Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: Inhibitor of reverse transcriptases or of RNA-directed DNA polymerases. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 9833525 |
| MeSH ID | M0548057 |
| Synonym |
|---|
| efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination |
| 731772-50-2 |
| efavirenz, emtricitabine, and tenofovir disoproxil fumarate |
| efavirenz / emtricitabine / tenofovir disoproxil |
| qdrmcfdxpieygx-nwrgjbojsa-n |
| 4-amino-5-fluoro-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one;[[(2r)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate;(e)-but-2-enedioic acid;(4s)-6-chloro-4-(2-cyc |
| efavirenz-emtricitabine-tenofovirdisoproxilfumaratemixt. |
| efavirenz-emtricitabine-tenofovir disoproxil fumarate mixt. |
| Excerpt | Reference | Relevance |
|---|---|---|
| " For TB drugs, equivalence was suggested for peak plasma concentrations when administered with and without efavirenz/tenofovir/emtricitabine." | ( Efavirenz, tenofovir and emtricitabine combined with first-line tuberculosis treatment in tuberculosis-HIV-coinfected Tanzanian patients: a pharmacokinetic and safety study. Aarnoutse, RE; Boeree, MJ; Burger, DM; Fillekes, Q; Kibiki, GS; Kisanga, ER; Kisonga, RM; Mleoh, L; Mtabho, CM; Ndaro, A; Semvua, HH; van den Boogaard, J; van der Ven, A, 2013) | 0.39 |
| Excerpt | Relevance | Reference |
|---|---|---|
| " Many HIV-1-infected patients who are treatment-naive or treatment-experienced with susceptible virus will potentially have more options to reduce pill burden and optimize dosage schedules with one pill once-daily regimens." | ( Once-daily single-tablet regimens: a long and winding road to excellence in antiretroviral treatment. Clotet, B; Llibre, JM, ) | 0.13 |
| "In this highly adherent population, the number of daily pills was related to self-reported health status but not to self-reported adherence, whereas the dosing interval did not influence self-reported adherence or health status." | ( Number of daily pills, dosing schedule, self-reported adherence and health status in 2010: a large cross-sectional study of HIV-infected patients on antiretroviral therapy. Bocchiola, B; Cahua, T; Castagna, A; Danise, A; Galli, L; Gianotti, N; Lazzarin, A; Maillard, M; Panzini, P; Pazzi, A; Salpietro, S; Zandonà, D, 2013) | 0.39 |
| " "Untimed" EFV concentrations with unknown dosing and collection time were assessed using a validated liquid chromatography-tandem mass spectrometry method." | ( Untimed Efavirenz Drug Levels After Switching From Brand to Generic Formulations: A Short Communication. Atkinson, K; Auyeung, K; Barrios, R; Baynes, KA; Brumme, CJ; Lepik, KJ; Sereda, P; Toy, J; Watson, BE, 2021) | 0.62 |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 16 (24.24) | 29.6817 |
| 2010's | 40 (60.61) | 24.3611 |
| 2020's | 10 (15.15) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be weak demand-to-supply ratio for research on this compound.
| This Compound (10.27) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 12 (16.44%) | 5.53% |
| Reviews | 6 (8.22%) | 6.00% |
| Case Studies | 10 (13.70%) | 4.05% |
| Observational | 1 (1.37%) | 0.25% |
| Other | 44 (60.27%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Efavirenz Once Daily Over 10 Days Following Drug Intake Cessation in Healthy Volunteers [NCT01108926] | Phase 1 | 19 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
| A Pilot Study to Determine if Raltegravir Eradicates HIV From Peripheral Blood Mononuclear Cells [NCT01173510] | Phase 4 | 0 participants (Actual) | Interventional | 2010-08-23 | Withdrawn(stopped due to This study was not feasible due to facility budget and contractual issues.) | ||
| 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 4 | 40 participants (Anticipated) | Interventional | 2011-05-31 | Not yet recruiting | ||
| Systematic Empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating Antiretroviral Therapy With CD4 Cell Counts <100/mm3: the STATIS Randomized Controlled Trial [NCT02057796] | Phase 4 | 1,050 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| Change in Sleep Architecture and Neuropsychological Performance Following Switch From Atripla to Stribild. [NCT02283060] | Phase 4 | 30 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting | ||
| A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir [NCT02285374] | Phase 4 | 40 participants (Anticipated) | Interventional | 2014-11-30 | Not yet recruiting | ||
| Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants [NCT03048422] | Phase 3 | 643 participants (Actual) | Interventional | 2018-01-19 | Completed | ||
| A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naiv [NCT01095796] | Phase 3 | 707 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects [NCT01263015] | Phase 3 | 844 participants (Actual) | Interventional | 2011-02-01 | Completed | ||
| Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppre [NCT02652260] | Phase 2 | 86 participants (Actual) | Interventional | 2016-03-04 | Active, not recruiting | ||
| 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 3 | 0 participants (Actual) | Interventional | 2011-06-30 | Withdrawn(stopped due to Decision not to go forth with study.) | ||
| The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants [NCT04424264] | Phase 1 | 18 participants (Actual) | Interventional | 2019-12-05 | Completed | ||
| A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching From a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raise [NCT00615810] | Phase 4 | 159 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| 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 2 | 51 participants (Actual) | Interventional | 2008-08-26 | Completed | ||
| Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients [NCT02556268] | Phase 1 | 40 participants (Actual) | Interventional | 2016-02-23 | Completed | ||
