overview]Change in Total CD4 Cell Count
NCT00515827 (9) [back to overview]Number of Participants Who Discontinued Study Drug
NCT00515827 (9) [back to overview]HIV-1 RNA Level
NCT00515827 (9) [back to overview]Change in Total CD8 Cell Count
NCT00515827 (9) [back to overview]Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From Week 12 to Week 24
NCT00515827 (9) [back to overview]Change in HIV-1 RNA Level
NCT00515827 (9) [back to overview]Change in CD4+/CD38+/HLA-DR+ Percent
NCT00515827 (9) [back to overview]Change in CD8+/CD38+/HLA-DR+ Percent
NCT00515827 (9) [back to overview]Number of Participants Who Experienced Study Related Grade 2 or Higher Signs/Symptoms, Grade 3 or Higher Laboratory Abnormalities and Clinical Events From First Day of Treatment to Week 12
NCT00523237 (1) [back to overview]The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir
NCT00525733 (1) [back to overview]The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.
NCT00529243 (2) [back to overview]Average Change in Cluster of Differentiation 4(CD4) Cell Count From Baseline at Week 24
NCT00529243 (2) [back to overview]Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.
NCT00537394 (15) [back to overview]Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure
NCT00537394 (15) [back to overview]Change in CD4 Count From Baseline
NCT00537394 (15) [back to overview]Change in Plasma HIV-1 Viral Load From Baseline to Week 1
NCT00537394 (15) [back to overview]Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry
NCT00537394 (15) [back to overview]Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment
NCT00537394 (15) [back to overview]Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment
NCT00537394 (15) [back to overview]Time From Treatment Dispensation to Serious Non-AIDS-defining Events
NCT00537394 (15) [back to overview]Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)
NCT00537394 (15) [back to overview]Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality
NCT00537394 (15) [back to overview]Time From Randomization to Confirmed Virological Failure
NCT00537394 (15) [back to overview]Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml
NCT00537394 (15) [back to overview]Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)
NCT00537394 (15) [back to overview]Change in Summarized Quality of Life Score
NCT00537394 (15) [back to overview]Change in Fasting Non-HDL Cholesterol From Baseline
NCT00537394 (15) [back to overview]Change in Cardiovascular Risk Score From Baseline
NCT00594646 (2) [back to overview]Medication Regimen Completion Rates
NCT00594646 (2) [back to overview]Number of HIV-1 Infected Participants
NCT00614458 (1) [back to overview]A Change in the Number of HIV Infected Cells.
NCT00614991 (7) [back to overview]Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.
NCT00614991 (7) [back to overview]Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00614991 (7) [back to overview]Number of Participants Who Experienced Adverse Events
NCT00614991 (7) [back to overview]CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00614991 (7) [back to overview]AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00614991 (7) [back to overview]AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00614991 (7) [back to overview]CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00618371 (1) [back to overview]Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load
NCT00631449 (2) [back to overview]Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.
NCT00631449 (2) [back to overview]Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24
NCT00632970 (1) [back to overview]Absolute Change in CD4 Cell Counts
NCT00641641 (1) [back to overview]Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
NCT00654147 (6) [back to overview]Study Medication Tolerability
NCT00654147 (6) [back to overview]Study Medication Toxicity-related Discontinuation .
NCT00654147 (6) [back to overview]Time to Confirmed Virologic Failure
NCT00654147 (6) [back to overview]Time to Virologic Failure
NCT00654147 (6) [back to overview]Weeks to HIV-1 RNA <200 Copies/ml
NCT00654147 (6) [back to overview]Change From Baseline CD4+ and CD8+ Cell Counts
NCT00656175 (1) [back to overview]Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)
NCT00661960 (1) [back to overview]the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.
NCT00666705 (6) [back to overview]Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
NCT00666705 (6) [back to overview]Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
NCT00666705 (6) [back to overview]Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
NCT00666705 (6) [back to overview]Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
NCT00666705 (6) [back to overview]Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)
NCT00666705 (6) [back to overview]Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)
NCT00672932 (2) [back to overview]Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR
NCT00672932 (2) [back to overview]Change in CSF Concentrations of Neopterin After 12 Weeks
NCT00700115 (2) [back to overview]Plasma Viral Loads (HIV-1 RNA PCR)
NCT00700115 (2) [back to overview]To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects
NCT00708162 (18) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48
NCT00708162 (18) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96
NCT00708162 (18) [back to overview]Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)
NCT00708162 (18) [back to overview]Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)
NCT00708162 (18) [back to overview]Change From Baseline in CD4 Cell Count at Week 48
NCT00708162 (18) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT00708162 (18) [back to overview]Change From Baseline in HIV-1 RNA at Week 48
NCT00708162 (18) [back to overview]Change From Baseline in HIV-1 RNA at Week 96
NCT00708162 (18) [back to overview]Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48
NCT00708162 (18) [back to overview]Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96
NCT00708162 (18) [back to overview]Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48
NCT00708162 (18) [back to overview]Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96
NCT00708162 (18) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
NCT00708162 (18) [back to overview]Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
NCT00708162 (18) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
NCT00708162 (18) [back to overview]Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
NCT00708162 (18) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48
NCT00708162 (18) [back to overview]Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lipase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Potassium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Platelet Count (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Neutrophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Monocytes (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Mid-Thigh Measurement (cm)
NCT00711009 (82) [back to overview]Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
NCT00711009 (82) [back to overview]Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
NCT00711009 (82) [back to overview]Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Albumin (Grams/Liter)
NCT00711009 (82) [back to overview]Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
NCT00711009 (82) [back to overview]Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Basophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Calcium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chest Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Chloride (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Cholesterol (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Creatinine (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
NCT00711009 (82) [back to overview]Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Eosinophils (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hematocrit (Fraction)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hemoglobin (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Hips Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Insulin (Picomoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lactate (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Leptin (Nanograms/Milliliter)
NCT00711009 (82) [back to overview]Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
NCT00711009 (82) [back to overview]Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00711009 (82) [back to overview]Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
NCT00711009 (82) [back to overview]Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
NCT00711009 (82) [back to overview]Mean Change From Baseline in Mid-Arm Measurement (cm)
NCT00711009 (82) [back to overview]Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
NCT00711009 (82) [back to overview]Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
NCT00711009 (82) [back to overview]Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
NCT00711009 (82) [back to overview]Mean Change From Baseline in Magnesium (Millimoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
NCT00711009 (82) [back to overview]Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
NCT00711009 (82) [back to overview]Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
NCT00711009 (82) [back to overview]Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
NCT00711009 (82) [back to overview]Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Weight (kg)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Waist Measurement (cm)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Urine Specific Gravity
NCT00711009 (82) [back to overview]Mean Change From Baseline in Urine pH
NCT00711009 (82) [back to overview]Mean Change From Baseline in Uric Acid (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Triglycerides (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Total Protein (Grams/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Temperature (°F)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Sodium (Micromoles/Liter)
NCT00711009 (82) [back to overview]Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
NCT00729924 (2) [back to overview]Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.
NCT00729924 (2) [back to overview]Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean Platelet Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean White Blood Cell Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 3 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 11 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 1 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 5 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 7 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 8 Months
NCT00734344 (32) [back to overview]Mean CD4 Count Between Treatment Groups at 9 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 10 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 12 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 14 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 2 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 4 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 6 Months
NCT00734344 (32) [back to overview]Mean Hematocrit Between Treatment Groups at 8 Months
NCT00745368 (8) [back to overview]Female Paired Plasma Concentration
NCT00745368 (8) [back to overview]Female Genital Tract:Plasma Concentration Ratio
NCT00745368 (8) [back to overview]Raltegravir Male Genital Tract Concentration
NCT00745368 (8) [back to overview]Raltegravir Female Genital Tract Concentration
NCT00745368 (8) [back to overview]Male Time Since Last Dose
NCT00745368 (8) [back to overview]Male Paired Plasma Concentration
NCT00745368 (8) [back to overview]Male Genital Tract:Plasma Concentration Ratio
NCT00745368 (8) [back to overview]Female Time Since Last Dose
NCT00745823 (5) [back to overview]Number of Participants With One or More Adverse Events at 48 Weeks
NCT00745823 (5) [back to overview]Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
NCT00745823 (5) [back to overview]Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks
NCT00745823 (5) [back to overview]Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
NCT00745823 (5) [back to overview]Mean Change From Baseline to Week 48 in CD4 Cell Count
NCT00749580 (2) [back to overview]Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen
NCT00749580 (2) [back to overview]Virologic Suppression of < 75 Copies/ml at 48 Weeks
NCT00751530 (5) [back to overview]Percentage of Participants Using Etravirine in Background Regimen
NCT00751530 (5) [back to overview]Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
NCT00751530 (5) [back to overview]Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
NCT00751530 (5) [back to overview]Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)
NCT00751530 (5) [back to overview]CD4 Cell Changes Among Participants in PI vs Non-PI Group
NCT00752856 (4) [back to overview]To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.
NCT00752856 (4) [back to overview]Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48
NCT00752856 (4) [back to overview]Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.
NCT00752856 (4) [back to overview]Viral Suppression Efficacy at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Lipids at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Log HIV Viral Load at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
NCT00762892 (5) [back to overview]Change From Baseline in Homocysteine at 6 Months
NCT00762892 (5) [back to overview]Change From Baseline in CD4 Count at 48 Weeks
NCT00764946 (7) [back to overview]Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
NCT00764946 (7) [back to overview]Number of Participants Without Loss of Virologic Response
NCT00764946 (7) [back to overview]Number of Participants With One or More Adverse Events
NCT00764946 (7) [back to overview]Number of Participants Who Discontinued Due to an Adverse Event
NCT00764946 (7) [back to overview]Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
NCT00764946 (7) [back to overview]Mean Change From Baseline to Week 48 in HIV RNA
NCT00764946 (7) [back to overview]Mean Change From Baseline to Week 48 in CD4 Cell Count
NCT00768989 (28) [back to overview]Atazanavir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
NCT00768989 (28) [back to overview]Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
NCT00768989 (28) [back to overview]Raltegravir AUC (0-12h) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir Cmax in 1 Dosing Interval
NCT00768989 (28) [back to overview]Raltegravir Cmin 12 Hours Postdose
NCT00768989 (28) [back to overview]Raltegravir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Raltegravir Terminal Elimination Half Life
NCT00768989 (28) [back to overview]Raltegravir Tmax
NCT00768989 (28) [back to overview]Baseline and Mean Change From Baseline in Total Cholesterol Levels
NCT00768989 (28) [back to overview]Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
NCT00768989 (28) [back to overview]Mean Change From Baseline in Electrocardiogram Findings
NCT00768989 (28) [back to overview]Mean Change From Baseline in Total Bilirubin Level
NCT00768989 (28) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation
NCT00768989 (28) [back to overview]Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)
NCT00768989 (28) [back to overview]Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
NCT00768989 (28) [back to overview]Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
NCT00768989 (28) [back to overview]Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
NCT00768989 (28) [back to overview]Number of Nonresponders at Week 8
NCT00768989 (28) [back to overview]Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
NCT00768989 (28) [back to overview]Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval
NCT00768989 (28) [back to overview]Atazanavir Cmin Prior to the Morning Dose
NCT00768989 (28) [back to overview]Atazanavir Individual Inhibitory Quotient (IQ)
NCT00768989 (28) [back to overview]Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
NCT00772590 (1) [back to overview]Mean Change From Baseline CD4+ Cell Count
NCT00802074 (7) [back to overview]Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00802074 (7) [back to overview]CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00802074 (7) [back to overview]AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
NCT00802074 (7) [back to overview]AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.
NCT00802074 (7) [back to overview]Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
NCT00802074 (7) [back to overview]Number of Participants Who Experienced Adverse Events
NCT00802074 (7) [back to overview]CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD
NCT00811954 (19) [back to overview]Presence of Mutations Associated With NRTI Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With INI Resistance
NCT00811954 (19) [back to overview]Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
NCT00811954 (19) [back to overview]Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)
NCT00811954 (19) [back to overview]Incidence of Death or AIDS Defining Events (CDC Category C)
NCT00811954 (19) [back to overview]Change in Fasting HDL Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96
NCT00811954 (19) [back to overview]Cumulative Probability of First Virologic Failure by Week 96
NCT00811954 (19) [back to overview]Cumulative Incidence of First Adverse Event by Week 96
NCT00811954 (19) [back to overview]Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96
NCT00811954 (19) [back to overview]Self-reported Adherence
NCT00811954 (19) [back to overview]Change in Waist:Height Ratio From Baseline
NCT00811954 (19) [back to overview]Change in Waist Circumference From Baseline
NCT00811954 (19) [back to overview]Change in Framingham 10-year Risk of MI or Coronary Death From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Triglycerides Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Total Cholesterol Level From Baseline
NCT00811954 (19) [back to overview]Change in Fasting Plasma Glucose Level From Baseline
NCT00811954 (19) [back to overview]CD4+ T-cell Count
NCT00811954 (19) [back to overview]CD4+ T-cell Count Changes From Baseline
NCT00814879 (6) [back to overview]Cholesterol
NCT00814879 (6) [back to overview]Number of Patients With < 400 Copies HIV RNA/mL at Week 48
NCT00814879 (6) [back to overview]Number of Patients Reaching Virologic Failure at Week 48.
NCT00814879 (6) [back to overview]Mean Change in Total Bilirubin (mg/dL) From Baseline
NCT00814879 (6) [back to overview]CD4+ Cell Count
NCT00814879 (6) [back to overview]CD4+ Cell Count
NCT00830804 (17) [back to overview]Plasma Trough Concentration of Raltegravir
NCT00830804 (17) [back to overview]Plasma Trough Concentration of Darunavir
NCT00830804 (17) [back to overview]Number of Participants With Protease Drug Resistance at Virologic Failure
NCT00830804 (17) [back to overview]Number of Participants With Perfect Overall Adherence by Self Report
NCT00830804 (17) [back to overview]Number of Participants With Integrase Drug Resistance at Virologic Failure
NCT00830804 (17) [back to overview]Change in Fasting Low-density Lipoprotein at Week 48
NCT00830804 (17) [back to overview]Change in Fasting Low-density Lipoprotein at Week 24
NCT00830804 (17) [back to overview]Change in CD4 Count at Week 48
NCT00830804 (17) [back to overview]Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24
NCT00830804 (17) [back to overview]Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48
NCT00830804 (17) [back to overview]Change in Plasma HIV-1 RNA From Baseline to Week 1
NCT00830804 (17) [back to overview]Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment
NCT00830804 (17) [back to overview]Number of Participants With Pretreatment Drug Resistance
NCT00830804 (17) [back to overview]Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48
NCT00830804 (17) [back to overview]Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24
NCT00830804 (17) [back to overview]Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24
NCT00830804 (17) [back to overview]Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24
NCT00843713 (1) [back to overview]Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)
NCT00851799 (27) [back to overview]Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Fold Change in D-dimer From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
NCT00851799 (27) [back to overview]Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
NCT00851799 (27) [back to overview]Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
NCT00851799 (27) [back to overview]Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)
NCT00851799 (27) [back to overview]Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Lean Mass From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Total Limb Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Trunk Fat From Study Entry to Week 96
NCT00851799 (27) [back to overview]Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
NCT00851799 (27) [back to overview]CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
NCT00851799 (27) [back to overview]Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
NCT00851799 (27) [back to overview]Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
NCT00851799 (27) [back to overview]Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
NCT00851799 (27) [back to overview]Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
NCT00858962 (1) [back to overview]Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)
NCT00870363 (4) [back to overview]Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen
NCT00870363 (4) [back to overview]Changes in CD4+ T-cell Numbers by Treatment Regimen
NCT00870363 (4) [back to overview]Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received
NCT00870363 (4) [back to overview]Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy
NCT00884793 (4) [back to overview]"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"
NCT00884793 (4) [back to overview]Number of Subjects Who Experienced an Increase in CD4% in the Ileum.
NCT00884793 (4) [back to overview]Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.
NCT00884793 (4) [back to overview]Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum
NCT00887653 (3) [back to overview]Proportion of Patients With Plasma Viral Load Below the Limit of Detection
NCT00887653 (3) [back to overview]Change From Baseline Triglycerides
NCT00887653 (3) [back to overview]Change From Baseline Triglycerides
NCT00931463 (5) [back to overview]Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure
NCT00931463 (5) [back to overview]Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL
NCT00931463 (5) [back to overview]Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population
NCT00931463 (5) [back to overview]Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization
NCT00931463 (5) [back to overview]Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL
NCT00931801 (4) [back to overview]Maintenance of Virologic Suppression
NCT00931801 (4) [back to overview]The Difference in CD4 From Baseline to Week 48
NCT00931801 (4) [back to overview]The Change in Adherence to Study Treatment Arm From Baseline to Week 48
NCT00931801 (4) [back to overview]Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
NCT00939874 (2) [back to overview]Percentage of Participants With HIV Viral Load <50 Copies/mL
NCT00939874 (2) [back to overview]Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
NCT00976404 (5) [back to overview]Change From Baseline in CD4+ T Cell Count at Week 56
NCT00976404 (5) [back to overview]Change From Baseline in HIV DNA in PBMCs at Week 56
NCT00976404 (5) [back to overview]Change From Baseline in HIV DNA in Rectal Tissue at Week 56
NCT00976404 (5) [back to overview]HIV Specific T-cell Response to Env
NCT00976404 (5) [back to overview]Serious Adverse Events Attributed to Study Treatments
NCT00982553 (4) [back to overview]Raltegravir Minimum Plasma Concentrations
NCT00982553 (4) [back to overview]Raltegravir Maximum Plasma Concentration
NCT00982553 (4) [back to overview]Ribavirin Maximum Plasma Concentration
NCT00982553 (4) [back to overview]Ribavirin Minimum Plasma Concentration
NCT01000285 (8) [back to overview]Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA
NCT01000285 (8) [back to overview]Efficacy of Treatment as Measured by Best Overall Response
NCT01000285 (8) [back to overview]Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence
NCT01000285 (8) [back to overview]Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads
NCT01000285 (8) [back to overview]Relation of NFκB Gene Expression Profile on Response
NCT01000285 (8) [back to overview]Time to Progression
NCT01000285 (8) [back to overview]Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events
NCT01000285 (8) [back to overview]Effects of HTLV-1 Integration Sites After Treatment
NCT01000818 (1) [back to overview]Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir
NCT01025427 (1) [back to overview]Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24
NCT01044771 (2) [back to overview]Patients Without HIV Re-bound
NCT01044771 (2) [back to overview]Patients With Reduced or Resolved Proteinuria
NCT01048671 (6) [back to overview]Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants
NCT01048671 (6) [back to overview]Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir
NCT01048671 (6) [back to overview]Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24
NCT01048671 (6) [back to overview]Percentage of Participants Responding to Treatment: All Treated Participants
NCT01048671 (6) [back to overview]Number of Participants With at Least One Adverse Event
NCT01048671 (6) [back to overview]Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24
NCT01147107 (1) [back to overview]Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations
NCT01154673 (1) [back to overview]Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
NCT01195467 (2) [back to overview]The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment
NCT01195467 (2) [back to overview]The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment
NCT01204905 (2) [back to overview]Viral Suppression
NCT01204905 (2) [back to overview]Viral Load
NCT01213316 (11) [back to overview]Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Percentage of Aging Participants Taking Concomitant Medications at Baseline
NCT01213316 (11) [back to overview]Percentage of Aging Participants With Concomitant Diseases at Baseline
NCT01213316 (11) [back to overview]Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment
NCT01213316 (11) [back to overview]HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment
NCT01214759 (2) [back to overview]Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study
NCT01214759 (2) [back to overview]Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
NCT01227824 (12) [back to overview]Absolute Values in CD4+ Cell Counts Over Time
NCT01227824 (12) [back to overview]Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG
NCT01227824 (12) [back to overview]Number of Participants With Plasma HIV-1 RNA <400 c/mL
NCT01227824 (12) [back to overview]Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)
NCT01227824 (12) [back to overview]Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences
NCT01227824 (12) [back to overview]Change From Baseline in Plasma HIV-1 RNA Over Time
NCT01227824 (12) [back to overview]Number of Participants With Plasma HIV-1 RNA <50 c/mL
NCT01227824 (12) [back to overview]Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG
NCT01227824 (12) [back to overview]Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.
NCT01227824 (12) [back to overview]Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48
NCT01227824 (12) [back to overview]Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time
NCT01227824 (12) [back to overview]Absolute Values in Plasma HIV-1 RNA Over Time
NCT01231516 (14) [back to overview]Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
NCT01231516 (14) [back to overview]Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions
NCT01231516 (14) [back to overview]Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144
NCT01231516 (14) [back to overview]DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)
NCT01231516 (14) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score
NCT01231516 (14) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores
NCT01231516 (14) [back to overview]Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144
NCT01231516 (14) [back to overview]DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau])
NCT01231516 (14) [back to overview]Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF)
NCT01231516 (14) [back to overview]Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
NCT01231516 (14) [back to overview]Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
NCT01231516 (14) [back to overview]Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48
NCT01231516 (14) [back to overview]Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities
NCT01231516 (14) [back to overview]DTG PK Parameter Including Pre-dose Concentration (C0)
NCT01245101 (2) [back to overview]Episomal HIV cDNA Formation
NCT01245101 (2) [back to overview]Markers of Immune Activation
NCT01258374 (4) [back to overview]Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
NCT01258374 (4) [back to overview]Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
NCT01258374 (4) [back to overview]Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy
NCT01258374 (4) [back to overview]Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.
NCT01270802 (2) [back to overview]Change in Serum Levels of Vitamin D
NCT01270802 (2) [back to overview]Change in Flow-mediated Dilation (FMD) of the Brachial Artery
NCT01285050 (1) [back to overview]HCV RNA
NCT01327482 (2) [back to overview]Plasma Raltegravir Concentrations
NCT01327482 (2) [back to overview]Tissue Raltegravir Concentrations
NCT01332227 (7) [back to overview]Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
NCT01332227 (7) [back to overview]Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
NCT01332227 (7) [back to overview]Mean Changes in Fasting Lipid Levels From Baseline to Week 48
NCT01332227 (7) [back to overview]Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
NCT01332227 (7) [back to overview]Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
NCT01332227 (7) [back to overview]Number of Participants With Virologic Rebound at Weeks 24 and 48
NCT01332227 (7) [back to overview]Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
NCT01335620 (2) [back to overview]Drug Levels in Blood
NCT01335620 (2) [back to overview]Cerebral Function; Changes in Global Cognitive Z-score
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 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
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]Percentage of Time Spent in Hospital
NCT01352715 (9) [back to overview]Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
NCT01384734 (17) [back to overview]Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period
NCT01384734 (17) [back to overview]Number of Participants With SAE and Discontinuation Due to AEs During Primary Study
NCT01384734 (17) [back to overview]Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 96
NCT01384734 (17) [back to overview]Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 48
NCT01384734 (17) [back to overview]Number of Participants With Newly-emergent Genotypic Substitutions at Week 24
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy
NCT01384734 (17) [back to overview]Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy
NCT01384734 (17) [back to overview]Change From Baseline in CD4+ T-cell Count
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period
NCT01384734 (17) [back to overview]Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24
NCT01384734 (17) [back to overview]Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA
NCT01448486 (2) [back to overview]Cerebrospinal Fluid
NCT01448486 (2) [back to overview]Neurocognitive Function
NCT01450189 (30) [back to overview]Prevalence of AHI Among Persons Screened
NCT01450189 (30) [back to overview]Suppression of HIV RNA to <1000c/ml at 12 Weeks
NCT01450189 (30) [back to overview]Time to HIV RNA Suppression <1000 c/ml
NCT01450189 (30) [back to overview]Number of Adverse Events
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 12 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 26 Weeks
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 12, Women
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Month - 52 Weeks
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Women
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 52, Men
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Women
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 26, Men
NCT01450189 (30) [back to overview]Number of Partners Reporting for HIV Testing
NCT01450189 (30) [back to overview]Genital HIV RNA Concentration - Week 12, Men
NCT01450189 (30) [back to overview]Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
NCT01450189 (30) [back to overview]Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Cumulative Incidence Herpes Simplex Virus Type 2
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 52
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 26
NCT01450189 (30) [back to overview]Blood HIV RNA Concentration at Week 12
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 12 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 26 Weeks
NCT01450189 (30) [back to overview]Unprotected Sex Acts in Previous One Week - 52 Weeks
NCT01450189 (30) [back to overview]Proportion of Participants Completing Full Course of ARVs in Arm BIA
NCT01450189 (30) [back to overview]Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
NCT01450189 (30) [back to overview]Proportion of Partners Reporting for HIV Testing
NCT01450189 (30) [back to overview]Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
NCT01450189 (30) [back to overview]Proportion of Persons Completing All Scheduled Visits in Each Study Arm
NCT01450189 (30) [back to overview]Proportion of Persons With AHI Successfully Recruited Into the Study
NCT01513122 (6) [back to overview]Mean Glucose Changes From Baseline to 48 Weeks
NCT01513122 (6) [back to overview]Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan
NCT01513122 (6) [back to overview]Mean Total Cholesterol Changes From Baseline to 48 Weeks
NCT01513122 (6) [back to overview]Mean Triglycerides Changes From Baseline to 48 Weeks
NCT01513122 (6) [back to overview]Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan
NCT01513122 (6) [back to overview]Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan
NCT01529749 (17) [back to overview]Changes in CD4 CD38+ HLADR+ (%)
NCT01529749 (17) [back to overview]Proportion of Patients With Improvement in Neuropsychological Test
NCT01529749 (17) [back to overview]Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups
NCT01529749 (17) [back to overview]Proportion of Patients With Undetectable Plasma Viral Load in Different Groups
NCT01529749 (17) [back to overview]Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in Levels of Proteins.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in Levels of Metalloproteinases
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in Levels of CSF Cells.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in Levels of beta2-microglobulin.
NCT01529749 (17) [back to overview]Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in the Levels of CRP in Different Groups.
NCT01529749 (17) [back to overview]Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.
NCT01529749 (17) [back to overview]Proportion of Patients With Increased CD4 in Peripheral Blood.
NCT01529749 (17) [back to overview]Proportion of Patients With Increased CD4 in Lymphatic Tissue.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.
NCT01529749 (17) [back to overview]Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.
NCT01529749 (17) [back to overview]Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced a New AIDS-defining Illness or Died
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 72
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced a New AIDS-defining Illness
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 24
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 48
NCT01601626 (26) [back to overview]CD4 Count Change From Baseline to Week 8
NCT01601626 (26) [back to overview]Cumulative Probability of HIV Virologic Failure at Week 72
NCT01601626 (26) [back to overview]LPV AUC in Participants Enrolled in Arms A, B, and C
NCT01601626 (26) [back to overview]Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality
NCT01601626 (26) [back to overview]Number of Participants Reporting a Grade 3 or 4 Sign or Symptom
NCT01601626 (26) [back to overview]Number of Participants Who Experienced MTB IRIS
NCT01601626 (26) [back to overview]Percent of Participants Who Died
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced HIV Virologic Failure
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced Sputum Conversion at Week 8.
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Relapse/Recurrence
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance
NCT01601626 (26) [back to overview]Percent of Participants Who Experienced TB Treatment Failure
NCT01601626 (26) [back to overview]Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity
NCT01601626 (26) [back to overview]Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity
NCT01601626 (26) [back to overview]Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.
NCT01601626 (26) [back to overview]Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48
NCT01601626 (26) [back to overview]RAL AUC in Participants Enrolled in Arm C
NCT01601626 (26) [back to overview]RBT AUC in Participants Enrolled in Arms A and C
NCT01601626 (26) [back to overview]LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C
NCT01601626 (26) [back to overview]RAL Cmax and Cmin in Participants Enrolled in Arm C
NCT01601626 (26) [back to overview]RBT Cmax and Cmin in Participants Enrolled in Arms A and C
NCT01605890 (12) [back to overview]Median Change of CD4 Lymphocytes at Week 48
NCT01605890 (12) [back to overview]Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
NCT01605890 (12) [back to overview]Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire
NCT01605890 (12) [back to overview]Number of Participants With Clinical Progression
NCT01605890 (12) [back to overview]Median Change in CD4 Lymphocytes Count at Week 12
NCT01605890 (12) [back to overview]Number of Participants With Treatment Switch or Discontinuation
NCT01605890 (12) [back to overview]Number of Virological Failure Participants With Resistance Mutations
NCT01605890 (12) [back to overview]Number of Clinical and Biological Events
NCT01605890 (12) [back to overview]Percentage of Participants in Therapeutic Success
NCT01605890 (12) [back to overview]Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
NCT01605890 (12) [back to overview]Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
NCT01605890 (12) [back to overview]Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
NCT01618305 (17) [back to overview]Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation
NCT01618305 (17) [back to overview]Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery
NCT01618305 (17) [back to overview]Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.
NCT01618305 (17) [back to overview]Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation
NCT01618305 (17) [back to overview]Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).
NCT01618305 (17) [back to overview]Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.
NCT01618305 (17) [back to overview]Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).
NCT01618305 (17) [back to overview]Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)
NCT01618305 (17) [back to overview]Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)
NCT01618305 (17) [back to overview]Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.
NCT01618305 (17) [back to overview]Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.
NCT01618305 (17) [back to overview]Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery
NCT01618305 (17) [back to overview]Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table
NCT01618305 (17) [back to overview]Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen
NCT01622673 (8) [back to overview]Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
NCT01622673 (8) [back to overview]Number of Participants With Any Clinical or Laboratory Adverse Event (AE)
NCT01622673 (8) [back to overview]Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir
NCT01622673 (8) [back to overview]Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to First Dose Modification Due to Grade 3 or 4 Toxicity
NCT01641367 (60) [back to overview]Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
NCT01641367 (60) [back to overview]Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Death
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Triglycerides
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Total Cholesterol
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
NCT01641367 (60) [back to overview]Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
NCT01641367 (60) [back to overview]Percent of Participants With Death or Hospitalization by Week 48
NCT01641367 (60) [back to overview]Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Glucose
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation by Week 48
NCT01641367 (60) [back to overview]Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up
NCT01641367 (60) [back to overview]Number of Weeks of Follow-up [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death by Week 48
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
NCT01641367 (60) [back to overview]Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Change From Baseline in CD4+ T-cell Count
NCT01641367 (60) [back to overview]Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death or Hospitalization.
NCT01641367 (60) [back to overview]Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
NCT01641367 (60) [back to overview]Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
NCT01717287 (9) [back to overview]Percentage of Participants Achieving HIV RNA <200 Copies/mL
NCT01717287 (9) [back to overview]Percentage of Participants Achieving HIV RNA <40 Copies/mL
NCT01717287 (9) [back to overview]Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
NCT01717287 (9) [back to overview]Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
NCT01717287 (9) [back to overview]Percentage of Participants With at Least One Clinical Adverse Experience
NCT01717287 (9) [back to overview]Percentage of Participants With at Least One Laboratory Adverse Experience
NCT01717287 (9) [back to overview]Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
NCT01717287 (9) [back to overview]Change From Baseline in CD4 Cell Percentage
NCT01717287 (9) [back to overview]Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL
NCT01751568 (8) [back to overview]Number of Participants Who Experienced Death, Grade 4 Life-threatening Adverse Events Deemed at Least Possibly Related to Raltegravir
NCT01751568 (8) [back to overview]Number of Participants Who Experienced Adverse Event(s) of Greater Than or Equal to Grade 3 Deemed at Least Possibly Related to Raltegravir
NCT01751568 (8) [back to overview]Number of Participants Who Developed of New Opportunistic Infection(s) (OIs)
NCT01751568 (8) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)
NCT01751568 (8) [back to overview]Number of Participants Who Failed to Respond Virologically at Week 8, Which Means Having HIV RNA (Copies/mL) Greater Than 400 Copies/mL AND Less Than 1-log10 Drop From Baseline
NCT01751568 (8) [back to overview]Number of Participants Who Permanently Discontinued Treatment Due to Adverse Event(s) of Greater Than or Equal to Grade 3 Deemed at Least Possibly Related to Raltegravir
NCT01751568 (8) [back to overview]Number of Participants Who Experienced Grade 4 Non-life Threatening Adverse Event(s) Deemed as Probably or Definitely Related to Raltegravir
NCT01751568 (8) [back to overview]Pharmacokinetic (PK) Parameter: Concentration at 12h (C12)
NCT01767701 (8) [back to overview]Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.
NCT01767701 (8) [back to overview]The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI
NCT01767701 (8) [back to overview]The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.
NCT01767701 (8) [back to overview]Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline
NCT01767701 (8) [back to overview]Mean Number of Adverse Events Per Patient
NCT01767701 (8) [back to overview]Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.
NCT01767701 (8) [back to overview]Cumulative Number of Gd-T1 Enhancing Lesions
NCT01767701 (8) [back to overview]Changes in Kurtzke Extended Disability Status Scale (EDSS) Score
NCT01780831 (13) [back to overview]RAL AUC12 for Cohort 2 at 15-18 Days of Life
NCT01780831 (13) [back to overview]RAL C12 for Cohort 2 at 15-18 Days of Life
NCT01780831 (13) [back to overview]Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 24 Weeks of Life
NCT01780831 (13) [back to overview]AUC24 for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)
NCT01780831 (13) [back to overview]AUC24 for Cohort 2 Initial RAL Dose (Within 48 and 12-60 Hours of Birth for RAL-naive and RAL-exposed Groups, Respectively)
NCT01780831 (13) [back to overview]Clast for Cohort 2 Initial RAL Dose (Within 48 and Between 12-60 Hours of Birth for RAL-naïve and RAL-exposed Groups, Respectively)
NCT01780831 (13) [back to overview]Cmax for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)
NCT01780831 (13) [back to overview]Cohort 1 Dose #1 Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group
NCT01780831 (13) [back to overview]Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 6 Weeks of Life
NCT01780831 (13) [back to overview]Cohort 2 Initial Dose Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group
NCT01780831 (13) [back to overview]Cohort 2 Neonatal RAL Elimination (CL/F) at 15-18 Days of Life by UGT1A1 Genotype Group
NCT01780831 (13) [back to overview]Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 6 Weeks of Life
NCT01780831 (13) [back to overview]Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 24 Weeks of Life
NCT01785160 (2) [back to overview]Cmax ,ss
NCT01785160 (2) [back to overview]AUC( Tau,ss)
NCT01828073 (7) [back to overview]Ratio of Cord Blood to Maternal Blood RAL Concentrations
NCT01828073 (7) [back to overview]Infant Direct Bilirubin
NCT01828073 (7) [back to overview]Infant Total Bilirubin
NCT01828073 (7) [back to overview]Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death)
NCT01828073 (7) [back to overview]Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice
NCT01828073 (7) [back to overview]Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation)
NCT01828073 (7) [back to overview]PK Parameter: Neonatal RAL Elimination Half-life (T1/2)
NCT01841593 (5) [back to overview]Raltegravir C12h
NCT01841593 (5) [back to overview]Raltegravir AUC(0-12h )
NCT01841593 (5) [back to overview]Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.
NCT01841593 (5) [back to overview]Amlodipine C24h
NCT01841593 (5) [back to overview]Amlodipine AUC(0-24h)
NCT01896921 (3) [back to overview]Number of Participants With Adverse Events
NCT01896921 (3) [back to overview]Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.
NCT01896921 (3) [back to overview]Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)
NCT01930045 (6) [back to overview]Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2
NCT01930045 (6) [back to overview]Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1
NCT01930045 (6) [back to overview]Maximum Plasma Concentration (C Max) of Raltegravir in Part 1
NCT01930045 (6) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2
NCT01930045 (6) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1
NCT01930045 (6) [back to overview]Maximum Plasma Concentration (C Max) of Raltegravir in Part 2
NCT01978743 (9) [back to overview]Sleep Quality
NCT01978743 (9) [back to overview]Other Neurometabolite Changes Measured by MRS
NCT01978743 (9) [back to overview]Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI
NCT01978743 (9) [back to overview]Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
NCT01978743 (9) [back to overview]Markers of Immune Activation
NCT01978743 (9) [back to overview]Fasting Lipid Profile
NCT01978743 (9) [back to overview]Change in Level of EFV and Metabolites
NCT01978743 (9) [back to overview]ART Regimen Preference
NCT01978743 (9) [back to overview]Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)
NCT01989910 (3) [back to overview]The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.
NCT01989910 (3) [back to overview]The Proportion of Treatment Failure at Week 48 for Both Arms.
NCT01989910 (3) [back to overview]The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.
NCT02097108 (4) [back to overview]Triglycerides Baseline and After 24 Weeks
NCT02097108 (4) [back to overview]High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
NCT02097108 (4) [back to overview]Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
NCT02097108 (4) [back to overview]Total Cholesterol Baseline and After 24 Weeks
NCT02116660 (1) [back to overview]Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
NCT02131233 (14) [back to overview]Change From Baseline in CD4 Cell Count at Week 96
NCT02131233 (14) [back to overview]Percentage of Participants With a Serious Adverse Event (SAE) at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment
NCT02131233 (14) [back to overview]Percentage of Participants With a Serious and Drug-Related AE at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants With a Drug-Related AE at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment
NCT02131233 (14) [back to overview]Percentage of Participants With an Adverse Event (AE) at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants With an AE After 96 Weeks of Treatment
NCT02131233 (14) [back to overview]Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96
NCT02131233 (14) [back to overview]Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96
NCT02131233 (14) [back to overview]Percentage of Participants With a SAE After 96 Weeks of Treatment
NCT02131233 (14) [back to overview]Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
NCT02131233 (14) [back to overview]Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48
NCT02212379 (24) [back to overview]Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples
NCT02212379 (24) [back to overview]Median Time of Virological Failure
NCT02212379 (24) [back to overview]Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure
NCT02212379 (24) [back to overview]Percent Change of Renal Function
NCT02212379 (24) [back to overview]Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48
NCT02212379 (24) [back to overview]Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)
NCT02212379 (24) [back to overview]Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio
NCT02212379 (24) [back to overview]Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)
NCT02212379 (24) [back to overview]Evolution of the Calibrated 5-year Framingham Risk Score
NCT02212379 (24) [back to overview]Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots
NCT02212379 (24) [back to overview]Evolution of Total Cell-associated HIV-DNA
NCT02212379 (24) [back to overview]Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL
NCT02212379 (24) [back to overview]Inflammatory Parameters
NCT02212379 (24) [back to overview]Number of Participants Experiencing Adverse Events and Effects
NCT02212379 (24) [back to overview]Percentage of Participants Compliant With Treatment Program.
NCT02212379 (24) [back to overview]Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96
NCT02212379 (24) [back to overview]Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96
NCT02212379 (24) [back to overview]Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL
NCT02212379 (24) [back to overview]Percentage of Patients With Therapeutic Success at Week 48 and Week 96
NCT02212379 (24) [back to overview]Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96
NCT02212379 (24) [back to overview]Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)
NCT02212379 (24) [back to overview]Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status
NCT02212379 (24) [back to overview]Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96
NCT02212379 (24) [back to overview]Sub-study: Bone Mineral Density
NCT02218320 (3) [back to overview]Percentage of Total CD8+ T-cells With CCR5 Expression
NCT02218320 (3) [back to overview]Rectal Tissue Concentrations of Ralegravir and Dolutegravir
NCT02218320 (3) [back to overview]RNA Concentrations From Gastrointestinal Tissues
NCT02336074 (6) [back to overview]Histone H4 Acetylation
NCT02336074 (6) [back to overview]Quantitative Viral Outgrowth
NCT02336074 (6) [back to overview]CD8+ T-cell Responses
NCT02336074 (6) [back to overview]Total HIV DNA From CD4 T-cells
NCT02336074 (6) [back to overview]Percentage of CD4+ CD154+ IFNγ+ T Cells
NCT02336074 (6) [back to overview]Viral Inhibition
NCT02383355 (5) [back to overview]Platelet Reactivity Measured by Expression of P-selectin (CD62p) and Fibrinogen Binding
NCT02383355 (5) [back to overview]Circulating Levels of High Sensitive C-reactive Protein (Hs-CRP)
NCT02383355 (5) [back to overview]Platelet-leukocyte Aggregates (Platelet Monocyte Complex Measured by Flow-cytometry)
NCT02383355 (5) [back to overview]T-cell Dysfunction (CD4-cells)
NCT02383355 (5) [back to overview]Persistent Immune Activation - Monocyte Subsets
NCT02473367 (3) [back to overview]Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir
NCT02473367 (3) [back to overview]Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir
NCT02473367 (3) [back to overview]Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir
NCT02577042 (2) [back to overview]Changes in Plasma Soluble Markers (D-dimer)
NCT02577042 (2) [back to overview]Changes in the Inflammatory Marker IL-6
NCT03205566 (5) [back to overview]The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
NCT03205566 (5) [back to overview]The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.
NCT03205566 (5) [back to overview]The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.
NCT03205566 (5) [back to overview]The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV
NCT03205566 (5) [back to overview]Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals
NCT03374358 (8) [back to overview]Change in Metabolic and Inflammatory Biomarkers: IL-6
NCT03374358 (8) [back to overview]Change in Liver Stiffness
NCT03374358 (8) [back to overview]Change in Liver Fat
NCT03374358 (8) [back to overview]Change in Fasting Plasma Glucose
NCT03374358 (8) [back to overview]Change in Metabolic and Inflammatory Biomarkers: hsCRP
NCT03374358 (8) [back to overview]Change in Subcutaneous and Visceral Adipose Tissue Volume
NCT03374358 (8) [back to overview]Change in Fasting Serum Lipid Profile
NCT03374358 (8) [back to overview]Change in Body Weight and Total Body Fat
NCT03537404 (10) [back to overview]AUCtau of Raltegravir
NCT03537404 (10) [back to overview]Number of Patients With Changes in Vital Signs
NCT03537404 (10) [back to overview]Number of Patients With Abnormal ECG Changes
NCT03537404 (10) [back to overview]Number of Patients With Abnormal Laboratory Values
NCT03537404 (10) [back to overview]AUCtau of Tenofovir
NCT03537404 (10) [back to overview]AUCtau of Narlaprevir
NCT03537404 (10) [back to overview]Cmax of Narlaprevir
NCT03537404 (10) [back to overview]Cmax of Raltegravir
NCT03537404 (10) [back to overview]Cmax of Tenofovir
NCT03537404 (10) [back to overview]Number of Patients With Adverse Events
NCT03667547 (11) [back to overview]Number of Participants Discontinued From the Study Due to an AE
NCT03667547 (11) [back to overview]Maximum Plasma Concentration (Cmax) of Raltegravir
NCT03667547 (11) [back to overview]Time of Maximum Plasma Concentration (Tmax) of Raltegravir
NCT03667547 (11) [back to overview]Number of Participants With a Drug-related AE
NCT03667547 (11) [back to overview]Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24)
NCT03667547 (11) [back to overview]Number of Participants With an Adverse Event (AE)
NCT03667547 (11) [back to overview]Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir
NCT03667547 (11) [back to overview]Apparent Volume of Distribution (Vz/F) of Raltegravir
NCT03667547 (11) [back to overview]Apparent Plasma Half-life (t1/2) of Raltegravir
NCT03667547 (11) [back to overview]Number of Participants With a Serious Adverse Event (SAE)
NCT03667547 (11) [back to overview]Apparent Total Plasma Clearance (CL/F) of Raltegravir

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

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

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

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

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

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

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Plasma Concentration for Contraceptives

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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PK Parameter: Trough Concentration (C24) With Median (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: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs

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

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

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

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

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

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

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

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

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Number of Patients That Discontinued With CAEs

(NCT00100048)
Timeframe: 48 Weeks

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

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Number of Patients That Discontinued With LAEs

(NCT00100048)
Timeframe: 48 Weeks

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

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Number of Patients With Clinical Adverse Experiences (CAEs)

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

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

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

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

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

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

(NCT00100048)
Timeframe: 96 Weeks

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

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Number of Patients With Laboratory Adverse Experiences (LAEs)

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

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

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

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

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

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Change From Baseline in CD4 Cell Count at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

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

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

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

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

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

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

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

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Change From Baseline in Plasma HIV RNA at Week 96

(NCT00100048)
Timeframe: Baseline and Week 96

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

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

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

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

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

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

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

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

(NCT00100048)
Timeframe: Week 24

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

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

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

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

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

(NCT00100048)
Timeframe: 48 weeks

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

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

(NCT00100048)
Timeframe: Week 24

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

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

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

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

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

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

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

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Change From Baseline in Plasma HIV RNA at Week 240

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

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

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Number of Patients With Serious LAEs

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

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

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Number of Patients With Serious CAEs at 96 Weeks

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
MK0518 200 mg b.i.d.439
MK0518 400 mg b.i.d.936
MK0518 600 mg b.i.d.540
Placebo342

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Number of Patients With Serious CAEs at 48 Weeks

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
MK0518 200 mg b.i.d.340
MK0518 400 mg b.i.d.738
MK0518 600 mg b.i.d.441
Placebo342

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Number of Patients With Serious CAEs at 168 Weeks

Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
MK0518 200 mg b.i.d.637
MK0518 400 mg b.i.d.1332
MK0518 600 mg b.i.d.738
Placebo342

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Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
With LAEsWithout LAEs
MK0518 200 mg b.i.d.1231
MK0518 400 mg b.i.d.1530
MK0518 600 mg b.i.d.1728
Placebo1233

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Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
With LAEsWithout LAEs
MK0518 200 mg b.i.d.1033
MK0518 400 mg b.i.d.1233
MK0518 600 mg b.i.d.1431
Placebo1134

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Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
With LAEsWithout LAEs
MK0518 200 mg b.i.d.1726
MK0518 400 mg b.i.d.1629
MK0518 600 mg b.i.d.1827
Placebo1233

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Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
With CAEsWithout CAEs
MK0518 200 mg b.i.d.430
MK0518 400 mg b.i.d.423
MK0518 600 mg b.i.d.450
Placebo387

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Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
With CAEsWithout CAEs
MK0518 200 mg b.i.d.376
MK0518 400 mg b.i.d.378
MK0518 600 mg b.i.d.414
Placebo378

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Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
With CAEsWithout CAEs
MK0518 200 mg b.i.d.430
MK0518 400 mg b.i.d.432
MK0518 600 mg b.i.d.450
Placebo387

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Number of Patients That Discontinued With Serious CAEs at 96 Weeks

(NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
MK0518 200 mg b.i.d.241
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo144

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Number of Patients That Discontinued With Serious CAEs at 48 Weeks

(NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.144
Placebo144

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Number of Patients That Discontinued With Serious CAEs at 168 Weeks

(NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
MK0518 200 mg b.i.d.340
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo144

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Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks

(NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.045
Placebo045

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Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks

(NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.045
Placebo045

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Number of Patients Discontinued With LAEs at 168 Weeks

(NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
MK0518 200 mg b.i.d.241
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.045
Placebo045

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Number of Patients That Died by 168 Weeks

(NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
DiedDid not Die
MK0518 200 mg b.i.d.340
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo045

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Number of Patients That Died by 48 Weeks

(NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
DiedDid not Die
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.144
Placebo045

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Number of Patients That Died by 96 Weeks

(NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
DiedDid Not Die
MK0518 200 mg b.i.d.241
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo045

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Number of Patients That Discontinued With CAEs at 168 Weeks

(NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
MK0518 200 mg b.i.d.340
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo144

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Number of Patients That Discontinued With CAEs at 48 Weeks

(NCT00105157)
Timeframe: 48 weeks

,,,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.144
Placebo144

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Number of Patients That Discontinued With CAEs at 96 Weeks