| A Phase IV, Open-label, Prospective Observational Study to Evaluate Virological Response in Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla (Efavirenz/Emtricitabine/Tenofovir DF) on an Empty Stomach [NCT00615745] | Phase 4 | 115 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Anti [NCT00869557] | Phase 2 | 71 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| Phase 3 Randomized Trial Evaluating the Virological Efficacy and the Tolerance of 4 New Simplified Antiretroviral Treatments in Naive HIV-1 Infected Patients in Dakar and Yaounde [NCT00573001] | Phase 3 | 120 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens (REMEMBER) [NCT01380080] | Phase 4 | 851 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects [NCT02403674] | Phase 3 | 734 participants (Actual) | Interventional | 2015-06-05 | Completed | ||
| A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumara [NCT01309243] | Phase 3 | 799 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| A Randomized Controlled Trial to Compare the Effects of Highly Active Antiretroviral Therapy (HAART) Versus Statin Therapy on Endothelial Function and Markers of Inflammation/Coagulation In HIV-Infected Individuals With High CD4 Cell Counts [NCT01515813] | Phase 2 | 0 participants (Actual) | Interventional | 2011-11-30 | Withdrawn(stopped due to On 05/08/12, team working on revising protocol and re-open study under version 2.0) | ||
| WRHI 060 (ADVANCE): A Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared With DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected With HIV-1 Starting First-line Antiretroviral Therapy - Extension to 192 Weeks [NCT03122262] | Phase 3 | 1,110 participants (Actual) | Interventional | 2017-01-16 | Completed | ||
| Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine [NCT01778413] | Phase 4 | 60 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF [NCT02345226] | Phase 3 | 881 participants (Actual) | Interventional | 2015-01-26 | Completed | ||
| A Randomized Evaluation of Antiretroviral Therapy Alone or With Delayed Chemotherapy Versus Antiretroviral Therapy With Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) AMC 067 [NCT01352117] | Phase 3 | 192 participants (Actual) | Interventional | 2011-11-18 | Completed | ||
| Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults [NCT03532425] | Phase 4 | 28 participants (Actual) | Interventional | 2018-10-29 | Terminated(stopped due to Difficulties enrolling participants) | ||
| A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings [NCT01435018] | Phase 3 | 334 participants (Actual) | Interventional | 2013-10-01 | Completed | ||
| HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru [NCT01815580] | Phase 4 | 225 participants (Actual) | Interventional | 2013-07-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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
| Intervention | percentage of participants (Number) |
|---|---|
| 1 - Kaletra + Isentress Taken Twice Daily | 86 |
| 2 - Atripla Taken Once Daily | 87.5 |
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
| Intervention | log(10)/day (Median) |
|---|---|
| 1 - Kaletra + Isentress Taken Twice Daily | 0.47 |
| 2 - Atripla Taken Once Daily | 0.55 |
To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: 48 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| 1 - Kaletra + Isentress Taken Twice Daily | -2.24 |
| 2 - Atripla Taken Once Daily | -5.65 |
To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: Baseline to Week 4
| Intervention | cells/mm^3 (Mean) |
|---|---|
| 1 - Kaletra + Isentress Taken Twice Daily | -3.81 |
| 2 - Atripla Taken Once Daily | -1.18 |
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00869557)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 89.6 |
| Atripla | 87.0 |
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized. (NCT00869557)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 89.6 |
| Atripla | 87.0 |
Change = Week 48 value minus baseline value (NCT00869557)
Timeframe: Baseline to Week 48
| Intervention | cells/µL (Mean) |
|---|---|
| Stribild | 240 |
| Atripla | 166 |
Change = Week 24 value minus baseline value (NCT00869557)
Timeframe: Baseline to Week 24
| Intervention | cells/µL (Mean) |
|---|---|
| Stribild | 161 |
| Atripla | 117 |
The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized. (NCT00869557)
Timeframe: Baseline to Weeks 24 and 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Virologic Success at Week 24 | Virologic Success at Week 48 | |
| Atripla | 87.0 | 82.6 |
| Stribild | 89.6 | 91.7 |
Change = Week 24 or 48 value minus baseline value (NCT00869557)
Timeframe: Baseline to Weeks 24 and 48
| Intervention | log_10 copies/mL (Mean) | |
|---|---|---|
| Baseline to Week 24 | Baseline to Week 48 | |
| Atripla | -2.88 | -2.71 |
| Stribild | -2.87 | -2.89 |
(NCT01095796)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 87.6 |
| Atripla | 84.1 |
(NCT01095796)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 85.9 |
| Atripla | 83.2 |
(NCT01095796)
Timeframe: Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 80.2 |
| Atripla | 75.3 |
(NCT01095796)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 88.8 |
| Atripla | 85.5 |
(NCT01095796)
Timeframe: Week 192
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 76.1 |
| Atripla | 78.1 |
(NCT01095796)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Stribild | 84.2 |
| Atripla | 81.5 |
Change = value of the relevant time point minus the baseline value (NCT01095796)
Timeframe: Baseline; Weeks 48, 96, 144, and 192
| Intervention | cells/µL (Mean) | |||
|---|---|---|---|---|
| Change at Wk 48 (Stribild, n=325; Atripla, n=315) | Change at Wk 96 (Stribild, n=307; Atripla, n=302) | Change at Wk 144 (Stribild, n=294; Atripla, n=283) | Change at Wk 192 (Stribild, n=62; Atripla, n=69) | |
| Atripla | 206 | 273 | 300 | 328 |
| Stribild | 239 | 295 | 321 | 360 |