(NCT00105157)
Timeframe: 96 weeks

,,,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
MK0518 200 mg b.i.d.241
MK0518 400 mg b.i.d.144
MK0518 600 mg b.i.d.144
Placebo144

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Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies

Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases. (NCT00105157)
Timeframe: Baseline and Week 168

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK0518 200 mg b.i.d.96.9
MK0518 400 mg b.i.d.107.7
MK0518 600 mg b.i.d.147.4
Placebo25.5

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Change From Baseline in CD4 Cell Count at Week 24

Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) (NCT00105157)
Timeframe: Baseline and Week 24

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK0518 200 mg b.i.d.62.9
MK0518 400 mg b.i.d.112.8
MK0518 600 mg b.i.d.94.1
Placebo5.4

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Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies

Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases. (NCT00105157)
Timeframe: Baseline and Week 168

InterventionHIV RNA (log10 copies/mL) (Mean)
MK0518 200 mg b.i.d.-1.67
MK0518 400 mg b.i.d.-1.32
MK0518 600 mg b.i.d.-1.66
Placebo-0.33

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Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24

Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients (NCT00105157)
Timeframe: Baseline and Week 24

InterventionHIV RNA (log10 copies/mL) (Mean)
MK0518 200 mg b.i.d.-1.80
MK0518 400 mg b.i.d.-1.87
MK0518 600 mg b.i.d.-1.84
Placebo-0.35

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Number of Patients With Serious LAEs at 168 Weeks

Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
MK0518 200 mg b.i.d.142
MK0518 400 mg b.i.d.045
MK0518 600 mg b.i.d.144
Placebo045

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Number of Patients With Virologic Responses at Week 168 in Combined Substudies

Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168. (NCT00105157)
Timeframe: 168 weeks

,,,
InterventionParticipants (Number)
HIV RNA <400 copies/mLHIV RNA <50 copies/mL>1.0 log10 Drop in HIV RNA
MK0518 200 mg b.i.d.212022
MK0518 400 mg b.i.d.151315
MK0518 600 mg b.i.d.221923
Placebo555

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Number of Patients With Virologic Responses at Week 24

Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24 (NCT00105157)
Timeframe: 24 weeks

,,,
InterventionParticipants (Number)
HIV RNA <400 copies/mLHIV RNA <50 copies/mL>1.0 log10 Drop in HIV RNA
MK0518 200 mg b.i.d.302833
MK0518 400 mg b.i.d.322536
MK0518 600 mg b.i.d.323036
Placebo768

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Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48

Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL) (NCT00293254)
Timeframe: Baseline and Week 48

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.75
Placebo + OBT-0.87

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Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)

Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL) (NCT00293254)
Timeframe: Baseline and Week 156

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.37
Placebo + OBT-0.52

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Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156 (NCT00293254)
Timeframe: 156 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT50.2
Placebo + OBT21.0

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Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156 (NCT00293254)
Timeframe: 156 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT47.6
Placebo + OBT17.6

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Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48 (NCT00293254)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT71.1
Placebo + OBT37.8

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Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count(Cells/mm^3)

Mean change from baseline at Week 156 in CD4 cell count (cells/mm^3) (NCT00293254)
Timeframe: Baseline and Week 156

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT157.2
Placebo + OBT54.2

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Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240 (NCT00293254)
Timeframe: 240 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT41.3
Placebo + OBT13.4

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Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response

For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event-free). (NCT00293254)
Timeframe: 156 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT44.3
Placebo + OBT17.6

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Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)

Mean change from baseline at Week 240 in CD4 cell count (cells/mm^3) (NCT00293254)
Timeframe: Baseline and Week 240

InterventionCD4 Cell Count (Cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT172.1
Placebo + OBT54.1

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Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)

Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL) (NCT00293254)
Timeframe: Baseline and Week 240

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.31
Placebo + OBT-0.41

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Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240 (NCT00293254)
Timeframe: 240 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT45.7
Placebo + OBT13.4

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Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48 (NCT00293254)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT59.6
Placebo + OBT34.5

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Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16 (NCT00293254)
Timeframe: 16 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT62.0
Placebo + OBT36.1

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Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16 (NCT00293254)
Timeframe: 16 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT77.3
Placebo + OBT42.9

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16

Mean change from baseline at Week 16 in CD4 cell count (cells/mm^3) (NCT00293254)
Timeframe: Baseline and Week 16

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT85.8
Placebo + OBT39.9

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

Mean change from baseline at Week 48 in CD4 cell count (cells/mm^3) (NCT00293254)
Timeframe: Baseline and Week 48

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT98.4
Placebo + OBT39.8

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Change From Baseline in HIV RNA (Log 10 Copies/mL) at Week 16

Mean change from baseline at Week 16 in HIV RNA (log 10 copies/mL) (NCT00293254)
Timeframe: Baseline and Week 16

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.92
Placebo + OBT-1.06

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Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <50 Copies/mL

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 156 (NCT00293267)
Timeframe: 156 weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT53.4
Placebo + OBT25.6

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Double-Blind Extension - Week 156: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 156 (NCT00293267)
Timeframe: 156 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT57.3
Placebo + OBT25.6

[back to top]

Double-Blind Extension - Week 156: Change From Baseline in HIV RNA (log10 Copies/mL)

Mean change from baseline at Week 156 in HIV RNA (log10 copies/mL) (NCT00293267)
Timeframe: Baseline and Week 156

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.44
Placebo + OBT-0.51

[back to top]

Double-Blind Extension - Week 156: Change From Baseline in CD4 Cell Count (Cells/mm^3)

Mean change from baseline at Week 156 in CD4 Cell Count (cells/mm^3) (NCT00293267)
Timeframe: Baseline and Week 156

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT170.9
Placebo + OBT71.03

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Change From Baseline in HIV RNA (log10 Copies/mL) at Week 48

Mean change from baseline at Week 48 in HIV RNA (log10 copies/mL) (NCT00293267)
Timeframe: Baseline and Week 48

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.67
Placebo + OBT-0.68

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Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16

Mean change from baseline at Week 16 in HIV RNA (log10 copies/mL) (NCT00293267)
Timeframe: Baseline and Week 16

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.85
Placebo + OBT-0.78

[back to top]

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

Mean change from baseline at Week 48 in CD4 Cell Count (cells/mm^3) (NCT00293267)
Timeframe: Baseline and Week 48

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT120.2
Placebo + OBT49.4

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Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 48

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 48 (NCT00293267)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT64.5
Placebo + OBT31.4

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Percentage of Participants Achieving HIV RNA <50 Copies/mL at Week 16

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 16 (NCT00293267)
Timeframe: 16 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT61.6
Placebo + OBT33.3

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Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 48

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 48 (NCT00293267)
Timeframe: 48 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT73.6
Placebo + OBT36.4

[back to top]

Percentage of Participants Achieving HIV RNA <400 Copies/mL at Week 16

Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16 (NCT00293267)
Timeframe: 16 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT77.7
Placebo + OBT41.0

[back to top]

Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <50 Copies/mL

Percentage of participants who achieved HIV RNA <50 copies/mL at Week 240 (NCT00293267)
Timeframe: 240 weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT42.2
Placebo + OBT18.6

[back to top]

Open-Label Extension - Week 240: Percentage of Participants Achieving HIV RNA <400 Copies/mL

Percentage of participants who achieved HIV RNA <400 Copies/mL at Week 240 (NCT00293267)
Timeframe: 240 Weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT45.3
Placebo + OBT20.3

[back to top]

Open-Label Extension - Week 240: Change From Baseline in HIV RNA (log10 Copies/mL)

Mean change from baseline at Week 240 in HIV RNA (log10 copies/mL) (NCT00293267)
Timeframe: Baseline and Week 240

InterventionHIV RNA (log10 copies/mL) (Mean)
Raltegravir 400 mg b.i.d. + OBT-1.24
Placebo + OBT-0.45

[back to top]

Open-Label Extension - Week 240: Change From Baseline in CD4 Cell Count (Cells/mm^3)

Mean change from baseline at Week 240 in CD4 Cell Count (cells/mm^3) (NCT00293267)
Timeframe: Baseline and Week 240

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT193.6
Placebo + OBT68.2

[back to top]

Double-Blind Extension - Week 156: Percentage of Participants Without Loss of Virologic Response

For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). (NCT00293267)
Timeframe: 156 weeks

InterventionPercentage of Participants (Number)
Raltegravir 400 mg b.i.d. + OBT47.4
Placebo + OBT24.6

[back to top]

Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 16

Mean change from baseline at Week 16 in CD4 Cell Count (cells/mm^3) (NCT00293267)
Timeframe: Baseline and Week 16

InterventionCD4 Cell Count (cells/mm^3) (Mean)
Raltegravir 400 mg b.i.d. + OBT82.7
Placebo + OBT31.3

[back to top]

Number of Participants With Serious CAEs at Week 48

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.27255
MK-0518 400 mg b.i.d.28253

[back to top]

Number of Participants With Serious CAEs at Week 240

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.57225
MK-0518 400 mg b.i.d.57224

[back to top]

Number of Participants With Serious CAEs at Week 156

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.46236
MK-0518 400 mg b.i.d.46235

[back to top]

Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8

Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression (NCT00369941)
Timeframe: 8 Weeks

,
InterventionParticipants (Number)
With Nervous System SymptomsWithout Nervous System Symptoms
Efavirenz 600 mg q.h.s.147135
MK-0518 400 mg b.i.d.57224

[back to top]

Number of Participants With LAEs at Week 96

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.53229
MK-0518 400 mg b.i.d.33248

[back to top]

Number of Participants With LAEs at Week 240

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.77205
MK-0518 400 mg b.i.d.56225

[back to top]

Number of Participants With LAEs at Week 156

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.63219
MK-0518 400 mg b.i.d.41240

[back to top]

Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With LAEsWithout LAEs
Efavirenz 600 mg q.h.s.41241
MK-0518 400 mg b.i.d.27254

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Number of Participants With Serious LAEs at Week 96

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

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Number of Participants With Serious LAEs at Week 48

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

[back to top]

Number of Participants With Serious LAEs at Week 240

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

[back to top]

Number of Participants With Serious LAEs at Week 156

"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With Serious LAEsWithout Serious LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

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Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.27210
MK-0518 400 mg b.i.d.25328

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Number of Participants With CAEs at Week 96

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2748
MK-0518 400 mg b.i.d.26516

[back to top]

Number of Participants With CAEs at Week 240

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2766
MK-0518 400 mg b.i.d.27110

[back to top]

Number of Participants With CAEs at Week 156

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
With CAEsWithout CAEs
Efavirenz 600 mg q.h.s.2766
MK-0518 400 mg b.i.d.26714

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Number of Participants That Discontinued With Serious CAEs at Week 96

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.5277
MK-0518 400 mg b.i.d.8273

[back to top]

Number of Participants That Discontinued With Serious CAEs at Week 48

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with Serious CAEsDid Not Discontinue with Serious CAEs
Efavirenz 600 mg q.h.s.4278
MK-0518 400 mg b.i.d.7274

[back to top]

Number of Participants That Discontinued With Serious CAEs at Week 240

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.10272
MK-0518 400 mg b.i.d.11270

[back to top]

Number of Participants That Discontinued With Serious CAEs at Week 156

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With Serious CAEsDid Not Discontinue With Serious CAEs
Efavirenz 600 mg q.h.s.6276
MK-0518 400 mg b.i.d.10271

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Number of Participants That Discontinued With CAEs at Week 96

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.17265
MK-0518 400 mg b.i.d.10271

[back to top]

Number of Participants That Discontinued With CAEs at Week 48

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with CAEsDid Not Discontinue with CAEs
Efavirenz 600 mg q.h.s.17265
MK-0518 400 mg b.i.d.9272

[back to top]

Number of Participants That Discontinued With CAEs at Week 156

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.21261
MK-0518 400 mg b.i.d.13268

[back to top]

Number of Participants That Died by Week 96

All participant deaths in the span of 96 weeks on study were recorded. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.0282
MK-0518 400 mg b.i.d.3278

[back to top]

Number of Participants That Died by Week 48

All participant deaths in the span of 48 weeks on study were recorded. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.0282
MK-0518 400 mg b.i.d.2279

[back to top]

Number of Participants That Died by Week 240

All participant deaths in the span of 240 weeks on study were recorded. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.5277
MK-0518 400 mg b.i.d.5276

[back to top]

Number of Participants That Died by Week 156

All participant deaths in the span of 156 weeks on study were recorded. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
DiedDid Not Die
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.4277

[back to top]

Number of Participants That Discontinued With CAEs at Week 240

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With CAEsDid Not Discontinue With CAEs
Efavirenz 600 mg q.h.s.25257
MK-0518 400 mg b.i.d.14267

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Number of Participants Discontinued With LAEs at Week 96

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.2280
MK-0518 400 mg b.i.d.0281

[back to top]

Number of Participants Discontinued With LAEs at Week 48

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks

,
InterventionParticipants (Number)
Discontinued with LAEsDid Not Discontinue with LAEs
Efavirenz 600 mg q.h.s.1281
MK-0518 400 mg b.i.d.0281

[back to top]

Number of Participants With Serious CAEs at Week 96

Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
Efavirenz 600 mg q.h.s.33249
MK-0518 400 mg b.i.d.37244

[back to top]

Number of Participants Discontinued With LAEs at Week 156

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.3279
MK-0518 400 mg b.i.d.0281

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Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.241
Efavirenz 600 mg q.h.s.230

[back to top]

Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.228
Efavirenz 600 mg q.h.s.222

[back to top]

Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.198
Efavirenz 600 mg q.h.s.171

[back to top]

Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.212
Efavirenz 600 mg q.h.s.192

[back to top]

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.240
Efavirenz 600 mg q.h.s.229

[back to top]

Number of Participants Discontinued With LAEs at Week 240

A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks

,
InterventionParticipants (Number)
Discontinued With LAEsDid Not Discontinue With LAEs
Efavirenz 600 mg q.h.s.3279
MK-0518 400 mg b.i.d.0281

[back to top]

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.206
Efavirenz 600 mg q.h.s.181

[back to top]

Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.224
Efavirenz 600 mg q.h.s.203

[back to top]

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

Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 48

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.189.1
Efavirenz 600 mg q.h.s.163.3

[back to top]

Change From Baseline in CD4 Cell Count at Week 96

Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 96

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.239.6
Efavirenz 600 mg q.h.s.224.8

[back to top]

Change From Baseline in CD4 Cell Count at Week 240

Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 240

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.373.7
Efavirenz 600 mg q.h.s.311.6

[back to top]

Change From Baseline in CD4 Cell Count at Week 156

Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 156

InterventionCD4 Cell Count (cells/mm3) (Mean)
MK-0518 400 mg b.i.d.331.7
Efavirenz 600 mg q.h.s.295.2

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks

InterventionParticipants (Number)
MK-0518 400 mg b.i.d.252
Efavirenz 600 mg q.h.s.241

[back to top]

Number of Patients That Discontinued Due to CAEs Through 24 Weeks

(NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
Discontinued with CAEsDid not Discontinue with CAEs
KALETRA™ 400/100 mg b.i.d.4170
MK0518 400 mg b.i.d.4170

[back to top] [back to top]

Number of Patients That Discontinued Due to LAEs Through 24 Weeks

(NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
Discontinued with LAEsDid Not Discontinue with LAEs
KALETRA™ 400/100 mg b.i.d.1173
MK0518 400 mg b.i.d.2172

[back to top] [back to top]

Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks

An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product (NCT00443703)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
With CAEsWithout CAEs
KALETRA™ 400/100 mg b.i.d.10668
MK0518 400 mg b.i.d.10965

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Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks

A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S (Merck & Co., Inc.) product, whether or not considered related to the use of the product (NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
With LAEsWithout LAEs
KALETRA™ 400/100 mg b.i.d.7167
MK0518 400 mg b.i.d.11163

[back to top]

Number of Patients With Serious CAEs Through 24 Weeks

Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose (NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
With Serious CAEsWithout Serious CAEs
KALETRA™ 400/100 mg b.i.d.10164
MK0518 400 mg b.i.d.15159

[back to top] [back to top]

Number of Patients With Serious LAEs Through 24 Weeks

Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose (NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
With LAEsWithout LAEs
KALETRA™ 400/100 mg b.i.d.0174
MK0518 400 mg b.i.d.0174

[back to top]

Median Percent Change From Baseline in Serum Triglyceride at Week 12

Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. (NCT00443703)
Timeframe: Baseline and Week 12

InterventionPercent Change (Median)
MK0518 400 mg b.i.d.-41.50
KALETRA™ 400/100 mg b.i.d.3.56

[back to top]

Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12

(NCT00443703)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-12.83
KALETRA™ 400/100 mg b.i.d.0.70

[back to top]

Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24

(NCT00443703)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-13.81
KALETRA™ 400/100 mg b.i.d.2.70

[back to top]

Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 12

(NCT00443703)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-0.86
KALETRA™ 400/100 mg b.i.d.0.78

[back to top]

Mean Percent Change From Baseline in Fasting Serum High-Density Lipoprotein Cholesterol (HDL-C) at Week 24

(NCT00443703)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-4.42
KALETRA™ 400/100 mg b.i.d.-1.70

[back to top]

Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

(NCT00443703)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-2.43
KALETRA™ 400/100 mg b.i.d.2.05

[back to top]

Mean Percent Change From Baseline in Fasting Serum Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24

(NCT00443703)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-1.12
KALETRA™ 400/100 mg b.i.d.8.54

[back to top]

Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

(NCT00443703)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-15.17
KALETRA™ 400/100 mg b.i.d.2.31

[back to top]

Mean Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24

(NCT00443703)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-15.03
KALETRA™ 400/100 mg b.i.d.5.53

[back to top]

Median Percent Change From Baseline in Serum Triglyceride at Week 24

Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. (NCT00443703)
Timeframe: Baseline and Week 24

InterventionPercent Change (Median)
MK0518 400 mg b.i.d.-44.53
KALETRA™ 400/100 mg b.i.d.6.14

[back to top]

Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24

(NCT00443703)
Timeframe: Week 24

InterventionParticipants (Number)
MK0518 400 mg b.i.d.139
KALETRA™ 400/100 mg b.i.d.152

[back to top]

Number of Patients That Died by 24 Week Last Patient Last Visit

(NCT00443703)
Timeframe: 24 Week last patient last visit

,
Interventionparticipants (Number)
DiedDid Not Die
KALETRA™ 400/100 mg b.i.d.0174
MK0518 400 mg b.i.d.0174

[back to top]

Median Percent Change From Baseline in Serum Triglyceride at Week 12

Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. (NCT00443729)
Timeframe: Baseline and Week 12

InterventionPercent Change (Median)
MK0518 400 mg b.i.d.-42.82
KALETRA™ 400/100 mg b.i.d.8.20

[back to top]

Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

(NCT00443729)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.5.12
KALETRA™ 400/100 mg b.i.d.6.06

[back to top]

Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

(NCT00443729)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-14.77
KALETRA™ 400/100 mg b.i.d.2.91

[back to top]

Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24

(NCT00443729)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-15.83
KALETRA™ 400/100 mg b.i.d.5.26

[back to top]

Number of Patients That Discontinued Due to LAEs Through 24 Weeks

(NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
Discontinued with LAEsDid Not Discontinue with LAEs
KALETRA™ 400/100 mg b.i.d.0178
MK0518 400 mg b.i.d.0176

[back to top]

Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks

(NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
With CAEsWithout CAEs
KALETRA™ 400/100 mg b.i.d.11266
MK0518 400 mg b.i.d.12353

[back to top]

Median Percent Change From Baseline in Serum Triglyceride at Week 24

Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile. (NCT00443729)
Timeframe: Baseline and Week 24

InterventionPercent Change (Median)
MK0518 400 mg b.i.d.-44.50
KALETRA™ 400/100 mg b.i.d.7.06

[back to top]

Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24

(NCT00443729)
Timeframe: 24 Weeks

InterventionParticipants (Number)
MK0518 400 mg b.i.d.154
KALETRA™ 400/100 mg b.i.d.167

[back to top]

Number of Patients That Died by 24 Week Last Patient Last Visit

(NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
DiedDid Not Die
KALETRA™ 400/100 mg b.i.d.0178
MK0518 400 mg b.i.d.0176

[back to top]

Number of Patients With Serious LAEs Through 24 Weeks

Serious LAEs are any LAEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose (NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
With LAEsWithout LAEs
KALETRA™ 400/100 mg b.i.d.0178
MK0518 400 mg b.i.d.0176

[back to top] [back to top]

Number of Patients That Discontinued Due to CAEs Through 24 Weeks

(NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
Discontinued with CAEsDid Not Discontinue with CAEs
KALETRA™ 400/100 mg b.i.d.0178
MK0518 400 mg b.i.d.0176

[back to top]

Number of Patients With Serious CAEs Through 24 Weeks

Serious CAEs are any AEs occurring at any dose that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose (NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
With Serious CAEsWithout Serious CAEs
KALETRA™ 400/100 mg b.i.d.8170
MK0518 400 mg b.i.d.4172

[back to top]

Number of Patients With Laboratory Adverse Experiences (LAEs) Through 24 Weeks

(NCT00443729)
Timeframe: 24 Week last patient last visit

,
InterventionParticipants (Number)
With LAEsWithout LAEs
KALETRA™ 400/100 mg b.i.d.6172
MK0518 400 mg b.i.d.8168

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Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12

(NCT00443729)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-12.41
KALETRA™ 400/100 mg b.i.d.1.29

[back to top]

Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24

(NCT00443729)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-13.64
KALETRA™ 400/100 mg b.i.d.3.55

[back to top]

Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12

(NCT00443729)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-0.64
KALETRA™ 400/100 mg b.i.d.-2.50

[back to top]

Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24

(NCT00443729)
Timeframe: Baseline and Week 24

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.-1.77
KALETRA™ 400/100 mg b.i.d.-0.15

[back to top]

Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

(NCT00443729)
Timeframe: Baseline and Week 12

InterventionPercent Change (Mean)
MK0518 400 mg b.i.d.3.99
KALETRA™ 400/100 mg b.i.d.0.55

[back to top]

Change of CD4 Percent From Baseline

Change in CD4 percent from baseline was calculated as the value of the later visit minus the value at baseline. (NCT00485264)
Timeframe: Baseline, Week 24, 48

,,,,,
Interventionpercentage of total lymphocytes (Mean)
Baseline to Week 24Baseline to Week 48
Cohort I4.15.2
Cohort IIA2.26.0
Cohort IIB0.81.6
Cohort III5.34.3
Cohort IV6.26.4
Cohort V9.08.7

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Percentage of Participants With ≥1 log10 Drop From Baseline in HIV RNA or HIV RNA <400 Copies/mL

Plasma HIV RNA concentrations were determined at entry and at regular intervals using the HIV-1 MONITOR Test, version 1.5 (Roche Molecular Diagnostics) or RealTime HIV-1 (Abbott Molecular), and analyses used the Observed Failure Approach. (NCT00485264)
Timeframe: Baseline, Week 24, 48

,,,,,
Interventionpercentage of participants (Number)
Baseline to Week 24Baseline to Week 48
Cohort I72.475
Cohort IIA5075
Cohort IIB76.990.9
Cohort III7084.2
Cohort IV85.792.9
Cohort V10080

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Change of CD4 Count From Baseline

Change in CD4 cell count from baseline was calculated as the value at later visit minus the value at baseline. (NCT00485264)
Timeframe: Baseline, Week 24, 48

,,,,,
Interventioncells/µL (Mean)
Baseline to Week 24Baseline to Week 48
Cohort I114.6168.4
Cohort IIA-35.8189.5
Cohort IIB143.476.8
Cohort III147.2158.1
Cohort IV400.5278.8
Cohort V499.2876.0

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PK Parameter: Time to Half of Maximum Plasma Concentration Cmax (T1/2)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Time to half of maximum plasma concentration Cmax (T1/2) was taken directly from the observed concentration-time data. (NCT00485264)
Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionhour (Mean)
Cohort I4.9
Cohort IIA3.7
Cohort IIB4.5
Cohort III4.1
Cohort IV3.0
Cohort V2.1

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PK Parameter: Maximum Plasma Concentration (Cmax)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Maximum plasma concentration (Cmax) was taken directly from the observed concentration-time data. (NCT00485264)
Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionng/mL (Mean)
Cohort I2813.1
Cohort IIA4055.7
Cohort IIB5314.2
Cohort III5204.8
Cohort IV5683.0
Cohort V4299.0

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PK Parameter: Concentration at 12 Hours Postdose (C12h)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). Plasma concentration at 12 hours postdose (C12h) was taken directly from the observed concentration-time data. (NCT00485264)
Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionng/mL (Mean)
Cohort I197.0
Cohort IIA399.4
Cohort IIB78.7
Cohort III39.5
Cohort IV56.4
Cohort V99.6

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Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule. (NCT00485264)
Timeframe: Measured between days 5 and 12 of raltegravir initiation; Blood samples were drawn pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionhour*mg/L (Mean)
Cohort I10.2
Cohort IIA13.4
Cohort IIB10.5
Cohort III9.5
Cohort IV9.3
Cohort V10.9

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Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)

Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included. (NCT00485264)
Timeframe: From study entry through Week 48

Interventionpercentage of participants (Number)
Cohort I23.7
Cohort IIA25
Cohort IIB23.1
Cohort III40
Cohort IV42.9
Cohort V33.3

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Percentage of Participants With Grade 3 or 4 Adverse Events (AEs)

Adverse events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0. All grade 3 and higher signs, symptoms, and laboratory toxicities were included. (NCT00485264)
Timeframe: From study entry through Week 24

Interventionpercentage of participants (Number)
Cohort I20.3
Cohort IIA25
Cohort IIB15.4
Cohort III30
Cohort IV35.7
Cohort V33.3

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Number of Participants Who Died

Number of participants who died were summarized. (NCT00485264)
Timeframe: From study entry through Week 48

Interventionparticipants (Number)
Cohort I0
Cohort IIA0
Cohort IIB0
Cohort III0
Cohort IV0
Cohort V0

[back to top]

Number of Participants Who Died

Number of participants who died were summarized. (NCT00485264)
Timeframe: From study entry through Week 24

Interventionparticipants (Number)
Cohort I0
Cohort IIA0
Cohort IIB0
Cohort III0
Cohort IV0
Cohort V0

[back to top]

Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication

The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related. (NCT00485264)
Timeframe: From study entry through Week 48

Interventionparticipants (Number)
Cohort I0
Cohort IIA0
Cohort IIB0
Cohort III0
Cohort IV -Data Not Included in This Interim Analysis.0
Cohort V -Data Not Included in This Interim Analysis.0

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Number of Participants Terminated From Treatment Due to Suspected Adverse Drug Reaction (SADR) Attributable to the Study Medication

The attribution of relationship of serious adverse events to study drug for the purposes of employing the start, stop and pause rules was by consensus among the site investigator, study team (which includes representatives from Merck) and the Division of AIDS medical officer; if unanimous agreement between them cannot be established, the attribution made by the majority of these 3 persons or entities will be used. Gradation of relationship will use the following terminology: Not related, Probably not related, Possibly related, Probably related or Definitely related. (NCT00485264)
Timeframe: From study entry through Week 24

Interventionparticipants (Number)
Cohort I0
Cohort IIA0
Cohort IIB0
Cohort III0
Cohort IV0
Cohort V0

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Change in Total CD4 Cell Count

CD4 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12 (NCT00515827)
Timeframe: At pre-entry, entry, and week 12

Interventioncells/mm^3 (Median)
Raltegravir (Arm A)42
Placebo (Arm B)-44

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Number of Participants Who Discontinued Study Drug

Participants who discontinued randomized study treatment for any reason (NCT00515827)
Timeframe: From first day of treatment to week 12

Interventionparticipants (Number)
Raltegravir (Arm A)4
Placebo (Arm B)1

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HIV-1 RNA Level

HIV-1 RNA level, as measured by single copy assay (units are copies/ml), averaged at weeks 10 and 12. The quantification limit of single copy assay was determined by the volume of plasma tested. When averaging the week 10 and 12 measurements, if one of both measurements were below the single copy assay lower limits, the lower limit of quantification was used to compute the average and the result was treated as below the averaged value. (NCT00515827)
Timeframe: At Weeks 10 and 12

Interventioncopies/mL (Median)
Raltegravir (Arm A)1.2
Placebo (Arm B)1.7

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Change in Total CD8 Cell Count

CD8 cell counts were assessed by flow cytometry at pre-entry and entry (the baseline value was the average of the two measurements) and at week 12 (NCT00515827)
Timeframe: At pre-entry, entry, and week 12

Interventioncells/mm^3 (Median)
Raltegravir (Arm A)55
Placebo (Arm B)-39

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Change in HIV-1 RNA Level

Change in HIV-1 RNA level, as measured by single copy assay (units are copies/ml), from baseline to weeks 10/12 . When averaging the measurements at pre-entry and entry, and at weeks 10 and 12, measurements below the lower limit of quantification (LLQ) were imputed a value of the LLQ divided by 2. (NCT00515827)
Timeframe: At pre-entry, entry, weeks 10 and 12

Interventioncopies/mL (Median)
Raltegravir (Arm A)-0.2
Placebo (Arm B)-0.1

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Change in CD4+/CD38+/HLA-DR+ Percent

Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD4+/CD38+/HLA-DR+% at week 12 minus CD4+/CD38+/HLA-DR+% at baseline. (NCT00515827)
Timeframe: At pre-entry, entry, and week 12

Intervention% CD4 cells co-express CD38+ and HLA-DR+ (Median)
Raltegravir (Arm A)-1
Placebo (Arm B)0

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Change in CD8+/CD38+/HLA-DR+ Percent

Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38 and Human leukocyte antigen (HLA)-DR. Levels measured at pre-entry and entry were averaged. Change from baseline to week 12 was defined as CD8+/CD38+/HLA-DR+% at week 12 minus CD8+/CD38+/HLA-DR+% at baseline. (NCT00515827)
Timeframe: At pre-entry, entry, and week 12

Intervention% CD8 cells co-express CD38+ and HLA-DR+ (Median)
Raltegravir (Arm A)-1
Placebo (Arm B)0

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The Percentage of Patients Who Maintain a Viral Load < 50 Copies/ml After Being Switched From Enfuvirtide to Raltegravir

evaluate the percent of patients with viral load of <50 copies at week 24 of study after being switched from enfuvirtide to raltegravir (NCT00523237)
Timeframe: 24 weeks

Interventionpercentage (Number)
Enfuvirtide Switch to Raltegravir Arm86

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The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.

(NCT00525733)
Timeframe: 48 weeks

Intervention# subjects without detectable viremia (Number)
3-drug Standard Therapy3
5-drug Experimental Therapy9

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

To study the immunologic effect of changing enfuvirtide to MK-0518 (raltegravir) in HIV-1 infected patients who have an undetectable level of serum HIV (undetectable serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay)on their current HIV medication regimen. (NCT00529243)
Timeframe: 24 Weeks

Interventioncells/mm^3 (Mean)
MK-0518 (Raltegravir)32

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Number of Patients With Undetectable Human Immunodeficiency Virus (HIV) Viral Load at Week 24.

To assess the virologic effect of changing enfuvirtide to MK-0518 (raltegravir) in human immunodeficiency virus type 1 (HIV-1) infected patients who have an undetectable level of serum HIV (undetectable level of serum HIV defined as < 75 copies/ml by bDNA assay or < 50 copies/ml by Ultrasensitive PCR assay) on their current HIV medication regimen. (NCT00529243)
Timeframe: 24 Weeks

Interventionparticipants (Number)
MK-0518 (Raltegravir)49

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Participants With Newly Acquired HIV Drug Resistance Between Study Entry and Confirmed Virologic Failure

Defined among the subgroup of participants experiencing the outcome of confirmed virologic failure. Newly acquired HIV drug resistance is defined as one or more ARVs with partial resistance or resistance when pre-entry resistance was fully sensitive or resistant when pre-entry resistance was fully sensitive or partially sensitive. The ARVs included for resistance acquisition included the following: darunavir/ritonavir; etravirine, tipranavir, tenofovir, emtracitabine, lamivudine, zidovudine, abacavir. (NCT00537394)
Timeframe: Between baseline and confirmed virologic failure (up to 96 weeks)

Interventionparticipants (Number)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)18
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)13

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Change in CD4 Count From Baseline

Baseline CD4 calculated as average of pre-entry and entry values. Closest observed result between 42 and up to 54 weeks (for week 48) or between 90 and up to 110 weeks (for week 96), used if multiple results available. Missing values excluded. (NCT00537394)
Timeframe: From study entry to Weeks 48 and 96

,
Interventioncells/mm^3 (Median)
Change from entry to week 48 (N=166; N=163)Change from entry to week 96 (N= 154; N=157)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)105.5140.8
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)89.5115.5

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Change in Plasma HIV-1 Viral Load From Baseline to Week 1

Method of Kaplan and Meier used to accommodate left-censoring for those whose week 1 levels < 50 copies/mL. (NCT00537394)
Timeframe: From baseline to Week 1 evaluation

Interventionlog10 copies/mL (Median)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)1.3
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)1.4

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Number of Participants With Change in Virus Co-receptor Tropism Among Those With R5-only Tropic Virus at Study Entry

HIV Co-receptor tropism test result of either dual/mixed or evidence of X4 using virus from sample collected at confirmed virologic failure. (NCT00537394)
Timeframe: From study entry to time of confirmed virological failure (up to 96 weeks)

Interventionparticipants (Number)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)3
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)2

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Percent of Participants With Regimen Failure, Defined as a Confirmed Virologic Failure or Discontinuation of Randomized NRTI Component of Study Treatment

Virologic failure defined as confirmed plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for the discontinuation outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Results report percent of participants reaching regimen failure outcome by week 48 evaluation using Kaplan-Meier method. (NCT00537394)
Timeframe: From study entry to end of Week 48 evaluation window

Interventionpercentage of participants (Number)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)26.0
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)29.8

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Time From Randomization to Discontinuation of Randomized NRTI Component of Study Treatment

Discontinuation of Randomized NRTI component of Study Treatment is defined as permanently stopping all NRTIs among those randomized to add NRTIs, or starting any NRTI among those randomized to omit NRTIs. Subjects leaving the study for reasons other than death, relocation, incarceration, or site closure were reviewed for meeting this outcome by a blinded, independent panel. Additionally, any participant failing to start study treatment after randomization and prior to closure was also reviewed. Event times were scheduled study weeks when discontinuation events occurred. Censoring times were latest scheduled study visit weeks with evaluation. (NCT00537394)
Timeframe: From randomization to week 96 study visit

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)036NA
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)03648

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Time From Treatment Dispensation to Serious Non-AIDS-defining Events

Serious Non-AIDS defining Events were adjudicated by independent and blinded review and possible events included serious diagnoses in the following disease areas: liver, cardiovascular, end-stage renal, non-AIDS malignancy, and diabetes mellitus. Week 96 study visit could take place up to 110 weeks following randomization. Event times were the exact weeks following treatment initiation corresponding to the diagnosis dates of the qualifying serious non-AIDS defining events. Censoring times were the weeks following treatment initiation corresponding to the latest study visit. (NCT00537394)
Timeframe: From treatment initiation to week 96 study visit

,
Interventionweeks (Number)
1st percentile5th percentile
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)4.960.0
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)29.3NA

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Time From Treatment Dispensation to First Study ARV Modification (Excluding NRTIs, if Applicable)

First study ARV modification included any discontinuation or substitution of any chosen and initiated ARV for any reason. Events prompting study medication change could include protocol required (e.g. safety), protocol recommended but not required (e.g. virologic failure), or participant motivated (such as non-adherence, loss to follow-up or death; in other words, not protocol recommended or required). Event times were the exact weeks from treatment initiation to the time of qualifying regimen modification. Censoring times were the exact weeks from treatment initiation to the last date of study drugs. The week 96 (final study visit) could occur up through 110 weeks following randomization. (NCT00537394)
Timeframe: From treatment dispensation to week 96 study visit

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)9.031.198.0
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)24.038.0NA

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Time From Treatment Dispensation to First Grade 3 or Higher (and at Least One Grade Higher Than Baseline) Signs/Symptom or Laboratory Abnormality

Events following permanent discontinuation of NRTI assignment are excluded (i.e. censoring at time of this event, if applicable). Week 96 study visit could occur up to 110 weeks following randomization. Censoring time was the latest study visit when participant was evaluated or when NRTI assignment was discontinued (when applicable). Event time was the exact number of weeks following treatment initiation when the qualifying sign/symptom started (for those safety events triggered by a sign/symptom), or exact number of weeks following treatment initiation when specimen from qualifying laboratory result was drawn (for those safety events triggered by a laboratory abnormality). (NCT00537394)
Timeframe: From treatment dispensation to week 96 study visit

,
Interventionweeks (Number)
5th percentile25th percentile50th percentile
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)3.124.7NA
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)3.925.397.7

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Time From Randomization to Confirmed Virological Failure

Virologic failure defined as confirmed (two consecutive) plasma HIV-1 RNA meeting 1 of the following 4 criteria: < 1.0 log10 copies/mL reduction from baseline level and >= 200 copies/mL at or after week 12 evaluation; >= 200 copies/mL after 1 measurement < 200 copies/mL; absence of any values < 200 copies/mL by and including week 24 evaluation; >= 200 copies/mL at week 48 evaluation. Event time was the scheduled study visit week when the initial plasma HIV-1 RNA specimen meeting the failure definition was collected. Censoring time was the latest scheduled study visit week when a plasma HIV-1 RNA specimen was collected and tested. (NCT00537394)
Timeframe: From randomization to week 96 study visit

,
Interventionweeks (Number)
5th percentile10th percentile25th percentile
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)121248
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)121248

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Number of Participants With Plasma HIV-1 Viral Load < 50 Copies/ml

Number of participants with plasma HIV-1 Viral load < 50 copies/mL at study visit weeks 24, 48, and 96. Closest observed result between 20 and up to 30 weeks (for week 24), between 42 and up to 54 (for week 48), and between 90 and up to 110 (for week 96) used if multiple results available. Missing values excluded. (NCT00537394)
Timeframe: At Weeks 24, 48, 96

,
Interventionparticipants (Number)
Week 24: Number with RNA < 50 c/mL (N=170; N=171)Week 48: Number with RNA < 50 c/mL (N=169; N=165)Week 96: Number with RNA < 50 c/mL (N=158; N=158)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)122112107
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)117106109

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Number of Participants Self-reporting Non-adherence to Assigned Study ARVS (Excluding NRTIs, if Applicable)

Results represent self-report of non-adherence during the 4-day period prior to the outcome evaluation visit. Participants in follow-up for whom these data are missing for any reason are inferred as not-adherent. (NCT00537394)
Timeframe: At Weeks 24 and 48

,
Interventionparticipants (Number)
Week 24 (N=170; N=172)Week 48 (N=167; N=163)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)2530
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)2626

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Change in Summarized Quality of Life Score

Quality-of-life score at each evaluation based upon a single question assessing participants' self-report of general health with a range of 0 (representing worst health status) to 100 (representing perfect health). (NCT00537394)
Timeframe: At study entry and Weeks 24, 48, 96

,
Interventionunits on a scale (Median)
Change from baseline to week 24 (N=165; N=165)Change from baseline to week 48 (N=161; N=158)Change from baseline to week 96 (N=155; N=154)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)000
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)500.5

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Change in Fasting Non-HDL Cholesterol From Baseline

Fasting non-HDL cholesterol calculated from difference between fasting total cholesterol and fasting HDL level. Missing values and non-fasting values excluded. (NCT00537394)
Timeframe: From study entry to Weeks 24, 48

,
Interventionmg/dL (Mean)
Change from baseline to week 24 (N=131; N=121)Change from baseline to week 48 (N=125 ; N=117)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)4.17.6
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)20.819.8

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Change in Cardiovascular Risk Score From Baseline

Cardiovascular risk score defined by Framingham providing an estimate of the probability of developing cardiovascular disease over the next 10-year period. Persons with a historical cardiovascular event (CAD, cerebro- or peripheral- vascular disorder, MI or stroke), were excluded, and scores were not calculated at follow-up times after individuals had a cardiovascular event. Missing values for input data (e.g. smoking status) resulted in a missing value for Framingham score. (NCT00537394)
Timeframe: At Weeks 24, 48, and 96

,
Interventionunits on a scale (Mean)
Week 24 (N= 150; N=147)Week 48 (N=143; N=144)Week 96 (N=129; N=132)
Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)-0.70.10.5
Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)0.30.81.1

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Medication Regimen Completion Rates

Pill counts performed at 14 and 28 days (NCT00594646)
Timeframe: 28 days

Interventionparticipants (Number)
Completed as prescribedStopped or Modified regimenLost to follow-up
Group 1572815

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Number of HIV-1 Infected Participants

Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected (NCT00594646)
Timeframe: 90 days

Interventionparticipants (Number)
Group 10

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A Change in the Number of HIV Infected Cells.

A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment. (NCT00614458)
Timeframe: 20 weeks

Interventioninfected cells /million cells (Median)
Effect on Latent HIV of Adding Raltegravir and VPA to ART0.390

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Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent RTG 400mg BID.

RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00614991)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

,,
Interventionng/mL (Mean)
Cmin (ng/mL)Cmax (ng/mL)
Group A & B0.320.95
Group C & D0.460.44
Group E & F0.590.85

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Cmin/Cmax: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F (NCT00614991)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

,,
Interventionng/mL (Mean)
Cmin (ng/mL)Cmax (ng/mL)
Group A & B0.670.83
Group C & D0.670.75
Group E & F0.831.27

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Number of Participants Who Experienced Adverse Events

"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare adverse events for each sequence and not for each regimen. The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004." (NCT00614991)
Timeframe: Day 0 through Day 49

Interventionparticipants (Number)
Group A0
Group B4
Group C6
Group D5
Group E5
Group F4

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CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F (NCT00614991)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

InterventionL/h (Mean)
Group A & B1.02
Group C & D2.30
Group E & F1.46

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AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F (NCT00614991)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

Interventionng•h/mL (Mean)
Group A & B0.71
Group C & D0.46
Group E & F0.70

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AUC: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F (NCT00614991)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

Interventionng•h/mL (Mean)
Group A & B0.81
Group C & D0.75
Group E & F1.13

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CL/F: Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F (NCT00614991)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

InterventionL/H (Mean)
Group A & B1.26
Group C & D1.43
Group E & F1.05

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Number of Participants With HIV-1 RNA Response: ≥ 1 Log Decrease in Viral Load

HIV RNA levels were determined with a non-commercial, sensitive single copy assay for HIV. The primary outcome measure was to determine the number of individuals with ≥10fold decrease in HIV RNA (NCT00618371)
Timeframe: 4 weeks

Interventionparticipants (Number)
Raltegravir Intensification0

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Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.

(NCT00631449)
Timeframe: Week 12

Interventionparticipants (Number)
Raltegravir11
Placebo8

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Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24

(NCT00631449)
Timeframe: Baseline and Week 24

InterventionPercentage of Activated CD8+ T cells (Mean)
Raltegravir-1.1
Placebo-0.9

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Absolute Change in CD4 Cell Counts

(NCT00632970)
Timeframe: 24 and 48 weeks

Interventioncells/mm^3 (Mean)
Raltegravir50
Lopinavir/Ritonavir50

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Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)

change was calculated as the mean of 12 assessments minus the baseline value (NCT00641641)
Timeframe: 12 times within 48 weeks.

Interventionlog copies/mL plasma (Mean)
Drug Intervention5.4

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Study Medication Tolerability

study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment (NCT00654147)
Timeframe: date started study treatment to first week documented change study treatment up to week 48

Interventionparticipants (Number)
Raltegravir & Lopinavir/Ritonavir1
Raltegravir & Emtricitabine/Tenofovir0

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Time to Confirmed Virologic Failure

time to confirmed viologic failure at 24 weeks (up to 48 weeks) (NCT00654147)
Timeframe: weeks

Interventionweeks (Median)
Raltegravir & Lopinavir/Ritonavir28
Raltegravir & Emtricitabine/Tenofovir29

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Time to Virologic Failure

time to virologic failure at week 24 (up to 48 weeks) (NCT00654147)
Timeframe: week 24 (up to 48 weeks)

Interventionweeks (Median)
Raltegravir & Lopinavir/Ritonavir3.2296
Raltegravir & Emtricitabine/Tenofovir2.9952

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Weeks to HIV-1 RNA <200 Copies/ml

time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml (NCT00654147)
Timeframe: from date of treatment start to first week documented viral suppression

,
Interventionweek to viral supresssion (Median)
week to <200 Copies/mlweek to <50 Copies/ml
Raltegravir & Emtricitabine/Tenofovir2856
Raltegravir & Lopinavir/Ritonavir2856

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Change From Baseline CD4+ and CD8+ Cell Counts

mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms (NCT00654147)
Timeframe: Baseline, Weeks 16 and 24

,
Interventioncells/mm3 (Mean)
week 16 CD4 cellsweek 24 CD4 cells
Raltegravir & Emtricitabine/Tenofovir452.11482.36
Raltegravir & Lopinavir/Ritonavir516.34521.31

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Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)

Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field. (NCT00656175)
Timeframe: Baseline and 24 weeks

Interventioncm^2 (Median)
Immediate-6.6
Delayed1.8

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the Percentage of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Obtained From Volunteers to the Antiretroviral Therapy Regimen Over Time.