Viral suppression is defined as the first viral load value<50 c/mL. The Kaplan-Meier method was used to estimate time to viral suppression, defined as the time from the first dose of study treatment until the first viral load value <50 c/mL was reached. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)
| Intervention | Days (Median) |
|---|---|
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 28 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 84 |
CD4 lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the value at Indicated visit minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
| Intervention | cells per millimeters cubed (cells/mm^3) (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4, n=404,390 | Week 8, n=396,382 | Week 12, n=394,378 | Week 16, n=386,366 | Week 24, n=388,361 | Week 32, n=380,353 | Week 40, n=364,347 | Week 48, n=368,344 | Week 60, n=359,330 | Week 72, n=354,319 | Week 84, n=352,314 | Week 96, n=343,309 | Week 108, n=339,300 | Week 120, n=332,287 | Week 132, n=323,283 | Week 144, n=313,270 | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 117.6 | 164.6 | 187.5 | 214.7 | 216.9 | 250.5 | 265.5 | 267.5 | 271.3 | 306.1 | 315.2 | 322.6 | 349.3 | 347.0 | 377.9 | 379.5 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 80.9 | 124.4 | 153.0 | 174.1 | 177.8 | 208.1 | 216.2 | 209.5 | 235.3 | 269.6 | 272.1 | 286.0 | 298.9 | 311.0 | 327.2 | 333.3 |
Blood samples were collected for the measurement of HIV-1 RNA in plasma. Changes from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the indicated time points were assessed (represented by n=X, X in the category titles). (NCT01263015)
Timeframe: Baseline and at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144
| Intervention | log10 copies/mL (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2, n=387, 376 | Week 4, n=404, 391 | Week 8, n=395, 386 | Week 12, n=394, 377 | Week 16, n=386, 366 | Week 24, n=389, 364 | Week 32, n=380, 355 | Week 40, n=370, 345 | Week 48, n=370, 343 | Week 60, n=360, 330 | Week 72, n=354, 320 | Week 84, n=353, 314 | Week 96, n=345, 310 | Week 108, n=340, 300 | Week 120, n=333, 289 | Week 132, n=323, 284 | Week 144, n=313,269 | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | -2.46 | -2.88 | -2.99 | -3.01 | -3.03 | -3.05 | -3.04 | -3.05 | -3.03 | -3.03 | -3.03 | -3.02 | -2.99 | -3.01 | -3.00 | -3.03 | -3.02 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | -1.96 | -2.25 | -2.60 | -2.85 | -2.98 | -3.01 | -3.05 | -3.04 | -3.04 | -3.05 | -3.06 | -3.07 | -3.06 | -3.08 | -3.07 | -3.06 | -3.04 |
Data are presented as Kaplan Meier estimates of virologic failure (VF), defined as a confirmed plasma HIV-1 RNA level >=1000 c/mL at or after Week 16 and before Week 24, or a confirmed plasma HIV-1 RNA level >=200 c/mL at or after Week 24. A plasma HIV-1 RNA value was considered to be confirmed failure if a consecutive measurement satisfied the same failure criterion. The number of participants who experienced autoimmune deficiency syndrome (AIDS) Clinical Trials Group (ACTG) VFs was measured. For participants who withdrew from the study/were not documented to have reached confirmed VF at the cut off date of the Week 48 analysis, time to VF was to be censored at the planned visit week of the last measured plasma HIV-1 RNA sample. Data for participants who missed three consecutive scheduled plasma HIV-1 RNA measurements were to be censored at the planned visit week of the last assessment prior to the 3 consecutive missed visits. (NCT01263015)
Timeframe: From Baseline until Week 144) (average of 877.4 days for DTG; average of 788.8 study days for EFV/TDF/FTC)
| Intervention | Participants (Number) | |
|---|---|---|
| ACTG virologic failures | Censored participants | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 11 | 403 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 8 | 411 |
Whole blood samples were collected from participants to provide plasma for storage samples for potential viral genotypic and phenotypic analyses. Participants with confirmed virological failure (confirmed HIV-1 RNA >=50 copies/mL throughout the study and/or confirmed HIV-1 RNA >=200 copies/mL at Week 144) had plasma samples tested for HIV-1 RT genotype and HIV-1 integrase genotype from Baseline samples and from samples collected at the time of virological failure. Genotype testing was conducted at Day 1 and at the time of suspected protocol-defined virological failure (PDVF). A genotyping assessment was made of change across all amino acids within the integrase (IN)-encoding region, with particular attention paid to specific amino acid changes associated with the development of resistance to RAL, ELV, or DTG. (NCT01263015)
Timeframe: Through Week 144
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Week 144, RT mutation K65K/R | Week 144, RT mutation K101E | Week 144, RT mutation K103K/N | Week 144, RT mutation K103N | Week 144, RT mutation G190G/A | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 0 | 0 | 0 | 0 | 0 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 1 | 1 | 2 | 2 | 2 |
All Grade 1 to 4 post-Baseline-emergent chemistry toxicities included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), asparate aminotransferase (AST), carbon dioxide (CO2) content/bicarbonate, cholesterol, creatine kinase (CK), creatinine, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphorus inorganic, total bilirubin, and triglycerides. All Grade 1 to 4 post-Baseline-emergent hematology toxities included hemoglobin, platelet count, total neutrophils, and white blood cell count. The Division of AIDS (DAIDS) defined toxicity grades as follows: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening; Grade 5, death. (NCT01263015)
Timeframe: From Baseline until Week 144
| Intervention | Participants (Number) | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 144, ALT | Week 144, Albumin | Week 144, ALP | Week 144, AST | Week 144, CO2 content/bicarbonate | Week 144, Cholesterol | Week 144, CK | Week 144, Creatinine | Week 144, Hyperglycaemia | Week 144, Hyperkalemia | Week 144, Hypernatremia | Week 144, Hypoglycaemia | Week 144, Hypokalemia | Week 144, Hyponatremia | Week 144, LDL cholesterol calculation | Week 144, Lipase | Week 144, Phosphorus, inorganic | Week 144, Total bilirubin | Week 144, Triglycerides | Week 144, Hemoglobin | Week 144, Platelet count | Week 144, Total neutrophils | Week 144, White Blood Cell count | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 62 | 0 | 17 | 77 | 135 | 156 | 91 | 17 | 121 | 4 | 11 | 24 | 38 | 63 | 124 | 111 | 109 | 22 | 11 | 7 | 20 | 70 | 9 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 81 | 1 | 53 | 85 | 134 | 140 | 79 | 6 | 105 | 12 | 9 | 21 | 21 | 86 | 111 | 110 | 134 | 4 | 11 | 11 | 19 | 80 | 18 |
Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death. (NCT01263015)
Timeframe: From Baseline until Week 144
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Week 144, Any category condition | Week 144, Any Category B condition | Week 144, Any Category C condition | Week 144, Any death | Week 144, Progression from CAT A to CAT C | Week 144, Progression from CAT C to new CAT C | Week 144, Progression from CAT A, B, or C to death | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 17 | 12 | 5 | 0 | 4 | 1 | 0 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 24 | 17 | 6 | 2 | 4 | 2 | 2 |
The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 88 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 81 |
The percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 96 and Week 144 was assessed. Plasma samples were collected for the quantitative assessment of HIV-1 RNA based on the Missing, Switch, or Discontinuation equals Failure (MSDF) algorithm,as codified by the Food and Drug Administration's Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigationl product prior to the visit window) as non-responders, as well as participants who switched their concomitant antiretroviral therapy (ART) in certain scenarios. Since changes in ART were not permitted in this protocol, all such participants who changed ART were to be considered non-responders. Otherwise, virologic success or failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the visit of interest window. (NCT01263015)
Timeframe: Week 96 and Week 144
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Week 96 | Week 144 | |
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 77 | 71 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 70 | 63 |
Cluster of differentiation (CD4) lymphocyte cells (also called T-cells or T-helper cells) are the primary targets of HIV. The CD4 count and the CD4 percentage mark the degree of immunocompromise. The CD4 count is used to stage the patient's disease, determine the risk of opportunistic illnesses, assess prognosis, and guide decisions about when to start antiretroviral therapy. Change from Baseline was calculated as the Week 144 value minus the Baseline value. The least squares mean is the estimated mean change from Baseline in CD4+ cell counts at Week 144 calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, treatment*visit interaction, Baseline HIV-1 RNA*visit interaction, and Baseline CD4+ cell count*visit interaction. No assumptions were made about the correlations between a participant's readings of CD4+, i.e., the correlation matrix for within-participant errors is unstructured. (NCT01263015)
Timeframe: Baseline and Week 144
| Intervention | cells per millimeters cubed (cells/mm^3) (Least Squares Mean) |
|---|---|
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | 378.48 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | 331.57 |
"The Symptom Distress Module (SDM) is a 20-item, self-reported questionnaire measuring the presence/perceived distress linked to symptoms associated with HIV/its treatments. Developed with support from the AIDS Clinical Trials Group of the U.S. National Institute of Allergy and Infectious Diseases, it has demonstrated construct validity and has shown strong associations with physical/mental health summary scores and with disease severity. The SDM consists of 2 main scores: symptom count and the SBS, ranging from 0 (best) to 80 (worst) and based on the degree of bother that each symptom present posed. The SBS was calculated by adding the 20 individual bother item scores, which were calculated as: 0, I do not have this symptom; 1, It doesn't bother me; 2, It bothers me a little; 3, It bothers me; 4, It bothers me a lot. Estimates are calculated from an analysis of covariance (ANCOVA) model adjusting for age, sex, race, Baseline (BL) viral load, BL CD4+ cell count, and BL SBS." (NCT01263015)
Timeframe: Baseline and Week 4 through 48
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily | -1.818 |
| EFV/TDF/FTC 600/200/300 mg Once Daily | -1.246 |
Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis. (NCT01309243)
Timeframe: Baseline to Week 96
| Intervention | participants (Number) | ||
|---|---|---|---|
| Baseline through Week 48 | Week 48 through Week 96 | Baseline through Week 96 | |
| EFV/FTC/TDF | 3 | 1 | 4 |
| FTC/RPV/TDF | 17 | 4 | 21 |
Participants who experienced either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥ 50 copies/mL and < 1-log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥ 400 copies/mL after achieving HIV-1 RNA < 50 copies/mL, or as having 2 consecutive visits with > 1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥ 400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis. (NCT01309243)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Baseline through Week 48 | Week 48 through Week 96 | Baseline through Week 96 | |
| EFV/FTC/TDF | 0.8 | 0.3 | 1.0 |
| FTC/RPV/TDF | 4.3 | 1.0 | 5.3 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm. (NCT01309243)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TDF | 77.9 |