Duodenal tissue immune cell subsets were measured by flow cytometry. (NCT00661960)
Timeframe: nine months

Intervention% CD3/CD4 T-cells in GALT tissue (Median)
Negative Volunteers55.3
HIV-postive Randomized to Raltegravir11.7
HIV-postive Randomized to NNRTI9.9

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Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)

Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration. (NCT00666705)
Timeframe: Days 3 and 14

Interventionng/mL (Mean)
Maraviroc + Raltegravir (Test)2169.6
Raltegravir (Reference)3026.6

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Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). (NCT00666705)
Timeframe: Days 3 and 14

Interventionng.hr/mL (Mean)
Maraviroc + Raltegravir (Test)6287.5
Raltegravir (Reference)9122.4

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Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)

Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration. (NCT00666705)
Timeframe: Days 11 and 14

Interventionng/mL (Mean)
Maraviroc + Raltegravir (Test)691.6
Maraviroc (Reference)851.4

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Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)

Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). (NCT00666705)
Timeframe: Days 11 and 14

Interventionng.hr/mL (Mean)
Maraviroc + Raltegravir (Test)2551.9
Maraviroc (Reference)2971.6

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Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)

Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration. (NCT00666705)
Timeframe: Days 11 and 14

Interventionng/mL (Mean)
Maraviroc + Raltegravir (Test)48.34
Maraviroc (Reference)53.36

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Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)

Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration. (NCT00666705)
Timeframe: Days 3 and 14

Interventionng/mL (Mean)
Maraviroc + Raltegravir (Test)51.16
Raltegravir (Reference)73.69

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Change From Baseline in CD8+ T Cell Co-expression of CD38 and HLA-DR

Blood CD8+ T cell activation as indicated by percentage of cells in fresh specimens coexpressing surface CD38 and human leukocyte antigen (HLA)-DR. (NCT00672932)
Timeframe: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)

Interventionpercentage of cells (Mean)
Raltegravir Group0.51
No Augmented Treatment0.66

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Change in CSF Concentrations of Neopterin After 12 Weeks

CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline. (NCT00672932)
Timeframe: three months (Rollover subjects were assessed for a second baseline after the initial 12 week period)

Interventionnmol/L (Mean)
Raltegravir Group0.1
No Augmented Treatment0.3

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Plasma Viral Loads (HIV-1 RNA PCR)

Percentage subjects with undetectable Plasma viral loads (NCT00700115)
Timeframe: baseline to week 48

Interventionpercentage of subjects (Number)
Kaletra + Isentress92.7
Standard HAART88

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To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects

(NCT00700115)
Timeframe: 48 weeks

Interventionmg/dL (Mean)
Kaletra + Isentress238.1
Standard HAART133.3

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis. (NCT00708162)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
Elvitegravir35
Raltegravir35

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis. (NCT00708162)
Timeframe: Baseline to Week 96

Interventionpercentage of participants (Number)
Elvitegravir45
Raltegravir46

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Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)

Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time. (NCT00708162)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Elvitegravir52.4
Raltegravir53.0

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Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)

Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time. (NCT00708162)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Elvitegravir59.8
Raltegravir57.5

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Change From Baseline in CD4 Cell Count at Week 48

The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed. (NCT00708162)
Timeframe: Baseline to Week 48

Interventioncells/mm^3 (Mean)
Elvitegravir138
Raltegravir147

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Change From Baseline in CD4 Cell Count at Week 96

The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed. (NCT00708162)
Timeframe: Baseline to Week 96

Interventioncells/mm^3 (Mean)
Elvitegravir205
Raltegravir198

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Change From Baseline in HIV-1 RNA at Week 48

The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed. (NCT00708162)
Timeframe: Baseline to Week 48

Interventionlog10 copies/mL (Mean)
Elvitegravir-2.17
Raltegravir-2.18

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Change From Baseline in HIV-1 RNA at Week 96

The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed. (NCT00708162)
Timeframe: Baseline to Week 96

Interventionlog10 copies/mL (Mean)
Elvitegravir-2.26
Raltegravir-2.31

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Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding. (NCT00708162)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Elvitegravir68.1
Raltegravir67.2

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Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding. (NCT00708162)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Elvitegravir57.0
Raltegravir56.1

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Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding. (NCT00708162)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Elvitegravir59.0
Raltegravir57.8

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Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding. (NCT00708162)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Elvitegravir47.6
Raltegravir45.0

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method. (NCT00708162)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Elvitegravir70.1
Raltegravir72.1

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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method. (NCT00708162)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Elvitegravir61.3
Raltegravir63.0

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation. (NCT00708162)
Timeframe: Week 48

Interventionpercentage of participants (Number)
Elvitegravir61.0
Raltegravir60.7

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method. (NCT00708162)
Timeframe: Week 96

Interventionpercentage of participants (Number)
Elvitegravir53.6
Raltegravir56.4

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis. (NCT00708162)
Timeframe: Baseline to Week 48

Interventionpercentage of participants (Number)
Elvitegravir24
Raltegravir24

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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis. (NCT00708162)
Timeframe: Baseline to Week 96

Interventionpercentage of participants (Number)
Elvitegravir32
Raltegravir31

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Mean Change From Baseline in Lipase (Units/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF4.674
LPV/r + RAL-1.898

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Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.535
LPV/r + RAL0.715

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Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmm Hg (Mean)
LPV/r + FTC/TDF-0.7
LPV/r + RAL-2.4

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Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionbeats per minute (Mean)
LPV/r + FTC/TDF-4.6
LPV/r + RAL-6.3

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Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmm Hg (Mean)
LPV/r + FTC/TDF-2.4
LPV/r + RAL-1.8

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Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^12/liter (Mean)
LPV/r + FTC/TDF0.12
LPV/r + RAL0.16

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Mean Change From Baseline in Potassium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.13
LPV/r + RAL0.03

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Mean Change From Baseline in Platelet Count (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF46.8
LPV/r + RAL34.2

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Mean Change From Baseline in Neutrophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.509
LPV/r + RAL0.705

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Mean Change From Baseline in Monocytes (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.065
LPV/r + RAL0.112

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Mean Change From Baseline in Mid-Thigh Measurement (cm)

Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF2.09
LPV/r + RAL5.13

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Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF1.3
LPV/r + RAL1.3

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Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF-1.0
LPV/r + RAL-1.1

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Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicrograms/milliliter (Mean)
LPV/r + FTC/TDF2.112
LPV/r + RAL2.064

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Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-6.1
LPV/r + RAL-13.4

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Mean Change From Baseline in Albumin (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF1.4
LPV/r + RAL1.3

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Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF84.6
LPV/r + RAL86.2

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Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-0.8
LPV/r + RAL-9.6

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Mean Change From Baseline in Basophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.005
LPV/r + RAL0.003

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Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.5
LPV/r + RAL-0.8

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Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.00
LPV/r + RAL0.37

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Mean Change From Baseline in Calcium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.040
LPV/r + RAL-0.016

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Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmilliliters/second (Mean)
LPV/r + FTC/TDF-0.122
LPV/r + RAL-0.024

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Mean Change From Baseline in Chest Measurement (cm)

Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.13
LPV/r + RAL4.06

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Mean Change From Baseline in Chloride (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.4
LPV/r + RAL0.2

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Mean Change From Baseline in Cholesterol (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.808
LPV/r + RAL1.113

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Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF398.9
LPV/r + RAL157.2

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Mean Change From Baseline in Creatinine (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF5.7
LPV/r + RAL1.6

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Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.97
LPV/r + RAL2.27

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-3.69
LPV/r + RAL0.52

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/cm^2 (Mean)
LPV/r + FTC/TDF-2.48
LPV/r + RAL0.68

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF15.32
LPV/r + RAL28.82

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF4.32
LPV/r + RAL6.96

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF12.71
LPV/r + RAL25.31

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.08
LPV/r + RAL1.56

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Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionPercentage of Participants (Number)
LPV/r + FTC/TDF79.1
LPV/r + RAL77.8

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF13.75
LPV/r + RAL27.01

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF1.67
LPV/r + RAL2.56

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF3.48
LPV/r + RAL6.34

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF7.28
LPV/r + RAL21.53

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-1.49
LPV/r + RAL-1.25

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF-0.33
LPV/r + RAL1.52

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Mean Change From Baseline in Eosinophils (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF-0.012
LPV/r + RAL0.015

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Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF-0.011
LPV/r + RAL0.109

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Mean Change From Baseline in Hematocrit (Fraction)

Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples. (NCT00711009)
Timeframe: Baseline to Week 96

Intervention% by volume of packed RBCs in blood (Mean)
LPV/r + FTC/TDF0.038
LPV/r + RAL0.036

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Mean Change From Baseline in Hemoglobin (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF5.4
LPV/r + RAL5.1

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Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.257
LPV/r + RAL0.346

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Mean Change From Baseline in Hips Measurement (cm)

Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF2.45
LPV/r + RAL4.70

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Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-0.046
LPV/r + RAL-0.028

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Mean Change From Baseline in Insulin (Picomoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicomoles/liter (Mean)
LPV/r + FTC/TDF-6.724
LPV/r + RAL4.441

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Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionnanograms/liter (Mean)
LPV/r + FTC/TDF-1.584
LPV/r + RAL-53.286

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Mean Change From Baseline in Lactate (Millimoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF0.281
LPV/r + RAL0.444

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Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF-21.157
LPV/r + RAL-28.926

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Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionnanograms/milliliter (Mean)
LPV/r + FTC/TDF3.623
LPV/r + RAL2.927

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Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.

Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionParticipants (Number)
Lopinavir resistanceEmtricitabine resistanceTenofovir resistanceRaltegravir resistance
LPV/r + FTC/TDF010NA
LPV/r + RAL0003

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Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionPercentage of Participants (Number)
Week 2Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 60Week 72Week 84Week 96
LPV/r + FTC/TDF7.617.136.267.680.085.784.884.882.978.174.368.6
LPV/r + RAL33.763.475.281.283.285.187.183.275.271.370.366.3

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Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Baseline to Week 96

,
InterventionPercentage of participants (Number)
Alananine aminotransferase >5x upper limit normalAspartate aminotransferase >5x upper limit normalCreatinine phosphokinase >4x upper limit of normalCalcium <1.75 millimoles/literCholesterol >7.77 millimoles/literTriglycerides >8.475 millimoles/literCalc. creatinine clearance <50 milliliters/minuteLipase >2x upper limit of normalNeutrophils < 0.75 x 10^9/literMagnesium < 0.5 millimoles/liter
LPV/r + FTC/TDF2.92.98.7013.54.83.87.73.80
LPV/r + RAL5.05.019.82.016.89.91.04.002.0

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Mean Change From Baseline in Mid-Arm Measurement (cm)

Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.76
LPV/r + RAL4.71

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Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF82.5
LPV/r + RAL85.5

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Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionunits/liter (Mean)
LPV/r + FTC/TDF14.5
LPV/r + RAL1.7

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Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

(NCT00711009)
Timeframe: Baseline to Week 96

,
Interventioncells/microliter (Mean)
Week 4Week 8Week 16Week 24Week 32Week 40Week 48Week 60Week 72Week 84Week 96
LPV/r + FTC/TDF97.2107.9158.7154.9180.0204.6245.0243.4277.4309.6296.4
LPV/r + RAL113.4124.5141.6174.5188.2223.0241.9250.6269.9280.2281.0

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Mean Change From Baseline in Magnesium (Millimoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmillimoles/liter (Mean)
LPV/r + FTC/TDF0.019
LPV/r + RAL-0.009

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Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.332
LPV/r + RAL0.368

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Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionratio (Mean)
LPV/r + FTC/TDF-0.056
LPV/r + RAL-0.040

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Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction. (NCT00711009)
Timeframe: Week 96

InterventionScores on a scale (Mean)
LPV/r + FTC/TDF75.5
LPV/r + RAL76.0

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Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 48

InterventionPercentage of Participants (Number)
LPV/r + FTC/TDF84.8
LPV/r + RAL83.2

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Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S. (NCT00711009)
Timeframe: Baseline to Week 96

InterventionParticipants (Number)
LPV/r + FTC/TDF0
LPV/r + RAL1

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Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionnumber of cells x 10^9/liter (Mean)
LPV/r + FTC/TDF0.90
LPV/r + RAL1.20

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Mean Change From Baseline in Weight (kg)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionkg (Mean)
LPV/r + FTC/TDF1.83
LPV/r + RAL3.77

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Mean Change From Baseline in Waist Measurement (cm)

Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96

Interventioncm (Mean)
LPV/r + FTC/TDF1.88
LPV/r + RAL4.93

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Mean Change From Baseline in Urine Specific Gravity

Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density. (NCT00711009)
Timeframe: Baseline to Week 96

Interventionratio of urine density to water density (Mean)
LPV/r + FTC/TDF0.0042
LPV/r + RAL0.0052

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Mean Change From Baseline in Urine pH

(NCT00711009)
Timeframe: Baseline to Week 96

InterventionpH (Mean)
LPV/r + FTC/TDF0.00
LPV/r + RAL0.03

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Mean Change From Baseline in Uric Acid (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF-29.0
LPV/r + RAL-6.1

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Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.846
LPV/r + RAL1.103

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Mean Change From Baseline in Total Protein (Grams/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams/liter (Mean)
LPV/r + FTC/TDF-6.3
LPV/r + RAL-7.2

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Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.9
LPV/r + RAL1.9

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Mean Change From Baseline in Temperature (°F)

(NCT00711009)
Timeframe: Baseline to Week 96

Intervention°F (Mean)
LPV/r + FTC/TDF-0.152
LPV/r + RAL-0.183

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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicograms/milliliter (Mean)
LPV/r + FTC/TDF-1257.9
LPV/r + RAL-1594.7

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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96

Interventionpicograms/milliliter (Mean)
LPV/r + FTC/TDF-138.602
LPV/r + RAL-166.403

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Mean Change From Baseline in Sodium (Micromoles/Liter)

(NCT00711009)
Timeframe: Baseline to Week 96

Interventionmicromoles/liter (Mean)
LPV/r + FTC/TDF0.1
LPV/r + RAL0.7

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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96

Interventiongrams (Mean)
LPV/r + FTC/TDF2.9
LPV/r + RAL5.4

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Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Single Plasma Timepoint.

This outcome was the ratio of the 4-hour CSF concentration value (ng/mL) to the 4-hour plasma concentration value (ng/mL). (NCT00729924)
Timeframe: Day 7

Interventionratio (Median)
Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 C/C0.028
Raltegravir: 400mg Orally Every 12 Hours for 7 Days: ABCB1 T/T0.021

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Penetration of Raltegravir (RGV) Into Cerebrospinal Fluid (CSF) Based on Plasma Area-under-the-curve.

The primary outcome for this study was the ratio of the 4-hour CSF concentration value (ng/mL) to the partial plasma area-under-the-curve 0-4h value (h*ng/mL). (NCT00729924)
Timeframe: Day 7

Intervention1/h (Median)
Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 C/C0.0066
Raltegravir: 400mg Orally Every 12 Hours for 7 Days (ABCB1 T/T0.0070

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Mean Platelet Count Between Treatment Groups at 10 Months

The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 10 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada193500
Efavirenz Plus Truvada243300

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Mean Platelet Count Between Treatment Groups at 12 Months

The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 12 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada255600
Efavirenz Plus Truvada185500

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Mean Platelet Count Between Treatment Groups at 14 Months

The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada217400
Efavirenz Plus Truvada216800

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Mean Platelet Count Between Treatment Groups at 2 Months

The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter). (NCT00734344)
Timeframe: 2 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada232600
Efavirenz Plus Truvada225600

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Mean Platelet Count Between Treatment Groups at 4 Months

The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada210800
Efavirenz Plus Truvada197300

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Mean Platelet Count Between Treatment Groups at 6 Months

The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 6 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada230000
Efavirenz Plus Truvada224800

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Mean Platelet Count Between Treatment Groups at 8 Months

The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 8 months after baseline

Interventioncount per microliter (Mean)
Raltegravir Plus Truvada215700
Efavirenz Plus Truvada208100

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Mean White Blood Cell Count Between Treatment Groups at 12 Months

Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 12 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada6320
Efavirenz Plus Truvada4868

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Mean White Blood Cell Count Between Treatment Groups at 14 Months

Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 14 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada3180
Efavirenz Plus Truvada4903

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Mean White Blood Cell Count Between Treatment Groups at 2 Months

Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: baseline to 2 months

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5904
Efavirenz Plus Truvada4918

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Mean White Blood Cell Count Between Treatment Groups at 4 Months

Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 4 months post baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5850
Efavirenz Plus Truvada4948

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Mean White Blood Cell Count Between Treatment Groups at 6 Months

Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 6 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5219
Efavirenz Plus Truvada4522

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Mean White Blood Cell Count Between Treatment Groups at 8 Months

Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 8 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada6240
Efavirenz Plus Truvada4607

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Mean White Blood Cell Count Between Treatment Groups at 10 Months

Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 10 months after baseline

Interventionwhite blood cells per microliter (mcL). (Mean)
Raltegravir Plus Truvada5230
Efavirenz Plus Truvada4615

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Mean CD4 Count Between Treatment Groups at 3 Months

Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 3 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada716.4
Efavirenz Plus Truvada671.7

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Mean CD4 Count Between Treatment Groups at 6 Months

Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 6 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada652.2
Efavirenz Plus Truvada673.5

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Mean CD4 Count Between Treatment Groups at 2 Months

Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 2 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada703.1
Efavirenz Plus Truvada527.2

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Mean CD4 Count Between Treatment Groups at 11 Months

Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 11 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada495

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Mean CD4 Count Between Treatment Groups at 10 Months

Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 10 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada469
Efavirenz Plus Truvada571.5

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Mean CD4 Count Between Treatment Groups at 1 Months

Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 1 month after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada629.1
Efavirenz Plus Truvada535

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Mean CD4 Count Between Treatment Groups at 4 Months

Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 4 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada617.2
Efavirenz Plus Truvada646.5

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Mean CD4 Count Between Treatment Groups at 5 Months

Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 5 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada805.7
Efavirenz Plus Truvada539.6

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Mean CD4 Count Between Treatment Groups at 7 Months

Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 7 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada504
Efavirenz Plus Truvada552.5

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Mean CD4 Count Between Treatment Groups at 8 Months

Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 8 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada464.5
Efavirenz Plus Truvada586.5

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Mean CD4 Count Between Treatment Groups at 9 Months

Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 9 months after baseline

Interventioncells/mm3 (Mean)
Raltegravir Plus Truvada306
Efavirenz Plus Truvada571

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Mean Hematocrit Between Treatment Groups at 10 Months

Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 10 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada45
Efavirenz Plus Truvada38

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Mean Hematocrit Between Treatment Groups at 12 Months

Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 12 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41
Efavirenz Plus Truvada43.5

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Mean Hematocrit Between Treatment Groups at 14 Months

Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 14 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada36
Efavirenz Plus Truvada39.7

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Mean Hematocrit Between Treatment Groups at 2 Months

Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 2 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41.5
Efavirenz Plus Truvada41.8

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Mean Hematocrit Between Treatment Groups at 4 Months

Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 4 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada41.4
Efavirenz Plus Truvada43

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Mean Hematocrit Between Treatment Groups at 6 Months

Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 6 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada42.1
Efavirenz Plus Truvada39.8

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Mean Hematocrit Between Treatment Groups at 8 Months

Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 8 months after baseline

Interventionpercentage (Mean)
Raltegravir Plus Truvada40.3
Efavirenz Plus Truvada41.2

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Female Paired Plasma Concentration

This sample was taken as close to the time of genital tract sample as possible (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionng/mL (Median)
Raltegravir264.6

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Female Genital Tract:Plasma Concentration Ratio

Units of raltegravir concentration for genital tract and plasma sample are ng/mL (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionratio (Median)
Raltegravir2.2

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Raltegravir Male Genital Tract Concentration

(NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionng/mL (Median)
Raltegravir485.1

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Raltegravir Female Genital Tract Concentration

(NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionng/mL (Median)
Raltegravir879.1

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Male Time Since Last Dose

This measure describes the amount of time that expired between when the dose was administered and when the sample was taken (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionhours (Median)
Raltegravir8.0

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Male Paired Plasma Concentration

This sample was taken as close to the time of genital tract sample as possible (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionng/mL (Median)
Raltegravir172

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Male Genital Tract:Plasma Concentration Ratio

Units of raltegravir concentration for genital tract and plasma sample are ng/mL (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionratio (Median)
Raltegravir4.3

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Female Time Since Last Dose

This measure describes the amount of time that expired between when the dose was administered and when the sample was taken (NCT00745368)
Timeframe: 8-10 hours after raltegravir dose

Interventionhours (Median)
Raltegravir8.5

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Number of Participants With One or More Adverse Events at 48 Weeks

(NCT00745823)
Timeframe: Week 48

InterventionParticipants (Number)
Raltegravir 800 mg q.d.331
Raltegravir 400 mg b.i.d.337

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Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks

(NCT00745823)
Timeframe: Week 48

InterventionParticipants (Number)
Raltegravir 800 mg q.d.4
Raltegravir 400 mg b.i.d.3

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Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks

(NCT00745823)
Timeframe: 48 weeks

InterventionParticipants (Number)
Raltegravir 800 mg q.d.338
Raltegravir 400 mg b.i.d.361

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Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks

(NCT00745823)
Timeframe: Week 48

InterventionParticipants (Number)
Raltegravir 800 mg q.d.318
Raltegravir 400 mg b.i.d.343

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Mean Change From Baseline to Week 48 in CD4 Cell Count

(NCT00745823)
Timeframe: Baseline and Week 48

Interventioncells/mm^3 (Mean)
Raltegravir 800 mg q.d.209.76
Raltegravir 400 mg b.i.d.196.20

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Number of Patients With Suppressed Viral Load(<75 Copies/ml)in Raltegravir 400 mg Bid vs. NRTI Backbone, Each in Combination of Boosted PI Regimen

Number of patients with virologic suppression< 75 copies/ ml at 24 wk,in raltegravir 400 mg bid vs. NRTI backbone, each in combination of boosted PI regimen. (NCT00749580)
Timeframe: at 24weeks for each patient

Interventionparticipants (Number)
Boosted PI+RAL18
Boosted PI+NRTIs18

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Virologic Suppression of < 75 Copies/ml at 48 Weeks

(NCT00749580)
Timeframe: at 48 weeks for each patient

Interventionparticipants (Number)
Boosted PI+RAL14
Boosted PI+NRTIs16

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Percentage of Participants Using Etravirine in Background Regimen

These results report the percent of participants using Etravirine in the background regimen. (NCT00751530)
Timeframe: Background regimen (no specific time frame)

InterventionPercentage of Participants (Number)
Protease Inhibitor Group33
Non-protease Inhibitor58

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Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.

The HIV RNA (viral load) was measured using standard of care testing via local laboratories. (NCT00751530)
Timeframe: 12 Weeks

InterventionPercentage of Participants (Number)
Protease Inhibitor Group84
Non-protease Inhibitor86

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Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12

The HIV RNA (viral load) was measured using standard of care testing via local laboratories. (NCT00751530)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Protease Inhibitor Group84
Non-protease Inhibitor86

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Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen)

The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS. (NCT00751530)
Timeframe: Baseline

Interventionscore (Mean)
Protease Inhibitor Group1.8
Non-protease Inhibitor1.7

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CD4 Cell Changes Among Participants in PI vs Non-PI Group

CD4 cell counts were measured using standard of care testing via local laboratories. (NCT00751530)
Timeframe: baseline to 24 Weeks

Interventioncells/mm3 (Mean)
Protease Inhibitor Group-96.6
Non-protease Inhibitor-134.8

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To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.

Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary. (NCT00752856)
Timeframe: Baseline, days 2, 7, 10, 14

Interventionlog(10)/day (Median)
1 - Kaletra + Isentress Taken Twice Daily0.47
2 - Atripla Taken Once Daily0.55

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Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48

To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: 48 weeks

Interventioncells/mm^3 (Mean)
1 - Kaletra + Isentress Taken Twice Daily-2.24
2 - Atripla Taken Once Daily-5.65

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Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.

To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: Baseline to Week 4

Interventioncells/mm^3 (Mean)
1 - Kaletra + Isentress Taken Twice Daily-3.81
2 - Atripla Taken Once Daily-1.18

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Viral Suppression Efficacy at 48 Weeks

To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load (NCT00752856)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
1 - Kaletra + Isentress Taken Twice Daily86
2 - Atripla Taken Once Daily87.5

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Change From Baseline in Lipids at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

,
Interventionmg/dL (Mean)
Total cholesterolTriglyceridesHDL cholesterolLDL cholesterol
Atazanavir8.1316.88-1.385.88
Raltegravir-0.25-15.50-1.54.13

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Change From Baseline in Log HIV Viral Load at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncopies/mL (Mean)
Raltegravir-3.05
Atazanavir-3.29

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Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventionpg/mL (Mean)
Raltegravir-2.71
Atazanavir-4.47

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Change From Baseline in Homocysteine at 6 Months

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventionumol/L (Mean)
Raltegravir0.53
Atazanavir0.10

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Change From Baseline in CD4 Count at 48 Weeks

(NCT00762892)
Timeframe: Baseline and 48 weeks

Interventioncells/uL (Mean)
Raltegravir192
Atazanavir205

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Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48

Numbers of participants with HIV RNA copies <50 copies/mL were summarized by race for each time point. (NCT00764946)
Timeframe: Week 48

,,
InterventionParticipants (Number)
Black (n = 69, 62, 14)Non-Black (n = 25, 18, 7)
Treatment Experienced - Failing Current Therapy4416
Treatment Experienced - Treatment Intolerant4318
Treatment Naive115

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Number of Participants Without Loss of Virologic Response

For participants with confirmed HIV RNA levels <50 copies/mL on 2 consecutive visits, loss of virologic response is the occurrence of the first value >50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). (NCT00764946)
Timeframe: Week 48

,,
Interventionparticipants (Number)
Black (n = 70, 69, 14)Non-Black (n = 27, 19, 7)
Treatment Experienced - Failing Current Therapy4816
Treatment Experienced - Treatment Intolerant4917
Treatment Naive115

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Number of Participants With One or More Adverse Events

Numbers of participants with one or more adverse events were summarized by race. (NCT00764946)
Timeframe: Week 48

,,
InterventionParticipants (Number)
Black (n = 70, 69, 14)Non-Black (n = 27, 19, 7)
Treatment Experienced - Failing Current Therapy5523
Treatment Experienced - Intolerant To Current Therapy4013
Treatment Naive126

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Number of Participants Who Discontinued Due to an Adverse Event

Numbers of participants who discontinued due to an adverse event were summarized by race. (NCT00764946)
Timeframe: Week 48

,,
InterventionParticipants (Number)
Black (n = 70, 69, 14)Non-black (n = 27, 19, 7)
Treatment Experienced - Failing Current Therapy10
Treatment Experienced - Intolerant To Current Therapy20
Treatment Naive10

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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48

Numbers of participants with HIV RNA copies <400 copies/mL were summarized by race for each time point. (NCT00764946)
Timeframe: Week 48

,,
InterventionParticipants (Number)
Black (n = 69, 62, 14)Non-Black (n = 25, 18, 7)
Treatment Experienced - Failing Current Therapy5117
Treatment Naive125
Treatment-Experienced - Treatment Intolerant5018

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Mean Change From Baseline to Week 48 in HIV RNA

Mean changes from baseline in plasma HIV RNA were summarized by race at each time point. (NCT00764946)
Timeframe: Baseline and Week 48

,,
Interventionlog10 copies/mL (Mean)
Black (n = 55, 16, 13)Non-Black ( n= 22, 6, 6)
Treatment Experienced - Failing Current Therapy-1.62-1.52
Treatment Experienced - Treatment Intolerant-1.16-2.21
Treatment Naive-2.49-1.66

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Mean Change From Baseline to Week 48 in CD4 Cell Count

Mean changes from baseline in CD4 cell counts were summarized by race at each time point. (NCT00764946)
Timeframe: Baseline and Week 48

,,
Interventioncells/mm^3 (Mean)
Black (n = 66, 61, 12)Non-Black (n = 23, 15, 7)
Treatment Experienced - Failing Current Therapy141.0113.1
Treatment Experienced - Treatment Intolerant62.369.2
Treatment Naive208.8164.4

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Atazanavir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir5.0

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Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)

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

InterventionHours (Geometric Mean)
Atazanavir + Raltegravir3.0

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Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

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

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

(NCT00768989)
Timeframe: At Week 48 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir45
Atazanavir + Ritonavir + Tenofovir/Emtricitabine25

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

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

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

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

(NCT00768989)
Timeframe: At Week 2 from Baseline

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

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Raltegravir Cmax in 1 Dosing Interval

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

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

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Raltegravir Cmin 12 Hours Postdose

(NCT00768989)
Timeframe: At Week 2 from Baseline

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

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Raltegravir Cmin Prior to the Morning Dose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir445.42

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Raltegravir Terminal Elimination Half Life

(NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionHours (Mean)
Atazanavir + Raltegravir2.9

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Raltegravir Tmax

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

InterventionHours (Geometric Mean)
Atazanavir + Raltegravir2.08

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Baseline and Mean Change From Baseline in Total Cholesterol Levels

The mean change from baseline in participant fasting lipids was determined using fasting serum samples. (NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48

,
Interventionmg/dL (Mean)
Baseline (n=56, 26)Mean change from Baseline at Week 24 (n=51, 20)Mean change from Baseline at Week 48 (n=38, 20)
Atazanavir + Raltegravir164.614.718.0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine169.615.117.1

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Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count

(NCT00768989)
Timeframe: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24

,
Interventioncells/mm^3 (Mean)
Mean change from Baseline at Week 2 (n=59, 26)Mean change from Baseline at Week 4 (n=62, 27)Mean change from Baseline at Week 8 (n=60, 29)Mean change from Baseline at Week 12 (n=62, 28)Mean change from Baseline at Week 16 (n=58, 27)Mean change from Baseline at Week 20 (n=58, 24)Mean change from Baseline at Week 24 (n=55, 24)
Atazanavir + Raltegravir81.182.7111.5128.6143.6166.5166.0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine63.1100.1111.9129.3127.6140.7127.0

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Mean Change From Baseline in Electrocardiogram Findings

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

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

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Mean Change From Baseline in Total Bilirubin Level

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

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

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

AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event. (NCT00768989)
Timeframe: Week 1 to Week 96, continuously

,
InterventionParticipants (Number)
AEsSAEsDeathsAEs leading to discontinuationSAEs leading to discontinuation
Atazanavir + Raltegravir607041
Atazanavir + Ritonavir + Tenofovir/Emtricitabine292010

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

Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
HyperkalemiaHypokalemiaHypernatremiaHyponatremiaHyperclycemiaHypoglycemiaCreatine kinaseAlbumin
Atazanavir + Raltegravir210386213
Atazanavir + Ritonavir + Tenofovir/Emtricitabine11015472

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Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4

AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96

,
InterventionParticipants (Number)
Total BilirubinAST/SGOTALT/ SGPTLipaseProteinureaCreatine kinase
Atazanavir + Raltegravir621110111421
Atazanavir + Ritonavir + Tenofovir/Emtricitabine288813117

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

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

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

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Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24

NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed (NCT00768989)
Timeframe: At Week 24 from Baseline

,
InterventionParticipants (Number)
NC=F (n= 63, 30)NC=M (n=58, 27)VR-OC (n=52, 25)
Atazanavir + Raltegravir525246
Atazanavir + Ritonavir + Tenofovir/Emtricitabine262624

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Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24

The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC). (NCT00768989)
Timeframe: At Week 24 from Baseline

,
InterventionParticipants (Number)
NC=F (n=63, 30)NC=M (n=58, 27)VR-OC (n=52, 25)
Atazanavir + Raltegravir474741
Atazanavir + Ritonavir + Tenofovir/Emtricitabine191919

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Number of Nonresponders at Week 8

Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL. (NCT00768989)
Timeframe: At Week 8 from Baseline

InterventionParticipants (Number)
Atazanavir + Raltegravir0
Atazanavir + Ritonavir + Tenofovir/Emtricitabine1

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

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

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

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Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir19903.4

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Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval

AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2. (NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng•h/mL (Geometric Mean)
Atazanavir + Raltegravir39806.7

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Atazanavir Cmin Prior to the Morning Dose

(NCT00768989)
Timeframe: At Week 2 from Baseline

Interventionng*h / mL (Geometric Mean)
Atazanavir + Raltegravir879.25

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Atazanavir Individual Inhibitory Quotient (IQ)

Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates. (NCT00768989)
Timeframe: At Week 2 from Baseline

InterventionUnits on a Scale (Geometric Mean)
Atazanavir + Raltegravir23.47

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

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

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

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Mean Change From Baseline CD4+ Cell Count

Comparison of normalised mean change from baseline CD4+ cell count (NCT00772590)
Timeframe: 24 weeks

InterventionCells/microlitre (Mean)
Raltegravir + Hyper-immune Bovine Colostrum8.62
Hyper-immune Bovine Colostrum2.68
Raltegravir8.68
Placebo21.87

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Cmin/Cmax: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Admin of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

,,
Interventionng/mL (Mean)
Cmin (ng/mL)Cmax (ng/mL)
Group A & B0.570.73
Group C & D0.810.86
Group E & F0.500.82

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CL/F: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

InterventionL/h (Mean)
Group A & B1.57
Group C & D1.05
Group E & F1.63

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AUC: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

Interventionng*h/mL (Mean)
Group A & B0.63
Group C & D0.45
Group E & F0.85

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AUC: Fasting Steady-state Plasma Amprenavir (APV) Pharmacokinetics (PK) Following Administration of Fosamprenavir (FPV) 1400mg BID, FPV 700mg/Ritonavir (RTV) 100 mg BID, or FPV 1400mg/RTV 100mg QD With and Without Concurrent Raltegravir (RTG) 400mg BID.

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). APV minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from APV concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 14 of the FPV 1400mg BID, FPV 1400mg/RAL 400mg BID, FPV 700mg/RTV 100mg BID, FPV 700mg/RTV 100mg/RAL 400mg BID, FPV 1400mg/RTV 100mg QD, and FPV 1400mg/RTV 100mg QD plus RAL 400mg BID regimens

Interventionng•h/mL (Mean)
Group A & B0.64
Group C & D0.84
Group E & F0.76

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Cmin/Cmax: Steady-state Plasma RTG PK Following Admin of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

,,
Interventionng/mL (Mean)
Cmin (ng/mL)Cmax (ng/mL)
Group A & B0.620.72
Group C & D0.640.49
Group E & F0.751.06

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Number of Participants Who Experienced Adverse Events

"Safety/tolerability data included all adverse events (AEs) reported within the time frame of each regimen evaluated. The intent was to compare AE's for each sequence and not for each regimen. 3The regimens for which AE information was culled were:~RAL 400mg BID alone~FPV 1400mg BID alone~FPV 700mg/RTV 100 mg BID alone~FPV 1400mg/RTV 100mg QD alone~FPV 1400mg BID combined with RAL 400mg BID~FPV 700mg/RTV 100 mg BID combined with RAL 400mg BID~FPV 1400mg/RTV 100mg QD combined with RAL 400mg BID The severity of reported AEs was graded according to DAIDS criteria, Version 1.0 (National Institute of Allergy and Infectious Diseases (NIAID). Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. Division of Acquired Immunodeficiency Syndrome (DAIDS), Washington D.C.; 2004)." (NCT00802074)
Timeframe: Day 0 through Day 49

Interventionparticipants (Number)
Group A3
Group B3
Group C4
Group D4
Group E5
Group F5

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CL/F: Steady-state Plasma RTG PK Following Administration of RTG 400mg BID Alone and Following Co-administration With FPV 1400mg BID, FPV 700mg/RTV 100 mg BID, or FPV 1400mg/RTV 100mg QD

Amprenavir (APV) is the active ingredient/metabolite of Fosamprenavir (FPV). RAL minimum concentration (Cmin), maximum concentration (Cmax), area under the plasma concentration-time curve (AUC), and oral clearance (CL/F) as determined from RAL concentrations observed in blood samples obtained at baseline, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours during the period when RAL 400mg BID was administered with the FPV-Containing BID regimens (FPV 1400mg BID, FPV 700mg/RTV 100 mg BID), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours during the period when RAL 400mg BID was administered with the FPV QD regimen (FPV 1400mg/RTV 100mg QD). As Groups A and B received the same regimens (albeit in different order), PK data for these two groups were collated, then assessed. For the same reason, PK data from Groups C and D regimens were collated before assessment, as were the PK data from Groups E and F. (NCT00802074)
Timeframe: Day 7 of the RAL 400mg BID regimen and Day 14 of the RAL 400mg/FPV 1400mg BID, RAL 400mg/FPV 700mg/RTV 100mg BID, and RAL 400mg BID Plus FPV 1400mg/RTV 100mg QD regimens

InterventionL/h (Mean)
Group A & B1.46
Group C & D2.00
Group E & F1.18

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Presence of Mutations Associated With NRTI Resistance

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

Interventionparticipants (Number)
Arm A: ATV/RTV + FTC/TDF8
Arm B: RAL + FTC/TDF7
Arm C: DRV/RTV + FTC/TDF3

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Presence of Mutations Associated With INI Resistance

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

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

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

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

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

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

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

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

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

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

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

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Change in Fasting HDL Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=522, nB=542, nC=506)week 96 (nA=490, nB=505, nC=488)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF678
Arm B: RAL + FTC/TDF566
Arm C: DRV/RTV + FTC/TDF557

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Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96

"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative probability per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF31
Arm B: RAL + FTC/TDF16
Arm C: DRV/RTV + FTC/TDF24

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Cumulative Probability of First Virologic Failure by Week 96

"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative probability per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF13
Arm B: RAL + FTC/TDF10
Arm C: DRV/RTV + FTC/TDF15

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Cumulative Incidence of First Adverse Event by Week 96

"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up." (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative events per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF81
Arm B: RAL + FTC/TDF59
Arm C: DRV/RTV + FTC/TDF65

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Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96

The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. (NCT00811954)
Timeframe: From study entry to week 96

Interventioncumulative events per 100 persons (Number)
Arm A: ATV/RTV + FTC/TDF14
Arm B: RAL + FTC/TDF1
Arm C: DRV/RTV + FTC/TDF5

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Self-reported Adherence

Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144. (NCT00811954)
Timeframe: At Weeks 4, 24, 48, 96, and 144

,,
Interventionpercentage of prescribed medication (Mean)
week 4 (nA=584, nB=590, nC=583)week 24 (nA=570, nB=568, nC=562)week 48 (nA=555, nB=547, nC=536)week 96 (nA=508, nB=525, nC=507)week 144 (nA=361, nB=376, nC=350)
Arm A: ATV/RTV + FTC/TDF9897969697
Arm B: RAL + FTC/TDF9797979697
Arm C: DRV/RTV + FTC/TDF9896969698

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Change in Waist:Height Ratio From Baseline

Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventioncm:cm (Mean)
week 48 (nA=555, nB=551, nC=547)week 96 (nA=512, nB=526, nC=517)week 144 (nA=425, nB=419, nC=409)
Arm A: ATV/RTV + FTC/TDF0.010.020.02
Arm B: RAL + FTC/TDF0.020.020.02
Arm C: DRV/RTV + FTC/TDF0.010.020.02

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Change in Waist Circumference From Baseline

Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventioncm (Mean)
week 48 (nA=555, nB=551, nC=547)week 96 (nA=512, nB=526, nC=517)week 144 (nA=425, nB=419, nC=409)
Arm A: ATV/RTV + FTC/TDF2.33.33.6
Arm B: RAL + FTC/TDF3.14.04.0
Arm C: DRV/RTV + FTC/TDF2.12.83.4

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Change in Framingham 10-year Risk of MI or Coronary Death From Baseline

"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk." (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionpercent risk (Mean)
week 48 (nA=509, nB=537, nC=492)week 96 (nA=479, nB=493, nC=470)week 144 (nA=347, nB=383, nC=349)
Arm A: ATV/RTV + FTC/TDF0.40.50.6
Arm B: RAL + FTC/TDF0.00.20.4
Arm C: DRV/RTV + FTC/TDF0.40.40.9

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Change in Fasting Triglycerides Level From Baseline

Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=522, nB=542, nC=507)week 96 (nA=490, nB=505, nC=490)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF181912
Arm B: RAL + FTC/TDF-9-9-4
Arm C: DRV/RTV + FTC/TDF161620

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Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=521, nB=542, nC=507)week 96 (nA=490, nB=505, nC=490)week 144 (nA=364, nB=397, nC=363)
Arm A: ATV/RTV + FTC/TDF131620
Arm B: RAL + FTC/TDF136
Arm C: DRV/RTV + FTC/TDF151419

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Change in Fasting Plasma Glucose Level From Baseline

Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144

,,
Interventionmg/dL (Mean)
week 48 (nA=517, nB=535, nC=506)week 96 (nA=489, nB=499, nC=481)week 144 (nA=353, nB=392, nC=358)
Arm A: ATV/RTV + FTC/TDF2.23.02.2
Arm B: RAL + FTC/TDF1.30.90.9
Arm C: DRV/RTV + FTC/TDF2.12.53.6

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CD4+ T-cell Count

The absolute levels of CD4+ T-cell counts (cells/mm3) (NCT00811954)
Timeframe: At Weeks 24, 48, 96, and 144

,,
Interventioncells/mm^3 (Mean)
week 24 (nA=582, nB=574, nC=579)week 48 (nA=564, nB=565, nC=559)week 96 (nA=523, nB=541, nC=525)week 144 (nA=395, nB=418, nC=394)
Arm A: ATV/RTV + FTC/TDF462524587622
Arm B: RAL + FTC/TDF460526596631
Arm C: DRV/RTV + FTC/TDF457509564596

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CD4+ T-cell Count Changes From Baseline

Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count (NCT00811954)
Timeframe: Study entry to weeks 24, 48, 96, and 144

,,
Interventioncells/mm^3 (Mean)
week 24 (nA=582, nB=574, nC=579)week 48 (nA=564, nB=565, nC=559)week 96 (nA=523, nB=541, nC=525)week 144 (nA=395, nB=418, nC=394)
Arm A: ATV/RTV + FTC/TDF157218284324
Arm B: RAL + FTC/TDF153218288325
Arm C: DRV/RTV + FTC/TDF147201256288

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Cholesterol

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

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

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

(NCT00814879)
Timeframe: 48 weeks

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

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Number of Patients Reaching Virologic Failure at Week 48.

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

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

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

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

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

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CD4+ Cell Count

(NCT00814879)
Timeframe: Weeks 24

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

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CD4+ Cell Count

(NCT00814879)
Timeframe: Week 48

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

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Plasma Trough Concentration of Raltegravir

Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation. (NCT00830804)
Timeframe: From start of study treatment to week 52

Interventionng/ml (Median)
RAL+DRV/RTV117

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Plasma Trough Concentration of Darunavir

Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation. (NCT00830804)
Timeframe: From start of study treatment to week 52

Interventionng/ml (Median)
RAL+DRV/RTV1218

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Number of Participants With Protease Drug Resistance at Virologic Failure

Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure. (NCT00830804)
Timeframe: From 12 weeks after starting study treatment to week 52

Interventionparticipants (Number)
RAL+DRV/RTV0

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Number of Participants With Perfect Overall Adherence by Self Report

"At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall perfect adherence." (NCT00830804)
Timeframe: From one week after starting study treatment to week 52

Interventionparticipants (Number)
RAL + DRV/RTV95

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Number of Participants With Integrase Drug Resistance at Virologic Failure

Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure. (NCT00830804)
Timeframe: From 12 weeks after starting study treatment to week 52

Interventionparticipants (Number)
RAL+DRV/RTV5

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Change in Fasting Low-density Lipoprotein at Week 48

Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride. (NCT00830804)
Timeframe: From start of study treatment through week 48

Interventionmg/dL (Median)
RAL + DRV/RTV17

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Change in Fasting Low-density Lipoprotein at Week 24

Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride. (NCT00830804)
Timeframe: From start of study treatment through week 24

Interventionmg/dL (Median)
RAL + DRV/RTV16.0

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Change in CD4 Count at Week 48

Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry. (NCT00830804)
Timeframe: From start of study treatment through week 48

Interventioncells/mm3 (Median)
RAL + DRV/RTV200

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Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24

Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24. (NCT00830804)
Timeframe: From start of study treatment to week 24

Interventionproportion of participants (Number)
With HIV-1 RNA < 50 copies/mlWith HIV-1 RNA < 200 copies/ml
RAL+DRV/RTV0.790.93

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Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48

Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48. (NCT00830804)
Timeframe: From start of study treatment to week 48

Interventionproportion of participants (Number)
With HIV-1 RNA < 50 copies/mlWith HIV-1 RNA < 200 copies/ml
RAL+DRV/RTV0.710.86

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Change in Plasma HIV-1 RNA From Baseline to Week 1

Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry. (NCT00830804)
Timeframe: Baseline and week 1

Interventionlog10 copies/ml (Median)
RAL+DRV/RTV-1.67

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Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment

Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment. (NCT00830804)
Timeframe: From start of study treatment to week 52

Interventionproportion of participants (Number)
RAL+DRV/RTV0.20

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Number of Participants With Pretreatment Drug Resistance

Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant. (NCT00830804)
Timeframe: At screening

Interventionparticipants (Number)
With NNRTI mutations onlyWith NRTI mutations onlyWith Both NNRTI and NRTI mutationsWith PI mutations onlyWith PI, NNRTI and NRTI mutationsNo Resistance Detected
RAL + DRV/RTV9812191

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Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48

Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride. (NCT00830804)
Timeframe: From start of study treatment through week 48

Interventionmg/dL (Median)
Fasting Total CholesterolFasting High-density LipoproteinFasting Triglyceride
RAL + DRV/RTV30923

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Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24

Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride. (NCT00830804)
Timeframe: From start of study treatment through week 24

Interventionmg/dL (Median)
Fasting Total CholesterolFasting High-density LipoproteinFasting Triglyceride
RAL + DRV/RTV31.56.524.5

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Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24

The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval. (NCT00830804)
Timeframe: From start of study treatment to Week 24

InterventionProportion of participants (Number)
RAL+DRV/RTV0.21

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Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24

Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval. (NCT00830804)
Timeframe: From start of study treatment to week 24

InterventionProportion of participants (Number)
RAL+DRV/RTV0.16

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Endothelial Function Measured by Brachial Artery Flow-mediated Dilation(FMD)

Measurements in the change of brachial artery diameter from pre and post treatment. (NCT00843713)
Timeframe: 24 weeks

Interventionmillimeters (Median)
Placebo3.4
Raltegravir2.9

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Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96

Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF146910
Cohort B: RAL + FTC/TDF-12-16-13-7
Cohort C: DRV/RTV + FTC/TDF15280

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Fold Change in D-dimer From Study Entry to Weeks 48 and 96

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

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.570.52
Cohort B: RAL + FTC/TDF0.730.72
Cohort C: DRV/RTV + FTC/TDF0.650.65

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

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

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

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

IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.620.89
Cohort B: RAL + FTC/TDF0.710.82
Cohort C: DRV/RTV + FTC/TDF0.750.89

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Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96

Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 24Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.490.38
Cohort B: RAL + FTC/TDF0.510.34
Cohort C: DRV/RTV + FTC/TDF0.520.37

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Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96

Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 24Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.510.35
Cohort B: RAL + FTC/TDF0.560.36
Cohort C: DRV/RTV + FTC/TDF0.590.38

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Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96

Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF1.010.98
Cohort B: RAL + FTC/TDF0.910.90
Cohort C: DRV/RTV + FTC/TDF1.000.98

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Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96

Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96

,,
InterventionFold change (Median)
Fold change from study entry to week 48Fold change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0.540.51
Cohort B: RAL + FTC/TDF0.620.56
Cohort C: DRV/RTV + FTC/TDF0.610.58

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Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT)

"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors." (NCT00851799)
Timeframe: Study entry, week 144

Interventionmicron/year (Mean)
Cohort A: ATV/RTV + FTC/TDF8.2
Cohort B: RAL + FTC/TDF10.7
Cohort C: DRV/RTV + FTC/TDF12.9

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Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24

"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, week 24

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-0.05
Cohort B: RAL + FTC/TDF-0.27
Cohort C: DRV/RTV + FTC/TDF0.15

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Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96

Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-3.7
Cohort B: RAL + FTC/TDF-2.2
Cohort C: DRV/RTV + FTC/TDF-3.3

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Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96

Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-4.0
Cohort B: RAL + FTC/TDF-1.6
Cohort C: DRV/RTV + FTC/TDF-3.1

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Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96

Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF-1.9
Cohort B: RAL + FTC/TDF-0.9
Cohort C: DRV/RTV + FTC/TDF-1.0

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Percent Change in Lean Mass From Study Entry to Week 96

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

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

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

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

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

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Percent Change in Total Limb Fat From Study Entry to Week 96

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

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF9.8
Cohort B: RAL + FTC/TDF6.3
Cohort C: DRV/RTV + FTC/TDF7.9

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Percent Change in Trunk Fat From Study Entry to Week 96

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

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.8
Cohort B: RAL + FTC/TDF13.5
Cohort C: DRV/RTV + FTC/TDF9.7

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Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96

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

Interventionpercent (Median)
Cohort A: ATV/RTV + FTC/TDF10.7
Cohort B: RAL + FTC/TDF16.2
Cohort C: DRV/RTV + FTC/TDF9.5

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CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144

The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. (NCT00851799)
Timeframe: Study entry, weeks 24, 48, 96 and 144

,,
Interventioncell/mm^3 (Median)
Study EntryWeek 24Week 48Week 96Week 144
Cohort A: ATV/RTV + FTC/TDF350509573634658
Cohort B: RAL + FTC/TDF343445496569613
Cohort C: DRV/RTV + FTC/TDF355464528567560

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Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48

The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. (NCT00851799)
Timeframe: Study entry, weeks 4, 24 and 48

,,
Interventionmm (Mean)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48
Cohort A: ATV/RTV + FTC/TDF0.002-0.0020.002
Cohort B: RAL + FTC/TDF0.012-0.0040.005
Cohort C: DRV/RTV + FTC/TDF-0.0050.008-0.001

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Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48

"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, weeks 4 and 48

,,
Interventionpercent (Mean)
Change from study entry to week 4Change from study entry to week 48
Cohort A: ATV/RTV + FTC/TDF-0.04-0.04
Cohort B: RAL + FTC/TDF0.22-0.08
Cohort C: DRV/RTV + FTC/TDF-0.15-0.11

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Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144

Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). (NCT00851799)
Timeframe: Study entry to weeks 24, 48, 96, and 144

,,
Interventioncell/mm^3 (Median)
Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96Change from study entry to week 144
Cohort A: ATV/RTV + FTC/TDF161209280305
Cohort B: RAL + FTC/TDF133191247279
Cohort C: DRV/RTV + FTC/TDF118194248227

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Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96

Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF0212
Cohort B: RAL + FTC/TDF-3-2-1-1
Cohort C: DRV/RTV + FTC/TDF1356

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Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96

Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF3443
Cohort B: RAL + FTC/TDF3446
Cohort C: DRV/RTV + FTC/TDF2422

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Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96

HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF-1324
Cohort B: RAL + FTC/TDF-2324
Cohort C: DRV/RTV + FTC/TDF-3014

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Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96

Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
InterventionuIU/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF4.04.04.03.5
Cohort B: RAL + FTC/TDF3.03.03.03.0
Cohort C: DRV/RTV + FTC/TDF3.02.03.02.0

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Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96

Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96

,,
Interventionmg/dL (Median)
Change from study entry to week 4Change from study entry to week 24Change from study entry to week 48Change from study entry to week 96
Cohort A: ATV/RTV + FTC/TDF49812
Cohort B: RAL + FTC/TDF-7-4-11
Cohort C: DRV/RTV + FTC/TDF371214

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Area Under the Curve (AUC) of BUP/NLX With Raltegravir (hr*ng/mL)

PK parameters of BUP were determined by non-compartmental methods. AUC of BUP was determined by use of the trapezoidal rule. (NCT00858962)
Timeframe: 6-14 days after beginning co-administration of drugs

Interventionhr*ng/mL (Mean)
Raltegravir (400mg Twice Per Day)56.0

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Change in the Density of CD3+/CD4+ Cells Per Cubic Millimeter at the Effector Sites in the Duodenal Tissues Following Antiretroviral Therapy Regimen

immunohistochemistry for CD3+/CD4+ cells counted manually within the lamina propria (NCT00870363)
Timeframe: Baseline and nine months for 3 treatment cohorts and Baseline for the control group, which was only assessed at one time point

Interventioncells/mm^2 (Mean)
Maraviroc in Combination With 2 NRTIs24
Maraviroc PLUS Raltegravir in Combination With 2 NRTIs89
Efavirenz or Other NNRTI With 2 NRTIs119
HIV Negative Controls Not on ART566

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Changes in CD4+ T-cell Numbers by Treatment Regimen

peripheral absolute CD4+ T-cell counts increase from baseline to 9 months of cART by commercial assay (NCT00870363)
Timeframe: Baseline and nine months

Interventioncells/mL (Mean)
Maraviroc in Combination With 2 NRTIs221
Maraviroc PLUS Raltegravir in Combination With 2 NRTIs231
Efavirenz or Other NNRTI With 2 NRTIs194

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Change in HIV DNA Per 10^6 Cells in Duodenal Tissue Versus PBMC by Drug Regimen Received

single-cell suspension of digested duodenal tissue and Ficol-Hypaque separated PBMC underwent HIV-DNA PCR (NCT00870363)
Timeframe: Baseline and nine months

,,
Interventioncopies/10^6 cells (Mean)
PBMC HIV-DNADuodenal HIV-DNA
Efavirenz or Other NNRTI With 2 NRTIs-1330-325
Maraviroc in Combination With 2 NRTIs-1709-16
Maraviroc PLUS Raltegravir in Combination With 2 NRTIs-2500-846

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Trough Plasma and Tissue Drug Levels in Volunteers at the Time of the Upper Endoscopy

The reported drug level is for the primary ART agent for that cohort. For the maraviroc arm, maraviroc plasma and tissue levels are reported. For the maraviroc plus raltegravir arm, the raltegravir plasma and tissue levels are reported. For the efavirenz arm, the efavirenz plasma and tissue levels are reported. HIV negative controls were not on ART and did not have drug levels measured. (NCT00870363)
Timeframe: nine months

,,
Interventionng/mL (Median)
plasma primary ARTduodenal tissue primary ART
Efavirenz or Other NNRTI With 2 NRTIs245911.1
Maraviroc in Combination With 2 NRTIs94.50.7
Maraviroc PLUS Raltegravir in Combination With 2 NRTIs3970.1

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"Average Change in Activated (CD38+HLADR+) CD8+ T Cells in the Ileum"

Average of changes(week 0-week 12) in the % of CD8+ T cells that are CD38+HLA-DR+, by flow cytometry (NCT00884793)
Timeframe: 12 weeks

Interventionpercentage change (Mean)
Intensification Arm-5.4

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Number of Subjects Who Experienced an Increase in CD4% in the Ileum.