| EFV/FTC/TDF | 72.4 |
(NCT01309243)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Mean) |
|---|---|
| FTC/RPV/TDF | -8 |
| EFV/FTC/TDF | 8 |
(NCT01309243)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Mean) |
|---|---|
| FTC/RPV/TDF | 1 |
| EFV/FTC/TDF | 22 |
"The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm.~The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time." (NCT01309243)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TDF | 85.8 |
| EFV/FTC/TDF | 81.6 |
(NCT01309243)
Timeframe: Baseline to Week 48
| Intervention | cells/μL (Mean) |
|---|---|
| FTC/RPV/TDF | 200 |
| EFV/FTC/TDF | 191 |
(NCT01309243)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Mean) |
|---|---|
| FTC/RPV/TDF | 1 |
| EFV/FTC/TDF | 14 |
(NCT01309243)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Mean) |
|---|---|
| FTC/RPV/TDF | 2 |
| EFV/FTC/TDF | 8 |
(NCT01309243)
Timeframe: Baseline to Week 96
| Intervention | cells/μL (Mean) |
|---|---|
| FTC/RPV/TDF | 278 |
| EFV/FTC/TDF | 259 |
HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
| Intervention | percentage of participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Entry: HIV-1 RNA suppression | Week 12: HIV-1 RNA suppression | Week 24: HIV-1 RNA suppression | Week 32: HIV-1 RNA suppression | Week 48: HIV-1 RNA suppression | Week 72: HIV-1 RNA suppression | Week 96: HIV-1 RNA suppression | Step 2 entry: HIV-1 RNA suppression | Step 2 Week 12: HIV-1 RNA suppression | Step 2 Week 24: HIV-1 RNA suppression | Step 2 Week 32: HIV-1 RNA suppression | Step 2 Week 48: HIV-1 RNA suppression | Step 2 Week 72: HIV-1 RNA suppression | |
| Arm A: ART Alone or With Delayed ET | 4.3 | 90.3 | 94.5 | 92.0 | 95.3 | 91.2 | 92.9 | 93.3 | 100.0 | 95.8 | 96.0 | 100.0 | 100.0 |
Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Temporarily held | Resumed at a different dose | Deferred | Discontinued | Underdosed | |
| Arm A: ART With Delayed ET (Step 2) | 0 | 15.6 | 37.5 | 6.3 | 0 |
| Arm B: ART With Immediate ET | 5.2 | 9.4 | 24.0 | 10.4 | 1.0 |
HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Entry: HIV-1 RNA suppression | Week 12: HIV-1 RNA suppression | Week 24: HIV-1 RNA suppression | Week 32: HIV-1 RNA suppression | Week 48: HIV-1 RNA suppression | Week 72: HIV-1 RNA suppression | Week 96: HIV-1 RNA suppression | |
| Arm B: ART With Immediate ET | 4.2 | 90.6 | 97.5 | 94.7 | 98.6 | 96.6 | 93.8 |
KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks
| Intervention | cumulative events per 100 participants (Number) |
|---|---|
| Arm A: ART Alone Period (Step 1) | 39.89 |
| Arm B: ART With Immediate ET | 64.08 |
KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks
| Intervention | cumulative events per 100 participants (Number) |
|---|---|
| Arm A: ART Alone Period (Step 1) | 60.61 |
| Arm B: ART With Immediate ET | 52.73 |
KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
| Intervention | cumulative events per 100 participants (Number) |
|---|---|
| Arm A: ART With Delayed ET Period (Step 2) | 35.78 |
KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
| Intervention | cumulative events per 100 participants (Number) |
|---|---|
| Arm A: ART With Delayed ET Period (Step 2) | 62.57 |
KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease. (NCT01352117)
Timeframe: From study entry to Week 12
| Intervention | cumulative events per 100 participants (Number) |
|---|---|
| Arm A: ART Alone or With Delayed ET | 23.14 |
| Arm B: ART With Immediate ET | 7.40 |
Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. (NCT01352117)
Timeframe: From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A: ART Alone or With Delayed ET | 47 |
| Arm B: ART With Immediate ET | 42 |
Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
| Intervention | cells/mm^3 (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 12: CD4 change | Week 24: CD4 change | Week 32: CD4 change | Week 48: CD4 change | Week 72: CD4 change | Week 96: CD4 change | Step 2 Week 12: CD4 change | Step 2 Week 24: CD4 change | Step 2 Week 32: CD4 change | Step 2 Week 48: CD4 change | Step 2 Week 72: CD4 change | |
| Arm A: ART Alone or With Delayed ET | 40 | 57 | 90 | 125 | 143 | 149 | -13 | -15 | 28 | 2 | 51 |
Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
| Intervention | cells/mm^3 (Median) | |||||
|---|---|---|---|---|---|---|
| Week 12: CD4 change | Week 24: CD4 change | Week 32: CD4 change | Week 48: CD4 change | Week 72: CD4 change | Week 96: CD4 change | |
| Arm B: ART With Immediate ET | 67 | 121 | 119 | 121 | 125 | 206 |
ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From treatment dispensation to Week 96
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Temporarily held | Prematurely discontinued | Increased | |
| Arm A: ART Alone or With Delayed ET | 7.4 | 26.6 | 1.1 |
| Arm B: ART With Immediate ET | 11.5 | 21.9 | 0 |
The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition (NCT01380080)
Timeframe: From study entry to week 96
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: Empiric | 16.6 |
| Arm B: IPT | 11.3 |
Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48 (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.19 |
| Arm B: IPT | 0.21 |
Proportion of participants with premature discontinuation of any component of TB treatment by Week 48 (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.13 |
| Arm B: IPT | 0.05 |
Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48. Grade 3=Severe, Grade 4=Life-Threatening according to DAIDS AE Grading Table (see references). (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.32 |
| Arm B: IPT | 0.30 |
"Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48~The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST" (NCT01380080)
Timeframe: From study entry to week 48. The lab events were collected at study entry, weeks 2, 4, 8, 12, 16, 20, 24, and 48.
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.11 |
| Arm B: IPT | 0.13 |
Proportion of participants with IRIS (using current ACTG definition Appendix 60, see References) by Week 48. IRIS in participants with TB and other opportunistic infections may occur shortly after the initiation of potent combination ART, particularly in participants with advanced HIV disease. (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.04 |
| Arm B: IPT | 0.05 |
Proportion of participants with reportable hospitalization reported by Week 48 (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.10 |
| Arm B: IPT | 0.12 |
"The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24.~The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48." (NCT01380080)
Timeframe: From study entry to week 24
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: Empiric | 5.2 |
| Arm B: IPT | 5.2 |
Median time to TB treatment initiation since study entry (NCT01380080)
Timeframe: From study entry to week 96
| Intervention | Days (Median) |
|---|---|
| Arm A: Empiric | 0 |
| Arm B: IPT | 0 |
The absolute levels of CD4+ T-cell counts (cells/mm^3) (NCT01380080)
Timeframe: At weeks 0, 4, 24, and 48
| Intervention | cells/ mm^3 (Median) | |||
|---|---|---|---|---|
| Week 0 | Week 4 | Week 24 | Week 48 | |
| Arm A: Empiric | 18 | 74 | 121 | 176 |
| Arm B: IPT | 19 | 76 | 121 | 172 |
Change was calculated as the CD4+ T-cell count at the later weeks (4, 24 and 48) minus the baseline (week 0) CD4+ T-cell count. (NCT01380080)
Timeframe: Weeks 0, 4, 24 and 48
| Intervention | cells/ mm^3 (Median) | ||
|---|---|---|---|
| Week 4 | Week 24 | Week 48 | |
| Arm A: Empiric | 49 | 96 | 158 |
| Arm B: IPT | 54 | 102 | 146 |
Proportion of participants with HIV-1 RNA level <400 copies/mL. (NCT01380080)
Timeframe: At weeks 0, 4, 24, and 48
| Intervention | Proportion of participants (Number) | |||
|---|---|---|---|---|
| Week 0 | Week 4 | Week 24 | Week 48 | |
| Arm A: Empiric | 0 | 0.46 | 0.84 | 0.87 |
| Arm B: IPT | 0.01 | 0.49 | 0.85 | 0.89 |
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry. (NCT01380080)
Timeframe: From study entry to week 24
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: Empiric | 17.1 |
| Arm B: IPT | 12.5 |
The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 48. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry. (NCT01380080)
Timeframe: From study entry to week 48
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: Empiric | 19.3 |
| Arm B: IPT | 15.3 |
The Kaplan-Meier estimate of cumulative probability of death by week 24 (NCT01380080)
Timeframe: From study entry to week 24
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: Empiric | 4.8 |
| Arm B: IPT | 5.2 |
Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96 (NCT01380080)
Timeframe: From study entry to week 96
| Intervention | Proportion of participants (Number) |
|---|---|
| Arm A: Empiric | 0.08 |
| Arm B: IPT | 0.05 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 54.5 |
| PTX+ART | 36.2 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 77.5 |
| PTX+ART | 54.6 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 60.9 |
| PTX+ART | 42.0 |
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 69.8 |
| PTX+ART | 41.2 |
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 43.9 |
| PTX+ART | 25.7 |
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 7.4 |
| PTX+ART | 1.8 |
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 25.6 |
| PTX+ART | 10.7 |
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 18.5 |
| PTX+ART | 10.3 |
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 25.6 |
| PTX+ART | 10.7 |
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 18.5 |
| PTX+ART | 10.3 |
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 59.5 |
| PTX+ART | 26.0 |
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 32.5 |
| PTX+ART | 18.9 |
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144
| Intervention | Participants (Count of Participants) |
|---|---|
| ET+ART | 18 |
| PTX+ART | 34 |
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 7.8 |
| PTX+ART | 0.0 |
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 15.2 |
| PTX+ART | 28.6 |
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 17.9 |
| PTX+ART | 19.6 |
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| ET+ART | 6 |
| PTX+ART | 0 |
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| BV+ART | 2 |
| PTX+ART | 0 |
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144
| Intervention | weeks (Number) |
|---|---|
| ET+ART | 10.1 |
| PTX+ART | 19.9 |
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144
| Intervention | weeks (Number) |
|---|---|
| ET+ART | 21.0 |
| PTX+ART | 45.7 |
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 19.7 |
| PTX+ART | 49.8 |