Number of subjects who experienced an increase from week 0 to week 12 in CD4+ T cells (as a % of T cells, by flow cytometry) in the ileum (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm5

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Number of Subjects Who Experienced an Increase in CD4+ T Cells (as a % of All Cells) in the Ileum.

Number of subjects who experienced an increase in CD4+ T cells (as a % of all cells) in the ileum (by flow cytometry) from week 0 to week 12. (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm6

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Number of Subjects Who Had a Decrease in HIV RNA Per Million CD4+ T Cells in the Ileum

Number of subjects who had a decrease from week 0 to week 12 in unspliced cell-associated HIV RNA per million CD4+ T cells in the ileum (NCT00884793)
Timeframe: 12 weeks

Interventionparticipants (Number)
Intensification Arm5

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Proportion of Patients With Plasma Viral Load Below the Limit of Detection

Assess proportion of patients with PVL below limit of detection at end of study. (NCT00887653)
Timeframe: 6 months

Interventionproportion of participants (Number)
Raltegravir Arm0

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Change From Baseline Triglycerides

Assess changes from baseline triglycerides at 6 months (NCT00887653)
Timeframe: 6 months

Interventionunits on a scale (Median)
Raltegravir Arm120

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Change From Baseline Triglycerides

Assess changes from baseline triglycerides at 3 months (NCT00887653)
Timeframe: 3 months

Interventionunits on a scale (Median)
Raltegravir Arm125

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Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Non-completer Classed as Failure

"The non-completer classed as failure analysis will include all randomised participants; participants who meet the following criteria will be defined as failures:~i. week 48 HIV RNA being above each threshold ii. has missing HIV-1 RNA data for any reason iii. stops randomly assigned therapy" (NCT00931463)
Timeframe: 48 weeks

Interventionparticipants (Number)
Ritonavir-boosted Lopinavir and 2N(t)RTI208
Ritonavir-boosted Lopinavir and Raltegravir210

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Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, Baseline VL >100,000 Copies Per mL

The difference between treatment arms in proportion of participants with plasma HIV RNA < 200 copies/mL 48 weeks after randomization, per-protocol population: stratified analysis by baseline plasma viral load (less than or equal to 100,000 copies per mL or >100,000 copies per mL) on those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment (NCT00931463)
Timeframe: 48 weeks

Interventionparticipants (Number)
Ritonavir-boosted Lopinavir and 2N(t)RTI31
Ritonavir-boosted Lopinavir and Raltegravir39

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Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population

The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment (NCT00931463)
Timeframe: 48 weeks

Interventionparticipants (Number)
Ritonavir-boosted Lopinavir and 2N(t)RTI211
Ritonavir-boosted Lopinavir and Raltegravir211

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Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization

(NCT00931463)
Timeframe: 48 weeks following randomization

Interventionparticipants (Number)
Ritonavir-boosted Lopinavir and 2N(t)RTI219
Ritonavir-boosted Lopinavir and Raltegravir223

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Participants With Plasma HIV RNA < 200 Copies/mL 48 Weeks After Randomization, Per-protocol Population, VL Less Than or Equal to 100,000 Copies Per mL

The per- protocol population includes those participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment (NCT00931463)
Timeframe: 48 weeks

Interventionparticipants (Number)
Ritonavir-boosted Lopinavir and 2N(t)RTI188
Ritonavir-boosted Lopinavir and Raltegravir184

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Maintenance of Virologic Suppression

To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL. (NCT00931801)
Timeframe: 48 weeks

,,
Interventionparticipants (Number)
Virologic ResponseConfirmed Virologic FailuresWithdrawal Due to AE; HIV RNA < 50 copies/mLOther Withdrawal; HIV RNA < 50 copies/mL
Control Arm13001
Intervention Arm No.114001
Intervention Arm No.210310

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The Difference in CD4 From Baseline to Week 48

Change in mean CD4 from Baseline to Week 48. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventioncells/mm3 (Mean)
CD4 at BaselineCD4 at Week 48CD4 Change
Control Arm535.8611.275.4
Intervention Arm No.1514.1526.312.1
Intervention Arm No.2539.1507.2-31.9
Total528.3549.321.0

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The Change in Adherence to Study Treatment Arm From Baseline to Week 48

Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits. (NCT00931801)
Timeframe: Baseline and Week 48

,,,
Interventionpercentage of prescribed doses (Mean)
3 Day Adherence Recall at Baseline3 Day Adherence Recall at Week 48Change in 3 Day Adherence Recall
Control Arm1001000
Intervention Arm No.197.597.50
Intervention Arm No.296.795.0-1.7
Total98.197.6-0.5

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Change in Quality of Life From Baseline to 48 Weeks of Study Treatment

Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment. (NCT00931801)
Timeframe: baseline and 48 weeks

,,,
Interventionunits on a scale (Mean)
Mean Quality of Life Score at BaselineMean Quality of Life Score at Week 48Change in Quality of Life
Control Arm92.990.5-2.5
Intervention Arm No.177.478.20.8
Intervention Arm No.282.581.3-1.3
Total84.283.3-0.9

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Percentage of Participants With HIV Viral Load <50 Copies/mL

Plasma HIV viral load remained <50 copies/mL (NCT00939874)
Timeframe: from Baseline to Week 96

Interventionpercentage of participants (Number)
Raltegravir90.6

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Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips

Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96 (NCT00939874)
Timeframe: from Baseline to Weeks 48 and 96

Interventionpercent change (Mean)
Spine BMD, week 48 (n=37)Spine BMD, week 96 (n=32)Total hip BMD week 48 (n=37)Total hip BMD week 96 (n=32)
Raltegravir2.73.02.31.9

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Change From Baseline in CD4+ T Cell Count at Week 56

(NCT00976404)
Timeframe: Week 56

Interventioncells per mm^3 (Median)
Maraviroc + Raltegravir Intensification-1
Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine23

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Change From Baseline in HIV DNA in PBMCs at Week 56

(NCT00976404)
Timeframe: 56 weeks

Interventionlog^10 copies per 10^6 PBMCs (Median)
ART Intensification: Maraviroc +Raltegravir0.00
Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine0.04

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Change From Baseline in HIV DNA in Rectal Tissue at Week 56

(NCT00976404)
Timeframe: Week 56

Interventionlog^10 copies per 10^6 cells (Median)
Maraviroc + Raltegravir Intensification0.08
Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine-0.02

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HIV Specific T-cell Response to Env

HIV-specific immunity: Interferon gamma ELISpot response to Env (clades A) at week 36 (one month after rAd5 boosting) (NCT00976404)
Timeframe: 36 weeks

Interventionresponse per 10^6 PBMCs (Median)
Maraviroc + Raltegravir Intensification28
Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine86

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Serious Adverse Events Attributed to Study Treatments

Grade 3 or 4 serious adverse events related to study treatments (raltegravir, maraviroc, or HIV-recombinant Ad5-based vaccine) (NCT00976404)
Timeframe: 56 weeks

Interventionserious adverse events (Number)
Maraviroc + Raltegravir Intensification1
Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine3

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Raltegravir Minimum Plasma Concentrations

Raltegravir minimum plasma concentrations by pharmacokinetic analyses (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase2_Raltegravir83.97
Phase3_ribovarin and Raltegravir68.91

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Raltegravir Maximum Plasma Concentration

(NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase2_Raltegravir2227.41
Phase3_ribovarin and Raltegravir2591.19

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Ribavirin Maximum Plasma Concentration

Pharmacokinetic analyses of blood samples (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase1_ribavirin630.09
Phase3_ribovarin and Raltegravir496.71

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Ribavirin Minimum Plasma Concentration

Ribavirin minimum plasma concentration by pharmacokinetic analyses (NCT00982553)
Timeframe: Day 20

Interventionng/mL (Geometric Mean)
Phase1_Ribavirin184.71
Phase3_ribovarin and Raltegravir186.98

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Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA

(NCT01000285)
Timeframe: 6 months

,
Interventioncopies/peripheral blood mononuclear cell (Mean)
BaselineStudy completion
Non-responders41.935.7
Responders37.07.33

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Efficacy of Treatment as Measured by Best Overall Response

-The response definitions used for this study are the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy

Interventionparticipants (Number)
Progressive DiseaseStable diseasePartial responseComplete response
EPOCH Chemotherapy & Bortezomib3393

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Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence

(NCT01000285)
Timeframe: 6 months

Interventionpercentage of nucleotide divergence (Mean)
BaselineStudy completion
EPOCH Chemotherapy & Bortezomib0.490.52

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Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads

(NCT01000285)
Timeframe: 6 months

,
Interventioncopies/peripheral blood mononuclear cell (Mean)
BaselineStudy completion
Non-responders0.4170.033
Responders0.3720.0128

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Relation of NFκB Gene Expression Profile on Response

Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated. (NCT01000285)
Timeframe: 6 months

,,,,,,,
Interventionfold expression (Mean)
BLKCADMICD25CD4CD45
Patient A (Responder) Post-Therapy0.1780.0110.0351.3801.718
Patient A (Responder) Pre-Therapy1.0001.0001.0001.0001.000
Patient B (Responder) Post-Therapy0.1720.0070.0150.6070.959
Patient B (Responder) Pre-Therapy0.8890.6230.3031.4372.049
Patient C (Non-responder) Post-Therapy77.5901.8160.6911.9231.640
Patient C (Non-responder) Pre-Therapy68.8561.4940.8621.3191.163
Patient D (Non-responder) Post-Therapy46.8010.4700.5120.6480.714
Patient D (Non-responder) Pre-Therapy233.1792.0132.8973.0570.594

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Time to Progression

-The progression definitions used for this study are from the 2007 Cheson criteria. (NCT01000285)
Timeframe: Up to 4 years following completion of therapy

Interventiondays (Median)
Best response of complete responseBest response of partial responseBest response of stable diseaseAll participants
EPOCH Chemotherapy & Bortezomib19914388127

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Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. (NCT01000285)
Timeframe: Up to 30 days after completion of treatment

Interventionparticipants (Number)
FatigueVomitingSpontaneous bacterial peritonitisAbdominal distensionHemoglobinLeukocytes (WBC)LymphopeniaNeutrophilsPlateletsInfection without neutropeniaInfection with neutropeniaOmaya port infectionIV port infectionSepsisNeutropenic feverHypoglycemiaHyperglycemiaMagnesiumHypokalemiaHypertriglyceridemiaConfusionHeadacheEncephalitisAbdominal painCoughDyspnea
EPOCH Chemotherapy & Bortezomib11126716611112312111111111

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Effects of HTLV-1 Integration Sites After Treatment

(NCT01000285)
Timeframe: 6 months

Interventionnumber of integration sites (Mean)
BaselineStudy completion
EPOCH Chemotherapy & Bortezomib1.311.00

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Plasma Area Under Curve (AUC 0-12 hr ) for Raltegravir

Area Under the Plasma Concentration-Time Curve and peak concentration (NCT01000818)
Timeframe: 12 hours postdose

InterventionµM*hr (Geometric Mean)
400 mg Raltegravir12.36
20 mg Famotidine + 400 mg Raltegravir17.95
20 mg Omeprazole + 400 mg Raltegravir17.12

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Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24

The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to < 5 copies/mL. (NCT01025427)
Timeframe: 24 weeks

Interventionfold decrease in signal/cutoff ratio (Mean)
HIV Controller66

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Patients Without HIV Re-bound

HIV Viral load blood test at week 24 (NCT01044771)
Timeframe: 24 weeks

Interventionparticipants (Number)
Viral Rebound2

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Patients With Reduced or Resolved Proteinuria

Measurement of Protein in Urine samples at end of study visit (NCT01044771)
Timeframe: 24 weeks

Interventionparticipants (Number)
Change From Tenofovir to Raltegravir20

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Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count: All Treated Participants

(NCT01048671)
Timeframe: Baseline and 24 months after start of raltegravir treatment

Interventioncells/mm^3 (Mean)
ARV naïve at Baseline260.58
Suppressed at Baseline47.97
Virological Failure at Baseline149.98
All Participants107.53

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Percentage of Participants Receiving Antiretroviral Treatments Administered With Raltegravir

Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. ARV treatments included any nucleoside reverse transcriptase inhibitors (NRTIs), combination of tenovir/emitricitabine (FTC/TDF), combination of lamivudine/abacavir (3TC/ABC), protease inhibitors, and others. (NCT01048671)
Timeframe: Up to 25 months after start of raltegravir treatment

InterventionPercentage of participants (Number)
FTC/TDF + raltegravir3TC/ABC + raltegravirOther 2 NRTIs + raltegravirMulitple (>=3 ) ARV therapies + raltegravirProtease inhibitor + raltegravirOther strategies (each <5%)
Antiretroviral Combination Therapy Including Raltegravir44.414.01.315.78.815.7

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Percentage of Participants Responding to Treatment: Participants Still Receiving Raltegravir Treatment at Month 24

Response to treatment was defined as a viral load <50 RNA copies/mL (NCT01048671)
Timeframe: 24 months after start of raltegravir treatment

InterventionPercentage of participants (Number)
ARV naïve at Baseline94.9
Suppressed at Baseline95.4
Virological Failure at Baseline77.7
All Participants90.2

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Percentage of Participants Responding to Treatment: All Treated Participants

Response to treatment was defined as a viral load <50 RNA copies/mL (NCT01048671)
Timeframe: 24 months after start of raltegravir treatment

InterventionPercentage of participants (Number)
ARV naïve at Baseline94.2
Suppressed at Baseline94.3
Virological Failure at Baseline71.2
All Participants87.2

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Number of Participants With at Least One Adverse Event

An adverse event was defined as any untoward, undesired, or unplanned clinical event in the form of physical signs, symptoms, disease, laboratory or physiological observations in a participant administered the sponsor's product whether or not related to the use of the product. (NCT01048671)
Timeframe: Up to 25 months after start of raltegravir treatment

InterventionParticipants (Number)
Antiretroviral Combination Therapy Including Raltegravir287

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Mean Change From Baseline in CD4 Cell Count: Participants Still Receiving Raltegravir Treatment at Month 24

(NCT01048671)
Timeframe: Baseline and 24 months after start of raltegravir treatment

Interventioncells/mm^3 (Mean)
ARV naïve at Baseline285.05
Suppressed at Baseline49.21
Virological Failure at Baseline150.87
All Participants106.15

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Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations

To estimate the rates of grade 2*and higher ALT elevations in the two regimens. (NCT01147107)
Timeframe: over week 72

InterventionParticipants (Count of Participants)
Raltegravir Based Therapy24
Efavirenz Based Therapy30

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Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.

The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen. (NCT01154673)
Timeframe: Baseline to Week 48

InterventionHIV DNA copies/ million CD4 cells (Median)
Intensive HAART279
Placebo Arm244

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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment

To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) (NCT01195467)
Timeframe: 4 weeks

Interventionpercentage improvement in CNS score (Number)
Single Arm26

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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment

"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)" (NCT01195467)
Timeframe: baseline to week 12

Interventionpercentage of improvement in sleep score (Number)
Single Arm25

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Viral Suppression

Time to attainment of virologic suppression (NCT01204905)
Timeframe: 48 weeks

Interventionweeks (Number)
Open Label ART6

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Viral Load

Percentage of subjects with HIV-1 viral load < 50 copies/ml (NCT01204905)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Open Label ART4

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Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 96 Weeks of Raltegravir Treatment

The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 96 weeks of raltegravir treatment was determined. (NCT01213316)
Timeframe: Baseline and 96 weeks

InterventionPercentage of participants (Number)
Baseline96 weeks
Initial Cohort Participants43.868.0

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Percentage of Aging Participants Taking Concomitant Medications at Baseline

The percentage of aging participants taking concomitant medication in addition to their other antiretroviral therapy was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. (NCT01213316)
Timeframe: Baseline

InterventionPercentage of participants (Number)
Aging Participants74.9

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Percentage of Aging Participants With Concomitant Diseases at Baseline

The percentage of aging participants with Baseline comorbidities was reported. This Outcome Measure was added with Amendment 1 and applies only to aging participants. (NCT01213316)
Timeframe: Baseline

InterventionPercentage of participants (Number)
Aging Participants93.8

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Change From Baseline in CD4+ T-cell Counts After 96 Weeks of Raltegravir Treatment

Mean CD4+ T-cell counts were determined at baseline and after 96 weeks of raltegravir treatment. A positive change from baseline indicates an increase in CD4+ T-cell count. (NCT01213316)
Timeframe: Baseline and 96 weeks

InterventionCD4+ T-cells/µL (Mean)
BaselineChange from Baseline at 96 weeks: n=216
Initial Cohort Participants461.9161.7

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Change From Baseline in CD4+ T-cell Counts in Aging Participants After 48 Weeks of Raltegravir Treatment

Mean CD4+ T-cell counts were determined in aging participants (>=50 years old at initiation of raltegravir treatment) at baseline and after 48 weeks of raltegravir treatment was determined. A positive change from baseline indicates an increase in CD4+ T-cell count. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionCD4+ T-cells/µL (Mean)
BaselineChange from Baseline at 48 weeks: n=202
Aging Participants534.463.2

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Change From Baseline in Mean D:A:D Risk Score for the 5-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment

Mean Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Risk Score for 5-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. The score included the following 8 risk factors: sex, age, systolic blood pressure, family cardiovascular disease history, current smoking, previous cigarette smoker, diabetes, total cholesterol, high-density lipoprotein, currently on indinavir, currently on lopinavir, currently on abacavir, duration and current use of indinavir and duration and current use of lopinavir. The D:A:D Risk Score is interpreted as low: <1%; moderate: 1-5%; high: 5-10%; and very high: >10%. The change from baseline was calculated as Week 48 minus Baseline; a positive change indicates increased risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionPercentage risk (Mean)
Score at BaselineChange from Baseline at 48 weeks: n=57
Aging Participants9.44.2

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Change From Baseline in Mean Framingham Risk Score for the 10-Year Cardiovascular Risk in Aging Participants After 48 Weeks of Raltegravir Treatment

Mean Framingham Risk for 10-year cardiovascular risk was determined in aging participants (>=50 years old at initiation of raltegravir treatment). Points were allotted for each of following 8 risk factors : sex, age, systolic blood pressure, treatment for hypertension, smoking, diabetes, total cholesterol, and high-density lipoprotein. The sum of the points for each participant was assigned a percent 10-year cardiovascular risk on a lookup table, and could range from 0% to 100%. The mean Framingham Risk for 10-year cardiovascular risk was then calculated for the analysis population. The change from baseline was calculated as Baseline minus Week 48; a positive change indicates reduced risk. This Outcome Measure was added with Amendment 1 and applies only to aging participants. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionPercentage risk (Mean)
Score at BaselineChange from Baseline at 48 weeks: n=65
Aging Participants24.11.1

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HIV-1 Viral Load After 96 Weeks of Raltegravir Treatment

The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined at Baseline and after 96 weeks of raltegravir treatment. (NCT01213316)
Timeframe: Baseline and 96 weeks

InterventionLog10 Copies/mL (Mean)
Baseline96 weeks
Initial Cohort Participants2.901.52

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Percentage of Aging Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment

The percentage of aging participants (>=50 years old at initiation of raltegravir treatment) with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionPercentage of participants (Number)
Baseline48 weeks
Aging Participants62.177.5

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Percentage of Participants With an HIV-1 Viral Load <50 Copies/mL After 48 Weeks of Raltegravir Treatment

The percentage of participants with an HIV-1 viral load <50 copies/mL of HIV-1 RNA after 48 weeks of raltegravir treatment was determined. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionPercentage of participants (Number)
Baseline48 weeks
Overall Participants50.874.7

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HIV-1 Viral Load in Aging Participants After 48 Weeks of Raltegravir Treatment

The HIV-1 viral load (log10 copies/mL of HIV-1 RNA) was determined in aging participants (>=50 years old at initiation of raltegravir treatment) at Baseline and after 48 weeks of raltegravir treatment. (NCT01213316)
Timeframe: Baseline and 48 weeks

InterventionLog10 Copies/mL (Mean)
Baseline48 weeks
Aging Participants2.281.50

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Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study

(NCT01214759)
Timeframe: 28 days

Interventionparticipants (Number)
Truvada and Raltegravir85

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Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months

This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. (NCT01214759)
Timeframe: 6 months

Interventionparticipants (Number)
Truvada and Raltegravir0

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Absolute Values in CD4+ Cell Counts Over Time

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 immuno compromise. 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 absolute values in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles). (NCT01227824)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

,
Interventioncells/mm^3 (Mean)
Baseline n=411, 411Week 4, n=398, 403Week 8, n=398, 402Week 12, n=392, 397Week 16, n=394, 392Week 24, n=392, 389Week 32, n=384, 375Week 40, n=371, 357Week 48, n=374, 357Week 60, n=367, 355Week 72, n=360, 350Week 84, n=351, 338Week 96, n=343, 328
DTG 50 mg Once a Day379.2474.2502.3513.3536.4582.0606.5609.1623.8635.6635.2668.0679.8
RTG 400 mg BID374.3471.8502.4518.3550.1580.8618.7623.1641.2648.5664.0677.5672.4

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Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau [AUC(0-tau)] of DTG

AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. The predicted individual AUC(0-tau) were obtained from the final population PK model by an empirical Bayes estimation. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hours post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. The Pharmacokinetic (PK) Concentration Population comprised of all participants who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data. (NCT01227824)
Timeframe: Week 4, Week 24, and Week 48

InterventionMicrograms*hour per milliliter(µg*hr/mL) (Geometric Mean)
DTG 50 mg Once a Day53.6

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Number of Participants With Plasma HIV-1 RNA <400 c/mL

The number of participants with plasma HIV-1 RNA level <400 c/mL was assessed at Week 48 and Week 96. (NCT01227824)
Timeframe: Week 48 and Week 96

,
InterventionParticipants (Number)
Week 48Week 96
DTG 50 mg Once a Day369338
RTG 400 mg BID356321

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Number of Participants With the Indicated Grade 1 to 4 Clinical Chemistry and Hematology Toxicities/Laboratory Adverse Events (AEs)

All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), 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. Safety Population: all participants who received at least one dose of investigational product (NCT01227824)
Timeframe: From Baseline until Week 96

,
InterventionParticipants (Number)
ALTALPASTCO2 content/bicarbonateCholesterolCKCreatinineHyperglycaemiaHyperkalemiaHypernatremiaHypoglycaemiaHypokalemiaHyponatremiaLDL cholesterol calculationLipasePhosphorus, inorganicTotal bilirubinTriglyceridesHemoglobinPlatelet countTotal neutrophilsWhite Blood Cell count
DTG 50 mg Once a Day5776758906111707417103474556527710195419
RTG 400 mg BID70157567734778746271548496271248519487

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Number of Participants With the Indicated Post-Baseline HIV-associated Conditions and Progression, Excluding Recurrences

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 to a CDC CAT C event (EV); CDC CAT B at Baseline to a CDC CAT C EV; CDC CAT C at Baseline to a new CDC CAT C EV; or CDC CAT A, B, or C at Baseline to death. (NCT01227824)
Timeframe: From Baseline until Week 96

,
InterventionParticipants (Number)
Any category conditionAny Category B conditionAny Category C conditionAny deathProgression from CAT A to CAT CProgression from CAT B to CAT CProgression from CAT C to new CAT CProgression from CAT A, B, or C to death
DTG 50 mg Once a Day103614301
RTG 400 mg BID83412111

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Change From Baseline in Plasma HIV-1 RNA Over Time

Change from Baseline in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as the measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles). (NCT01227824)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

,
Interventionlog10 c/mL (Mean)
Baseline n=411, 411Week 4, n=402, 406Week 8, n=397, 402Week 12, n=396, 395Week 16, n=395, 388Week 24, n=393, 390Week 32, n=386, 377Week 40, n=375, 358Week 48, n=374, 358Week 60, n=366, 355Week 72, n=361, 350Week 84, n=352, 338Week 96, n=342, 329
DTG 50 mg Once a Day4.538-2.817-2.897-2.908-2.917-2.896-2.907-2.920-2.915-2.912-2.917-2.932-2.938
RTG 400 mg BID4.599-2.801-2.886-2.918-2.943-2.933-2.947-2.946-2.942-2.937-2.932-2.916-2.901

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Number of Participants With Plasma HIV-1 RNA <50 c/mL

The number of participants with plasma HIV-1 RNA level <50 c/mL was assessed at Week 96. (NCT01227824)
Timeframe: Week 96

InterventionParticipants (Number)
DTG 50 mg Once a Day332
RTG 400 mg BID314

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Maximum Plasma Concentration (Cmax) and Concentration at the End of a Dosing Interval (Ctau) of DTG

The maximum plasma concentration (Cmax) and concentration at the end of a dosing interval (Ctau) of DTG were assessed at Week 48. The predicted individual Cmax and Ctau were obtained from the final population PK model by simulation of the concentration-time profiles. Blood samples for PK assessments were collected at pre-dose (within 15 minutes prior to dose) at Week 4, Week 24, and Week 48 and 1 to 3 hours post-dose or 4 to 12 hours post-dose at Week 4 and Week 24. If 1 to 3 hour post-dose was completed at Week 4, then the 4 to12 hour post-dose must be obtained at Week 48, and vice versa. (NCT01227824)
Timeframe: Week 4, Week 24, and Week 48

InterventionMicrograms per milliliter (µg/mL) (Geometric Mean)
CmaxCtau
DTG 50 mg Once a Day3.691.10

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Number of Participants With Detectable HIV-1 Virus That Has Genotypic or Phenotypic Evidence of INI Resistance.

Number of participants with detectable virus that has genotypic or phenotypic evidence of Integrase Inhibitor (INI) resistance were assessed at Week 48 and Week 96. Integrase inhibitors are a class of antiretroviral drug designed to block the action of integrase, a viral enzyme that inserts the viral genome into the deoxyribonucleic acid (DNA) of the host cell. (NCT01227824)
Timeframe: Week 48 and Week 96

,
InterventionParticipants (Number)
Week 48, genotypicWeek 48, phenotypicWeek 96, genotypicWeek 96, phenotypic
DTG 50 mg Once a Day0101
RTG 400 mg BID1212

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Percentage of Participants With Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) [HIV-1RNA] <50 Copies (c)/Milliliter (mL) Through Week 48

Percentage of participants with plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) with <50 c/mL was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. The algorithm treats all participants without HIV-1 RNA data as non-responders, as well as participants who switch their concomitant Antiretroviral Therapy (ART) prior to Week 48 as follows: background ART substitutions not permitted per study; background ART substitutions permitted per study unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the subject was on-treatment. Intent-to-Treat Exposed (ITT-E) Population comprised all randomized participants who received at least one dose of study medication. (NCT01227824)
Timeframe: Baseline up to Week 48

InterventionPercentage of participants (Number)
DTG 50 mg Once a Day88
RTG 400 mg BID85

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Change From Baseline in Cluster of Differentiation (CD)4+ Cell Counts Over Time

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 immuno compromise. The CD4 count is used to stage the participants disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start ART. Changes from Baseline in CD4+ cell counts over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Baseline was defined as measurements performed on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles). (NCT01227824)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

,
InterventionCells per cubic millimeter (cells/mm^3) (Mean)
Baseline n=411, 411Week 4, n=398, 403Week 8, n=398, 402Week 12, n=392, 397Week 16, n=394, 392Week 24, n=392, 389Week 32, n=384, 375Week 40, n=371, 357Week 48, n=374, 357Week 60, n=367, 355Week 72, n=360, 350Week 84, n=351, 338Week 96, n=343, 328
DTG 50 mg Once a Day379.293.3121.6130.7155.1199.3223.4224.1238.9247.8247.8281.3292.2
RTG 400 mg BID374.397.2126.6145.1173.0204.2241.3239.8257.5264.2278.6292.9286.2

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Absolute Values in Plasma HIV-1 RNA Over Time

Absolute values in plasma HIV-1 RNA over time was assessed at Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96. Only those participants with data available at the specified time points were analyzed (represented by n=x,x in the category titles). (NCT01227824)
Timeframe: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96

,
Interventionlog10 c/mL (Mean)
Baseline n=411, 411Week 4, n=402, 406Week 8, n=397, 402Week 12, n=396, 395Week 16, n=395, 388Week 24, n=393, 390Week 32, n=386, 377Week 40, n=375, 358Week 48, n=374, 358Week 60, n=366, 355Week 72, n=361, 350Week 84, n=352, 338Week 96, n=342, 329
DTG 50 mg Once a Day4.5381.7181.6461.6261.6201.6431.6201.6031.6061.6051.6011.6071.599
RTG 400 mg BID4.5991.8001.7091.6721.6481.6551.6361.6011.5991.5991.6051.6141.630

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Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

Blood samples were collected for the analysis of clinical chemistry and hematology parameters: Alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hypoonatremia, LDL cholesterol, lipase, total bilirubin, triglycerides, hemoglibin, neutrophils, platelets, white blood cells. Any abnormality in clinical chemistry and hematology parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).Higher the grade, more severe the symptoms. (NCT01231516)
Timeframe: From Week 48 to Week 480

,
InterventionParticipants (Count of Participants)
ALT, Grades 1 to 4ALT, Grades 2 to 4ALT, Grades 3 to 4Albumin, Grades 1 to 4Albumin, Grades 2 to 4Albumin, Grades 3 to 4ALP, Grades 1 to 4ALP, Grades 2 to 4ALP, Grades 3 to 4AST, Grades 1 to 4AST, Grades 2 to 4AST, Grades 3 to 4CO2 content/bicarbonate, Grades 1 to 4CO2 content/bicarbonate, Grades 2 to 4CO2 content/bicarbonate, Grades 3 to 4Cholesterol, Grades 1 to 4Cholesterol, Grades 2 to 4Cholesterol, Grades 3 to 4CK, Grades 1 to 4CK, Grades 2 to 4CK, Grades 3 to 4Creatinine, Grades 1 to 4Creatinine, Grades 2 to 4Creatinine, Grades 3 to 4Hyperglycemia, Grades 1 to 4Hyperglycemia, Grades 2 to 4Hyperglycemia, Grades 3 to 4Hyperkalemia, Grades 1 to 4Hyperkalemia, Grades 2 to 4Hyperkalemia, Grades 3 to 4Hypernatremia, Grades 1 to 4Hypernatremia, Grades 2 to 4Hypernatremia, Grades 3 to 4Hypoglycemia, Grades 1 to 4Hypoglycemia, Grades 2 to 4Hypoglycemia, Grades 3 to 4Hypokalemia, Grades 1 to 4Hypokalemia, Grades 2 to 4Hypokalemia, Grades 3 to 4Hyponatremia, Grades 1 to 4Hyponatremia, Grades 2 to 4Hyponatremia, Grades 3 to 4LDL cholesterol, Grades 1 to 4LDL cholesterol, Grades 2 to 4LDL cholesterol, Grades 3 to 4Lipase, Grades 1 to 4Lipase, Grades 2 to 4Lipase, Grades 3 to 4Total bilirubin, Grades 1 to 4Total bilirubin, Grades 2 to 4Total bilirubin, Grades 3 to 4Triglycerides, Grades 1 to 4Triglycerides, Grades 2 to 4Triglycerides, Grades 3 to 4Hemoglobin, Grades 1 to 4Hemoglobin, Grades 2 to 4Hemoglobin, Grades 3 to 4Neutrophils, Grades 1 to 4Neutrophils, Grades 2 to 4Neutrophils, Grades 3 to 4Platelets, Grades 1 to 4Platelets, Grades 2 to 4Platelets, Grades 3 to 4White Blood Cells, Grades 1 to 4White Blood Cells, Grades 2 to 4White Blood Cells, Grades 3 to 4
DTG 50 mg OD361143302041361411001201386611351122082944079427102220291055201074615673512524218232311116237147221141770
RAL 400 mg BID9300001118002130261634112211061110100410131015002210373011106221600942710310

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Number of Participants With Post-Baseline HIV-associated Conditions, Excluding Recurrences, and Disease Progressions

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 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 clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C:Clinical CON listed in acquired immunodeficiency syndrome (AIDS) surveillance case definition. Indicators of CDP defined as:CDC CAT A at Baseline (BS) to CDC CAT C event (EV); CDC CAT B at BS to CDC CAT C EV; CDC CAT C at BS to new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. (NCT01231516)
Timeframe: Up to Week 480

,
InterventionParticipants (Count of Participants)
Any CATCAT BCAT CDeathProgression from CAT A to CAT CProgression from CAT B to CAT CProgression from CAT C to New CAT CProgression from CAT A, B, or C to Death
DTG 50 mg OD32161262096
RAL 400 mg BID2514841154

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Absolute Values of Cluster of Differentiation 4+ (CD4+) Cell Counts at Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144

Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Median and interquartile range are presented. Baseline was the latest pre-dose assessment value (Day 1). (NCT01231516)
Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144

,
InterventionCells per cubic millimeter (Median)
Baseline (Day 1), n=354, 361Week 4, n=341, 351Week 8, n=338, 346Week 12, n=335, 345Week 16, n=327, 338Week 24, n=326, 326Week 32, n=309, 309Week 40, n=299, 292Week 48, n=298, 286Week 96, n=260, 22Week 144, n=192, 18
DTG 50 mg OD204.5266.0280.0296.0299.0334.5332.0376.0387.0436.5500.0
RAL 400 mg BID193.0253.0268.0289.0293.0326.5338.0349.0378.5484.5535.0

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DTG PK Parameters Including Maximum Plasma Drug Concentration (Cmax), Minimal Plasma Drug Concentration (Cmin), and Average Plasma Pre-dose Concentration (C0_avg)

Cmax, Cmin and C0_avg were assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. Cmax, Cmin and C0_avg were estimated and reported here. (NCT01231516)
Timeframe: Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48

Interventionmicrogram/milliliter (µg/mL) (Geometric Mean)
C0_avg, n=342Cmax, n=340Cmin, n=340
DTG 50 mg OD0.9263.210.849

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Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Utility Score

The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-3L utility score ranges from -0.594 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT01231516)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionScores on a scale (Mean)
Week 24, n=350, 356Week 48, n=350, 356
DTG 50 mg OD0.0100.028
RAL 400 mg BID0.0190.013

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Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Thermometer Scores

The EQ-5D-3L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 3 levels for each dimension including 1=no problems, 2=some problems, 3=extreme problems. EQ-5D-3L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Participants were asked to rate their current health status using the visual analogue scale 'Thermometer'. Score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate better heath. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT01231516)
Timeframe: Baseline (Day 1) and at Weeks 24 and 48

,
InterventionScores on a scale (Mean)
Week 24, n=350, 355Week 48, n=350, 355
DTG 50 mg OD6.8008.894
RAL 400 mg BID4.6455.597

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Change From Baseline in CD4+ Cell Counts at Weeks 4, 8, 12,16, 24, 32, 40, 48, 96 and 144

Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline was the latest pre-dose assessment value (Day 1). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Median and interquartile range is presented. (NCT01231516)
Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 96 and 144

,
InterventionCells per cubic millimeter (Median)
Week 4, n=341, 351Week 8, n=338, 346Week 12, n=335, 345Week 16, n=327, 338Week 24, n=326, 326Week 32, n=309, 309Week 40, n=299, 292Week 48, n=298, 286Week 96, n=260, 22Week 144, n= 192, 18
DTG 50 mg OD53.060.574.076.099.0107.0125.0144.0198.5243.0
RAL 400 mg BID45.059.075.079.593.0116.0117.5137.0270302.5

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DTG PK Parameters Including Area Under the Plasma Concentration-time Curve From Time Zero to Time Tau Over a Dosing Interval at Steady State (AUC[0-tau])

AUC is defined as the area under the DTG concentration-time curve as a measure of drug exposure over time. AUC(0-tau) is defined as the area under the plasma concentration-time curve from time zero to time tau over a dosing interval at steady state, where tau is the length of the dosing interval of DTG. AUC was assessed by population pharmacokinetic (PK) modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. (NCT01231516)
Timeframe: Pre-dose and at 1 to 3 hours or 4 to 12 hours post-dose at Week 4; Pre-dose at Week 24; Pre-dose and 1 to 3 hours or 4 to 12 hours post-dose at Week 48

InterventionMicrograms*hour/milliliter (µg*hr/mL) (Geometric Mean)
DTG 50 mg OD44.7

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Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Integrase Inhibitor (INI) Resistance at Time of Protocol Defined Virology Failure (PDVF)

For par. meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure and Baseline were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) virologic non-response: a decrease in plasma HIV-1 RNA of <1 logarithm to base 10 (log10) copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/ mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) virologic rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline. (NCT01231516)
Timeframe: Baseline (Day 1) until PDVF (Up to Week 48)

InterventionParticipants (Count of Participants)
DTG 50 mg OD4
RAL 400 mg BID17

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Number of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24

"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 24 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 24 as nonresponders, as well as participants who switched their concomitant ART prior to Week 24 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurement through Week 24 (within window) while the participant was on-treatment. The result below corresponds to the Week 24 interim analysis." (NCT01231516)
Timeframe: At Week 24

InterventionParticipants (Count of Participants)
DTG 50 mg OD281
RAL 400 mg BID252

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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48

"The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 c/mL at Week 48 was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the randomized phase of the study." (NCT01231516)
Timeframe: At Week 48

InterventionPercentage of participants (Number)
DTG 50 mg OD71
RAL 400 mg BID64

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Number of Participants With Plasma HIV-1 RNA <400 c/mL at Week 24 and Week 48

"The number of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <400 c/mL at the visit of interest was assessed using the Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm. This algorithm treated all participants without HIV-1 RNA at the visit of interest as nonresponders, as well as participants who switched their concomitant ART prior to the visit of interest as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA measurment (within window) for the timepoint of interest while the participant was on-treatment." (NCT01231516)
Timeframe: At Week 24 and Week 48

,
InterventionParticipants (Count of Participants)
Week 24Week 48
DTG 50 mg OD307278
RAL 400 mg BID287257

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Number of Participants With Post-Baseline Emergent Grade 1 to 4 Clinical Chemistry and Hematology Toxicities

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, 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. Higher the grade, more severe the symptoms. (NCT01231516)
Timeframe: From Baseline (Day 1) until Week 48, including participants with post-treatment events occurring after Week 48 for participants not entering the post-Week 48 Open-Label phase of the study

,
InterventionParticipants (Count of Participants)
ALTAlbuminALPASTCO2 content/bicarbonateCholesterolCKCreatinineHyperglycaemiaHyperkalemiaHypernatremiaHypoglycaemiaHypokalemiaHyponatremiaLDL cholesterol calculationLipaseTotal bilirubinTriglyceridesHemoglobinPlatelet countTotal neutrophilsWhite Blood Cell count
DTG 50 mg OD47427499799281871752137766863561419364919
RAL 400 mg BID4634252109103291380671441798268532427324929

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DTG PK Parameter Including Pre-dose Concentration (C0)

C0 was assessed by population PK modeling using sparse PK samples which were collected as follows: one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 4, one pre-dose sample at Week 24, and one pre-dose sample and one post-dose sample at 1 to 3 hours/4 to 12 hours at Week 48. DTG predose concentration (C0) at Week 4, Week 24, and Week 48 was estimated and reported here. (NCT01231516)
Timeframe: Pre-dose at Weeks 4, 24 and 48

Interventionmicrogram/milliliter (µg/mL) (Geometric Mean)
Week 4, n=329Week 24, n=298Week 48, n=276
DTG 50 mg OD0.7860.9400.932

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Episomal HIV cDNA Formation

These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication. (NCT01245101)
Timeframe: 16 weeks

Interventioncopies/million (Mean)
RaltegravirObservation
Raltegravir Then Observation4.5810.7173

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Markers of Immune Activation

Flow cytometry will be performed in whole blood for analysis of markers of immune activation by standard methodology using a LSR-II flow cytometer. Percentage and absolute counts of CD8+CD38+ cells will be determined as the main outcome measure. (NCT01245101)
Timeframe: 16 weeks

InterventionPercentage of activated CD8+CD38+ cells (Mean)
RaltegravirObservation
Raltegravir Then Observation22.3726.72

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Geometric Mean of C-max, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.

Geometric mean of C-max of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-max, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations. (NCT01258374)
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.

Interventionng/mL (Geometric Mean)
Cmax DarunavirCmax RaltegravirCmax Ritonavir
Single Arm With Dual Therapy7630970490

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Geometric Mean of AUC, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.

Geometric mean of AUC0 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations. (NCT01258374)
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.

Interventionng.h/mL (Geometric Mean)
AUC RaltegravirAUC DarunavirAUC Ritonavir
Single Arm With Dual Therapy305068,7305470

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Geometric Mean of t1/2, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy

Geometric mean of t1/2 of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy. The treating physician chose an NRTI-Geometric mean of t1/2, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations. (NCT01258374)
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.

Interventionh (Geometric Mean)
t1/2 Darunavirt1/2 Raltegravirt1/2 Ritonavir
Single Arm With Dual Therapy10.912.689.48

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Geometric Mean of C-Trough, of Raltegravir (RAL) at a Dose of 400 mg Twice a Day Plus Darunavir/Ritonavir (DRV/RTV) at a Dose of 800/100 mg Once a Day in HIV-1-infected Patients Were Mesured After 15 Days of Therapy.