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 44.1 |
| PTX+ART | 64.2 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 72.4 |
| PTX+ART | 54.6 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| BV+ART | 56.7 |
| PTX+ART | 42.1 |
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48
| Intervention | Cumulative events per 100 persons (Number) |
|---|---|
| ET+ART | 57.6 |
| PTX+ART | 33.9 |
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144
| Intervention | Participants (Count of Participants) |
|---|---|
| BV+ART | 80 |
| PTX+ART | 91 |
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240
| Intervention | weeks (Number) |
|---|---|
| BV+ART | 24.7 |
| PTX+ART | 38.6 |
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240
| Intervention | weeks (Number) |
|---|---|
| ET+ART | 17.9 |
| PTX+ART | 30.0 |
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48
| Intervention | cells/mm^3 (Median) | ||
|---|---|---|---|
| Week 12 CD4 change | Week 24 CD4 change | Week 48 CD4 change | |
| BV+ART | 21 | 43 | 112 |
| PTX+ART | 37 | 65 | 105 |
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48
| Intervention | cells/mm^3 (Median) | ||
|---|---|---|---|
| Week 12 CD4 change | Week 24 CD4 change | Week 48 CD4 change | |
| ET+ART | 37 | 106 | 69 |
| PTX+ART | 47 | 95 | 157 |
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm. (NCT01435018)
Timeframe: From Step 2 study entry to Step 2 discontinuation, up to 144 weeks
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response | |
| BV+ART | 1 | 0 | 1 | 1 | 2 | 7 |
| ET+ART | 1 | 0 | 0 | 0 | 1 | 0 |
| PTX+ART | 1 | 0 | 5 | 0 | 1 | 5 |
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 3 treatment arm. (NCT01435018)
Timeframe: From Step 3 study entry to Step 3 discontinuation, up to 144 weeks
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response | |
| BV+ART | 6 | 0 | 3 | 5 | 2 | 18 |
| ET+ART | 2 | 0 | 0 | 0 | 2 | 5 |
| PTX+ART | 8 | 0 | 7 | 7 | 1 | 29 |
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 4 treatment arm. (NCT01435018)
Timeframe: From Step 4 study entry to Step 4 discontinuation, up to 96 weeks
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response | |
| BV+ART | 2 | 0 | 3 | 0 | 1 | 3 |
| PTX+ART | 3 | 0 | 2 | 0 | 0 | 3 |
Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes. (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Screening | Week 3 | Week 6 | Week 9 | Week 12 | Week 15 | Week 18 | Week 21 | |
| BV+ART | 7 | 1 | 1 | 3 | 3 | 2 | 6 | 5 |
| ET+ART | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PTX+ART | 0 | 0 | 2 | 2 | 4 | 3 | 1 | 2 |
"SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) pins and needles in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade >=1 in at least one of the three assessments." (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Screening | Week 3 | Week 6 | Week 9 | Week 12 | Week 15 | Week 18 | Week 21 | |
| BV+ART | 76 | 62 | 46 | 40 | 36 | 26 | 25 | 30 |
| ET+ART | 24 | 0 | 0 | 14 | 0 | 0 | 0 | 4 |
| PTX+ART | 59 | 34 | 32 | 27 | 23 | 16 | 15 | 20 |
Adverse events classified by the site personnel as possibly, probably or definitely related to ART or chemotherapy. (NCT01435018)
Timeframe: From study entry to week 240
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Any Laboratory, Diagnosis or Signs/Symptoms | Any Laboratory | Any Diagnosis | Any Signs/Symptoms | |
| BV+ART | 32 | 27 | 12 | 9 |
| ET+ART | 25 | 25 | 10 | 5 |
| PTX+ART | 48 | 39 | 16 | 18 |
ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses. (NCT01435018)
Timeframe: At Weeks 6, 12, 18, 30 and 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 6 Perfect Adherence | Week 12 Perfect Adherence | Week 18 Perfect adherence | Week 30 Perfect adherence | Week 48 Perfect adherence | |
| BV+ART | 101 | 101 | 85 | 66 | 13 |
| ET+ART | 43 | 36 | 29 | 13 | 0 |
| PTX+ART | 106 | 103 | 97 | 85 | 20 |
To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation. (NCT01815580)
Timeframe: 48 weeks
| Intervention | Percent of dispensed pills taken (Mean) |
|---|---|
| Immediate ART (Atripla or Stribild) | 93.6 |
| Deferred ART (Atripla or Stribild) | 91.5 |
To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care. (NCT01815580)
Timeframe: within 3 months of diagnosis of acute HIV infection
| Intervention | Participants (Count of Participants) |
|---|---|
| Acute | 71 |
Partner tracing and notification (NCT01815580)
Timeframe: within 3 months of diagnosis
| Intervention | Participants (Count of Participants) |
|---|---|
| HIV Positive Participants | 0 |
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. (NCT01815580)
Timeframe: HIV diagnosis visit
| Intervention | percentage of participants (Number) |
|---|---|
| Cluster Membership | 27 |