Geometric mean of C-Trough, of raltegravir (RAL) at a dose of 400 mg twice a day plus darunavir/ritonavir (DRV/RTV) at a dose of 800/100 mg once a day in HIV-1-infected patients were mesured after 15 days of therapy.The treating physician chose an NRTI-sparing regimen because of toxicity or resistance mutations to NRTIs, which included DRV/RTV 800/100 mg once daily plus RAL 400 mg twice daily. All patients were RAL and DRV naive and had no evidence of protease inhibitor mutations. (NCT01258374)
Timeframe: After at least 15 days on therapy, patients were admitted for a 24-hour PK study. The moorning dose of RAL adn DRV/r was administered in the clinic with. Blood samples were drawn immediatly before breakfast and 0.5, 1,2,3,4,6,8,12 and 24 hours afterward.

Interventionng/ml (Geometric Mean)
C trough DarunavirC trough RaltegravirC trough Ritonavir
Single Arm With Dual Therapy13304090

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Change in Serum Levels of Vitamin D

Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body (NCT01270802)
Timeframe: Baseline and 24 weeks

Interventionng/mL (Mean)
Continued Tenofovir/Emtricitabine/Efavirenz0.06
Switch to Tenofovir/Emtricitabine Plus Raltegravir0.14

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Change in Flow-mediated Dilation (FMD) of the Brachial Artery

Change in FMD is a measure of change in endothelial function (NCT01270802)
Timeframe: Baseline and 24 weeks

Intervention% change from baseline (Mean)
Continued Tenofovir/Emtricitabine/Efavirenz-0.67
Switch to Tenofovir/Emtricitabine Plus Raltegravir-0.1

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HCV RNA

HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg. (NCT01285050)
Timeframe: 48 hours after interferon administration

Interventionlog IU/ml (Median)
Pre ART HCV RNA Decline0.65
Post ART HCV Decline0.81

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Plasma Raltegravir Concentrations

Mean trough concentration from all 3 days (NCT01327482)
Timeframe: 7, 14, 21 days

Interventionng/mL (Mean)
Raltegravir160

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Tissue Raltegravir Concentrations

Mean trough concentration from all three days. Tissue concentrations are measured from cervical biopsy homogenate using a mass-spectroscopy-based method. (NCT01327482)
Timeframe: 7, 14, 21 days

Interventionng/mL (Mean)
Raltegravir117

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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24

HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. (NCT01332227)
Timeframe: From Day 1 to Week 24

InterventionPercentage of participants (Number)
Atazanavir/Ritonavir + Raltegravir80.6
Atazanavir/Ritonavir + Tenofovir/Emtricitabine94.6

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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48

Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. (NCT01332227)
Timeframe: From Day 1 to Week 48

InterventionPercentage of participants (Number)
Atazanavir/Ritonavir + Raltegravir69.4
Atazanavir/Ritonavir + Tenofovir/Emtricitabine86.5

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Mean Changes in Fasting Lipid Levels From Baseline to Week 48

LD=low-density lipoprotein; HDL=high-density lipoprotein. (NCT01332227)
Timeframe: From Baseline to Week 48

,
Interventionmg/dL (Mean)
Fasting total cholesterolFasting LDL cholesterolFasting HDL cholesterolFasting non-HDL cholesterolFasting triglycerides
Atazanavir/Ritonavir + Raltegravir11.77.72.79.014.7
Atazanavir/Ritonavir + Tenofovir/Emtricitabine-10.2-5.4-0.3-9.8-17.6

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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 24

,
InterventionParticipants (Number)
Genotypable (GI)/phenotypable isolates (PI)Emergent genotypic substitutions in GI pts (n=4,0)Phenotypic resistance in PI pts (n=4,0)
Atazanavir/Ritonavir + Raltegravir441
Atazanavir/Ritonavir + Tenofovir/Emtricitabine000

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Number of Participants With Virologic Rebound at Weeks 24 and 48

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. (NCT01332227)
Timeframe: Day 1 to Weeks 28 and 48

,
InterventionParticipants (Number)
Week 24: Virologic reboundWeek 48: Virologic rebound
Atazanavir/Ritonavir + Raltegravir79
Atazanavir/Ritonavir + Tenofovir/Emtricitabine11

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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48

Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 48

,
InterventionParticipants (Number)
Genotypable (GI)/phenotypable isolates (PI)Emergent genotypic substitutions in GI pts (n=5,0)Phenotypic resistance in PI pts (n=5,0)
Atazanavir/Ritonavir + Raltegravir551
Atazanavir/Ritonavir + Tenofovir/Emtricitabine000

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Drug Levels in Blood

rategravir concentration (NCT01335620)
Timeframe: Day 28

Interventionng/ml (Geometric Mean)
Truvada Plus Raltegravir1732

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Cerebral Function; Changes in Global Cognitive Z-score

"Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.~Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion." (NCT01335620)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Truvada Plus Raltegravir0.91

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Number of Participants 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 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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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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Percentage of Time Spent in Hospital

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

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

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

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

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

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Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 24

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.350
FTR 800 mg BID/RAL/TDF1014.748
FTR 600 mg QD/RAL/TDF101.627
FTR 1200 mg QD/RAL/TDF39.030

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 48

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF-2.624
FTR 800 mg BID/RAL/TDF586.776
FTR 600 mg QD/RAL/TDF81.729
FTR 1200 mg QD/RAL/TDF449.092

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Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
FTR 1200 mg QD/RAL/TDF00
FTR 400 mg BID/RAL/TDF00
FTR 600 mg QD/RAL/TDF00
FTR 800 mg BID/RAL/TDF00

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Number of Participants With SAE and Discontinuation Due to AEs During Primary Study

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionParticipants (Count of Participants)
SAE, Week 48SAE, Week 96AEs leading to discontinuation, Week 48AEs leading to discontinuation, Week 96
ATV/r/RAL/TDF5735
FTR 1200 mg QD/RAL/TDF2412
FTR 400 mg BID/RAL/TDF3511
FTR 600 mg QD/RAL/TDF4600
FTR 800 mg BID/RAL/TDF5722

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Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
SAEAEs leading to discontinuation
ATV/r/RAL/TDF52
FTR 1200 mg QD/RAL/TDF21
FTR 400 mg BID/RAL/TDF31
FTR 600 mg QD/RAL/TDF40
FTR 800 mg BID/RAL/TDF42

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. (NCT01384734)
Timeframe: Weeks 48 and 96

,,,,
InterventionPercentage of Participants (Number)
Week 48Week 96
ATV/r/RAL/TDF7157
FTR 1200 mg QD/RAL/TDF6858
FTR 400 mg BID/RAL/TDF8278
FTR 600 mg QD/RAL/TDF6963
FTR 800 mg BID/RAL/TDF6149

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 96

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 96

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase RAL substitution
ATV/r/RAL/TDF010
FTR 1200 mg QD/RAL/TDF223
FTR 400 mg BID/RAL/TDF322
FTR 600 mg QD/RAL/TDF221
FTR 800 mg BID/RAL/TDF112

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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96

Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 96

InterventionIC50 Fold Change (Mean)
FTR 400 mg BID/RAL/TDF25.480
FTR 800 mg BID/RAL/TDF419.901
FTR 600 mg QD/RAL/TDF46.351
FTR 1200 mg QD/RAL/TDF777.818

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 48

Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 48

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF122
FTR 400 mg BID/RAL/TDF101
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF001

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Number of Participants With Newly-emergent Genotypic Substitutions at Week 24

Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 24

,,,,
InterventionParticipants (Count of Participants)
PI substitutionRT substitutionIntegrase substitution
ATV/r/RAL/TDF000
FTR 1200 mg QD/RAL/TDF011
FTR 400 mg BID/RAL/TDF000
FTR 600 mg QD/RAL/TDF001
FTR 800 mg BID/RAL/TDF000

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Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period

Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

,,,
Interventionlog10 c/mL (Mean)
Day 2, n=7, 5, 10, 9Day 5, n=7, 4, 10, 10Day 6, n=7, 5, 10, 10Day 7, n=6, 5, 10, 10Day 8, n=6, 4, 9, 9
FTR 1200 mg QD/RAL/TDF0.126-0.767-1.053-1.198-1.470
FTR 400 mg BID/RAL/TDF0.220-0.340-0.530-0.556-0.691
FTR 600 mg QD/RAL/TDF0.126-0.593-0.822-1.086-1.218
FTR 800 mg BID/RAL/TDF0.149-0.811-1.082-1.443-1.372

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Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy

Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF63.467.6
FTR 400 mg BID/RAL/TDF58.4134.2
FTR 600 mg QD/RAL/TDF71.8188.0
FTR 800 mg BID/RAL/TDF134.8216.3

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Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy

Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8

,,,
Interventioncells per cubic millimeter (Mean)
CD4+CD8+
FTR 1200 mg QD/RAL/TDF0.014-0.021
FTR 400 mg BID/RAL/TDF-0.005-0.003
FTR 600 mg QD/RAL/TDF0.008-0.009
FTR 800 mg BID/RAL/TDF0.023-0.040

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Change From Baseline in CD4+ T-cell Count

Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and Weeks 24, 48 and 96

,,,,
InterventionCells per cubic millimeter (Mean)
Week 24, n=41, 38, 48, 42, 40Week 48, n=43, 34, 43, 41, 41Week 96, n=42, 28, 35, 28, 31
ATV/r/RAL/TDF119.4178.7250.1
FTR 1200 mg QD/RAL/TDF124.5155.4211.7
FTR 400 mg BID/RAL/TDF134.3199.1264.6
FTR 600 mg QD/RAL/TDF109.5140.5175.7
FTR 800 mg BID/RAL/TDF111.0158.7210.8

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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF0
FTR 800 mg BID/RAL/TDF0
FTR 600 mg QD/RAL/TDF0
FTR 1200 mg QD/RAL/TDF11

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Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24

Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. (NCT01384734)
Timeframe: Week 24

InterventionPercentage of Participants (Number)
FTR 400 mg BID/RAL/TDF80
FTR 800 mg BID/RAL/TDF69
FTR 600 mg QD/RAL/TDF76
FTR 1200 mg QD/RAL/TDF72
ATV/r/RAL/TDF75

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Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA

Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period

Interventionlog10 c/mL (Mean)
FTR 400 mg BID/RAL/TDF-0.770
FTR 800 mg BID/RAL/TDF-1.524
FTR 600 mg QD/RAL/TDF-1.250
FTR 1200 mg QD/RAL/TDF-1.399

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Cerebrospinal Fluid

To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir. (NCT01448486)
Timeframe: Baseline and 12 months

,
Interventionnmol/L (Mean)
Baseline12 months
Raltegravir11.6717.00
Standard of Care HAART34.0012.00

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Neurocognitive Function

Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment. (NCT01448486)
Timeframe: Baseline, 6 months and 12 months

,
InterventionGlobal Neurocognitive Z-Score (Mean)
Baseline6 months12 months
Raltegravir-0.83-0.55-0.47
Standard of Care HAART-0.39-0.48-0.54

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Prevalence of AHI Among Persons Screened

Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. (NCT01450189)
Timeframe: 1 year

Interventionproportion of participants (Number)
Overall0.0073

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Suppression of HIV RNA to <1000c/ml at 12 Weeks

Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks (NCT01450189)
Timeframe: 12 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only0.25
Behavioral Intervention Plus ARV0.72

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Time to HIV RNA Suppression <1000 c/ml

median time to viral load suppression (<1000 c/ml) (NCT01450189)
Timeframe: From date of randomization until viral load suppression, up to 52 weeks

Interventionweeks (Median)
Standard Counseling Arm39
Behavioral Intervention Arm Only26
Behavioral Intervention Plus ARV16

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Number of Adverse Events

Mean number of adverse events per group (NCT01450189)
Timeframe: one year

Interventionnumber of events (Mean)
Standard Counseling Arm0.78
Behavioral Intervention Arm Only1.3
Behavioral Intervention Plus ARV1.3

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Genital HIV RNA Concentration - Week 12, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm82.5
Behavioral Intervention Arm Only0
Behavioral Intervention Plus ARV38.5

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Genital HIV RNA Concentration - Week 52, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm0
Behavioral Intervention Arm Only219
Behavioral Intervention Plus ARV2111

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Genital HIV RNA Concentration - Week 52, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm13088
Behavioral Intervention Arm Only66
Behavioral Intervention Plus ARV0

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Genital HIV RNA Concentration - Week 26, Women

median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm11.5
Behavioral Intervention Arm Only0
Behavioral Intervention Plus ARV164

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Genital HIV RNA Concentration - Week 26, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm9456
Behavioral Intervention Arm Only292
Behavioral Intervention Plus ARV0

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Number of Partners Reporting for HIV Testing

Number of partners per index reporting for HIV testing at any time during follow-up (NCT01450189)
Timeframe: 52 weeks

Interventionpartners per index participant (Mean)
Standard Counseling Arm0.4
Behavioral Intervention Arm Only0.4
Behavioral Intervention Plus ARV0.4

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Genital HIV RNA Concentration - Week 12, Men

median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm25364
Behavioral Intervention Arm Only446
Behavioral Intervention Plus ARV0

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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 26 weeks

Interventionproportion of participants (Number)
Standard Counseling Arm0.14
Behavioral Intervention Arm Only0.33
Behavioral Intervention Plus ARV0.12

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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)

At least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 52 weeks

Interventionproportion of participants (Number)
Standard Counseling Arm0.14
Behavioral Intervention Arm Only0.42
Behavioral Intervention Plus ARV0.15

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Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 52 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only1.0
Behavioral Intervention Plus ARV0.3

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Cumulative Incidence Herpes Simplex Virus Type 2

cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 26 weeks

InterventionProportion of participants (Number)
Standard Counseling Arm0.5
Behavioral Intervention Arm Only0.5
Behavioral Intervention Plus ARV0.25

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Blood HIV RNA Concentration at Week 52

(NCT01450189)
Timeframe: 52 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm3248.5
Behavioral Intervention Arm Only6467.5
Behavioral Intervention Plus ARV10876

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Blood HIV RNA Concentration at Week 26

(NCT01450189)
Timeframe: 26 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm8661
Behavioral Intervention Arm Only58504
Behavioral Intervention Plus ARV6788

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Blood HIV RNA Concentration at Week 12

(NCT01450189)
Timeframe: 12 weeks

Interventioncopies/ml (Median)
Standard Counseling Arm19411
Behavioral Intervention Arm Only22734
Behavioral Intervention Plus ARV20

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Proportion of Participants Completing Full Course of ARVs in Arm BIA

Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that (NCT01450189)
Timeframe: 1 year

Interventionproportion of BIA participants (Number)
Behavioral Intervention Plus Antiretrovirals (BIA)0.917

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Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.

In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms. (NCT01450189)
Timeframe: 1 year

Interventionproportion of participants (Number)
Combined Behavioral Intervention Arms0.216

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Proportion of Partners Reporting for HIV Testing

Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants (NCT01450189)
Timeframe: 52 weeks

Interventionproportion of sex partners (Number)
Standard Counseling Arm0.1
Behavioral Intervention Arm Only0.1
Behavioral Intervention Plus ARV0.1

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Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening

(NCT01450189)
Timeframe: 1 year

Interventionproportion of participants screened (Number)
Overall0.622

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Proportion of Persons Completing All Scheduled Visits in Each Study Arm

(NCT01450189)
Timeframe: 1 year

InterventionProportion of participants (Number)
Standard Counseling Arm0.44
Behavioral Intervention Arm0.44
Behavioral Intervention Plus Antiretrovirals (BIA)0.37

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Proportion of Persons With AHI Successfully Recruited Into the Study

This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization. (NCT01450189)
Timeframe: 1 year

InterventionProportion of persons with AHI recruited (Number)
Overall0.69

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Mean Glucose Changes From Baseline to 48 Weeks

(NCT01513122)
Timeframe: 48 weeks

Interventionmmol/L (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI-0.04
Arm 2. Lopinavir /Ritonavir + Raltegravir-0.1

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Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan

(NCT01513122)
Timeframe: 48 weeks

Interventionkg (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI1.4
Arm 2. Lopinavir /Ritonavir + Raltegravir2.1

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Mean Total Cholesterol Changes From Baseline to 48 Weeks

(NCT01513122)
Timeframe: 48 weeks

Interventionmmol/L (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI0.4
Arm 2. Lopinavir /Ritonavir + Raltegravir0.6

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Mean Triglycerides Changes From Baseline to 48 Weeks

(NCT01513122)
Timeframe: 48 weeks

Interventionmmol/L (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI0.6
Arm 2. Lopinavir /Ritonavir + Raltegravir0.8

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Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan

(NCT01513122)
Timeframe: 48 weeks

Interventionpercentage change (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI-5.2
Arm 2. Lopinavir /Ritonavir + Raltegravir-2.9

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Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan

(NCT01513122)
Timeframe: 48 weeks

Interventionpercentage change (Mean)
Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI15.7
Arm 2. Lopinavir /Ritonavir + Raltegravir21.1

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Changes in CD4 CD38+ HLADR+ (%)

Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline) (NCT01529749)
Timeframe: 0, 48 weeks

Interventionpercentage of CD4 T cells (Median)
EFV/FTC/TDF2.3
EFV/FTC/TDF + Losartan4
FTC/TDF + MK-05181.8
FTC/TDF+MK-0518+Losartan2.2

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Proportion of Patients With Improvement in Neuropsychological Test

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups

(NCT01529749)
Timeframe: week 48

Interventionparticipants (Number)
EFV/FTC/TDF12
EFV/FTC/TDF + Losartan10
FTC/TDF + MK-051810
FTC/TDF+MK-0518+Losartan10

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Proportion of Patients With Undetectable Plasma Viral Load in Different Groups

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF12
EFV/FTC/TDF + Losartan10
FTC/TDF + MK-051810
FTC/TDF+MK-0518+Losartan10

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Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in Levels of Proteins.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in Levels of Metalloproteinases

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in Levels of CSF Cells.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in Levels of beta2-microglobulin.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in the Levels of CRP in Different Groups.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.

(NCT01529749)
Timeframe: 48 weeks

Interventionratio (Median)
EFV/FTC/TDF-0.03
EFV/FTC/TDF + Losartan0.04
FTC/TDF + MK-05180.36
FTC/TDF+MK-0518+Losartan0.37

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Proportion of Patients With Increased CD4 in Peripheral Blood.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Increased CD4 in Lymphatic Tissue.

(NCT01529749)
Timeframe: week 48

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.

(NCT01529749)
Timeframe: 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF0
EFV/FTC/TDF + Losartan0
FTC/TDF + MK-05180
FTC/TDF+MK-0518+Losartan0

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Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.

(NCT01529749)
Timeframe: up to 48 weeks

Interventionparticipants (Number)
EFV/FTC/TDF6
EFV/FTC/TDF + Losartan6
FTC/TDF + MK-05183
FTC/TDF+MK-0518+Losartan6

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Percent of Participants Who Experienced a New AIDS-defining Illness or Died

New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness or died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT4.2
B: Double-dose LPV/r w/RIF8.3
C: Standard-Dose LPV/r + RAL w/RBT4.3

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CD4 Count Change From Baseline to Week 72

The difference in CD4 count from baseline to week 72 was calculated as the CD4 count at week 72 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 72 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT126
B: Double-dose LPV/r w/RIF212
C: Standard-Dose LPV/r + RAL w/RBT54

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Percent of Participants Who Experienced a New AIDS-defining Illness

New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF4.2
C: Standard-Dose LPV/r + RAL w/RBT0.0

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CD4 Count Change From Baseline to Week 24

The difference in CD4 count from baseline to week 24 was calculated as the CD4 count at week 24 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 24 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT20
B: Double-dose LPV/r w/RIF56
C: Standard-Dose LPV/r + RAL w/RBT13

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CD4 Count Change From Baseline to Week 48

The difference in CD4 count from baseline to week 48 was calculated as the CD4 count at week 48 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 48 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT99
B: Double-dose LPV/r w/RIF119
C: Standard-Dose LPV/r + RAL w/RBT74

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CD4 Count Change From Baseline to Week 8

The difference in CD4 count from baseline to week 8 was calculated as the CD4 count at week 8 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: Baseline and 8 weeks

Interventioncells/mm^3 (Median)
A: Standard-dose LPV/r w/RBT7
B: Double-dose LPV/r w/RIF26
C: Standard-Dose LPV/r + RAL w/RBT37

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Cumulative Probability of HIV Virologic Failure at Week 72

Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. The percent of participants with HIV virologic failure at week 72 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At weeks 16, 24, 48, and 72

Interventioncumulative events per 100 participants (Number)
A: Standard-dose LPV/r w/RBT29.2
B: Double-dose LPV/r w/RIF50.0
C: Standard-Dose LPV/r + RAL w/RBT30.4

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LPV AUC in Participants Enrolled in Arms A, B, and C

Describe LPV plasma PK characteristics (area under the curve [AUC] between 0 and 12 hours) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose

Interventionhours*ng/mL (Median)
A: Standard-dose LPV/r w/RBT159796
B: Double-dose LPV/r w/RIF161772
C: Standard-Dose LPV/r + RAL w/RBT149247

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Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality

The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) laboratory abnormality were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT6
B: Double-dose LPV/r w/RIF3
C: Standard-Dose LPV/r + RAL w/RBT5

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Number of Participants Reporting a Grade 3 or 4 Sign or Symptom

The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) sign or symptom were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT7
B: Double-dose LPV/r w/RIF5
C: Standard-Dose LPV/r + RAL w/RBT5

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Number of Participants Who Experienced MTB IRIS

The number of participants who experienced MTB immune reconstitution inflammatory syndrome (IRIS) was summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

InterventionParticipants (Count of Participants)
A: Standard-dose LPV/r w/RBT1
B: Double-dose LPV/r w/RIF2
C: Standard-Dose LPV/r + RAL w/RBT3

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Percent of Participants Who Died

The percent of participants who died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT4.2
B: Double-dose LPV/r w/RIF4.7
C: Standard-Dose LPV/r + RAL w/RBT4.3

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Percent of Participants Who Experienced HIV Virologic Failure

Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. Participants who were missing data due to being lost-to-follow-up or dead were coded as virologic failures. The percent of participants who experienced HIV virologic failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At weeks 16, 24, 48, and 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT29.2
B: Double-dose LPV/r w/RIF50.0
C: Standard-Dose LPV/r + RAL w/RBT30.4

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Percent of Participants Who Experienced Sputum Conversion at Week 8.

Sputum conversion was defined as culture MTB-negative at week 8 or AFB smear negative at week 8 (and culture contaminated or missing at week 8); there were no Xpert MTB/RIF results at week 8. The percent of participants experienced sputum conversion at week 8 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT87.5
B: Double-dose LPV/r w/RIF81.8
C: Standard-Dose LPV/r + RAL w/RBT70.0

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Percent of Participants Who Experienced TB Relapse/Recurrence

TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The percent of participants who experienced TB relapse/recurrence was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At or after 24 weeks and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF4.2
C: Standard-Dose LPV/r + RAL w/RBT4.3

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Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance

TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The drug resistance was determined based on phenotypic methods. The percent of participants who experienced TB relapse/recurrence and who had TB drug resistance was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At or after 24 weeks and through week 72

Interventionparticipants (Number)
B: Double-dose LPV/r w/RIF0
C: Standard-Dose LPV/r + RAL w/RBT0

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Percent of Participants Who Experienced TB Treatment Failure

TB treatment failure was defined as having a MTB-positive culture after 16 weeks of TB treatment for a participant who was documented to be taking TB medications. The percent of participants who experienced TB treatment failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After 16 weeks and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT0.0
B: Double-dose LPV/r w/RIF0.0
C: Standard-Dose LPV/r + RAL w/RBT0.0

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Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity

The percent of participants who interrupted or discontinued at least one HIV drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through week 72

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT20.8
B: Double-dose LPV/r w/RIF16.7
C: Standard-Dose LPV/r + RAL w/RBT21.7

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Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity

The percent of participants who interrupted or discontinued at least one TB drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: After randomization and through to the discontinuation of the last TB drug

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT20.8
B: Double-dose LPV/r w/RIF8.3
C: Standard-Dose LPV/r + RAL w/RBT13.0

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Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.

The percent of participants whose HIV viral load was less than 400 copies/mL at week 48 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. Participants who were lost-to-follow-up or dead by week 48 or had missing results at week 48 were coded as having HIV viral load greater than 400 copies/mL. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT58.3
B: Double-dose LPV/r w/RIF66.7
C: Standard-Dose LPV/r + RAL w/RBT60.9

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Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48

The percent of participants whose HIV viral load was less than 50 copies/mL at week 48 was calculated with an associated standard error. Participants who were lost-to-follow-up or dead by week 48 or had missing RNA at week 48 were coded as having HIV viral load greater than 50 copies/mL. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: 48 weeks

Interventionpercentage of participants (Number)
A: Standard-dose LPV/r w/RBT45.8
B: Double-dose LPV/r w/RIF54.2
C: Standard-Dose LPV/r + RAL w/RBT56.5

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RAL AUC in Participants Enrolled in Arm C

Describe RAL plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionhours*ng/mL (Median)
C: Standard-Dose LPV/r + RAL w/RBT11338

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RBT AUC in Participants Enrolled in Arms A and C

Describe RBT plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionhours*ng/mL (Median)
A: Standard-dose LPV/r w/RBT7374
C: Standard-Dose LPV/r + RAL w/RBT5516

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LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C

Describe LPV plasma pharmacokinetic (PK) characteristics (maximum concentration [Cmax] and minimum concentration [Cmin]) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose

,,
Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
A: Standard-dose LPV/r w/RBT185319920
B: Double-dose LPV/r w/RIF181388033
C: Standard-Dose LPV/r + RAL w/RBT168028548

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RAL Cmax and Cmin in Participants Enrolled in Arm C

Describe RAL plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
C: Standard-Dose LPV/r + RAL w/RBT2830166

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RBT Cmax and Cmin in Participants Enrolled in Arms A and C

Describe RBT plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size. (NCT01601626)
Timeframe: At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose

,
Interventionng/mL (Median)
Maximum Concentration (Cmax)Minimum Concentration (Cmin)
A: Standard-dose LPV/r w/RBT461161
C: Standard-Dose LPV/r + RAL w/RBT349115

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Median Change of CD4 Lymphocytes at Week 48

(NCT01605890)
Timeframe: between Week 0 and Week 48

Interventioncells/µL (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate87

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Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL

(NCT01605890)
Timeframe: between Week 0 and Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate96.4

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Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire

"The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:~Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated." (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionScore on a scale (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate45

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Number of Participants With Clinical Progression

"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death." (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate0

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Median Change in CD4 Lymphocytes Count at Week 12

(NCT01605890)
Timeframe: between Week 0 and Week 12

Interventioncells/µL (Median)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate73

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Number of Participants With Treatment Switch or Discontinuation

Overall (regardless of the molecule) (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate4

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Number of Virological Failure Participants With Resistance Mutations

Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. (NCT01605890)
Timeframe: from Week 0 to Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate1

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Number of Clinical and Biological Events

(NCT01605890)
Timeframe: from Week 0 to Week 48

Interventionclinical and biological events (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate61

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Percentage of Participants in Therapeutic Success

"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee" (NCT01605890)
Timeframe: at Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate40

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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24

(NCT01605890)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate5

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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48

(NCT01605890)
Timeframe: at Week 48

InterventionParticipants (Count of Participants)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate3

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Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence

(NCT01605890)
Timeframe: from Week 4 to Week 48

Interventionpercentage of participants (Number)
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate76

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Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery

If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered. (NCT01618305)
Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

InterventionProportion (Number)
Arm A (Women).84
Arm B (Women).94

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Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation

"The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose).~Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure." (NCT01618305)
Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

,
InterventionProportion (Number)
Week 4Week 6
Arm A (Women).97.98
Arm B (Women).95.94

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Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery

"Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA).~For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1." (NCT01618305)
Timeframe: Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16.

,
InterventionLog10 copies/mL (Median)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16
Arm A (Women)-1.4-1.8-2.0-2.1-2.2-2.3-2.4-2.5-2.5
Arm B (Women)-1.5-2.1-2.4-2.4-2.4-2.3-2.5-2.5-2.7

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Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs

Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants. (NCT01618305)
Timeframe: Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24

,
InterventionProportion (Number)
Reverse transcriptase resistanceIntegrase resistance
Arm A (Infants).20.00
Arm B (Infants).00.00

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Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.

"Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately.~Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response.~Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed." (NCT01618305)
Timeframe: Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).

InterventionProportion (Number)
Reverse transcriptase resistance at screeningIntegrase resistance at screeningReverse transcriptase resistance at viral failure
Arm A (Women).07.00.60

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Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.

"Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately.~Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response.~Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed." (NCT01618305)
Timeframe: Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).

InterventionProportion (Number)
Reverse transcriptase resistance at screeningIntegrase resistance at screeningReverse transcriptase resistance at viral failureIntegrase resistance at viral failure
Arm B (Women).11.00.30.00

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Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation

The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose). (NCT01618305)
Timeframe: Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery

,
InterventionProportion (Number)
Week 4Week 6
Arm A (Women).75.85
Arm B (Women).95.96

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Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).

The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 1,000 grams, this mother-infant set would count as one instance of extremely low birth weight in analysis because at least one of the infants had the outcome). (NCT01618305)
Timeframe: Measured within 72 hours after delivery

InterventionProportion (Number)
Arm A (Women).000
Arm B (Women).005

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Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.

The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used. (NCT01618305)
Timeframe: Measured at delivery (approximately 36 to 40 weeks gestation)

InterventionProportion (Number)
Arm A (Women).005
Arm B (Women).015

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Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).

"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome).~Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational age where this outcome could have occurred at entry." (NCT01618305)
Timeframe: At delivery (within 72 hours).

InterventionProportion (Number)
Arm A (Women).036
Arm B (Women).023

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Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)

"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome).~All mother-infant sets that delivered at least one live birth on study were eligible for this outcome." (NCT01618305)
Timeframe: Measured at delivery (within 72 hours).

InterventionProportion (Number)
Arm A (Women).105
Arm B (Women).123

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Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)

The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 3,000 grams, this mother-infant set would count as one instance of low birth weight in analysis because at least one of the infants had the outcome). (NCT01618305)
Timeframe: Measured within 72 hours after delivery

InterventionProportion (Number)
Arm A (Women).124
Arm B (Women).127

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Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.

All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table. (NCT01618305)
Timeframe: Measured from birth through infants' last study visit, approximately 24 weeks after delivery

InterventionProportion (Number)
Arm A (Infants).25
Arm B (Infants).25

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Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.

Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up. (NCT01618305)
Timeframe: Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation)

InterventionProportion (Number)
Arm A (Women).05
Arm B (Women).03

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Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery

"A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL.~If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered." (NCT01618305)
Timeframe: Measured at participants' delivery visit (or last visit within three weeks prior to delivery)

InterventionProportion (Number)
Arm A (Women).58
Arm B (Women).86

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Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table

"New adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered New if they increased in grade on or after randomization.~All women who received at least one dose of study drug were eligible for this analysis." (NCT01618305)
Timeframe: Measured from entry through participants' last study visit, approximately 24 weeks after delivery

InterventionPropotion (Number)
Arm A (Women).30
Arm B (Women).30

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Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen

A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load <200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry. (NCT01618305)
Timeframe: Measured from entry through delivery (approximately 36 to 40 weeks gestation).

InterventionProportion (Number)
Arm A (Women).63
Arm B (Women).89

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Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir5678.90
MINTOX® Before Raltegravir2753.64
MINTOX® After Raltegravir4399.66

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Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir5427.15
TUMS® + Raltegravir2584.78
MINTOX® + Raltegravir3013.88

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Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM*hr (Least Squares Mean)
Raltegravir17577.15
MINTOX® Before Raltegravir8521.95
MINTOX® After Raltegravir12226.11

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Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

InterventionnM*hr (Least Squares Mean)
Raltegravir16399.76
TUMS® + Raltegravir7294.30
MINTOX® + Raltegravir8358.67

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Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)

Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®. (NCT01622673)
Timeframe: 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir132.30
TUMS® + Raltegravir89.75
MINTOX® + Raltegravir49.38

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Number of Participants With Any Clinical or Laboratory Adverse Event (AE)

"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience." (NCT01622673)
Timeframe: Up to 7 days after the last dose of study drug

Interventionparticipants (Number)
Raltegravir1
TUMS® + Raltegravir2
MINTOX® + Raltegravir2
MINTOX® Before Raltegravir2
MINTOX® After Raltegravir1

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Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir

Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid (NCT01622673)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose

Interventionhr (Mean)
Raltegravir2.06
TUMS® + Raltegravir2.08
MINTOX® + Raltegravir1.48
MINTOX® Before Raltegravir1.52
MINTOX® After Raltegravir1.78

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Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)

Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®. (NCT01622673)
Timeframe: 12 hours postdose

InterventionnM (Least Squares Mean)
Raltegravir125.75
MINTOX® Before Raltegravir54.92
MINTOX® After Raltegravir54.47

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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]

Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)4.027.660.6NA
Standard of Care (SOC)4.042.377.9NA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)1.05.123.684.0
Standard of Care (SOC)2.422.338.9111.1

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Experimental: Cohort A2.1106.1NA
Experimental: Cohort C0.1NANA
Experimental: Cohort DNANANA
Experimental: Sub-cohort B115.0NANA
Experimental: Sub-cohort B26.4134.0NA
Experimental: Sub-cohort B3NANANA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.1NA
Standard of Care (SOC)9.0NA

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Time From Study Entry/Randomization to Treatment Modification or Discontinuation.

Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A1.08.425.358.6NA
Experimental: Cohort C0.14.129.7NANA
Experimental: Cohort D2.45.147.698.9NA
Experimental: Sub-cohort B13.133.459.0NANA
Experimental: Sub-cohort B24.436.038.6165.6NA
Experimental: Sub-cohort B34.44.44.4NANA

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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A1.33.43.9
Experimental: Cohort C12.215.313.6
Experimental: Cohort D9.914.419.7
Experimental: Sub-cohort B113.316.322.4
Experimental: Sub-cohort B221.528.227.8
Experimental: Sub-cohort B3-0.50.316.6

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)24242460NA
Standard of Care (SOC)24242424NA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Experimental: Cohort A242424144
Experimental: Cohort C48NANANA
Experimental: Cohort D242424NA
Experimental: Sub-cohort B124NANANA
Experimental: Sub-cohort B224NANANA
Experimental: Sub-cohort B3NANANANA

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)2424NANA
Standard of Care (SOC)242448NA

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Time to First Dose Modification Due to Grade 3 or 4 Toxicity

Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile
Experimental: Cohort A45.7NA
Experimental: Cohort CNANA
Experimental: Cohort DNANA
Experimental: Sub-cohort B163.3NA
Experimental: Sub-cohort B2NANA
Experimental: Sub-cohort B3NANA

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Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]

Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)45.7NA
Standard of Care (SOC)NANA

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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A0.7
Experimental: Sub-cohort B10
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D3.0

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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.4
Standard of Care (SOC)1.1

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Cell Phone Intervention (CPI) + Standard of Care (SOC)20
Standard of Care (SOC)32

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Time From Study Entry/Randomization to Death

Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Experimental: Cohort A11.362.4NA
Experimental: Cohort C77.9NANA
Experimental: Cohort D2.4NANA
Experimental: Sub-cohort B13.1NANA
Experimental: Sub-cohort B244.6NANA
Experimental: Sub-cohort B3NANANA

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Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)15.32.213.7
Standard of Care (SOC)18.719.67.1

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Change From Baseline in Fasting Values of Triglycerides

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A15.412.217.5
Experimental: Cohort C15.49.911.8
Experimental: Cohort D28.924.46.7
Experimental: Sub-cohort B1-3.6-11.5-31.3
Experimental: Sub-cohort B227.619.918.9
Experimental: Sub-cohort B336.022.220.7

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Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)10.115.117.4
Standard of Care (SOC)14.414.118.7

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Change From Baseline in Fasting Values of Total Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A5.74.47.6
Experimental: Cohort C16.520.022.1
Experimental: Cohort D7.919.124.5
Experimental: Sub-cohort B116.719.722.6
Experimental: Sub-cohort B232.540.440.4
Experimental: Sub-cohort B312.49.928.2

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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.95.66.0
Standard of Care (SOC)3.63.76.6

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Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A1.0
Experimental: Sub-cohort B10
Experimental: Sub-cohort B20
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D0

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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A2.83.54.7
Experimental: Cohort C1.02.35.8
Experimental: Cohort D-2.21.83.4
Experimental: Sub-cohort B13.25.34.4
Experimental: Sub-cohort B211.413.415.7
Experimental: Sub-cohort B32.13.84.6

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Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)1.2
Standard of Care (SOC)0

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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A2424242460
Experimental: Cohort C2448120NANA
Experimental: Cohort D242424NANA
Experimental: Sub-cohort B12448NANANA
Experimental: Sub-cohort B22472144NANA
Experimental: Sub-cohort B3NANANANANA

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Percent of Participants With Confirmed Virologic Failure by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A48.9
Experimental: Sub-cohort B18.2
Experimental: Sub-cohort B22.9
Experimental: Sub-cohort B30
Experimental: Cohort C5.8
Experimental: Cohort D18.6

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Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)24.9
Standard of Care (SOC)32.2

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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A16.6
Experimental: Sub-cohort B11.4
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C1.5
Experimental: Cohort D15.4

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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)7.8
Standard of Care (SOC)12.1

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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)

Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile
Experimental: Cohort ANANA
Experimental: Cohort CNANA
Experimental: Cohort D13.0NA
Experimental: Sub-cohort B1NANA
Experimental: Sub-cohort B225.0NA
Experimental: Sub-cohort B3NANA

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Percent of Participants With Death or Hospitalization by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A12.3
Experimental: Sub-cohort B18.1
Experimental: Sub-cohort B29.7
Experimental: Sub-cohort B312.5
Experimental: Cohort C5.7
Experimental: Cohort D5.9

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Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)10.6
Standard of Care (SOC)10.6

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Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.73.63.6
Standard of Care (SOC)3.75.11.5

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Change From Baseline in Fasting Values of Glucose

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72

,,,,,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A1.92.13.0
Experimental: Cohort C2.13.0-0.9
Experimental: Cohort D3.24.27.8
Experimental: Sub-cohort B18.89.36.8
Experimental: Sub-cohort B26.16.2-5.2
Experimental: Sub-cohort B36.61.74.3

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Experimental: Cohort A145
Experimental: Sub-cohort B16
Experimental: Sub-cohort B24
Experimental: Sub-cohort B30
Experimental: Cohort C5
Experimental: Cohort D6

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Cell Phone Intervention (CPI) + Standard of Care (SOC)66
Standard of Care (SOC)89

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Percent of Participants With Treatment Modification or Discontinuation by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A19.9
Experimental: Sub-cohort B16.8
Experimental: Sub-cohort B219.4
Experimental: Sub-cohort B312.5
Experimental: Cohort C14.3
Experimental: Cohort D11.8

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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventionmg/dL (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)5.512.011.9
Standard of Care (SOC)9.510.112.8

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Number of Weeks of Follow-up

All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up

Interventionweeks (Median)
Experimental: Cohort A72
Experimental: Sub-cohort B196
Experimental: Sub-cohort B284
Experimental: Sub-cohort B396
Experimental: Cohort C72
Experimental: Cohort D96

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Number of Weeks of Follow-up [CPI+SOC v SOC]

All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up

Interventionweeks (Median)
Cell Phone Intervention (CPI) + Standard of Care (SOC)72
Standard of Care (SOC)72

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Percent of Participants Experiencing Death by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A3.9
Experimental: Sub-cohort B11.4
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C0
Experimental: Cohort D2.9

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Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)3.9
Standard of Care (SOC)1.5

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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A8.8
Experimental: Sub-cohort B15.4
Experimental: Sub-cohort B24.2
Experimental: Sub-cohort B30
Experimental: Cohort C5.8
Experimental: Cohort D5.9

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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)8.2
Standard of Care (SOC)6.5

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Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)19.1
Standard of Care (SOC)13.6

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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.8
Standard of Care (SOC)2.3

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks

"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 24 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.43
Experimental: Sub-cohort B10.89
Experimental: Sub-cohort B20.88
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.90
Experimental: Cohort D0.74

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 24 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.68
Standard of Care (SOC)0.61

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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing

Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

InterventionParticipants (Count of Participants)
Experimental: Cohort A48
Experimental: Sub-cohort B11
Experimental: Sub-cohort B22
Experimental: Sub-cohort B30
Experimental: Cohort C1
Experimental: Cohort D5

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks

"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 48 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.44
Experimental: Sub-cohort B10.88
Experimental: Sub-cohort B20.88
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.90
Experimental: Cohort D0.74

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 48 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.66
Standard of Care (SOC)0.62

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Time From Study Entry/Randomization to Death [CPI+SOC v SOC]

Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)11.3NANA
Standard of Care (SOC)15.982.1NA

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]

"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 72 weeks after the date of entry

Interventionproportion of participants (Number)
Cell Phone Intervention (CPI) + Standard of Care (SOC)0.69
Standard of Care (SOC)0.62

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Change From Baseline in CD4+ T-cell Count

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,,,,,
Interventioncells/mm^3 (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Experimental: Cohort A396587
Experimental: Cohort C100160185
Experimental: Cohort D90135165
Experimental: Sub-cohort B1109157182
Experimental: Sub-cohort B2116158197
Experimental: Sub-cohort B314286238

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Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]

Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72

,
Interventioncells/mm^3 (Mean)
Change from baseline at week 24Change from baseline at week 48Change from baseline at week 72
Cell Phone Intervention (CPI) + Standard of Care (SOC)72112145
Standard of Care (SOC)74107134

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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48

Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48

Interventionpercentage of participants (Number)
Experimental: Cohort A3.2
Experimental: Sub-cohort B12.7
Experimental: Sub-cohort B21.4
Experimental: Sub-cohort B30
Experimental: Cohort C4.3
Experimental: Cohort D0

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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]

Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)NANA
Standard of Care (SOC)25.0NA

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Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]

Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Cell Phone Intervention (CPI) + Standard of Care (SOC)2.311.344.6168.9
Standard of Care (SOC)2.320.345.3NA

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Time From Study Entry/Randomization to the First of Death or Hospitalization.

Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile50th percentile
Experimental: Cohort A2.413.432.6120.1168.9
Experimental: Cohort C2.07.777.9NANA
Experimental: Cohort D2.35.696.1NANA
Experimental: Sub-cohort B12.320.380.7NANA
Experimental: Sub-cohort B23.028.049.7NANA
Experimental: Sub-cohort B316.416.416.4NANA

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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event

Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks

,,,,,
Interventionweeks (Number)
1st percentile5th percentile10th percentile25th percentile
Experimental: Cohort A4.027.657.9NA
Experimental: Cohort C3.336.077.9142.4
Experimental: Cohort D2.424.048.496.3
Experimental: Sub-cohort B13.136.084.0NA
Experimental: Sub-cohort B216.350.3120.0NA
Experimental: Sub-cohort B3NANANANA

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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks

"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 72 weeks after the date of entry

Interventionproportion of participants (Number)
Overall Study0.64
Experimental: Cohort A0.44
Experimental: Sub-cohort B10.92
Experimental: Sub-cohort B20.87
Experimental: Sub-cohort B31.00
Experimental: Cohort C0.85
Experimental: Cohort D0.77

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Percentage of Participants Achieving HIV RNA <200 Copies/mL

This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL (NCT01717287)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet50.0
Raltegravir Chewable Tablet76.0

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Percentage of Participants Achieving HIV RNA <40 Copies/mL

This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL (NCT01717287)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet50.0
Raltegravir Chewable Tablet44.0

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Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience

A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. (NCT01717287)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet0.0
Raltegravir Chewable Tablet0.0

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Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience

A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. (NCT01717287)
Timeframe: Up to Week 24

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet0.0
Raltegravir Chewable Tablet0.0

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Percentage of Participants With at Least One Clinical Adverse Experience

A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. (NCT01717287)
Timeframe: Up to Week 26

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet0.0
Raltegravir Chewable Tablet42.9

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Percentage of Participants With at Least One Laboratory Adverse Experience

A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. (NCT01717287)
Timeframe: Up to Week 26

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet0.0
Raltegravir Chewable Tablet3.6

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Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count

This outcome is a measure of immunological response to treatment (NCT01717287)
Timeframe: Baseline and Week 24

Interventioncells/mm^3 (Mean)
Raltegravir Film-coated Tablet30.3
Raltegravir Chewable Tablet296.3

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Change From Baseline in CD4 Cell Percentage

This outcome is a measure of immunological response to treatment (NCT01717287)
Timeframe: Baseline and Week 24

InterventionPercentage change (Mean)
Raltegravir Film-coated Tablet4.0
Raltegravir Chewable Tablet6.0

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Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL

This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL (NCT01717287)
Timeframe: Week 24

InterventionPercentage of participants (Number)
Raltegravir Film-coated Tablet75.0
Raltegravir Chewable Tablet88.0

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Number of Participants Who Developed of New Opportunistic Infection(s) (OIs)

Number (Frequency) of participants who developed of new opportunistic infection(s) (OIs) (NCT01751568)
Timeframe: Measured from the first dose of raltegravir through a participant's last study visit (median of 34 weeks)

InterventionParticipants (Count of Participants)
Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment1
Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment0
Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment1

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Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC12h)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (Phoenix WinNonlin 8.1, Certara, Princeton, New Jersey). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule. Geometric Means (GM) for AUC12h were calculated for each cohort. (NCT01751568)
Timeframe: At the study visit between days 5 and 8 of raltegravir initiation; A (0.5) mL of blood sample was drawn at each time point: pre-dose (0), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionh*mg/L (Geometric Mean)
Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment12.8
Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment17.2
Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment14.6

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Number of Participants Who Failed to Respond Virologically at Week 8, Which Means Having HIV RNA (Copies/mL) Greater Than 400 Copies/mL AND Less Than 1-log10 Drop From Baseline

Number (Frequency) of Participants who failed to respond virologically at Week 8, which includes HIV RNA (copies/mL) greater than 400 copies/mL AND less than 1-log10 drop from baseline. Please note that the protocol definition of virologic response was: achieving at least a 1-log10 reduction from baseline in HIV-1 RNA (copies/mL) or HIV-1 RNA ≤ 400 copies/mL at week 8. An As-Treated (AT) analysis was carried out, such that participants who permanently discontinued treatment before week 8, without evaluable data were not included in the analyses. (NCT01751568)
Timeframe: Measured at Week 8

InterventionParticipants (Count of Participants)
Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment1
Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment1
Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment1

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Pharmacokinetic (PK) Parameter: Concentration at 12h (C12)

Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (Phoenix WinNonlin 8.1, Certara, Princeton, New Jersey). AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear-log trapezoidal rule. Geometric Means (GM) for C12 were calculated for each cohort. (NCT01751568)
Timeframe: At the study visit between days 5 and 8 of raltegravir initiation; A (0.5) mL of blood sample was drawn at each time point: pre-dose (0), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post dosing.

Interventionng/mL (Geometric Mean)
Cohort 1: ≥ 2 to < 6 Years of Age on TB Treatment101.8
Cohort 2: ≥ 6 to < 12 Years of Age on TB Treatment101.2
Cohort 3: : ≥ 4 Weeks to < 2 Years of Age on TB Treatment47.3

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Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.

Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by Patient Reported Outcomes (Questionnaires). The MSFC is a composite score consisting of the standardly derived composite score from 9-hole peg test (9HPT), timed walk and PASAT scores. 9HPT is measured as timed speed to complete the task; higher scores indicate less disability. The 25-foot walk is measured as timed speed; higher scores indicate less disability. The Paced Auditory Serial Addition Test (PASAT) The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It is a timed speed test measured in seconds. In the PASAT a lower score indicates less disability. (NCT01767701)
Timeframe: Baseline and monthly until month 6.

Interventionseconds (Mean)
25 foot walking test in seconds9 hole peg test as a timed measurementPASAT. This is a TIMED measurement
Raltegravir-0.240.0549.72

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The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI

"Demonstrate in subjects with relapsing remitting multiple sclerosis a reduction in the number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI over the period of treatment with raltegravir, compared to baseline.~Within patient change in number of lesions was calculated by subtracting the after treatment period (3 months) minus before treatment period (3 months)." (NCT01767701)
Timeframe: Baseline and at 6 months

Interventionlesions (Mean)
Raltegravir0.12

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The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.

"Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline.~Within-patient changes in lesion count calculated after-before." (NCT01767701)
Timeframe: Baseline and monthly for 6 months

InterventionT2-weighted lesions (Mean)
Raltegravir0.19

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Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline

This measure is the cumulative percentage of subjects who had scans free from Gd enhancing lesions during the first three months (baseline) compared with the second three months (treatment). These percentages are expressed as a total percentage for the baseline and for the treatment periods. (NCT01767701)
Timeframe: Baseline to 6 months

Interventionpercentage of subjects (Number)
Raltegravir15

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Mean Number of Adverse Events Per Patient

"This outcome will be assessed by blood and urine sampling; collection of patient reported symptoms and neurological and physical exams.~This measure is the total number of adverse events recorded for each type of event during the study period. The number of participants is 31 which is the number screened and enrolled in the study. Eleven participants did not meet the criterion for baseline i.e. having a gadolinium enhancing lesion on MRI at the baseline visit and therefore did not continue to the baseline observation period. The adverse events for the 11 participants who did not begin the study observation period were recorded during the screening period and added to the 20 participants who were studied during the 6 months of the study. Adverse events are recorded as total number during the study period. Each patient may have had more than one adverse event." (NCT01767701)
Timeframe: Screening to six months

InterventionAdverse events (Mean)
Raltegravir7.9

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Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.

Measured by Human C-Reactive Protein (HCRP) which is a measure of general inflammation. The higher the value the more inflammatory response is present. The HCRP was measured monthly for six months. The mean value for the baseline three months was compared with the mean value taken for the second (treatment) three months. (NCT01767701)
Timeframe: Baseline to 6 months

Interventionng/mL (Mean)
Raltegravir535.82

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Cumulative Number of Gd-T1 Enhancing Lesions

This measure is the number of gadolinium-enhancing T1 lesions as determined by MRI taken on the monthly basis during the six months of the study. (NCT01767701)
Timeframe: At Baseline and monthly for 6 months

InterventionGadolinium enhancing T1 lesions (Mean)
Raltegravir3.08

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Changes in Kurtzke Extended Disability Status Scale (EDSS) Score

"The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The scale has been developed by John F. Kurtzke. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. 0 = Normal 1-1.5 = No disability, but some abnormal neurological signs 2-2.5 = Minimal disability 3-4.5 = Moderate disability, affecting daily activities, but you can still walk. A lower score indicates less disability.~5-8 = More severe disability, impairing your daily activities and requiring assistance with walking 8.5-9.5 = Very severe disability, restricting you to bed 10 = Death EDSS scores were measured monthly over 6 months and the mean of the measurements for the first three months (baseline) was recorded to use calculate the change from baseline compared with the mean of measurements taken monthly during the second three months (treatment)." (NCT01767701)
Timeframe: Baseline and monthly to month 6

Interventionunits on a scale (Mean)
Raltegravir2.55

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RAL AUC12 for Cohort 2 at 15-18 Days of Life

Area Under the Concentration-time Curve at 12-hour interval (AUC12) of RAL for Cohort 2 at 15-18 days of life. (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2, 4-6, 8-12 hours post-dose.

Interventionmg*h/L (Geometric Mean)
Cohort 2 RAL-naive: 3 mg/kg Twice Daily on Days 8-18 of Life14.3
Cohort 2 RAL-exposed: 3 mg/kg Twice Daily on Days 8-28 of Life18.25

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RAL C12 for Cohort 2 at 15-18 Days of Life

RAL concentration at 12 hours (C12) for Cohort 2 at 15-18 days of life. (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2, 4-6, 8-12 hours post-dose.

Interventionmg*h/L (Geometric Mean)
Cohort 2 RAL-naive: 3 mg/kg Twice Daily on Days 8-28 of Life176.11
Cohort 2 RAL-exposed: 3 mg/kg Twice Daily on Days 8-28 of Life273.59

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Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 24 Weeks of Life

Number of infants who died or had adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table. Events with onset dates prior to first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. (NCT01780831)
Timeframe: From first RAL dose through 24 weeks of life

InterventionParticipants (Count of Participants)
Cohort 1 RAL-naive2
Cohort 1 RAL-exposed2
Cohort 1 Total4
Cohort 2 RAL-naive11
Cohort 2 RAL-exposed4
Cohort 2 Total15

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AUC24 for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)

Area Under the Concentration-time Curve at 24-hour interval (AUC24) based on intensive PK sampling around Cohort 1 RAL dose #1 (within 48 hours of birth) (NCT01780831)
Timeframe: Cohort 1 RAL dose #1 (within 48 hours of birth) intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12 (±1), 24 (±1) hours post-dose.

Interventionmg*h/L (Geometric Mean)
Cohort 1 RAL-naive: 3 mg/kg for First Dose53.88
Cohort 1 RAL-naive: 2 mg/kg for First Dose44.26
Cohort 1 RAL-exposed 1.5 mg/kg37.42

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AUC24 for Cohort 2 Initial RAL Dose (Within 48 and 12-60 Hours of Birth for RAL-naive and RAL-exposed Groups, Respectively)

Area Under the Concentration-time Curve at the 24-hour interval (AUC24) for Cohort 2 initial RAL dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed, respectively). (NCT01780831)
Timeframe: Cohort 2 initial dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed, respectively) intensive PK sampling: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose.

Interventionmg*h/L (Geometric Mean)
Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life38.2
Cohort 2 RAL-exposed: 1.5mg/kg Once Daily on Days 1-7 of Life42.89

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Clast for Cohort 2 Initial RAL Dose (Within 48 and Between 12-60 Hours of Birth for RAL-naïve and RAL-exposed Groups, Respectively)

Last concentration of the drug (Clast) at 24 hour interval post dosing for the Cohort 2 initial RAL dose (within 48 and at 12-60 hours of birth for RAL-naive and RAL-exposed, respectively). This is the plasma RAL concentration from a sample collected at or close to 24 hours post dose. (NCT01780831)
Timeframe: Cohort 2 initial dose (within 48 and between 12-60 hours of birth for RAL-naive and RAL-exposed groups, respectively) intensive PK sampling: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 2 RAL-naive: 1.5 mg/kg Once Daily on Days 1-7 of Life947.90
Cohort 2 RAL-exposed: 1.5 mg/kg Once Daily on Days 1-7 of Life946.24

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Cmax for Cohort 1 RAL Dose #1 (Within 48 Hours of Birth)

Maximum concentration (Cmax) for Cohort 1 dose #1 (within 48 hours of birth) (NCT01780831)
Timeframe: Cohort 1 dose #1(within 48 hours of birth) intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12 (±1), 24 (±1) hours post-dose.

Interventionng/mL (Geometric Mean)
Cohort 1 RAL-naive: 3 mg/kg for First Dose3360.89
Cohort 1 RAL-naive: 2 mg/kg for First Dose3405.24
Cohort 1 RAL-exposed: 1.5 mg/kg for First Dose2188.82

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Cohort 1 Dose #1 Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group

Cohort 1 Dose #1 neonatal RAL elimination was represented by Clearance (CL/F), which is the volume of plasma cleared of the drug per unit time. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians (i.e. genotyping was optional) . (NCT01780831)
Timeframe: Cohort 1 Dose #1 Intensive PK sampling: within 30 min pre-dose; and 1-2, 4-8, 12, 24 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

InterventionL/hr (Median)
(TA)6(TA)60.11
(TA)6(TA)70.06

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Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 6 Weeks of Life

"Number of infants who died or had Suspected Adverse Drug Reaction (SADR) of Grade 3 or 4 as defined in DAIDS AE Grading Table.~Events with onset dates prior to the first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. SADRs are AEs assessed as definitely related, probably related or possibly related to RAL." (NCT01780831)
Timeframe: From first RAL dose through 6 weeks of life

InterventionParticipants (Count of Participants)
Cohort 1 RAL-naive1
Cohort 1 RAL-exposed0
Cohort 1 Total1
Cohort 2 RAL-naive0
Cohort 2 RAL-exposed0
Cohort 2 Total0

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Cohort 2 Initial Dose Neonatal RAL Elimination (CL/F) by UGT1A1 Genotype Group

Cohort 2 initial dose neonatal RAL elimination was represented by Clearance (CL/F), which is defined as the volume of plasma cleared of the drug per unit time. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians (i.e. genotyping was optional) . (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 initial dose: within 1 hour pre-dose; and 1-2, 6-10, 20-24 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

InterventionL/hr (Median)
(TA)6(TA)6 Wildtype0.1
Mutation0.1

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Cohort 2 Neonatal RAL Elimination (CL/F) at 15-18 Days of Life by UGT1A1 Genotype Group

Cohort 2 15-18 days of life dose neonatal RAL elimination was represented by Clearance (CL/F), which is defined as the volume of plasma cleared of the drug per unit time at 15-18 days of life when RAL dosing would have been 3 mg/kg twice daily. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians(i.e. genotyping was optional) . (NCT01780831)
Timeframe: Intensive PK sampling for Cohort 2 at 15-18 days of life: within 1 hour pre-dose; and 1-2 hours post-dose, 4-6, 8-12 hours post-dose. Samples for UGT1A1 genotype testing were collected at study entry.

InterventionL/hr (Median)
(TA)6(TA)6 Wildtype0.5
Mutation0.5

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Number of Infants Who Died or Had Grade 3/4 Adverse Event Through 6 Weeks of Life

Number of infants who died or had adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table. Events with onset dates prior to first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. (NCT01780831)
Timeframe: From first dosing of RAL through 6 weeks of life

InterventionParticipants (Count of Participants)
Cohort 1 RAL-naive2
Cohort 1 RAL-exposed2
Cohort 1 Total4
Cohort 2 RAL-naive7
Cohort 2 RAL-exposed4
Cohort 2 Total11

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Number of Infants Who Died or Had SADR of Grade 3 or 4 Through 24 Weeks of Life

"Number of infants who died or had Suspected Adverse Drug Reaction (SADR) of Grade 3 or 4 as defined in DAIDS AE Grading Table.~Events with onset dates prior to the first RAL dosing and congenital anomalies assessed as baseline by the study team were considered baseline events and not AEs. SADRs are AEs assessed as definitely related, probably related or possibly related to RAL." (NCT01780831)
Timeframe: From first RAL dose through 24 weeks of life

InterventionParticipants (Count of Participants)
Cohort 1 RAL-naive1
Cohort 1 RAL-exposed0
Cohort 1 Total1
Cohort 2 RAL-naive0
Cohort 2 RAL-exposed0
Cohort 2 Total0

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Cmax ,ss

"C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.~RAL: Raltegravir , FDV: Faldaprevir" (NCT01785160)
Timeframe: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration

Interventionng/mL (Geometric Mean)
Raltegravir1300
Raltegravir + Faldaprevir3220

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AUC( Tau,ss)

"AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.~RAL: Raltegravir , FDV: Faldaprevir" (NCT01785160)
Timeframe: 0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration

Interventionng*h/mL (Geometric Mean)
Raltegravir4070
Raltegravir + Faldaprevir11100

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Ratio of Cord Blood to Maternal Blood RAL Concentrations

Ratio of the neonatal cord blood RAL concentration to the mother's plasma RAL concentration at birth (NCT01828073)
Timeframe: Maternal blood samples were scheduled to be collected within 1 hour after delivery and cord blood sample were collected immediately after cord was clamped

Interventionratio (Median)
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL1.48
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL2.62

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Infant Direct Bilirubin

Direct bilirubin measured from infant blood specimens. (NCT01828073)
Timeframe: Measured at 8-14 hours (Visit 1), 30-36 hours (Visit 2) and 1-2 weeks (Visit 3) after birth for Cohort 1; and at 36-48 hours (Visit 1), 72-84 hours (Visit 2) and 1 week (Visit 3)after birth for Cohort 2.

,
Interventionmg/dL (Median)
Visit 1Visit 2Visit 3
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL0.30.40.3
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL0.50.40.5

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Infant Total Bilirubin

Total bilirubin measured from infant blood specimens. (NCT01828073)
Timeframe: Measured at 8-14 hours (Visit 1), 30-36 hours (Visit 2) and 1-2 weeks (Visit 3) after birth for Cohort 1; and at 36-48 hours (Visit 1), 72-84 hours (Visit 2) and 1 week (Visit 3)after birth for Cohort 2.

,
Interventionmg/dL (Median)
Visit 1Visit 2Visit 3
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL3.75.72.7
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL6.610.74.6

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Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death)

"An infant was said to have met the composite safety endpoint if any of the following was observed:~adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table~adverse birth outcomes including stillbirth and low birth weight (LBW), or~death.~Stillbirth could only be observed on infants enrolled prior to delivery. Cohort 2 enrolled LBW infants and prematurity and growth restriction which were highly linked to LBW were considered as baseline events and not AEs or adverse birth outcome for Cohort 2 infants." (NCT01828073)
Timeframe: Assessed at entry through Week 20 for Cohort 1 infants and through Week 6 for Cohort 2 infants.

InterventionParticipants (Count of Participants)
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL7
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL9

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Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice

Assessment if infant received exchange transfusion, Phototherapy, or other treatment to reduce bilirubin or for jaundice (NCT01828073)
Timeframe: Assessed from entry through around week 1 after birth

,
InterventionParticipants (Count of Participants)
Exchange transfusion therapyPhototherapyOther treatment
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL010
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL040

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Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation)

Neonatal RAL elimination was the time required for neonatal plasma concentration to decrease by one-half. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians(i.e. genotyping was optional) . The goal of the genotypic analysis is to determine if certain polymorphisms, particularly those with the UGT1A1*28/*28 genotype have slower RAL elimination than those with the UGT1A1*1/*1 genotype. (NCT01828073)
Timeframe: Genotype was assessed close to birth and if this is not possible at 1-2 wks after birth. PK samples were collected at 1-5, 8-14, 18-24 and 30-36 hrs after birth for Cohort 1; 1-6, 12-24, 36-48, 72-84 and 108-132 hrs after birth, and day 7-14 for Cohort 2.

InterventionHours (Median)
Cohort 1 Infants With UGT1A1 Mutation40.85
Cohort 1 Infants With Normal UGT1A1 Phenotype32.75
Cohort 2 Infants With UGT1A1 Mutation21.1
Cohort 2 Infants With Normal UGT1A1 Phenotype39.7

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PK Parameter: Neonatal RAL Elimination Half-life (T1/2)

Time required for neonatal plasma concentration to decrease by one-half. T1/2 was estimated using the terminal 3 concentration-time points for each infant when available. (NCT01828073)
Timeframe: Infant blood specimens were collected at 1-5, 8-14, 18-24, and 30-36 hours after birth for Cohort 1; and at 1-6, 12-24, 36-48, 72-84, and 108-132 hours after birth, and on day 7-14 for Cohort 2.

InterventionHours (Median)
Cohort 1: Full Term Infants Exposed in Utero to Maternal RAL26.6
Cohort 2: LBW Infants Exposed in Utero to Maternal RAL24.4

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Raltegravir C12h

measured concentration 12 hours after dose in the absence, and presence, of amlodipine. (NCT01841593)
Timeframe: 12 hours post-dose on day 7 of daily dosing.

Interventionng/mL (Geometric Mean)
Raltegravir PK (Alone)48
Raltegravir PK (Administered With Amlodipine)37

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Raltegravir AUC(0-12h )

AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine. (NCT01841593)
Timeframe: Post dose after day 7 of daily dosing

Interventionng*h/mL (Geometric Mean)
Raltegravir PK (Alone)4600
Raltegravir PK (Administered With Amlodipine)6410

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Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.

"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).~All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0." (NCT01841593)
Timeframe: Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))

Interventionng/mL (Geometric Mean)
Raltegravir PK (Alone)1178
Raltegravir PK (Administered With Amlodipine)1866
Amlodipine PK (Alone)8.47
Amlodipine PK (Administered With Raltegravir)8.49

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Amlodipine C24h

measured concentration 24 hours after dose in the absence, and presence, of raltegravir (NCT01841593)
Timeframe: 12 hours post-dose on day 7 of daily dosing.

Interventionng/mL (Geometric Mean)
Amlodipine PK (Alone)4.91
Amlodipine PK (Administered With Raltegravir)4.55

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Amlodipine AUC(0-24h)

AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir (NCT01841593)
Timeframe: Post-dose on day 7 of daily dosing

Interventionng*h/mL (Geometric Mean)
Amlodipine PK (Alone)166.0
Amlodipine PK (Administered With Raltegravir)165.9

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Number of Participants With Adverse Events

Number of participants with adverse events (NCT01896921)
Timeframe: 96 weeks

InterventionParticipants (Count of Participants)
Maraviroc + Raltegravir or Dolutegravir3

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Number of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.

Number of patients virologically suppressed (HIV RNA <50 copies/ml) at 48 weeks. (NCT01896921)
Timeframe: 48 weeks

InterventionParticipants (Count of Participants)
Maraviroc + Raltegravir or Dolutegravir5

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Number of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)

Number of patients who are virologically suppressed (HIV RNA < 50 copies/ml) (NCT01896921)
Timeframe: 96 weeks

InterventionParticipants (Count of Participants)
Maraviroc + Raltegravir or Dolutegravir4

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Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2

Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration. (NCT01930045)
Timeframe: 12 hours after dosing on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir241.35
Maalox → 6 Hours → Raltegravir121.52
Raltegravir → 6 Hours → Maalox122.39

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Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1

Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration. (NCT01930045)
Timeframe: 12 hours after dosing on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir241.35
Maalox → 4 Hours → Raltegravir96.29
Raltegravir → 4 Hours → Maalox92.22

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Maximum Plasma Concentration (C Max) of Raltegravir in Part 1

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir4723.00
Maalox → 4 Hours → Raltegravir3690.96
Raltegravir → 4 Hours → Maalox3324.84

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Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

Interventionhr.nM (Geometric Mean)
Raltegravir17055.21
Maalox → 6 Hours → Raltegravir14799.48
Raltegravir → 6 Hours → Maalox15104.15

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Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

Interventionhr.nM (Geometric Mean)
Raltegravir17055.21
Maalox → 4 Hours → Raltegravir13881.87
Raltegravir → 4 Hours → Maalox11602.02

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Maximum Plasma Concentration (C Max) of Raltegravir in Part 2

Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration. (NCT01930045)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period

InterventionnM (Geometric Mean)
Raltegravir4723.00
Maalox → 6 Hours → Raltegravir4268.72
Raltegravir → 6 Hours → Maalox4256.01

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Sleep Quality

Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality. (NCT01978743)
Timeframe: week 0 and week 8

Interventionunits on a scale (Mean)
pre-switch PSQI indexpost-switch PSQI index
Raltegravir5.33.8

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Other Neurometabolite Changes Measured by MRS

Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) to evaluate for prominent and significant changes associated with EFV use. (NCT01978743)
Timeframe: week 0 and week 8

Interventionarbitrary units (Mean)
Pre-switch Posterior Cingulate GlutathionePost-switch Posterior Cingulate GlutathionePre-switch Posterior Cingulate AspartatePost-switch Posterior Cingulate AspartatePre-switch Anterior Cingulate GlutathionePost-switch Anterior Cingulate GlutathionePre-switch Anterior Cingulate AspartatePost-switch Anterior Cingulate Aspartate
Raltegravir5.114.704.323.314.253.183.152.18

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Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI

"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain dmamage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80." (NCT01978743)
Timeframe: week 0 and week 8

Interventionunits on a scale (Mean)
pre-switch WAISpost-switch WAISpre-switch FRSBEpost-switch FRSBEpre-switch HAMDpost-switch HAMDpre-switch DASS depressionpost-switch DASS depressionpre-switch STAIpost-switch STAI
Raltegravir48.153.579.272.44.72.76.43.429.427.2

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Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)

Assess changes in neural activation correlated with affective disturbances associated with EFV vs. RAL using fMRI employing a paradigm that probes affective symptomatologies typical with EFV use; anxiety/dysphoria and affective dysregulation, and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-/Post-/ Pre-vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect, and Age incorporated as a co-variate of no interest. A z-score is the Mean with a SD=1 and Measure of Dispersion equal to 1. (NCT01978743)
Timeframe: week 0 and week 8

Interventionz-score (Number)
PreVsPostXNegVsNeuXNoGoVsGo: aFPPreVsPostXNegVsNeuXNoGoVsGo: pCGPreVsPostXNegVsNeuXNoGoVsGo: daCGPreVsPostXNegVsNeuXNoGoVsGo:LHCPre: NegVsNeuXNoGoVsGo: aFPPre: NegVsNeuXNoGoVsGo:pCGPre: NegVsNeuXNoGoVsGo: daCGPre: NegVsNeuXNoGoVsGo: LHCPost: NegVsNeuXNoGoVsGo: aFPPost: NegVsNeuXNoGoVsGo: pCGPost: NegVsNeuXNoGoVsGo: daCGPost: NegVsNeuXNoGoVsGo: LHC
Raltegravir3.193.00-2.53-3.644.013.61-2.94-3.07-3.03-3.133.652.88

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Markers of Immune Activation

Change in markers of immune activation and inflammation associated with change to RAL (ie, sCD14, IL-6, hsCRP, D-dimer, CRP, LPS, sCD163, EndoCab) (NCT01978743)
Timeframe: week 0 and week 8

Interventionpg/ml (Mean)
pre-switch sCD14post-switch sCD14pre-switch IP-10post-switch IP-10pre-switch sCD163post-switch sCD163pre-switch MCP-1post-switch MCP-1pre-switch IL-6post-switch IL-6pre-switch TNFR1post-switch TNFR1
Raltegravir3652333.63135828.52195.84202.8567284473353695.57892.7941.491.69771.18829.12

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Fasting Lipid Profile

Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen. (NCT01978743)
Timeframe: week 0 and week 8

Interventionmg/dL (Mean)
pre-switch total cholesterolpost-switch total cholesterolpre-switch HDLpost-switch HDLpre-switch LDLpost-switch LDLpre-switch triglyceridepost-switch triglyceride
Raltegravir200.9176.758.853.1118.8103.5116.4100.6

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Change in Level of EFV and Metabolites

Correlate change in level of EFV and metabolites with neurocognitive and neuroimaging changes (NCT01978743)
Timeframe: week 0 and week 8

Interventionparticipants (Number)
pre-switch detectable 7-OH and 8-OH EFV metablitespost-switch detectable 7-OH and 8-OH EFVmetaboites
Raltegravir91

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ART Regimen Preference

Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus RAL + FTC/TDF) through self-administered questionnaires. (NCT01978743)
Timeframe: week 0 and week 8

Interventionparticipants (Number)
Prefer Raltegravir-based ARTPrefer Atripla (EFV-based ART)No preference
Raltegravir703

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Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)

Assess the levels of neuro-metabolites measured by MRS at week 0 before switching to the efavirenz-based therapy. Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain creatine (Cr), gamma-aminobutyric acid (GABA) and glutathione (GLU). (NCT01978743)
Timeframe: week 0 and week 8

Interventionarbitrary units (Mean)
Pre-switch Posterior Cingulate CreatinePost-switch Posterior Cingulate CreatinePre-switch Posterior Cingulate GlutamatePost-switch Posterior Cingulate GlutamatePre-switch Posterior Cingulate GABAPost-switch Posterior Cingulate GABAPre-switch Anterior Cingulate CreatinePost-switch Anterior Cingulate CreatinePre-switch Anterior Cingulate GlutamatePost-switch Anterior Cingulate GlutamatePre-switch Anterior Cingulate GABAPost-switch Anterior Cingulate GABA
Raltegravir19.3818.9427.8324.955.275.3214.8614.3419.0922.254.733.14

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The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.

Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms. (NCT01989910)
Timeframe: At week 48 of both arms

InterventionParticipants (Count of Participants)
Raltegravir41
Efavirenz36

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The Proportion of Treatment Failure at Week 48 for Both Arms.

The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms. (NCT01989910)
Timeframe: At week 48 of both arms

InterventionParticipants (Count of Participants)
Raltegravir2
Efavirenz2

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The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.

Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms. (NCT01989910)
Timeframe: At week 48 of both arms

InterventionParticipants (Count of Participants)
Raltegravir41
Efavirenz36

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Triglycerides Baseline and After 24 Weeks

(NCT02097108)
Timeframe: baseline to week 24

Interventionmg/dl (Mean)
Baseline24 weeks
Raltegravir168.4583.3

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High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks

(NCT02097108)
Timeframe: baseline to week 24

Interventionmg/dl (Mean)
Baseline24 weeks
Raltegravir5864

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Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction

A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues. (NCT02097108)
Timeframe: baseline to week 12

Interventionpercentage of participants (Number)
Raltegravir90.9

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Total Cholesterol Baseline and After 24 Weeks

(NCT02097108)
Timeframe: baseline to week 24

Interventionmg/dl (Mean)
Baseline24 weeks
Raltegravir247.55215.7

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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. (NCT02116660)
Timeframe: Baseline and Week 48

InterventionmL/min (Mean)
Raltegravir Plus Nevirapine Plus Lamivudine-1.1
Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine-5.5

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Change From Baseline in CD4 Cell Count at Week 96

CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values. (NCT02131233)
Timeframe: Baseline and Week 96

Interventioncells/mm^3 (Mean)
Reformulated Raltegravir261.6
Raltegravir262.2

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Percentage of Participants With a Serious Adverse Event (SAE) at Week 48

A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. (NCT02131233)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Reformulated Raltegravir6.2
Raltegravir9.4

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Percentage of Participants With an Adverse Event (AE) at Week 48

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02131233)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Reformulated Raltegravir83.2
Raltegravir88.0

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Percentage of Participants With an AE After 96 Weeks of Treatment

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)

InterventionPercentage of participants (Number)
Reformulated Raltegravir90.8
Raltegravir94.0

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Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE (NCT02131233)
Timeframe: Up to Week 96

InterventionPercentage of participants (Number)
Reformulated Raltegravir1.3
Raltegravir2.3

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Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE (NCT02131233)
Timeframe: Up to Week 48

InterventionPercentage of participants (Number)
Reformulated Raltegravir1.1
Raltegravir2.3

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Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96

"From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason." (NCT02131233)
Timeframe: Week 96

InterventionPercentage of participants (Number)
Reformulated Raltegravir81.5
Raltegravir80.1

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Percentage of Participants With a SAE After 96 Weeks of Treatment

A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)

InterventionPercentage of participants (Number)
Reformulated Raltegravir9.6
Raltegravir15.8

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

CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values. (NCT02131233)
Timeframe: Baseline and Week 48

Interventioncells/mm^3 (Mean)
Reformulated Raltegravir232.0
Raltegravir234.1

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Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48

"From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason." (NCT02131233)
Timeframe: Week 48

InterventionPercentage of participants (Number)
Reformulated Raltegravir88.9
Raltegravir88.3

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Evolution of the Level of MCP1 From D0 to W48 on Frozen Samples

(NCT02212379)
Timeframe: from day 0, to week 48

InterventionPercentage change (Median)
Premenopausal with mesurable AMHPremenopausal with reduced ovarian reservePost-menopausal
Raltegravir and Etravirine3.13.5-2.4

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Median Time of Virological Failure

Time between the date of the study treatment initiation and the date of virological failure (NCT02212379)
Timeframe: week 96

Interventionweeks (Median)
Raltegravir and Etravirine96

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Number of Patients With RAL and/or ETR Resistance Mutations Among Those With Virological Failure

(NCT02212379)
Timeframe: week 96

Interventionparticipants (Number)
Raltegravir and Etravirine1

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Percent Change of Renal Function

Percent change of the estimated Glomerular Filtration Rate (eGFR) calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Calculator) formula (NCT02212379)
Timeframe: from day 0 to week 96

InterventionMedian percent change, as median (IQR) (Median)
Raltegravir and Etravirine-0.6

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Percentage of Participants With Detectable Seminal HIV-RNA Viral Load at Week 48

• Assessment of HIV-RNA viral load in human male genital compartment (20 patients) at week 48 (NCT02212379)
Timeframe: week 48

InterventionParticipants (Count of Participants)
Raltegravir and Etravirine1

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Evolution of Body Fat Distribution From Day 0 to W96 (DXA Scan Sub-study, 80 Patients)

Evolution of total fat mass, limb fat and trunk fat from day 0 to week 96 (NCT02212379)
Timeframe: from day 0 to week 96

Interventionpercentage of change (Median)
Total fat mass, KgLimb fat, KgTrunk fat, Kg
Raltegravir and Etravirine12.211.612.2

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Evolution of CD4+, CD8+ T Cells Counts and CD4/CD8 Ratio

(NCT02212379)
Timeframe: from day 0 to week 48 and week 96

Interventionpercentage of change (Median)
CD4: 0-48 weekCD8: 0-48 weekCD4/CD8: 0-48 weekCD4: 0-96 weekCD8: 0-96 weekCD4/CD8: 0-96 week
Raltegravir and Etravirine1.1-1.85.75.0-5.27.4

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Evolution of Metabolic Parameters (Fasting Triglycerides, Total Cholesterol, HDL-cholesterol, LDL-cholesterol and Fasting Glycemia)

(NCT02212379)
Timeframe: from day 0 to week 96

Interventionpercentage of change (Median)
fasting triglyceridestotal cholesterolHDL-cholesterolLDL-cholesterolfasting glycemia
Raltegravir and Etravirine-18.8-0.55.4-4.30

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Evolution of the Calibrated 5-year Framingham Risk Score

"The Framingham risk score is expressed as a percentage. Higher scores mean a worse outcome and lower scores mean better outcome.~Median percent change expressed as median (interquartile range (IQR))" (NCT02212379)
Timeframe: from day 0 to week 48 and at week 96

InterventionMedian percent change as median (IQR) (Median)
from D0 to week 48from D0 to week 96
Raltegravir and Etravirine1.09.7

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Evolution of the Ovarian Reserve From D0 to W48 Measured by AMH on Frozen Aliquots

We measured the Anti-mullerian Hormone (AMH) level to evaluate the ovarian reserve (from D0 to W48) (NCT02212379)
Timeframe: from day 0, to week 48

Interventionng/mL (Median)
Reproductive activity: D0Pre-menopausal: D0Post-menopausal: D0Reproductive activity: W48Pre-menopausal: W48Post-menopausal: W48
Raltegravir and Etravirine0.1720.0090.0090.1520.0080.005

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Evolution of Total Cell-associated HIV-DNA

(NCT02212379)
Timeframe: from day 0 to week 48 and week 96

Interventionpercentage of change (Median)
Change from baseline to week 48Change from baseline to week 96
Raltegravir and Etravirine00

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Factors Associated With the Occurrence of Plasma HIV-RNA Viral Load > 50 Copies/mL

(NCT02212379)
Timeframe: week 96

Interventionhazard ratio (Number)
Age >60 years>=2 glasses/day alcohol consumption
Raltegravir and Etravirine3.711.3

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Inflammatory Parameters

• Evolution of the inflammation markers (IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, CRPus and insulin) on frozen plasma aliquots (NCT02212379)
Timeframe: from day 0 to week 96

Interventionpercentage of change (Median)
IL-6IP-10sCD163sCD14IgGhsCRPD-DimerInsulin
Raltegravir and Etravirine0.8-8.10.7-270016.54.6

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Number of Participants Experiencing Adverse Events and Effects

Number of all clinical and biological adverse events effects. Number of grade 3 or 4 clinical and biological adverse events and effects. (NCT02212379)
Timeframe: From day 0 to week 48 and week 96

InterventionParticipants (Count of Participants)
Any AE: 0-48 weekGrade 3 or 4 AE: 0-48 weekAny AE : 48-96Grade 3 or 4 AE: 48-96
Raltegravir and Etravirine1541510811

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Percentage of Participants Compliant With Treatment Program.

The compliance rate was estimated as the number of pills consumed (recorded using the self-reported 90 questionnaire) divided by the number of pills theoretically consumed, classified as low (80%), medium (80%-95%) or high (95%). (NCT02212379)
Timeframe: at week 0, week 48, and week 96

InterventionParticipants (Count of Participants)
low (<80) at W0medium (80-95) at W0high (>95) at W0low (<80) at W48medium (80-95) at W48high (>95) at W48low (<80) at W96medium (80-95) at W96high (>95) at W96
Raltegravir and Etravirine133139716123129115

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Percentage of Participants Reporting a Very Good or an Excellent Quality of Life at Day 0, Weeks 48 and 96

(NCT02212379)
Timeframe: day 0 and weeks 48 and 96

InterventionParticipants (Count of Participants)
day 0week 48week 96
Raltegravir and Etravirine637877

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Percentage of Participants With Successful Virological Suppression at Weeks 48 and 96

"Virological success is defined as the absence of 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks of a dual raltegravir/etravirine regimen.~The proportion of patients who maintained viral suppression under raltegravir plus etravirine was 99.4% (95% confidence interval (95% CI:95.6 -99.9) at week 48 and 98.7% (95% CI: 95.0 -99.7) at week 96" (NCT02212379)
Timeframe: at week48 and at week 96

Interventionpercentage of participant (Number)
at week 48at week 96
Raltegravir and Etravirine99.498.7

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Percentage of Patients With High Grade of Virological Failure Defined as HIV RNA > 200 Copies/mL

(NCT02212379)
Timeframe: weeks 48 and 96

Interventionpercentage of participants (Mean)
week 48week 96
Raltegravir and Etravirine0.60

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Percentage of Patients With Therapeutic Success at Week 48 and Week 96

Therapeutic success was defined as the absence of virological failure (i.e. 2 consecutive plasma viral loads (VL) > 50 copies/mL within 2 to 4 weeks) and the absence of treatment interruption due to adverse event judged by DSMB as related to the study treatment or procedure (NCT02212379)
Timeframe: weeks 48 and 96

Interventionpercentage of participants (Number)
at week 48at week 96
Raltegravir and Etravirine95.192.7

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Percentage of Patients With Trial Treatment Interruption at Week 48 and Week 96

(NCT02212379)
Timeframe: weeks 48 and 96

Interventionpercentage of participant (Number)
at week 48at week 96
Raltegravir and Etravirine4.36.1

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Percentage of Patients With With Grade Virological Failure (HIV-RNA Plasma VL Between 51 and 200 Copies/mL)

(NCT02212379)
Timeframe: weeks 48 and 96

Interventionpercentage of participants (Number)
at week 48at week 96
Raltegravir and Etravirine00.6

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Sub-study in Women : Comparison of the Evolution Fat Distribution Measured by DXA Scan and Body Weight According to AMH Status

BMI, Hip circumference, Waist circumference, waist/hip ratio, Limb fat, Trunk fat, Total fat, Limb lean, Trunk lean, and Total lean (NCT02212379)
Timeframe: from day 0, to week 96

,,
InterventionPercentage of change (Median)
Body mass index (BMI)Hip circumferenceWaist circumferenceWaist/hip ratioLimb fatTrunk fatTotal fatLimb leanTrunk leanTotal lean
Postmenopausal2.073.096.521.8510.8921.2724.39-1.44-3.24-3.01
Premenopausal With Mesurable AMH-0.967.062.74-3.43-2.94-6.90-2.59-0.70-0.79-1.35
Premenopausal With Reduced Ovarian Reserve5.692.804.200.026.7418.8016.772.135.535.83

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Sub-study in Women : Comparison of the Metabolic/Inflammatory Profile in Women According to Their Ovarian Reserve and Menopausal Status at D0 and Its Evolution up to Week 96

"Metabolic markers measures are total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides.~Inflammatory and innate immune activation markers measures are: IL-6hs, sCD14, sCD163, D-Dimers, IP-10, IgG, hsCRP and Insulin.~Ovarian reserve measure is AMH" (NCT02212379)
Timeframe: from day 0, to week 96

,,
InterventionPercentage of change (Median)
Total cholesterolLDL-cholesterolHDL-cholesterolTriglyceridessCD14sCD163hsCRPD-dimersIgGIL-6hsIP-10Insulin
Postmenopausal-11.35-6.58-4.84-0.99-18.84.8-31.423.1-1.2-0.9-5.411.4
Premenopausal With Mesurable AMH6.625.5218.475.59-31.610.85.76.80.75.9-18.3-29.2
Premenopausal With Reduced Ovarian Reserve6.915.6227.74-38.37-32.815.931.834.81.8-49.98.230.3

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Sub-study: Bone Mineral Density

"• Evolution of bone mineral density (BMD) measured by DXA scans (DXA scan sub-study, 81 patients)~Lumbar spine BMD, mg/cm2~Total hip BMD, mg/cm2" (NCT02212379)
Timeframe: from day 0, to week 48 and week 96

Interventionpercentage of change (Median)
Lumbar spine BMD from D0 to week 48Lumbar spine BMD at week 96Total hip BMD from D0 to week 48Total hip BMD at week 96
Raltegravir and Etravirine0.7-1.00.60

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Percentage of Total CD8+ T-cells With CCR5 Expression

Local immunologic markers in gastrointestinal tract tissues (NCT02218320)
Timeframe: 2 to 6 hours post dose

Interventionpercentage of total cells (Median)
Group A0.15
Group B0.64

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Rectal Tissue Concentrations of Ralegravir and Dolutegravir

(NCT02218320)
Timeframe: 2 to 6 hours post dose

Interventionng/g (Median)
Group A5308
Group B810

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RNA Concentrations From Gastrointestinal Tissues

We measured RNA concentrations in copies/1000cells for both drug groups (NCT02218320)
Timeframe: 2 to 6 hours post dose

Interventioncopies/1000cells (Median)
Group A0.05
Group B0.16

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Histone H4 Acetylation

Histone H4 acetylation using a H4K5/8/12/16 immunoassay with thawed PBMC derived cell lysates added to an ELISA using anti-H4 monoclonal antibody (NCT02336074)
Timeframe: 12 weeks

InterventionFold increase pre to post vorinostat (Mean)
Intervention (Arm B - ART + Vaccines + Vorinostat)3.19

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Quantitative Viral Outgrowth

Number of Participants with undetectable quantitative viral outgrowth (NCT02336074)
Timeframe: At week 16

InterventionParticipants with undetectable outgrowth (Number)
Control (Arm A - ART Only)12
Intervention (Arm B - ART + Vaccines + Vorinostat)6

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CD8+ T-cell Responses

Percentage of CD8+ CD107a+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel. (NCT02336074)
Timeframe: 12 weeks

,
Intervention% cells CD8+ CD107a+ IFNγ+ (Median)
Post randomisation week 9Post randomisation week 12
Control (Arm A - ART Only)0.0520.062
Intervention (Arm B - ART + Vaccines + Vorinostat)0.1940.263

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Total HIV DNA From CD4 T-cells

The average of two measures taken at post-randomisation week 16 and 18 (NCT02336074)
Timeframe: Averaged across post-randomisation week 16 and 18

InterventionHIV-DNA copies/mill CD4+ T cells (log10) (Mean)
Control (Arm A - ART Only)2.95
Intervention (Arm B - ART + Vaccines + Vorinostat)3.06

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Percentage of CD4+ CD154+ IFNγ+ T Cells

Percentage of CD4+ CD154+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel. (NCT02336074)
Timeframe: 12 weeks

,
Intervention% cells CD4+ CD154+ IFNγ+ (Median)
Post randomisation week 9Post randomisation week 12
Control (Arm A - ART Only)0.0060.006
Intervention (Arm B - ART + Vaccines + Vorinostat)0.0970.109

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Viral Inhibition

"CD8+ T cell antiviral suppressive activity was expressed as percentage elimination and determined as follows: [(fraction of p24+ cells in CD4+ T cells cultured alone) - (fraction of p24 + in CD4+ T cells cultured with CD8+ cells)]/(fraction of p24+ cells in CD4+ T cells cultured alone) × 100.~Viral inhibition Assay" (NCT02336074)
Timeframe: 12 weeks

InterventionPercentage elimination (Mean)
Control (Arm A - ART Only)-18.25
Intervention (Arm B - ART + Vaccines + Vorinostat)1.50

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Platelet Reactivity Measured by Expression of P-selectin (CD62p) and Fibrinogen Binding

Platelet expression of the platelet activation marker CD62P (P-selectin) and of the activated fibrinogen receptor (αIIbβ3) through fibrinogen binding following stimulation with two concentrations of the platelet agonists ADP (adenosine diphosphate) and CRP-XL (crosslinked collagen related peptide). Difference between week 0 and week 10. Primary outcome is CD62p expression upon stimulation with ADP (power calculation based on this measure). Expression of both markers are expressed as MFI (Median fluorescence intensity) and measured by flowcytometry. Change after 10 weeks was calculated as a ratio between baseline and week 10. (NCT02383355)
Timeframe: Baseline and week 10

,
InterventionRatio (Median)
ADP 125uM CD62p expressionADP 125uM Fibrinogen bindingADP 7.8uM CD62p expressionADP 7.8uM fibrinogen bindingCRP (collagen) XL 655ng/ml CD62p expressionCRP (collagen) XL 655ng/ml fibrinogen bindingCRP (collagen) XL 27.33ng/ml CD62p expressionCRP (collagen) XL 27.33 ng/ml fibrinogen binding
Continuation Group0.960.990.991.020.940.80.841.04
Switch Group0.910.880.850.950.80.870.88

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Circulating Levels of High Sensitive C-reactive Protein (Hs-CRP)

Plasma levels of hs-CRP (ng/mL) measured by ELISA . Change in concentration was calculated as a ratio between baseline (week 0) and week 10. (NCT02383355)
Timeframe: Baseline and week 10

Interventionratio (Mean)
Switch Group1.208
Continuation Group1.103

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Platelet-leukocyte Aggregates (Platelet Monocyte Complex Measured by Flow-cytometry)

Platelet monocyte complex (PMCs) measured by flow-cytometry. % of CD61+ (platelet-marker) monocytes. Change after 10 weeks was calculated as a ratio between baseline and week 10. (NCT02383355)
Timeframe: Baseline and week 10

Interventionratio (Median)
Switch Group0.95
Continuation Group0.932

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T-cell Dysfunction (CD4-cells)

Markers of persistent immune activation measured by flow cytometry (% of CD4-cells positive for CD38HLA-DR cells). Change after 10 weeks was calculated as a ratio between baseline and week 10. (NCT02383355)
Timeframe: Baseline and Week 10

Interventionratio (Median)
Switch Group1.314
Continuation Group1.016

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Persistent Immune Activation - Monocyte Subsets

Monocyte subsets measured by flowcytometry. Classical monocytes (CD14+,CD16-), intermediate (CD14+CD16+), Non-classical (CD14dimCD16+). Reported values are change between baseline and week 10 and reported as ratio. (NCT02383355)
Timeframe: Baseline and week 10

,
Interventionratio (Median)
classical monocytes as % of total monocytesintermediate monocytes as % of total monocytesnon-classical monocytes as % of total monocytes
Continuation Group0.9980.9791.089
Switch Group0.981.0421

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Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir

In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means. (NCT02473367)
Timeframe: 24 hours post-dose

InterventionnM (Least Squares Mean)
Period 1: Raltegravir Only75.6
Period 2: Raltegravir + TUMS Concomitantly39.6
Period 3: Raltegravir + 12 Hrs Leader Antacid32.0
Period 4: Raltegravir + 12 Hrs TUMS32.4

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Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir

In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means. (NCT02473367)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Interventionhr*µM (Least Squares Mean)
Period 1: Raltegravir Only53.7
Period 2: Raltegravir + TUMS Concomitantly14.8
Period 3: Raltegravir + 12 Hrs Leader Antacid46.3
Period 4: Raltegravir + 12 Hrs TUMS48.5

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Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir

In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means. (NCT02473367)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

InterventionnM (Least Squares Mean)
Period 1: Raltegravir Only20000
Period 2: Raltegravir + TUMS Concomitantly5240
Period 3: Raltegravir + 12 Hrs Leader Antacid17300
Period 4: Raltegravir + 12 Hrs TUMS19500

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Changes in Plasma Soluble Markers (D-dimer)

Changes in plasma soluble markers (D-dimer) (NCT02577042)
Timeframe: baseline, wk24 and wk72

,
Interventionng/mL (Median)
Baselinewk24wk72
PI-based Regimen + Atorvastatin199019171868
Raltegravir + Atorvastatin174318442051

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Changes in the Inflammatory Marker IL-6

Switching the PI by raltegravir, plus Kivexa or Truvada for 24 weeks. After that, atorvastatin, 20mg/day has been added for 48 weeks. (intergroup and intragroup) (NCT02577042)
Timeframe: baseline, wk24 and wk72

,
Interventionpg/mL (Mean)
Baselineweek 24week 72
PI-based Regimen + Atorvastatin40.041.141.7
Raltegravir + Atorvastatin42.539.343.2

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The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

InterventionDays (Mean)
Time from first dose of drug to maximum rectal ex vivo protection from high titer HIV infectionTime from first dose of drug to maximum rectal ex vivo protection from low titer HIV infectionTime from first dose of drug to maximum vaginal ex vivo protection from low titer HIV infection
Raltegravir322.673

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The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.

Time in days from stopping antiretroviral (Raltegravir 400mg +/-lamivudine) until ex vivo protection (against high or low viral titre of HIV-1BaL) was no longer observed. (NCT03205566)
Timeframe: 5 days post last dose

,
InterventionDays (Mean)
Time to cessation of rectal ex vivo protection from high HIV dose challenge post ART at steady stateTime to cessation of rectal ex vivo protection from low HIV dose challenge post ART at steady stateTime to cessation of vaginal ex vivo protection from high HIVdose challenge post ART at steady stateTime to cessation of vaginal ex vivo protection from low HIV dose challenge post ART at steady state
Raltegravir3.33NA45
Raltegravir LamivudineNANANANA

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The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

InterventionDays (Mean)
Time from first dose of drug to maximum rectal ex vivo protection from low titer HIV infectionTime from first dose of drug to maximum rectal ex vivo protection from High titer HIV infectionTime from first dose of drug to maximum vaginal ex vivo protection from low titer HIV infection
Raltegravir Lamivudine2233.67

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The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV

"The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for 100% ex vivo protection from HIV .~High viral dose challenge: ex vivo challenge of tissue with 104 TCID50/mL HIV-1BaL Low viral dose challenge: ex vivo challenge of tissue with 102 TCID50/mL HIV-1BaL" (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

,,
Interventionng/mL (Mean)
Plasma: High Dose Challenge in rectal tissuePlasma: Low viral dose challenge in rectal tissueRectal: high viral dose challenge in rectal tissueRectal: Low viral dose challenge in rectal tissuePlasma: high viral dose challenge in vaginal tissuPlasma: low viral dose challenge in vaginal tissuePlasma: high dose in vaginal tissuePlasma: low dose in vaginal tissue
Lamivudine During Combination Treatment265.10265.101722.021722.02266.40169.101557.801437.80
RaltegravirNA979.8NA729.36NA979.8NA607.60
Raltegravir During Combination Treatment669.90669.90862.35862.35828.60281.60648.24273.02

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Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals

Subject safety and tolerability will be determined by physical examination, blood tests and adverse event reporting. FBC, U&E and LFTs will be carried out at baseline and thereafter as symptom directed. Adverse event review. If significant adverse events have been reported, these will be clinically followed in accordance to the instruction of the study physician. (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

InterventionAdverse event (Number)
Arm A Raltegravir12
Arm B Raltegravir Lamivudine15

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Change in Metabolic and Inflammatory Biomarkers: IL-6

24 week value minus baseline value, change in circulating metabolic and inflammatory biomarkers: interleukin 6 (IL-6 pg/mL) (NCT03374358)
Timeframe: Baseline and 24 weeks

Interventionpg/mL (Median)
Control (= no Intervention Arm).0.83
Raltegravir Arm.0.00

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Change in Liver Stiffness

24 week minus baseline value, change in liver stiffness (kPa) measured by transient elastography (Fibroscan ®). (NCT03374358)
Timeframe: Baseline and 24 weeks

InterventionkPa (Median)
Control (= no Intervention Arm).-0.5
Raltegravir Arm.-0.2

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Change in Liver Fat

24 week value minus baseline value, liver fat % measured by proton magnetic resonance spectroscopy. (NCT03374358)
Timeframe: Baseline and 24 weeks

Intervention% hepatic fat fraction (Median)
Control (= no Intervention Arm).0.3
Raltegravir Arm.0.6

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Change in Fasting Plasma Glucose

24 week value minus baseline value, change in fasting plasma glucose (mg/dL). (NCT03374358)
Timeframe: Baseline and 24 weeks

Interventionmg/dL (Median)
Control (= no Intervention Arm).0.0
Raltegravir Arm.-1.8

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Change in Metabolic and Inflammatory Biomarkers: hsCRP

24 week value minus baseline value, change in circulating metabolic and inflammatory biomarkers: high sensitivity C-reactive protein (hsCRP mg/L) (NCT03374358)
Timeframe: Baseline and 24 weeks

Interventionmg/L (Median)
Control (= no Intervention Arm).0.66
Raltegravir Arm.-0.06

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Change in Subcutaneous and Visceral Adipose Tissue Volume

24 week value minus baseline value: change in subcutaneous (SAT) and visceral (VAT) adipose tissue volume (mL) measured by magnetic resonance imaging. Analysis included a series of T1-weighted trans-axial images from 8 cm above to 8 cm below the 4th and 5th lumbar intervertebral disc (16 slices, field of view 375 x 500 mm2, slice thickness 10 mm). (NCT03374358)
Timeframe: Baseline and 24 weeks

,
InterventionmL (Median)
Change in SAT (24 weeks - baseline)Change in VAT (24 weeks - baseline)
Control (= no Intervention Arm).-74100
Raltegravir Arm.24266

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Change in Fasting Serum Lipid Profile

24 week value minus baseline value, change in fasting serum lipid profile: LDL and HDL cholesterol, triglyceride (all values in mmol/L) (NCT03374358)
Timeframe: Baseline and 24 weeks

,
Interventionmmol/L (Median)
Change in fasting serum LDL (24 weeks - baseline)Change in fasting serum HDL (24 weeks - baseline)Change in fasting serum triglycerides (24 weeks - baseline)
Control (= no Intervention Arm).0.10.04-0.05
Raltegravir Arm.-0.5-0.07-0.18

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Change in Body Weight and Total Body Fat

24 week value minus baseline value, change in body weight (kg) and total body fat (kg) measured by Bioelectrical Impedance Analysis. (NCT03374358)
Timeframe: Baseline and 24 weeks

,
Interventionkg (Median)
Change in body weight (24 weeks - baseline)Change in body fat (24 weeks - baseline)
Control (= no Intervention Arm).0.9-0.3
Raltegravir Arm.2.01.5

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AUCtau of Raltegravir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)

Interventionng*h/ml (Geometric Mean)
Treatment B (Part 2)2912.45
Treatment C (Part 2)2653.65

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Number of Patients With Changes in Vital Signs

There were no subjects with abnormal changes in vital signs (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

InterventionParticipants (Count of Participants)
Treatment A (Part 1)0
Treatment B (Part 1)0
Treatment C (Part 1)0
Treatment A (Part 2)0
Treatment B (Part 2)0
Treatment C (Part 2)0

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Number of Patients With Abnormal ECG Changes

There were no subjects with abnormal ECG changes during the study (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

,,
InterventionParticipants (Count of Participants)
Part 1Part 2
Treatment A (Part 1/Part 2)00
Treatment B (Part 1/Part 2)00
Treatment C (Part 1/Part 2)00

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Number of Patients With Abnormal Laboratory Values

(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

,,
InterventionParticipants (Count of Participants)
Part 1Part 2
Treatment A (Part 1)00
Treatment B (Part 1)00
Treatment C (Part 1)21

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AUCtau of Tenofovir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)

Interventionng*h/ml (Geometric Mean)
Treatment B (Part 1)2599.95
Treatment C (Part 1)2799.72

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AUCtau of Narlaprevir

Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)

Interventionng*h/ml (Geometric Mean)
Treatment A (Part 1)20504.31
Treatment C (Part 1)21366.2
Treatment A (Part 2)26199.19
Treatment C (Part 2)24458.48

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Cmax of Narlaprevir

Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)

Interventionng/ml (Geometric Mean)
Treatment A (Part 1)2130.2742
Treatment C (Part 1)2172.233
Treatment A (Part 2)2946.131
Treatment C (Part 2)2880.612

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Cmax of Raltegravir

Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)

Interventionng/ml (Geometric Mean)
Treatment B (Part 2)830.204
Treatment C (Part 2)715.726

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Cmax of Tenofovir

Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)

Interventionng/ml (Geometric Mean)
Treatment B (Part 1)263.037
Treatment C (Part 1)344.796

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Number of Patients With Adverse Events

(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study

InterventionParticipants (Count of Participants)
Treatment A (Part 1)1
Treatment B (Part 1)0
Treatment C (Part 1)4
Treatment A (Part 2)0
Treatment B (Part 2)0
Treatment C (Part 2)1

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Number of Participants Discontinued From the Study Due to an AE

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants discontinued from the study due to an AE was reported. (NCT03667547)
Timeframe: Up to Day 14 after dosing

InterventionParticipants (Count of Participants)
Raltegravir0

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Maximum Plasma Concentration (Cmax) of Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Maximum plasma concentration (Cmax) of raltegravir was calculated based on natural log-transformed values. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

InterventionnM (Geometric Mean)
Raltegravir20163

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Time of Maximum Plasma Concentration (Tmax) of Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The time at which Cmax of plasma raltegravir is achieved (Tmax) was reported. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

InterventionHours (Median)
Raltegravir1.75

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Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24)

Blood samples were collected at 24 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The plasma concentration of raltegravir at 24 hours after dosing (C24) was calculated based on natural log-transformed values. (NCT03667547)
Timeframe: 24 hours after dosing

InterventionnM (Geometric Mean)
Raltegravir74.5

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Number of Participants With an Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants with an AE was reported. (NCT03667547)
Timeframe: Up to Day 14 after dosing

InterventionParticipants (Count of Participants)
Raltegravir0

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Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of plasma raltegravir was calculated based on natural log-transformed values. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

Intervention(μM•hr) (Geometric Mean)
Raltegravir62.8

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Apparent Volume of Distribution (Vz/F) of Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent volume of distribution of raltegravir during the terminal phase (Vz/F) was reported. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

InterventionLiters (Geometric Mean)
Raltegravir429

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Apparent Plasma Half-life (t1/2) of Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent plasma half-life (t1/2) of raltegravir was reported. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

InterventionHours (Geometric Mean)
Raltegravir7.50

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Number of Participants With a Serious Adverse Event (SAE)

A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly or birth defect, is another medically important event, is a new cancer, or is an overdose. The number of participants with an SAE was reported. (NCT03667547)
Timeframe: Up to Day 14 after dosing

InterventionParticipants (Count of Participants)
Raltegravir0

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Apparent Total Plasma Clearance (CL/F) of Raltegravir

Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent total plasma clearance of raltegravir after oral dosing (CL/F) was reported. (NCT03667547)
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing

InterventionL/hr (Geometric Mean)
Raltegravir39.6

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
adenine
[no description available]		16.6670366-aminopurines;
purine nucleobase		Daphnia magna metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
carbamates
[no description available]		4.8571amino-acid anion
creatine
[no description available]		3.5911glycine derivative;
guanidines;
zwitterion		geroprotector;
human metabolite;
mouse metabolite;
neuroprotective agent;
nutraceutical
lactic acid
Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed). 2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group.		2.47202-hydroxy monocarboxylic acidalgal metabolite;
Daphnia magna metabolite
glycerol
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.		2.0610alditol;
triol		algal metabolite;
detergent;
Escherichia coli metabolite;
geroprotector;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
solvent
methanol
Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group.		3.3820alkyl alcohol;
one-carbon compound;
primary alcohol;
volatile organic compound		amphiprotic solvent;
Escherichia coli metabolite;
fuel;
human metabolite;
mouse metabolite;
Mycoplasma genitalium metabolite
nitrates
Nitrates: Inorganic or organic salts and esters of nitric acid. These compounds contain the NO3- radical.		4.6111monovalent inorganic anion;
nitrogen oxoanion;
reactive nitrogen species
pyridine
azine : An organonitrogen compound of general structure RCH=N-N=CHR or RR'C=N-N=CRR'.		2.4920azaarene;
mancude organic heteromonocyclic parent;
monocyclic heteroarene;
pyridines		environmental contaminant;
NMR chemical shift reference compound
uracil
2,4-dihydroxypyrimidine: a urinary biomarker for bipolar disorder		3.9721pyrimidine nucleobase;
pyrimidone		allergen;
Daphnia magna metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
prodrug;
Saccharomyces cerevisiae metabolite
amlodipine
Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.		2.110dihydropyridine;
ethyl ester;
methyl ester;
monochlorobenzenes;
primary amino compound		antihypertensive agent;
calcium channel blocker;
vasodilator agent
camostat
camostat : A benzoate ester resulting from the formal condensation of the carboxy group of 4-guanidinobenzoic acid with the hydroxy group of 2-(dimethylamino)-2-oxoethyl (4-hydroxyphenyl)acetate. It is a potent inhibitor of the human transmembrane protease serine 2 (TMPRSS2) and its mesylate salt is currently under investigation for its effectiveness in COVID-19 patients.		2.3110benzoate ester;
carboxylic ester;
diester;
guanidines;
tertiary carboxamide		anti-inflammatory agent;
anticoronaviral agent;
antifibrinolytic drug;
antihypertensive agent;
antineoplastic agent;
antiviral agent;
serine protease inhibitor
citalopram
Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group.		4.43112-benzofurans;
cyclic ether;
nitrile;
organofluorine compound;
tertiary amino compound
valproic acid
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.		7.4844branched-chain fatty acid;
branched-chain saturated fatty acid		anticonvulsant;
antimanic drug;
EC 3.5.1.98 (histone deacetylase) inhibitor;
GABA agent;
neuroprotective agent;
psychotropic drug;
teratogenic agent
ebselen
ebselen : A benzoselenazole that is 1,2-benzoselenazol-3-one carrying an additional phenyl substituent at position 2. Acts as a mimic of glutathione peroxidase.		2.4110benzoselenazoleanti-inflammatory drug;
antibacterial agent;
anticoronaviral agent;
antifungal agent;
antineoplastic agent;
antioxidant;
apoptosis inducer;
EC 1.13.11.33 (arachidonate 15-lipoxygenase) inhibitor;
EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor;
EC 1.3.1.8 [acyl-CoA dehydrogenase (NADP(+))] inhibitor;
EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor;
EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor;
EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor;
EC 3.1.3.25 (inositol-phosphate phosphatase) inhibitor;
EC 3.4.22.69 (SARS coronavirus main proteinase) inhibitor;
EC 3.5.4.1 (cytosine deaminase) inhibitor;
EC 5.1.3.2 (UDP-glucose 4-epimerase) inhibitor;
enzyme mimic;
ferroptosis inhibitor;
genotoxin;
hepatoprotective agent;
neuroprotective agent;
radical scavenger
erythrosine
Fluoresceins: A family of spiro(isobenzofuran-1(3H),9'-(9H)xanthen)-3-one derivatives. These are used as dyes, as indicators for various metals, and as fluorescent labels in immunoassays.		2.5120
gabexate
Gabexate: A serine proteinase inhibitor used therapeutically in the treatment of pancreatitis, disseminated intravascular coagulation (DIC), and as a regional anticoagulant for hemodialysis. The drug inhibits the hydrolytic effects of thrombin, plasmin, and kallikrein, but not of chymotrypsin and aprotinin.		2.3110benzoate ester
hydroxychloroquine
Hydroxychloroquine: A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970). hydroxychloroquine : An aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions.		3.4611aminoquinoline;
organochlorine compound;
primary alcohol;
secondary amino compound;
tertiary amino compound		anticoronaviral agent;
antimalarial;
antirheumatic drug;
dermatologic drug
isoniazid
Hydra: A genus of freshwater polyps in the family Hydridae, order Hydroida, class HYDROZOA. They are of special interest because of their complex organization and because their adult organization corresponds roughly to the gastrula of higher animals.. hydrazide : Compounds derived from oxoacids RkE(=O)l(OH)m (l =/= 0) by replacing -OH by -NRNR2 (R groups are commonly H). (IUPAC).		3.5111carbohydrazideantitubercular agent;
drug allergen
ketoconazole
1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively.		3.4811dichlorobenzene;
dioxolane;
ether;
imidazoles;
N-acylpiperazine;
N-arylpiperazine
lamotrigine
[no description available]		4.35111,2,4-triazines;
dichlorobenzene;
primary arylamine		anticonvulsant;
antidepressant;
antimanic drug;
calcium channel blocker;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
excitatory amino acid antagonist;
geroprotector;
non-narcotic analgesic;
xenobiotic
lansoprazole
Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers.		2.110benzimidazoles;
pyridines;
sulfoxide		anti-ulcer drug;
EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor
losartan
Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position		3.711biphenylyltetrazole;
imidazoles		angiotensin receptor antagonist;
anti-arrhythmia drug;
antihypertensive agent;
endothelin receptor antagonist
methadone
Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3). methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.. 6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4.		3.4411benzenes;
diarylmethane;
ketone;
tertiary amino compound
midazolam
Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively.		4.4122imidazobenzodiazepine;
monofluorobenzenes;
organochlorine compound		anticonvulsant;
antineoplastic agent;
anxiolytic drug;
apoptosis inducer;
central nervous system depressant;
GABAA receptor agonist;
general anaesthetic;
muscle relaxant;
sedative
nevirapine
Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection.		7.93122cyclopropanes;
dipyridodiazepine		antiviral drug;
HIV-1 reverse transcriptase inhibitor
omeprazole
Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5.		3.8530aromatic ether;
benzimidazoles;
pyridines;
sulfoxide
prednisolone
Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.		3.993011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
drug metabolite;
environmental contaminant;
immunosuppressive agent;
xenobiotic
prednisone
Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.		3.024011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
immunosuppressive agent;
prodrug
alanine
Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.		3.6620alanine zwitterion;
alanine;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid		EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor;
fundamental metabolite
sucrose
Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar.		2.1110glycosyl glycosidealgal metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
osmolyte;
Saccharomyces cerevisiae metabolite;
sweetening agent
ethinyl estradiol
Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration.		7.54417-hydroxy steroid;
3-hydroxy steroid;
terminal acetylenic compound		xenoestrogen
carbostyril
Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2.		16.331368monohydroxyquinoline;
quinolone		bacterial xenobiotic metabolite
tyrosine
Tyrosine: A non-essential amino acid. In animals it is synthesized from PHENYLALANINE. It is also the precursor of EPINEPHRINE; THYROID HORMONES; and melanin.. tyrosine : An alpha-amino acid that is phenylalanine bearing a hydroxy substituent at position 4 on the phenyl ring.		2.0810amino acid zwitterion;
erythrose 4-phosphate/phosphoenolpyruvate family amino acid;
L-alpha-amino acid;
proteinogenic amino acid;
tyrosine		EC 1.3.1.43 (arogenate dehydrogenase) inhibitor;
fundamental metabolite;
micronutrient;
nutraceutical
leucine
Leucine: An essential branched-chain amino acid important for hemoglobin formation.. leucine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isobutyl group.		3.511amino acid zwitterion;
L-alpha-amino acid;
leucine;
proteinogenic amino acid;
pyruvate family amino acid		algal metabolite;
Escherichia coli metabolite;
human metabolite;
mouse metabolite;
plant metabolite;
Saccharomyces cerevisiae metabolite
phenylalanine
Phenylalanine: An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.. L-phenylalanine : The L-enantiomer of phenylalanine.. phenylalanine : An aromatic amino acid that is alanine in which one of the methyl hydrogens is substituted by a phenyl group.		2.2510amino acid zwitterion;
erythrose 4-phosphate/phosphoenolpyruvate family amino acid;
L-alpha-amino acid;
phenylalanine;
proteinogenic amino acid		algal metabolite;
EC 3.1.3.1 (alkaline phosphatase) inhibitor;
Escherichia coli metabolite;
human xenobiotic metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
plant metabolite;
Saccharomyces cerevisiae metabolite
valine
Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine.		4.2331L-alpha-amino acid zwitterion;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid;
valine		algal metabolite;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
acetonitrile
acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group.		2.9610aliphatic nitrile;
volatile organic compound		EC 3.5.1.4 (amidase) inhibitor;
NMR chemical shift reference compound;
polar aprotic solvent
methylene chloride
Methylene Chloride: A chlorinated hydrocarbon that has been used as an inhalation anesthetic and acts as a narcotic in high concentrations. Its primary use is as a solvent in manufacturing and food technology.. dichloromethane : A member of the class of chloromethanes that is methane in which two of the hydrogens have been replaced by chlorine. A dense, non-flammible colourless liquid at room temperature (b.p. 40degreeC, d = 1.33) which is immiscible with water, it is widely used as a solvent, a paint stripper, and for the removal of caffeine from coffee and tea.		2.0310chloromethanes;
volatile organic compound		carcinogenic agent;
polar aprotic solvent;
refrigerant
quinoxalines
quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4.		3.921mancude organic heterobicyclic parent;
naphthyridine;
ortho-fused heteroarene
2-naphthylamine
2-Naphthylamine: A naphthalene derivative with carcinogenic action.. 2-naphthylamine : A naphthylamine carrying the amino group at position 2.		3.9721naphthylaminecarcinogenic agent
2-methylpentane
Hexanes: Six-carbon saturated hydrocarbon group of the methane series. Include isomers and derivatives. Various polyneuropathies are caused by hexane poisoning.		2.0310alkane
pyrroles
1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen.		8.3675pyrrole;
secondary amine
catechin
Catechin: An antioxidant flavonoid, occurring especially in woody plants as both (+)-catechin and (-)-epicatechin (cis) forms.. catechin : Members of the class of hydroxyflavan that have a flavan-3-ol skeleton and its substituted derivatives.. rac-catechin : A racemate comprising equimolar amounts of (+)- and (-)-catechin. (+)-catechin : The (+)-enantiomer of catechin and a polyphenolic antioxidant plant metabolite.		2.0510catechinantioxidant;
plant metabolite
thiazoles
[no description available]		3.5111,3-thiazoles;
mancude organic heteromonocyclic parent;
monocyclic heteroarene
pyrimidine
pyrimidine : The parent compound of the pyrimidines; a diazine having the two nitrogens at the 1- and 3-positions.		2.0610diazine;
pyrimidines		Daphnia magna metabolite
pyrazines
Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms.		2.3110diazine;
pyrazines		Daphnia magna metabolite
azacitidine
Azacitidine: A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.. 5-azacytidine : An N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia.		2.4620N-glycosyl-1,3,5-triazine;
nucleoside analogue		antineoplastic agent
cuprizone
[no description available]		2.3110organonitrogen compound;
organooxygen compound
fluorobenzenes
Fluorobenzenes: Derivatives of BENZENE that contain FLUORINE.. monofluorobenzene : The simplest member of the class of monofluorobenzenes that is benzene carrying a single fluoro substituent.. fluorobenzenes : Any fluoroarene that is a benzene or a substituted benzene carrying at least one fluoro group.		7.544monofluorobenzenesNMR chemical shift reference compound
dihydroergotamine
Dihydroergotamine: A 9,10alpha-dihydro derivative of ERGOTAMINE. It is used as a vasoconstrictor, specifically for the therapy of MIGRAINE DISORDERS.. dihydroergotamine : Ergotamine in which a single bond replaces the double bond between positions 9 and 10. A semisynthetic ergot alkaloid with weaker oxytocic and vasoconstrictor properties than ergotamine, it is used (as the methanesulfonic or tartaric acid salts) for the treatment of migraine and orthostatic hypotension.		2.3110ergot alkaloid;
semisynthetic derivative		dopamine agonist;
non-narcotic analgesic;
serotonergic agonist;
sympatholytic agent;
vasoconstrictor agent
hesperidin
Hesperidin: A flavanone glycoside found in CITRUS fruit peels.. hesperidin : A disaccharide derivative that consists of hesperetin substituted by a 6-O-(alpha-L-rhamnopyranosyl)-beta-D-glucopyranosyl moiety at position 7 via a glycosidic linkage.		2.6103'-hydroxyflavanones;
4'-methoxyflavanones;
dihydroxyflavanone;
disaccharide derivative;
flavanone glycoside;
monomethoxyflavanone;
rutinoside		mutagen
azomycin
azomycin: RN given refers to parent cpd with specified locant; structure		2.0610C-nitro compound;
imidazoles		antitubercular agent
deoxycytidine
[no description available]		14.824222pyrimidine 2'-deoxyribonucleosideEscherichia coli metabolite;
human metabolite;
mouse metabolite;
Saccharomyces cerevisiae metabolite
stavudine
Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase		2.830dihydrofuran;
nucleoside analogue;
organic molecular entity		antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
dithiothreitol
1,4-dimercaptobutane-2,3-diol : A glycol that is butane-2,3-diol in which a hydrogen from each of the methyl groups is replaced by a thiol group.. 1,4-dithiothreitol : The threo-diastereomer of 1,4-dimercaptobutane-2,3-diol.		2.1101,4-dimercaptobutane-2,3-diol;
butanediols;
dithiol;
glycol;
thiol		chelator;
human metabolite;
reducing agent
carbonates
Carbonates: Salts or ions of the theoretical carbonic acid, containing the radical CO2(3-). Carbonates are readily decomposed by acids. The carbonates of the alkali metals are water-soluble; all others are insoluble. (From Grant & Hackh's Chemical Dictionary, 5th ed). carbonates : Organooxygen compounds that are salts or esters of carbonic acid, H2CO3.		2.1110carbon oxoanion
manganese
Manganese: A trace element with atomic symbol Mn, atomic number 25, and atomic weight 54.94. It is concentrated in cell mitochondria, mostly in the pituitary gland, liver, pancreas, kidney, and bone, influences the synthesis of mucopolysaccharides, stimulates hepatic synthesis of cholesterol and fatty acids, and is a cofactor in many enzymes, including arginase and alkaline phosphatase in the liver. (From AMA Drug Evaluations Annual 1992, p2035). manganese(4+) : A manganese cation that is monoatomic and has a formal charge of +4.		2.7630elemental manganese;
manganese group element atom		Escherichia coli metabolite;
micronutrient
ruthenium
Ruthenium: A hard, brittle, grayish-white rare earth metal with an atomic symbol Ru, atomic number 44, and atomic weight 101.07. It is used as a catalyst and hardener for PLATINUM and PALLADIUM.		2.0810iron group element atom;
platinum group metal atom
gadolinium
Gadolinium: An element of the rare earth family of metals. It has the atomic symbol Gd, atomic number 64, and atomic weight 157.25. Its oxide is used in the control rods of some nuclear reactors.		3.5611f-block element atom;
lanthanoid atom
gold
Gold: A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts.		2.1110copper group element atom;
elemental gold
sodium nitrate
sodium nitrate : The inorganic nitrate salt of sodium.		4.6111inorganic nitrate salt;
inorganic sodium salt		fertilizer;
NMR chemical shift reference compound
camptothecin
NSC 100880: carboxylate (opened lactone) form of camptothecin; RN refers to (S)-isomer; structure given in first source		4.4311delta-lactone;
pyranoindolizinoquinoline;
quinoline alkaloid;
tertiary alcohol		antineoplastic agent;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
genotoxin;
plant metabolite
zinc sulfate
Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995). zinc sulfate : A metal sulfate compound having zinc(2+) as the counterion.		2.9610metal sulfate;
zinc molecular entity		fertilizer
fluorine
Fluorine: A nonmetallic, diatomic gas that is a trace element and member of the halogen family. It is used in dentistry as fluoride (FLUORIDES) to prevent dental caries.		2.0310diatomic fluorine;
gas molecular entity		NMR chemical shift reference compound
fluorides
[no description available]		2.0410halide anion;
monoatomic fluorine
triamcinolone
Triamcinolone: A glucocorticoid given, as the free alcohol or in esterified form, orally, intramuscularly, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. (From Martindale, The Extra Pharmacopoeia, 30th ed, p739). triamcinolone : A C21-steroid hormone that is 1,4-pregnadiene-3,20-dione carrying four hydroxy substituents at positions 11beta, 16alpha, 17alpha and 21 as well as a fluoro substituent at position 9. Used in the form of its 16,17-acetonide to treat various skin infections.		2.081011beta-hydroxy steroid;
16alpha-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(4) steroid;
C21-steroid hormone;
fluorinated steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		anti-allergic agent;
anti-inflammatory drug
benzonidazole
benzonidazole: used in treatment of Chagas' disease. benznidazole : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease.		2.0610C-nitro compound;
imidazoles;
monocarboxylic acid amide		antiprotozoal drug
sodium azide
Sodium Azide: A cytochrome oxidase inhibitor which is a nitridizing agent and an inhibitor of terminal oxidation. (From Merck Index, 12th ed). sodium azide : The sodium salt of hydrogen azide (hydrazoic acid).		2.1110inorganic sodium saltantibacterial agent;
explosive;
mitochondrial respiratory-chain inhibitor;
mutagen
amoxicillin
Amoxicillin: A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.. amoxicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group.		2.110penicillin allergen;
penicillin		antibacterial drug
zidovudine
Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase.		9.39202azide;
pyrimidine 2',3'-dideoxyribonucleoside		antimetabolite;
antiviral drug;
HIV-1 reverse transcriptase inhibitor
etoposide
[no description available]		2.5920beta-D-glucoside;
furonaphthodioxole;
organic heterotetracyclic compound		antineoplastic agent;
DNA synthesis inhibitor
ribavirin
Rebetron: Rebetron is tradename		7.3621-ribosyltriazole;
aromatic amide;
monocarboxylic acid amide;
primary carboxamide		anticoronaviral agent;
antiinfective agent;
antimetabolite;
antiviral agent;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
simvastatin
Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug.		7.544delta-lactone;
fatty acid ester;
hexahydronaphthalenes;
statin (semi-synthetic)		EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor;
EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor;
ferroptosis inducer;
geroprotector;
prodrug
pravastatin
Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin.		4.36113-hydroxy carboxylic acid;
carbobicyclic compound;
carboxylic ester;
hydroxy monocarboxylic acid;
secondary alcohol;
statin (semi-synthetic)		anticholesteremic drug;
environmental contaminant;
metabolite;
xenobiotic
gemcitabine
gemcitabine : A 2'-deoxycytidine having geminal fluoro substituents in the 2'-position. An inhibitor of ribonucleotide reductase, gemcitabine is used in the treatment of various carcinomas, particularly non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer.		2.0710organofluorine compound;
pyrimidine 2'-deoxyribonucleoside		antimetabolite;
antineoplastic agent;
antiviral drug;
DNA synthesis inhibitor;
EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor;
environmental contaminant;
immunosuppressive agent;
photosensitizing agent;
prodrug;
radiosensitizing agent;
xenobiotic
atorvastatin
[no description available]		8.5966aromatic amide;
dihydroxy monocarboxylic acid;
monofluorobenzenes;
pyrroles;
statin (synthetic)		environmental contaminant;
xenobiotic
lamivudine
[no description available]		15.976122monothioacetal;
nucleoside analogue;
oxacycle;
primary alcohol		allergen;
anti-HBV agent;
antiviral drug;
EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor;
prodrug
irinotecan
[no description available]		4.4311carbamate ester;
delta-lactone;
N-acylpiperidine;
pyranoindolizinoquinoline;
ring assembly;
tertiary alcohol;
tertiary amino compound		antineoplastic agent;
apoptosis inducer;
EC 5.99.1.2 (DNA topoisomerase) inhibitor;
prodrug
emtricitabine
Emtricitabine: A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.. emtricitabine : An organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 infection.		16.557237monothioacetal;
nucleoside analogue;
organofluorine compound;
pyrimidone		antiviral drug;
HIV-1 reverse transcriptase inhibitor
efavirenz
efavirenz: HIV-1 reverse transcriptase inhibitor. efavirenz : 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection.		16.57736acetylenic compound;
benzoxazine;
cyclopropanes;
organochlorine compound;
organofluorine compound		antiviral drug;
HIV-1 reverse transcriptase inhibitor
nelfinavir
Nelfinavir: A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.. nelfinavir : An aryl sulfide that is used (as its mesylate salt) for treatment of HIV and also exhibits some anticancer properties.		2.0510aryl sulfide;
benzamides;
organic heterobicyclic compound;
phenols;
secondary alcohol;
tertiary amino compound		antineoplastic agent;
HIV protease inhibitor
plerixafor
plerixafor: a bicyclam derivate, highly potent & selective inhibitor of HIV-1 & HIV-2. plerixafor : An azamacrocycle consisting of two cyclam rings connected by a 1,4-phenylenebis(methylene) linker. It is a CXCR4 chemokine receptor antagonist and a hematopoietic stem cell mobilizer. It is used in combination with grulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the perpheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.		2.0710azacycloalkane;
azamacrocycle;
benzenes;
crown amine;
secondary amino compound;
tertiary amino compound		anti-HIV agent;
antineoplastic agent;
C-X-C chemokine receptor type 4 antagonist;
immunological adjuvant
amprenavir
[no description available]		2.4620carbamate ester;
sulfonamide;
tetrahydrofuryl ester		antiviral drug;
HIV protease inhibitor
epigallocatechin gallate
epigallocatechin gallate: a steroid 5alpha-reductase inhibitor and antimutagen in green tea (Camellia sinensis). (-)-epigallocatechin 3-gallate : A gallate ester obtained by the formal condensation of gallic acid with the (3R)-hydroxy group of (-)-epigallocatechin.		2.0510flavans;
gallate ester;
polyphenol		antineoplastic agent;
antioxidant;
apoptosis inducer;
geroprotector;
Hsp90 inhibitor;
neuroprotective agent;
plant metabolite
triazoles
Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms.		14.5465151,2,3-triazole
doripenem
Doripenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of infections such as HOSPITAL-ACQUIRED PNEUMONIA, and complicated intra-abdominal or urinary-tract infections, including PYELONEPHRITIS.		2.0410carbapenems
atovaquone
Atovaquone: A hydroxynaphthoquinone that has antimicrobial activity and is being used in antimalarial protocols.. atovaquone : A naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position.		3.4110hydroxy-1,2-naphthoquinone
clarithromycin
Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis.		2.110macrolide antibioticantibacterial drug;
environmental contaminant;
protein synthesis inhibitor;
xenobiotic
lopinavir
[no description available]		15.235531amphetamines;
dicarboxylic acid diamide		anticoronaviral agent;
antiviral drug;
HIV protease inhibitor
1-benzylindole
1-benzylindole: structure		2.0610
1,3,4-oxadiazole
1,3,4-oxadiazole: structure in first source		2.610
cobalt
Cobalt: A trace element that is a component of vitamin B12. It has the atomic symbol Co, atomic number 27, and atomic weight 58.93. It is used in nuclear weapons, alloys, and pigments. Deficiency in animals leads to anemia; its excess in humans can lead to erythrocytosis.. cobalt(1+) : A monovalent inorganic cation obtained from cobalt.. cobalt atom : A cobalt group element atom that has atomic number 27.		2.0610cobalt group element atom;
metal allergen		micronutrient
epicatechin gallate
epicatechin gallate: a steroid 5alpha-reductase inhibitor; RN given refers to the (cis)-isomer; structure given in first source; isolated from green tea. (-)-epicatechin-3-O-gallate : A gallate ester obtained by formal condensation of the carboxy group of gallic acid with the (3R)-hydroxy group of epicatechin. A natural product found in Parapiptadenia rigida.		2.0510catechin;
gallate ester;
polyphenol		EC 3.2.1.1 (alpha-amylase) inhibitor;
EC 3.2.1.20 (alpha-glucosidase) inhibitor;
metabolite
imatinib mesylate
imatinib methanesulfonate : A methanesulfonate (mesylate) salt that is the monomesylate salt of imatinib. Used for treatment of chronic myelogenous leukemia and gastrointestinal stromal tumours.		310methanesulfonate saltanticoronaviral agent;
antineoplastic agent;
apoptosis inducer;
tyrosine kinase inhibitor
methotrexate
[no description available]		2.7830dicarboxylic acid;
monocarboxylic acid amide;
pteridines		abortifacient;
antimetabolite;
antineoplastic agent;
antirheumatic drug;
dermatologic drug;
DNA synthesis inhibitor;
EC 1.5.1.3 (dihydrofolate reductase) inhibitor;
immunosuppressive agent
fosamprenavir
fosamprenavir: a prodrug of the protease inhibitor amprenavir. fosamprenavir : A sulfonamide with a structure based on that of sulfanilamide substituted on the sulfonamide nitrogen by a (2R,3S)-4-phenyl-2-(phosphonooxy)-3-({[(3S)-tetrahydrofuran-3-yloxy]carbonyl}amino)butyl group. It is a pro-drug of the HIV protease inhibitor and antiretroviral drug amprenavir.		2.4520sulfonamideprodrug
carbapenems
[no description available]		2.0410
beta-lactams
2-azetidinone: structure in first source. azetidin-2-one : An unsubstituted beta-lactam compound.. beta-lactam : A lactam in which the amide bond is contained within a four-membered ring, which includes the amide nitrogen and the carbonyl carbon.		2.4110beta-lactam antibiotic allergen;
beta-lactam
proline
Proline: A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.. proline : An alpha-amino acid that is pyrrolidine bearing a carboxy substituent at position 2.		8.0774amino acid zwitterion;
glutamine family amino acid;
L-alpha-amino acid;
proline;
proteinogenic amino acid		algal metabolite;
compatible osmolytes;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
drospirenone and ethinyl estradiol combination
drospirenone and ethinyl estradiol combination: female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)		7.544
ezetimibe
Ezetimibe: An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.. ezetimibe : A beta-lactam that is azetidin-2-one which is substituted at 1, 3, and 4 by p-fluorophenyl, 3-(p-fluorophenyl)-3-hydroxypropyl, and 4-hydroxyphenyl groups, respectively (the 3R,3'S,4S enantiomer).		3.4511azetidines;
beta-lactam;
organofluorine compound		anticholesteremic drug;
antilipemic drug;
antimetabolite
moxifloxacin
Moxifloxacin: A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.. moxifloxacin : A quinolone that consists of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid bearing a cyclopropyl substituent at position 1, a fluoro substitiuent at position 6, a (4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl group at position 7 and a methoxy substituent at position 8. A member of the fluoroquinolone class of antibacterial agents.		4.3411aromatic ether;
cyclopropanes;
fluoroquinolone antibiotic;
pyrrolidinopiperidine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone		antibacterial drug
atazanavir sulfate
Atazanavir Sulfate: An azapeptide and HIV-PROTEASE INHIBITOR that is used in the treatment of HIV INFECTIONS and AIDS in combination with other ANTI-HIV AGENTS.		15.365726organic sulfate salt
combivir
lamivudine, zidovudine drug combination: contains half the typical daily doses of both drugs in one tablet		2.4920
organophosphonates
hydrogenphosphite : A divalent inorganic anion resulting from the removal of a proton from two of the hydroxy groups of phosphorous acid.		16.156535divalent inorganic anion;
phosphite ion
etravirine
[no description available]		14.376313aminopyrimidine;
aromatic ether;
dinitrile;
organobromine compound		antiviral agent;
HIV-1 reverse transcriptase inhibitor
darunavir
Darunavir: An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.. darunavir : An N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors.		17.3910636carbamate ester;
furofuran;
sulfonamide		antiviral drug;
HIV protease inhibitor
dapivirine
Dapivirine: effectively prevented human immunodeficiency virus (HIV) infection in cocultures of monocyte-derived dendritic cells and T cells, representing primary targets in sexual transmission		2.3110
benzofurans
Benzofurans: Compounds that contain a BENZENE ring fused to a furan ring.		3.5911
trimethoprim, sulfamethoxazole drug combination
Trimethoprim, Sulfamethoxazole Drug Combination: A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.. co-trimoxazole : A two-component mixture comprising trimethoprim and sulfamethoxazole.		3.7820
bortezomib
[no description available]		2.1310amino acid amide;
L-phenylalanine derivative;
pyrazines		antineoplastic agent;
antiprotozoal drug;
protease inhibitor;
proteasome inhibitor
calcein am
calcein AM: a non-fluorescent compound cleaved to a fluorescent compound by non-specific intracellular esterases. calcein am : An organic heteropentacyclic compound that is calcein in which all four carboxy group hydrogens have been substituted by (acetyloxy)methoxy groups and the hyrodgens of the two hydroxy groups have been substituted by acetyl groups. It is a a non-fluorescent probe cleaved to a fluorescent probe by non-specific intracellular esterases.		2.51202-benzofurans;
acetate ester;
gamma-lactone;
organic heteropentacyclic compound;
oxaspiro compound;
xanthene dye		fluorochrome
ritonavir
Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		18.09124621,3-thiazoles;
carbamate ester;
carboxamide;
L-valine derivative;
ureas		antiviral drug;
environmental contaminant;
HIV protease inhibitor;
xenobiotic
saquinavir
Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease.		3.5720L-asparagine derivative;
quinolines		antiviral drug;
HIV protease inhibitor
abacavir
abacavir: a carbocyclic nucleoside with potent selective anti-HIV activity. abacavir : A 2,6-diaminopurine that is (1S)-cyclopent-2-en-1-ylmethanol in which the pro-R hydrogen at the 4-position is substituted by a 2-amino-6-(cyclopropylamino)-9H-purin-9-yl group. A nucleoside analogue reverse transcriptase inhibitor (NRTI) with antiretroviral activity against HIV, it is used (particularly as the sulfate) with other antiretrovirals in combination therapy of HIV infection.		9.181832,6-diaminopurinesantiviral drug;
drug allergen;
HIV-1 reverse transcriptase inhibitor
tacrolimus
Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.		5.0140macrolide lactambacterial metabolite;
immunosuppressive agent
mycophenolic acid
Mycophenolic Acid: Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.. mycophenolate : A monocarboxylic acid anion resulting from the removal of a proton from the carboxy group of mycophenolic acid.. mycophenolic acid : A member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases.		3.41102-benzofurans;
gamma-lactone;
monocarboxylic acid;
phenols		anticoronaviral agent;
antimicrobial agent;
antineoplastic agent;
EC 1.1.1.205 (IMP dehydrogenase) inhibitor;
environmental contaminant;
immunosuppressive agent;
mycotoxin;
Penicillium metabolite;
xenobiotic
epothilone a
Epothilones: A group of 16-member MACROLIDES which stabilize MICROTUBULES in a manner similar to PACLITAXEL. They were originally found in the myxobacterium Sorangium cellulosum, now renamed to Polyangium (MYXOCOCCALES).		2.0410epothilone;
epoxide		antineoplastic agent;
metabolite;
microtubule-stabilising agent;
tubulin modulator
decitabine
[no description available]		2.07102'-deoxyribonucleoside
bevirimat
bevirimat: an HIV inhibitor; disrupts late step in processing HIV Major Core Protein p24, preventing the capsid precursor p25 from being converted to mature capsid p24. bevirimat : A pentacyclic triterpenoid obtained by the formal condensation of 2,2-dimethylsuccinic acid with the 3-hydroxy group of betulinic acid. It is isolated from the Chinese herb Syzygium claviflorum. The first in the class of HIV-1 maturation inhibitors to be studied in humans, bevirimat was identified as a potent HIV drug candidate and several clinical trials were conducted, but development into a new drug was plagued by numerous resistance-related problems.		2.0510dicarboxylic acid monoester;
monocarboxylic acid;
pentacyclic triterpenoid		HIV-1 maturation inhibitor;
metabolite
5-(1,1-dioxido-1,2-thiazinan-2-yl)-n-(4-fluorobenzyl)-8-hydroxy-1,6-naphthyridine-7-carboxamide
5-(1,1-dioxido-1,2-thiazinan-2-yl)-N-(4-fluorobenzyl)-8-hydroxy-1,6-naphthyridine-7-carboxamide: structure in first source		2.0410
tenofovir
tenofovir (anhydrous) : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens is replaced by a [(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(isopropyloxycarbonyloxymethyl) ester (disoproxil ester) prodrug is used as the fumaric acid salt in combination therapy for the treatment of HIV infection.		18.1811251nucleoside analogue;
phosphonic acids		antiviral drug;
drug metabolite;
HIV-1 reverse transcriptase inhibitor
l 731988
L 731988: structure in first source		2.0510
favipiravir
favipiravir : A member of the class of pyrazines that is pyrazine substituted by aminocarbonyl, hydroxy and fluoro groups at positions 2, 3 and 6, respectively. It is an anti-viral agent that inhibits RNA-dependent RNA polymerase of several RNA viruses and is approved for the treatment of influenza in Japan.		2.3110hydroxypyrazine;
organofluorine compound;
primary carboxamide		anticoronaviral agent;
antiviral drug;
EC 2.7.7.48 (RNA-directed RNA polymerase) inhibitor
buprenorphine
Buprenorphine: A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.. buprenorphine : A morphinane alkaloid that is 7,8-dihydromorphine 6-O-methyl ether in which positions 6 and 14 are joined by a -CH2CH2- bridge, one of the hydrogens of the N-methyl group is substituted by cyclopropyl, and a hydrogen at position 7 is substituted by a 2-hydroxy-3,3-dimethylbutan-2-yl group. It is highly effective for the treatment of opioid use disorder and is also increasingly being used in the treatment of chronic pain.		3.4711morphinane alkaloiddelta-opioid receptor antagonist;
kappa-opioid receptor antagonist;
mu-opioid receptor agonist;
opioid analgesic
s 1033
[no description available]		2.0410(trifluoromethyl)benzenes;
imidazoles;
pyridines;
pyrimidines;
secondary amino compound;
secondary carboxamide		anticoronaviral agent;
antineoplastic agent;
tyrosine kinase inhibitor
mezlocillin
Mezlocillin: Semisynthetic ampicillin-derived acylureido penicillin. It has been proposed for infections with certain anaerobes and may be useful in inner ear, bile, and CNS infections.. mezlocillin : A penicillin in which the substituent at position 6 of the penam ring is a (2R)-2-[3-(methanesulfonyl)-2-oxoimidazolidine-1-carboxamido]-2-phenylacetamido group.		2.2510penicillin allergen;
penicillin		antibacterial drug
maraviroc
[no description available]		14.646716tropane alkaloid
vicriviroc
vicriviroc: structure in first source		2.7430(trifluoromethyl)benzenes
telaprevir
[no description available]		5.2731cyclopentapyrrole;
cyclopropanes;
oligopeptide;
pyrazines		antiviral drug;
hepatitis C protease inhibitor;
peptidomimetic
sodium dodecyl sulfate
Sodium Dodecyl Sulfate: An anionic surfactant, usually a mixture of sodium alkyl sulfates, mainly the lauryl; lowers surface tension of aqueous solutions; used as fat emulsifier, wetting agent, detergent in cosmetics, pharmaceuticals and toothpastes; also as research tool in protein biochemistry.. sodium dodecyl sulfate : An organic sodium salt that is the sodium salt of dodecyl hydrogen sulfate.		2.110organic sodium saltdetergent;
protein denaturant
osteoprotegerin
Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B.		3.4611long-chain fatty acid
rhodamine 123
Rhodamine 123: A fluorescent probe with low toxicity which is a potent substrate for ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 and the bacterial multidrug efflux transporter. It is used to assess mitochondrial bioenergetics in living cells and to measure the efflux activity of ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 in both normal and malignant cells. (Leukemia 1997;11(7):1124-30). rhodamine 123(1+) : A cationic fluorescent dye derived from 9-phenylxanthene.		2.0810organic cation;
xanthene dye		fluorochrome
abacavir, lamivudine drug combination
abacavir, lamivudine drug combination: combination of Epivir and Ziagen		11.86196
catechin gallate
catechin gallate: structure in first source. (+)-catechin-3-O-gallate : A gallate ester obtained by formal condensation of the carboxy group of gallic acid with the (3S)-hydroxy group of (+)-catechin.		2.0510flavans;
gallate ester;
polyphenol		metabolite
gallocatechin-3-gallate
gallocatechin gallate: structure in first source. (+)-gallocatechin gallate : A gallate ester obtained by formal condensation of the carboxy group of gallic acid with the (3S)-hydroxy group of (+)-gallocatechin.		2.0510catechin;
gallate ester;
polyphenol		plant metabolite
jtk-303
[no description available]		16.351388aromatic ether;
monochlorobenzenes;
organofluorine compound;
quinolinemonocarboxylic acid;
quinolone		HIV-1 integrase inhibitor
bilirubin
[no description available]		3.3920biladienes;
dicarboxylic acid		antioxidant;
human metabolite;
mouse metabolite
naloxone
Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose.		3.4711morphinane alkaloid;
organic heteropentacyclic compound;
tertiary alcohol		antidote to opioid poisoning;
central nervous system depressant;
mu-opioid receptor antagonist
sirolimus
Sirolimus: A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.. sirolimus : A macrolide lactam isolated from Streptomyces hygroscopicus consisting of a 29-membered ring containing 4 trans double bonds, three of which are conjugated. It is an antibiotic, immunosupressive and antineoplastic agent.		2.4420antibiotic antifungal drug;
cyclic acetal;
cyclic ketone;
ether;
macrolide lactam;
organic heterotricyclic compound;
secondary alcohol		antibacterial drug;
anticoronaviral agent;
antineoplastic agent;
bacterial metabolite;
geroprotector;
immunosuppressive agent;
mTOR inhibitor
morphine
Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn.		2.2110morphinane alkaloid;
organic heteropentacyclic compound;
tertiary amino compound		anaesthetic;
drug allergen;
environmental contaminant;
geroprotector;
mu-opioid receptor agonist;
opioid analgesic;
plant metabolite;
vasodilator agent;
xenobiotic
indinavir sulfate
Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability.		2.2510dicarboxylic acid diamide;
N-(2-hydroxyethyl)piperazine;
piperazinecarboxamide		HIV protease inhibitor
carbocyanines
Carbocyanines: Compounds that contain three methine groups. They are frequently used as cationic dyes used for differential staining of biological materials.		2.0610cyanine dye;
organic iodide salt		fluorochrome
ixabepilone
[no description available]		2.04101,3-thiazoles;
beta-hydroxy ketone;
epoxide;
lactam;
macrocycle		antineoplastic agent;
microtubule-destabilising agent
s 1360
[no description available]		2.7330
rilpivirine
[no description available]		6.3130aminopyrimidine;
nitrile		EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor;
HIV-1 reverse transcriptase inhibitor
valopicitabine
valopicitabine: prodrug of 2'-C-methylcytidine; an anti-hepatitis C virus agent; structure in first source		3.1410
gs-7340
tenofovir alafenamide: component of Biktarvy. tenofovir alafenamide : An L-alanine derivative that is isopropyl L-alaninate in which one of the amino hydrogens is replaced by an (S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl group. A prodrug for tenofovir, it is used (as the fumarate salt) in combination therapy for the treatment of HIV-1 infection.		3.66206-aminopurines;
ether;
isopropyl ester;
L-alanine derivative;
phosphoramidate ester		antiviral drug;
HIV-1 reverse transcriptase inhibitor;
prodrug
efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: Inhibitor of reverse transcriptases or of RNA-directed DNA polymerases.		5.6232
zibotentan
ZD4054: a potent endothelin receptor A antagonist that inhibits ovarian carcinoma cell proliferation		3.1710phenylpyridine
oxadiazoles
Oxadiazoles: Compounds containing five-membered heteroaromatic rings containing two carbons, two nitrogens, and one oxygen atom which exist in various regioisomeric forms.		4.350
cenicriviroc
cenicriviroc: an inhibitor of HIV-1. cenicriviroc : A member of the class of benzazocines that is (5Z)-1,2,3,4-tetrahydro-1-benzazocine which is substituted by a 2-methylpropyl, N-{4-[(S)-(1-propyl-1H-imidazol-5-yl)methanesulfinyl]phenyl}carboxamide and 4-(2-butoxyethoxy)phenyl groups at positions 1, 5 and 8, respectively. It is a potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with nonalcoholic steatohepatitis (NASH).		2.2110aromatic ether;
benzazocine;
diether;
imidazoles;
secondary carboxamide;
sulfoxide		anti-HIV agent;
anti-inflammatory agent;
antirheumatic drug;
chemokine receptor 2 antagonist;
chemokine receptor 5 antagonist
sitagliptin phosphate
Sitagliptin Phosphate: A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES.		2.1710
norgestimate
[no description available]		3.4511
emtricitabine, tenofovir disoproxil fumarate drug combination
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.		7.59113
bms-650032
asunaprevir: an NS3 protease inhibitor against hepatitis C virus		2.1110oligopeptide
t 30177
T 30177: an oligonucleotide composed of only deoxyguanosine and thymidine; 17 nucleotides long; contains single phosphorothioate internucleoside linkages at its 5' and 3' ends; nucleotide sequence given in first source		2.0510
enfuvirtide
Enfuvirtide: A synthetic 36-amino acid peptide that corresponds to the heptad repeat sequence of HIV-1 gp41. It blocks HIV cell fusion and viral entry and is used with other anti-retrovirals for combination therapy of HIV INFECTIONS and AIDS.. enfuvirtide : A synthetic 36-amino acid peptide consisting of N-acetyltyrosyl, threonyl, seryl, leucyl, isoleucyl, histidyl, seryl, leucyl, isoleucyl, alpha-glutamyl, alpha-glutamyl, seryl, glutaminyl, asparaginyl, glutaminyl, glutaminyl, alpha-glutamyl, lysyl, asparaginyl, alpha-glutamyl, alpha-glutamyl, alpha-glutamyl, leucyl, leucyl, alpha-glutamyl, leucyl, alpha-aspartyl, lysyl, tryptophyl, alanyl, seryl, leucyl, tryptophyl, asparaginyl, tryptophyl, and phenylalaninamide residues joined in sequence. An HIV fusion inhibitor, it was the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It interferes with entry of HIV into cells by binding to the gp41 sub-unit of the viral envelope glycoprotein, so inhibiting fusion of viral and cellular membranes.		12.882411
oligonucleotides
[no description available]		2.0510
uk 453,061
UK 453,061: a reverse transcriptase inhibitor/anti-HIV agent; structure in first source		3.4611aromatic ether
cobicistat
[no description available]		5.33801,3-thiazoles;
carbamate ester;
monocarboxylic acid amide;
morpholines;
ureas		P450 inhibitor
bms-790052
daclatasvir: an HCV NS5A inhibitor. daclatasvir : A member of the class of biphenyls that is a potent inhibitor of nonstructural protein 5A and is used (as its hydrochloride salt) for treatment of hepatitis C.		2.1110biphenyls;
carbamate ester;
carboxamide;
imidazoles;
valine derivative		antiviral drug;
nonstructural protein 5A inhibitor
bi 201335
faldaprevir: inhibits hepatitis C virus NS3 protease		3.511
idx 899
IDX 899: a reverse transcriptase inhibitor		7.544
interleukin-8
Interleukin-8: A member of the CXC chemokine family that plays a role in the regulation of the acute inflammatory response. It is secreted by variety of cell types and induces CHEMOTAXIS of NEUTROPHILS and other inflammatory cells.		2.110
grazoprevir
grazoprevir: has antiviral activity; component of Zepatier. grazoprevir : An azamacrocyclic compound that is a hepatitis C protease inhibitor used in combination with elbasvir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults.		3.5911aromatic ether;
azamacrocycle;
carbamate ester;
cyclopropanes;
lactam;
N-sulfonylcarboxamide;
quinoxaline derivative		antiviral drug;
hepatitis C protease inhibitor;
hepatoprotective agent
abt-450
paritaprevir: inhibits HCV NS3 protease. paritaprevir : An azamacrocycle which is used which is in combination with dasabuvir sodium hydrate, ombitasvir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		3.9721
sofosbuvir
Sofosbuvir: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.. sofosbuvir : A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection.		2.2110isopropyl ester;
L-alanyl ester;
nucleotide conjugate;
organofluorine compound;
phosphoramidate ester		antiviral drug;
hepatitis C protease inhibitor;
prodrug
raltegravir
[no description available]		2.48201,2,4-oxadiazole;
dicarboxylic acid amide;
hydroxypyrimidine;
monofluorobenzenes;
pyrimidone;
secondary carboxamide		antiviral drug;
HIV-1 integrase inhibitor
acenocoumarol
Acenocoumarol: A coumarin that is used as an anticoagulant. Its actions and uses are similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p233). acenocoumarol : A hydroxycoumarin that is warfarin in which the hydrogen at position 4 of the phenyl substituent is replaced by a nitro group.		2.0610C-nitro compound;
hydroxycoumarin;
methyl ketone		anticoagulant;
EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor
warfarin
Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group.		2.0710benzenes;
hydroxycoumarin;
methyl ketone
tipranavir
tipranavir: inhibits HIV-1 protease. tipranavir : A pyridine-2-sulfonamide substituted at C-5 by a trifluoromethyl group and at the sulfonamide nitrogen by a dihydropyrone-containing m-tolyl substituent. It is an HIV-1 protease inhibitor.		6.7971sulfonamideantiviral drug;
HIV protease inhibitor
gsk1265744
[no description available]		5.380difluorobenzene;
monocarboxylic acid amide;
organic heterotricyclic compound;
secondary carboxamide		HIV-1 integrase inhibitor
dolutegravir
[no description available]		18.5715522difluorobenzene;
monocarboxylic acid amide;
organic heterotricyclic compound;
secondary carboxamide		HIV-1 integrase inhibitor
abt-267
ombitasvir: inhibits HCV NS5A protein, component of Viekirax. ombitasvir : A dipeptide derivative which is used which is in combination with dasabuvir sodium hydrate, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		3.9721aromatic amide;
carbamate ester;
dipeptide;
pyrrolidines		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor
abt-333
dasabuvir: an antiviral agent. dasabuvir : A member of the class of pyrimidone, which is (as the monohydrate of its sodium salt) in combination with ombitasvir, paritaprevir and ritonavir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver.		3.9721aromatic ether;
naphthalenes;
pyrimidone;
sulfonamide		antiviral drug;
nonnucleoside hepatitis C virus polymerase inhibitor
doravirine
[no description available]		3.2230
mk-8742
elbasvir: inhibits NS5A protein of hepatitis C virus. elbasvir : A complex organic heterotetracyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with grazoprevir (under the brand name Zepatier) for treatment of chronic HCV genotypes 1 or 4 infection in adults.		3.5911carbamate ester;
imidazoles;
L-valine derivative;
N-acylpyrrolidine;
organic heterotetracyclic compound;
ring assembly		antiviral drug;
hepatitis C virus nonstructural protein 5A inhibitor;
hepatoprotective agent
bictegravir
bictegravir: HIV Integrase Inhibitors. bictegravir : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2R,5S,13aR)-8-hydroxy-7,9-dioxo-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepine-10-carboxylic acid with the amino group of 2,4,6-trifluorobenzylamine. It is a second-generation integrase strand transfer inhibitor (INSTI) and used (as its sodium salt) for the treatment of HIV-1.		8.49210monocarboxylic acid amide;
organic heterotetracyclic compound;
secondary carboxamide;
trifluorobenzene		HIV-1 integrase inhibitor
norgestrel
Norgestrel: A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.		3.4511
cyclosporine
Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).		3.3720
exudates
Malaysia: A parliamentary democracy with a constitutional monarch in southeast Asia, consisting of 11 states (West Malaysia) on the Malay Peninsula and two states (East Malaysia) on the island of BORNEO. It is also called the Federation of Malaysia. Its capital is Kuala Lumpur. Before 1963 it was the Union of Malaya. It reorganized in 1948 as the Federation of Malaya, becoming independent from British Malaya in 1957 and becoming Malaysia in 1963 as a federation of Malaya, Sabah, Sarawak, and Singapore (which seceded in 1965). The form Malay- probably derives from the Tamil malay, mountain, with reference to its geography. (From Webster's New Geographical Dictionary, 1988, p715 & Room, Brewer's Dictionary of Names, 1992, p329)		4.3911
acyclovir
Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections.		2.03102-aminopurines;
oxopurine		antimetabolite;
antiviral drug
sapropterin
sapropterin: RN given refers to parent cpd; co-factor required for catalytic activity of nitric oxide synthases. (6R)-5,6,7,8-tetrahydrobiopterin : A 5,6,7,8-tetrahydrobiopterin in which the stereocentre at position 6 has R-configuration.. sapropterin : A tetrahydropterin that is 2-amino-5,6,7,8-tetrahydropteridin-4(3H)-one in which a hydrogen at position 6 is substituted by a 1,2-dihydroxypropyl group (6R,1'R,2'S-enantiomer).		2.04105,6,7,8-tetrahydrobiopterincoenzyme;
cofactor;
diagnostic agent;
human metabolite
neopterin
[no description available]		5.7232
rifampin
Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160)		10.76159cyclic ketal;
hydrazone;
N-iminopiperazine;
N-methylpiperazine;
rifamycins;
semisynthetic derivative;
zwitterion		angiogenesis inhibitor;
antiamoebic agent;
antineoplastic agent;
antitubercular agent;
DNA synthesis inhibitor;
EC 2.7.7.6 (RNA polymerase) inhibitor;
Escherichia coli metabolite;
geroprotector;
leprostatic drug;
neuroprotective agent;
pregnane X receptor agonist;
protein synthesis inhibitor
ganciclovir
[no description available]		3.46112-aminopurines;
oxopurine		antiinfective agent;
antiviral drug
rifapentine
rifapentine: cyclopentyl derivative of rifampicin		5.8322N-alkylpiperazine;
N-iminopiperazine;
rifamycins		antitubercular agent;
leprostatic drug
valganciclovir
Valganciclovir: A ganciclovir prodrug and antiviral agent that is used to treat CYTOMEGALOVIRUS RETINITIS in patients with AIDS, and for the prevention of CYTOMEGALOVIRUS INFECTIONS in organ transplant recipients who have received an organ from a CMV-positive donor.. valganciclovir : The L-valinyl ester of ganciclovir, into which it is rapidly converted by intestinal and hepatic esterases. It is a synthetic analogue of 2'-deoxyguanosine.		3.4611L-valyl ester;
purines		antiviral drug;
prodrug
carbovir triphosphate
carbovir triphosphate: metabolite of abacavir. carbovir triphosphate : The organic triphosphate that is the 5'-triphosphate of (-)-carbovir.		3.4611organic triphosphate
cyanine dye 3
cyanine dye 3: structures of Cy3 derivatives given in first source		2.0610
leptin
Leptin: A 16-kDa peptide hormone secreted from WHITE ADIPOCYTES. Leptin serves as a feedback signal from fat cells to the CENTRAL NERVOUS SYSTEM in regulation of food intake, energy balance, and fat storage.		2.9130
pyrimidinones
Pyrimidinones: Heterocyclic compounds known as 2-pyrimidones (or 2-hydroxypyrimidines) and 4-pyrimidones (or 4-hydroxypyrimidines) with the general formula C4H4N2O.		8.14153
ConditionIndicatedRelationship StrengthStudiesTrials
HIV Coinfection
[description not available]		027.311,190453
HIV Infections
Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).		132.082,380906
HIV
Human immunodeficiency virus. A non-taxonomic and historical term referring to any of two species, specifically HIV-1 and/or HIV-2. Prior to 1986, this was called human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV). From 1986-1990, it was an official species called HIV. Since 1991, HIV was no longer considered an official species name; the two species were designated HIV-1 and HIV-2.		013.18466
Familial Spastic Paraparesis, Htlv-1-Associated
[description not available]		04.9421
Paraparesis, Tropical Spastic
A subacute paralytic myeloneuropathy occurring endemically in tropical areas such as the Caribbean, Colombia, India, and Africa, as well as in the southwestern region of Japan; associated with infection by HUMAN T-CELL LEUKEMIA VIRUS I. Clinical manifestations include a slowly progressive spastic weakness of the legs, increased reflexes, Babinski signs, incontinence, and loss of vibratory and position sensation. On pathologic examination inflammatory, demyelination, and necrotic lesions may be found in the spinal cord. (Adams et al., Principles of Neurology, 6th ed, p1239)		04.9421
Co-infection
[description not available]		013.293514
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
[description not available]		012.032511
Hepatitis C
INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.		012.032511
Complications, Infectious Pregnancy
[description not available]		012.1326
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		014.1609
AIDS Seroconversion
[description not available]		05.18160
Genome Instability
[description not available]		02.4110
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		07.6843
Acquired Immune Deficiency Syndrome
[description not available]		010.95258
Acquired Immunodeficiency Syndrome
An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.		010.95258
Viremia
The presence of viruses in the blood.		016.278455
Koch's Disease
[description not available]		010.16157
Tuberculosis
Any of the infectious diseases of man and other animals caused by species of MYCOBACTERIUM TUBERCULOSIS.		010.16157
Weight Gain
Increase in BODY WEIGHT over existing weight.		08.8996
Preterm Birth
[description not available]		02.7620
Premature Birth
CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION).		02.7620
Innate Inflammatory Response
[description not available]		010.641914
Inflammation
A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.		010.641914
Fetal Resorption
The disintegration and assimilation of the dead FETUS in the UTERUS at any stage after the completion of organogenesis which, in humans, is after the 9th week of GESTATION. It does not include embryo resorption (see EMBRYO LOSS).		02.4110
Colorectal Cancer
[description not available]		04.9221
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.		04.9221
Germinoblastoma
[description not available]		02.6120
Lymphoma
A general term for various neoplastic diseases of the lymphoid tissue.		02.6120
Neutropenia
A decrease in the number of NEUTROPHILS found in the blood.		02.610
Lung Injury, Acute
[description not available]		02.4110
Acute Lung Injury
A condition of lung damage that is characterized by bilateral pulmonary infiltrates (PULMONARY EDEMA) rich in NEUTROPHILS, and in the absence of clinical HEART FAILURE. This can represent a spectrum of pulmonary lesions, endothelial and epithelial, due to numerous factors (physical, chemical, or biological).		02.4110
2019 Novel Coronavirus Disease
[description not available]		04.6370
Kahler Disease
[description not available]		02.610
Multiple Myeloma
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.		02.610
Edema-Proteinuria-Hypertension Gestosis
[description not available]		02.610
Pre-Eclampsia
A complication of PREGNANCY, characterized by a complex of symptoms including maternal HYPERTENSION and PROTEINURIA with or without pathological EDEMA. Symptoms may range between mild and severe. Pre-eclampsia usually occurs after the 20th week of gestation, but may develop before this time in the presence of trophoblastic disease.		02.610
Adverse Drug Event
[description not available]		011.12227
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		011.12227
Drug Overdose
Accidental or deliberate use of a medication or street drug in excess of normal dosage.		02.9430
AIDS, Simian
[description not available]		03.3360
Chronic Hepatitis C
[description not available]		08.24141
Hepatitis C, Chronic
INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS.		08.24141
Dyslipidemia
[description not available]		02.5220
Dyslipidemias
Abnormalities in the serum levels of LIPIDS, including overproduction or deficiency. Abnormal serum lipid profiles may include high total CHOLESTEROL, high TRIGLYCERIDES, low HIGH DENSITY LIPOPROTEIN CHOLESTEROL, and elevated LOW DENSITY LIPOPROTEIN CHOLESTEROL.		02.5220
Infant, Newborn, Diseases
Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts.		03.6411
Insulin Sensitivity
[description not available]		05.3862
Insulin Resistance
Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS.		05.3862
Acute Ischemic Stroke
[description not available]		02.2510
Cardiovascular Stroke
[description not available]		02.2510
Ischemic Stroke
Stroke due to BRAIN ISCHEMIA resulting in interruption or reduction of blood flow to a part of the brain. When obstruction is due to a BLOOD CLOT formed within in a cerebral blood vessel it is a thrombotic stroke. When obstruction is formed elsewhere and moved to block a cerebral blood vessel (see CEREBRAL EMBOLISM) it is referred to as embolic stroke. Wake-up stroke refers to ischemic stroke occurring during sleep while cryptogenic stroke refers to ischemic stroke of unknown origin.		02.2510
Myocardial Infarction
NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).		02.2510
Asymptomatic Conditions
[description not available]		02.5420
Cognitive Decline
[description not available]		02.2510
Cognitive Dysfunction
Diminished or impaired mental and/or intellectual function.		02.2510
Infections, Coronavirus
[description not available]		02.9430
Asthma, Bronchial
[description not available]		02.2510
P carinii Pneumonia
[description not available]		03.620
Asthma
A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).		02.2510
Pneumonia, Pneumocystis
A pulmonary disease in humans occurring in immunodeficient or malnourished patients or infants, characterized by DYSPNEA, tachypnea, and HYPOXEMIA. Pneumocystis pneumonia is a frequently seen opportunistic infection in AIDS. It is caused by the fungus PNEUMOCYSTIS JIROVECII. The disease is also found in other MAMMALS where it is caused by related species of Pneumocystis.		03.620
Pneumonia, Viral
Inflammation of the lung parenchyma that is caused by a viral infection.		02.9430
Coronavirus Infections
Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE).		02.9430
Acute Post-Traumatic Stress Disorder
[description not available]		02.3110
Stress Disorders, Post-Traumatic
A class of traumatic stress disorders with symptoms that last more than one month.		02.3110
DRESS Syndrome
[description not available]		04.4470
Eosinophilia, Tropical
[description not available]		03.250
Eosinophilia
Abnormal increase of EOSINOPHILS in the blood, tissues or organs.		03.250
Abnormalities, Congenital
[description not available]		02.6620
Abnormalities, Drug-Induced
Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment.		03.7430
Recrudescence
[description not available]		02.5420
ATLL
[description not available]		02.5920
Leukemia-Lymphoma, Adult T-Cell
Aggressive T-Cell malignancy with adult onset, caused by HUMAN T-LYMPHOTROPIC VIRUS 1. It is endemic in Japan, the Caribbean basin, Southeastern United States, Hawaii, and parts of Central and South America and sub-Saharan Africa.		02.5920
Genetic Predisposition
[description not available]		05.3541
Menopause
The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age.		03.9721
Idiopathic Inflammatory Myopathies
[description not available]		03.2310
Myositis
Inflammation of a muscle or muscle tissue.		03.2310
Cirrhosis
[description not available]		03.711
Fibrosis
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.		03.711
Sensitivity and Specificity
Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)		05.32120
Acquired-Immune Deficiency Syndrome Dementia Complex
[description not available]		03.3560
AIDS Dementia Complex
A neurologic condition associated with the ACQUIRED IMMUNODEFICIENCY SYNDROME and characterized by impaired concentration and memory, slowness of hand movements, ATAXIA, incontinence, apathy, and gait difficulties associated with HIV-1 viral infection of the central nervous system. Pathologic examination of the brain reveals white matter rarefaction, perivascular infiltrates of lymphocytes, foamy macrophages, and multinucleated giant cells. (From Adams et al., Principles of Neurology, 6th ed, pp760-1; N Engl J Med, 1995 Apr 6;332(14):934-40)		03.3560
Hyperlipemia
[description not available]		03.7130
Hyperlipidemias
Conditions with excess LIPIDS in the blood.		03.7130
Behavior Disorders
[description not available]		03.520
Mental Disorders
Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.		03.520
Fatty Liver, Nonalcoholic
[description not available]		04.4511
Non-alcoholic Fatty Liver Disease
Fatty liver finding without excessive ALCOHOL CONSUMPTION.		04.4511
Hepatitis B Virus Infection
[description not available]		08.585
Hepatitis B
INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.		08.585
Benign Neoplasms
[description not available]		012.542017
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		012.542017
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		05.3341
Diabetes Mellitus, Adult-Onset
[description not available]		02.1710
Acidosis, Diabetic
[description not available]		02.1710
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		02.1710
Diabetic Ketoacidosis
A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by KETOSIS; DEHYDRATION; and depressed consciousness leading to COMA.		02.1710
Chronic Kidney Failure
[description not available]		02.7830
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.		02.7830
Cardiometabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY.		07.954
Liver Steatosis
[description not available]		03.4320
Fatty Liver
Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS.		03.4320
Obesity
A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).		03.0910
Metabolic Syndrome
A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state.		07.954
Disease Exacerbation
[description not available]		07.7472
Acute Relapsing Multiple Sclerosis
[description not available]		03.5611
Multiple Sclerosis, Relapsing-Remitting
The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)		03.5611
Stillbirth
The event that a FETUS is born dead or stillborn.		02.2110
Nervous System Disorders
[description not available]		02.2110
Nervous System Diseases
Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.		02.2110
Bile Duct Obstruction, Intrahepatic
[description not available]		02.2110
Cholestasis, Intrahepatic
Impairment of bile flow due to injury to the HEPATOCYTES; BILE CANALICULI; or the intrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC).		02.2110
Dysphagia
[description not available]		02.2110
Deglutition Disorders
Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS.		02.2110
Acrania
[description not available]		02.6120
Delayed Effects, Prenatal Exposure
[description not available]		02.5420
Neural Tube Defects
Congenital malformations of the central nervous system and adjacent structures related to defective neural tube closure during the first trimester of pregnancy generally occurring between days 18-29 of gestation. Ectodermal and mesodermal malformations (mainly involving the skull and vertebrae) may occur as a result of defects of neural tube closure. (From Joynt, Clinical Neurology, 1992, Ch55, pp31-41)		02.6120
B Virus Infection
[description not available]		03.5911
Infections, Respiratory
[description not available]		03.5911
Cat Diseases
Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used.		03.9121
Viral Conjunctivitis
[description not available]		03.5911
Conjunctivitis, Viral
Inflammation, often mild, of the conjunctiva caused by a variety of viral agents. Conjunctival involvement may be part of a systemic infection.		03.5911
Respiratory Tract Infections
Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.		03.5911
Central Nervous System Infection
[description not available]		03.1210
Drug Withdrawal Symptoms
[description not available]		03.4711
Substance Withdrawal Syndrome
Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug.		03.4711
Acute Liver Injury, Drug-Induced
[description not available]		07.6991
Chemical and Drug Induced Liver Injury
A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment.		07.6991
Hyperlactatemia
Increase in blood LACTATE concentration often associated with SEPTIC SHOCK; LUNG INJURY; SEPSIS; and DRUG TOXICITY. When hyperlactatemia is associated with low body pH (acidosis) it is LACTIC ACIDOSIS.		02.1310
Rhabdomyolysis
Necrosis or disintegration of skeletal muscle often followed by myoglobinuria.		03.3260
Icterus
[description not available]		02.0810
Colicky Pain
[description not available]		02.0810
AIDS-Related Opportunistic Infections
Opportunistic infections found in patients who test positive for human immunodeficiency virus (HIV). The most common include PNEUMOCYSTIS PNEUMONIA, Kaposi's sarcoma, cryptosporidiosis, herpes simplex, toxoplasmosis, cryptococcosis, and infections with Mycobacterium avium complex, Microsporidium, and Cytomegalovirus.		06.2241
Cholangitis
Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both.		02.0810
Jaundice
A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction.		02.0810
Abdominal Pain
Sensation of discomfort, distress, or agony in the abdominal region.		02.0810
Low Bone Density
[description not available]		05.8322
Age-Related Osteoporosis
[description not available]		04.3911
Bone Diseases, Metabolic
Diseases that affect the METABOLIC PROCESSES of BONE TISSUE.		05.8322
Osteoporosis
Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.		04.3911
Postherpetic Neuralgia
[description not available]		02.0810
Exanthem
[description not available]		02.4820
Pyrexia
[description not available]		02.0810
Exanthema
Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology.		02.4820
Fever
An abnormal elevation of body temperature, usually as a result of a pathologic process.		02.0810
Neuralgia, Postherpetic
Pain in nerves, frequently involving facial SKIN, resulting from the activation the latent varicella-zoster virus (HERPESVIRUS 3, HUMAN). The two forms of the condition preceding the pain are HERPES ZOSTER OTICUS; and HERPES ZOSTER OPHTHALMICUS. Following the healing of the rashes and blisters, the pain sometimes persists.		02.0810
HIV Lipodystrophy Syndrome
[description not available]		07.4352
Aging
The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time.		0310
HIV-Associated Lipodystrophy Syndrome
Defective metabolism leading to fat maldistribution in patients infected with HIV. The etiology appears to be multifactorial and probably involves some combination of infection-induced alterations in metabolism, direct effects of antiretroviral therapy, and patient-related factors.		07.4352
Cirrhosis, Liver
[description not available]		07.7172
Cardiomyopathies, Primary
[description not available]		02.0710
Liver Cirrhosis
Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.		07.7172
Cardiomyopathies
A group of diseases in which the dominant feature is the involvement of the CARDIAC MUSCLE itself. Cardiomyopathies are classified according to their predominant pathophysiological features (DILATED CARDIOMYOPATHY; HYPERTROPHIC CARDIOMYOPATHY; RESTRICTIVE CARDIOMYOPATHY) or their etiological/pathological factors (CARDIOMYOPATHY, ALCOHOLIC; ENDOCARDIAL FIBROELASTOSIS).		02.0710
Cardiovascular Diseases
Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.		09.67116
Lipodystrophy
A collection of heterogenous conditions resulting from defective LIPID METABOLISM and characterized by ADIPOSE TISSUE atrophy. Often there is redistribution of body fat resulting in peripheral fat wasting and central adiposity. They include generalized, localized, congenital, and acquired lipodystrophy.		08.3875
Kidney Failure
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.		06.7742
Renal Insufficiency
Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.		06.7742
Injuries, Needlestick
[description not available]		02.8130
HTLV-II Infections
Diseases caused by HUMAN T-LYMPHOTROPIC VIRUS 2.		02.110
Prurigo
A name applied to several itchy skin eruptions of unknown cause. The characteristic course is the formation of a dome-shaped papule with a small transient vesicle on top, followed by crusting over or lichenification. (From Dorland, 27th ed)		02.4820
Overweight
A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat.		03.4811
Complications, Pregnancy
[description not available]		02.110
Diffuse Large B-Cell Lymphoma
[description not available]		02.4820
Infections, Helicobacter
[description not available]		02.110
AIDS-Associated Lymphoma
[description not available]		02.7630
Lymphoma, Large B-Cell, Diffuse
Malignant lymphoma composed of large B lymphoid cells whose nuclear size can exceed normal macrophage nuclei, or more than twice the size of a normal lymphocyte. The pattern is predominantly diffuse. Most of these lymphomas represent the malignant counterpart of B-lymphocytes at midstage in the process of differentiation.		02.4820
Helicobacter Infections
Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.		02.110
Lymphoma, AIDS-Related
B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.		02.7630
Muscular Weakness
[description not available]		02.7930
Muscle Pain
[description not available]		02.7930
Muscle Weakness
A vague complaint of debility, fatigue, or exhaustion attributable to weakness of various muscles. The weakness can be characterized as subacute or chronic, often progressive, and is a manifestation of many muscle and neuromuscular diseases. (From Wyngaarden et al., Cecil Textbook of Medicine, 19th ed, p2251)		02.7930
Myalgia
Painful sensation in the muscles.		02.7930
Acute Respiratory Distress Syndrome
[description not available]		02.110
Pleural Effusion
Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.		02.110
Respiratory Distress Syndrome
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.		02.110
Chromosome-Defective Micronuclei
[description not available]		02.110
Abdominal Obesity
[description not available]		03.4811
Chronic Liver Failure
[description not available]		02.4920
End Stage Liver Disease
Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.		02.4920
Cytomegalovirus
A genus of the family HERPESVIRIDAE, subfamily BETAHERPESVIRINAE, infecting the salivary glands, liver, spleen, lungs, eyes, and other organs, in which they produce characteristically enlarged cells with intranuclear inclusions. Infection with Cytomegalovirus is also seen as an opportunistic infection in AIDS.		02.5220
Blood Pressure, High
[description not available]		02.110
Hypertension
Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.		02.110
Arteriosclerosis, Coronary
[description not available]		03.0110
Coronary Artery Disease
Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.		03.0110
Cognition Disorders
Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment.		02.110
Feline Leukemia
[description not available]		02.4920
Viral Hepatitis, Human
[description not available]		02.1310
Hepatitis, Viral, Human
INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).		02.1310
Nausea
An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.		03.4520
Peripheral Nerve Diseases
[description not available]		03.5111
Pulmonary Consumption
[description not available]		03.5111
Peripheral Nervous System Diseases
Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves.		03.5111
Tuberculosis, Pulmonary
MYCOBACTERIUM infections of the lung.		03.5111
Cytomegalic Inclusion Disease
[description not available]		02.1310
Cytomegalovirus Infections
Infection with CYTOMEGALOVIRUS, characterized by enlarged cells bearing intranuclear inclusions. Infection may be in almost any organ, but the salivary glands are the most common site in children, as are the lungs in adults.		02.1310
Albers-Schoenberg Disease
[description not available]		04.4111
Osteopetrosis
Excessive formation of dense trabecular bone leading to pathological fractures; OSTEITIS; SPLENOMEGALY with infarct; ANEMIA; and extramedullary hemopoiesis (HEMATOPOIESIS, EXTRAMEDULLARY).		04.4111
Clerambault Syndrome
[description not available]		03.5111
Eczema, Atopic
[description not available]		02.1110
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.		02.1110
Autosomal Hemophilia A
[description not available]		02.7730
Hemophilia A
The classic hemophilia resulting from a deficiency of factor VIII. It is an inherited disorder of blood coagulation characterized by a permanent tendency to hemorrhage.		02.7730
Human T-lymphotropic Virus 1 Infection
[description not available]		03.4220
HTLV-I Infections
Diseases caused by HUMAN T-LYMPHOTROPIC VIRUS 1.		03.4220
Chronic Kidney Diseases
[description not available]		03.0610
Proteinuria
The presence of proteins in the urine, an indicator of KIDNEY DISEASES.		03.0610
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)		03.0610
Hepatic Failure
[description not available]		03.0610
Liver Failure
Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASES; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)		03.0610
Diseases, Occupational
[description not available]		02.1510
Acute Disease
Disease having a short and relatively severe course.		02.1510
Diabetes Mellitus
A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.		02.1510
Cardiomyopathy, Congestive
[description not available]		04.4311
Cervix Dysplasia
[description not available]		04.4311
Cancer of Cervix
[description not available]		04.4311
Libman-Sacks Disease
[description not available]		05.5431
Hepatitis, Viral, Animal
INFLAMMATION of the LIVER in animals due to viral infection.		04.4311
Cardiomyopathy, Dilated
A form of CARDIAC MUSCLE disease that is characterized by ventricular dilation, VENTRICULAR DYSFUNCTION, and HEART FAILURE. Risk factors include SMOKING; ALCOHOL DRINKING; HYPERTENSION; INFECTION; PREGNANCY; and mutations in the LMNA gene encoding LAMIN TYPE A, a NUCLEAR LAMINA protein.		04.4311
Uterine Cervical Dysplasia
Abnormal development of immature squamous EPITHELIAL CELLS of the UTERINE CERVIX, a term used to describe premalignant cytological changes in the cervical EPITHELIUM. These atypical cells do not penetrate the epithelial BASEMENT MEMBRANE.		04.4311
Uterine Cervical Neoplasms
Tumors or cancer of the UTERINE CERVIX.		04.4311
Lupus Erythematosus, Systemic
A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.		05.5431
Hidradenitis
The inflammation of a sweat gland (usually of the apocrine type). The condition can be idiopathic or occur as a result of or in association with another underlying condition. Neutrophilic eccrine hidradenitis is a relatively rare variant that has been reported in patients undergoing chemotherapy, usually for non-Hodgkin lymphomas or leukemic conditions.		02.1510
Dermatitis Medicamentosa
[description not available]		02.1310
Lassitude
[description not available]		02.1510
Fatigue
The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli.		02.1510
Inappropriate GH Secretion Syndrome (Acromegaly)
[description not available]		02.0410
BH4 Deficiency
[description not available]		02.0410
Acromegaly
A condition caused by prolonged exposure to excessive HUMAN GROWTH HORMONE in adults. It is characterized by bony enlargement of the FACE; lower jaw (PROGNATHISM); hands; FEET; HEAD; and THORAX. The most common etiology is a GROWTH HORMONE-SECRETING PITUITARY ADENOMA. (From Joynt, Clinical Neurology, 1992, Ch36, pp79-80)		02.0410
Phenylketonurias
A group of autosomal recessive disorders marked by a deficiency of the hepatic enzyme PHENYLALANINE HYDROXYLASE or less frequently by reduced activity of DIHYDROPTERIDINE REDUCTASE (i.e., atypical phenylketonuria). Classical phenylketonuria is caused by a severe deficiency of phenylalanine hydroxylase and presents in infancy with developmental delay; SEIZURES; skin HYPOPIGMENTATION; ECZEMA; and demyelination in the central nervous system. (From Adams et al., Principles of Neurology, 6th ed, p952).		02.0410
Drug Abuse, Intravenous
[description not available]		03.8520
Depression
Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders.		02.0410
Cancer of Colon
[description not available]		02.0410
Colonic Neoplasms
Tumors or cancer of the COLON.		02.0410
Acute Hepatic Failure
[description not available]		02.0510
Liver Failure, Acute
A form of rapid-onset LIVER FAILURE, also known as fulminant hepatic failure, caused by severe liver injury or massive loss of HEPATOCYTES. It is characterized by sudden development of liver dysfunction and JAUNDICE. Acute liver failure may progress to exhibit cerebral dysfunction even HEPATIC COMA depending on the etiology that includes hepatic ISCHEMIA, drug toxicity, malignant infiltration, and viral hepatitis such as post-transfusion HEPATITIS B and HEPATITIS C.		02.0510
Hepatic Insufficiency
Conditions in which the LIVER functions fall below the normal ranges. Severe hepatic insufficiency may cause LIVER FAILURE or DEATH. Treatment may include LIVER TRANSPLANTATION.		04.3511
Cholera Infantum
[description not available]		02.9610
Bilateral Headache
[description not available]		02.9610
Ache
[description not available]		02.9610
Headache
The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.		02.9610
Pain
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.		02.9610
Chronic Insomnia
[description not available]		05.0531
Sleep Initiation and Maintenance Disorders
Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition.		05.0531
T-Cell Lymphoma
[description not available]		02.0510
Central Nervous System Neoplasm
[description not available]		02.0510
Lymphoma, T-Cell
A group of heterogeneous lymphoid tumors representing malignant transformations of T-lymphocytes.		02.0510
Central Nervous System Neoplasms
Benign and malignant neoplastic processes that arise from or secondarily involve the brain, spinal cord, or meninges.		02.0510
Diathesis
[description not available]		02.0510
Autoimmune Disease
[description not available]		02.4720
Autoimmune Diseases
Disorders that are characterized by the production of antibodies that react with host tissues or immune effector cells that are autoreactive to endogenous peptides.		14.4720
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		02.0510
Primary Peritonitis
[description not available]		02.0510
Hepatitis
INFLAMMATION of the LIVER.		02.0510
Peritonitis
INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.		02.0510
Addiction, Opioid
[description not available]		03.4411
Opioid-Related Disorders
Disorders related to or resulting from abuse or misuse of OPIOIDS.		03.4411
Cancer of Prostate
[description not available]		02.4620
Infections, Retroviridae
[description not available]		02.7530
Fibroma, Shope
[description not available]		02.7530
Prostatic Neoplasms
Tumors or cancer of the PROSTATE.		02.4620
Retroviridae Infections
Virus diseases caused by the RETROVIRIDAE.		02.7530
Chronic Fatigue and Immune Dysfunction Syndrome
[description not available]		02.0510
Fatigue Syndrome, Chronic
A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9)		02.0510
Acute Kidney Failure
[description not available]		02.4520
Acute Kidney Injury
Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.		02.4520
American Trypanosomiasis
[description not available]		02.0610
Chagas Disease
Infection with the protozoan parasite TRYPANOSOMA CRUZI, a form of TRYPANOSOMIASIS endemic in Central and South America. It is named after the Brazilian physician Carlos Chagas, who discovered the parasite. Infection by the parasite (positive serologic result only) is distinguished from the clinical manifestations that develop years later, such as destruction of PARASYMPATHETIC GANGLIA; CHAGAS CARDIOMYOPATHY; and dysfunction of the ESOPHAGUS or COLON.		02.0610
Adiadochokinesis
[description not available]		02.0510
Cerebellar Ataxia
Incoordination of voluntary movements that occur as a manifestation of CEREBELLAR DISEASES. Characteristic features include a tendency for limb movements to overshoot or undershoot a target (dysmetria), a tremor that occurs during attempted movements (intention TREMOR), impaired force and rhythm of diadochokinesis (rapidly alternating movements), and GAIT ATAXIA. (From Adams et al., Principles of Neurology, 6th ed, p90)		02.0510
Cafe-au-Lait Spots with Pulmonic Stenosis
[description not available]		02.0610
Adult Rickets
[description not available]		02.0610
Neurofibromatosis 1
An autosomal dominant inherited disorder (with a high frequency of spontaneous mutations) that features developmental changes in the nervous system, muscles, bones, and skin, most notably in tissue derived from the embryonic NEURAL CREST. Multiple hyperpigmented skin lesions and subcutaneous tumors are the hallmark of this disease. Peripheral and central nervous system neoplasms occur frequently, especially OPTIC NERVE GLIOMA and NEUROFIBROSARCOMA. NF1 is caused by mutations which inactivate the NF1 gene (GENES, NEUROFIBROMATOSIS 1) on chromosome 17q. The incidence of learning disabilities is also elevated in this condition. (From Adams et al., Principles of Neurology, 6th ed, pp1014-18) There is overlap of clinical features with NOONAN SYNDROME in a syndrome called neurofibromatosis-Noonan syndrome. Both the PTPN11 and NF1 gene products are involved in the SIGNAL TRANSDUCTION pathway of Ras (RAS PROTEINS).		02.0610
Osteomalacia
Disorder caused by an interruption of the mineralization of organic bone matrix leading to bone softening, bone pain, and weakness. It is the adult form of rickets resulting from disruption of VITAMIN D; PHOSPHORUS; or CALCIUM homeostasis.		02.0610
Hypophosphatemia
A condition of an abnormally low level of PHOSPHATES in the blood.		02.0610
Deep Vein Thrombosis
[description not available]		02.0610
Venous Thrombosis
The formation or presence of a blood clot (THROMBUS) within a vein.		02.0610
Anxiety Neuroses
[description not available]		03.4511
Anxiety Disorders
Persistent and disabling ANXIETY.		03.4511
Chronic Illness
[description not available]		04.3120
EBV Infections
[description not available]		02.9810
Duncan Disease
[description not available]		02.9810
MS (Multiple Sclerosis)
[description not available]		02.9810
Hives
[description not available]		02.9810
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		04.3120
Lymphoproliferative Disorders
Disorders characterized by proliferation of lymphoid tissue, general or unspecified.		02.9810
Multiple Sclerosis
An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)		02.9810
Urticaria
A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress.		02.9810
Epstein-Barr Virus Infections
Infection with human herpesvirus 4 (HERPESVIRUS 4, HUMAN); which may facilitate the development of various lymphoproliferative disorders. These include BURKITT LYMPHOMA (African type), INFECTIOUS MONONUCLEOSIS, and oral hairy leukoplakia (LEUKOPLAKIA, HAIRY).		02.9810
Allergy, Drug
[description not available]		02.0610
Symptom Cluster
[description not available]		02.0610
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		02.0610
Syndrome
A characteristic symptom complex.		02.0610
African Lymphoma
[description not available]		02.0610
Cancer of Duodenum
[description not available]		02.0610
Burkitt Lymphoma
A form of undifferentiated malignant LYMPHOMA usually found in central Africa, but also reported in other parts of the world. It is commonly manifested as a large osteolytic lesion in the jaw or as an abdominal mass. B-cell antigens are expressed on the immature cells that make up the tumor in virtually all cases of Burkitt lymphoma. The Epstein-Barr virus (HERPESVIRUS 4, HUMAN) has been isolated from Burkitt lymphoma cases in Africa and it is implicated as the causative agent in these cases; however, most non-African cases are EBV-negative.		02.0610
Diarrhea
An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.		09.6999
Emergencies
Situations or conditions requiring immediate intervention to avoid serious adverse results.		02.0710
Encephalopathy, Hypertensive
[description not available]		02.0710
Leukoencephalopathy Syndrome, Posterior
[description not available]		02.0710
Brain Swelling
[description not available]		02.0710
Malignant Hypertension
[description not available]		02.0710
Central Nervous System Toxoplasmosis
[description not available]		02.0710
Encephalitis, JC Polyomavirus
[description not available]		02.0710
Brain Edema
Increased intracellular or extracellular fluid in brain tissue. Cytotoxic brain edema (swelling due to increased intracellular fluid) is indicative of a disturbance in cell metabolism, and is commonly associated with hypoxic or ischemic injuries (see HYPOXIA, BRAIN). An increase in extracellular fluid may be caused by increased brain capillary permeability (vasogenic edema), an osmotic gradient, local blockages in interstitial fluid pathways, or by obstruction of CSF flow (e.g., obstructive HYDROCEPHALUS). (From Childs Nerv Syst 1992 Sep; 8(6):301-6)		02.0710
Hypertension, Malignant
A condition of markedly elevated BLOOD PRESSURE with DIASTOLIC PRESSURE usually greater than 120 mm Hg. Malignant hypertension is characterized by widespread vascular damage, PAPILLEDEMA, retinopathy, HYPERTENSIVE ENCEPHALOPATHY, and renal dysfunction.		02.0710
Leukoencephalopathy, Progressive Multifocal
An opportunistic viral infection of the central nervous system associated with conditions that impair cell-mediated immunity (e.g., ACQUIRED IMMUNODEFICIENCY SYNDROME and other IMMUNOLOGIC DEFICIENCY SYNDROMES; HEMATOLOGIC NEOPLASMS; IMMUNOSUPPRESSION; and COLLAGEN DISEASES). The causative organism is JC Polyomavirus (JC VIRUS) which primarily affects oligodendrocytes, resulting in multiple areas of demyelination. Clinical manifestations include DEMENTIA; ATAXIA; visual disturbances; and other focal neurologic deficits, generally progressing to a vegetative state within 6 months. (From Joynt, Clinical Neurology, 1996, Ch26, pp36-7)		02.0710
Toxoplasmosis, Cerebral
Infections of the BRAIN caused by the protozoan TOXOPLASMA gondii that primarily arise in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES (see also AIDS-RELATED OPPORTUNISTIC INFECTIONS). The infection may involve the brain diffusely or form discrete abscesses. Clinical manifestations include SEIZURES, altered mentation, headache, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. (From Joynt, Clinical Neurology, 1998, Ch27, pp41-3)		02.0710
Cancer of Stomach
[description not available]		02.0710
Extranodal NK-T-Cell Lymphoma
[description not available]		02.0710
Stomach Neoplasms
Tumors or cancer of the STOMACH.		02.0710
Dermatoses
[description not available]		02.0710
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		02.0710
Liver Dysfunction
[description not available]		02.9910
Liver Diseases
Pathological processes of the LIVER.		02.9910
Nephrolithiasis
Formation of stones in the KIDNEY.		02.0710
Immune Reconstitution Disease
[description not available]		04.3711
Hypertrophy
General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).		04.3711
Atherogenesis
[description not available]		03.4611
Atherosclerosis
A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA.		03.4611
Autoimmune Thrombocytopenia
[description not available]		02.0810
Purpura, Thrombocytopenic, Idiopathic
Thrombocytopenia occurring in the absence of toxic exposure or a disease associated with decreased platelets. It is mediated by immune mechanisms, in most cases IMMUNOGLOBULIN G autoantibodies which attach to platelets and subsequently undergo destruction by macrophages. The disease is seen in acute (affecting children) and chronic (adult) forms.		02.0810
Muscle Disorders
[description not available]		03.4711
Muscular Diseases
Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE.		03.4711
Acidosis, Renal Tubular, Type I
[description not available]		02.0410
Acidosis, Renal Tubular
A group of genetic disorders of the KIDNEY TUBULES characterized by the accumulation of metabolically produced acids with elevated plasma chloride, hyperchloremic metabolic ACIDOSIS. Defective renal acidification of URINE (proximal tubules) or low renal acid excretion (distal tubules) can lead to complications such as HYPOKALEMIA, hypercalcinuria with NEPHROLITHIASIS and NEPHROCALCINOSIS, and RICKETS.		02.0410