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48 (NCT01815580)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| CD4 at Baseline | CD4 at Week 12 | CD4 at Week 24 | CD4 at Week 36 | CD4 at Week 48 | |
| Deferred ART (Atripla or Stribild) | 110 | 104 | 104 | 100 | 98 |
| Immediate ART (Atripla or Stribild) | 103 | 99 | 97 | 97 | 96 |
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48 (NCT01815580)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| CASI at Baseline | CASI at Week 12 | CASI at Week 24 | CASI at Week 36 | CASI at Week 48 | |
| Deferred ART (Atripla or Stribild) | 109 | 102 | 100 | 99 | 92 |
| Immediate ART (Atripla or Stribild) | 100 | 96 | 95 | 92 | 90 |
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48 (NCT01815580)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| VL at Baseline | VL at Week 12 | VL at Week 24 | VL at week 36 | VL at Week 48 | |
| Deferred ART (Atripla or Stribild) | 111 | 104 | 104 | 99 | 98 |
| Immediate ART (Atripla or Stribild) | 105 | 98 | 95 | 96 | 95 |
To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48 (NCT01815580)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Retained at Week 12 | Retained at Week 24 | Retained at Week 36 | Retained at Week 48 | |
| Deferred ART (Atripla or Stribild) | 106 | 105 | 103 | 101 |
| Immediate ART (Atripla or Stribild) | 102 | 101 | 98 | 96 |
To quantify HIV viral load suppression (<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was <1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was <1000 copies/mL etc. (NCT01815580)
Timeframe: Baseline, Week 12, Week 24, Week 36, and Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Suppressed at Baseline | Suppressed at week 12 | Suppressed at week 24 | Suppressed at week 36 | Suppressed at week 48 | |
| Deferred ART (Atripla or Stribild) | 1 | 8 | 18 | 89 | 92 |
| Immediate ART (Atripla or Stribild) | 2 | 84 | 93 | 91 | 94 |
To quantify HIV viral load suppression (<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks (NCT01815580)
Timeframe: Baseline, Week 12, and Week 24
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Suppressed Baseline | Suppressed week 12 | Suppressed week 24 | |
| Deferred ART (Atripla or Stribild) | 7 | 17 | 9 |
| Immediate ART (Atripla or Stribild) | 4 | 21 | 19 |
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. (NCT01815580)
Timeframe: HIV diagnosis visit
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Heavy drinker71951426 | Heavy drinker71951427 | Audit Score >=2071951426 | Audit Score >=2071951427 | Any illicit drug use71951426 | Any illicit drug use71951427 | Sex Work71951426 | Sex Work71951427 | Met a sex partner at any venue71951426 | Met a sex partner at any venue71951427 | |||||||||||||||||||||
| Yes | No | Missing data | ||||||||||||||||||||||||||||
| Not in Cluster | 30 | |||||||||||||||||||||||||||||
| In a Cluster | 14 | |||||||||||||||||||||||||||||
| Not in Cluster | 57 | |||||||||||||||||||||||||||||
| In a Cluster | 26 | |||||||||||||||||||||||||||||
| Not in Cluster | 52 | |||||||||||||||||||||||||||||
| In a Cluster | 22 | |||||||||||||||||||||||||||||
| Not in Cluster | 16 | |||||||||||||||||||||||||||||
| In a Cluster | 4 | |||||||||||||||||||||||||||||
| Not in Cluster | 117 | |||||||||||||||||||||||||||||
| In a Cluster | 49 | |||||||||||||||||||||||||||||
| Not in Cluster | 6 | |||||||||||||||||||||||||||||
| In a Cluster | 9 | |||||||||||||||||||||||||||||
| Not in Cluster | 13 | |||||||||||||||||||||||||||||
| Not in Cluster | 126 | |||||||||||||||||||||||||||||
| In a Cluster | 58 | |||||||||||||||||||||||||||||
| Not in Cluster | 0 | |||||||||||||||||||||||||||||
| In a Cluster | 0 | |||||||||||||||||||||||||||||
| In a Cluster | 5 | |||||||||||||||||||||||||||||
| Not in Cluster | 123 | |||||||||||||||||||||||||||||
| In a Cluster | 56 | |||||||||||||||||||||||||||||
| In a Cluster | 1 | |||||||||||||||||||||||||||||
| Not in Cluster | 62 | |||||||||||||||||||||||||||||
| In a Cluster | 37 | |||||||||||||||||||||||||||||
| Not in Cluster | 77 | |||||||||||||||||||||||||||||
| In a Cluster | 25 | |||||||||||||||||||||||||||||
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TAF | 0.7 |
| EFV/FTC/TDF | 0.9 |
The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. (NCT02345226)
Timeframe: Baseline; Week 48
| Intervention | units on a scale (Mean) |
|---|---|
| FTC/RPV/TAF | 0 |
| EFV/FTC/TDF | -1 |
(NCT02345226)
Timeframe: Baseline; Week 48
| Intervention | cells/µL (Mean) |
|---|---|
| FTC/RPV/TAF | 23 |
| EFV/FTC/TDF | 12 |
(NCT02345226)
Timeframe: Baseline; Week 96
| Intervention | cells/µL (Mean) |
|---|---|
| FTC/RPV/TAF | 12 |
| EFV/FTC/TDF | 6 |
The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. (NCT02345226)
Timeframe: Baseline; Week 96
| Intervention | units on a scale (Mean) |
|---|---|
| FTC/RPV/TAF | 0 |
| EFV/FTC/TDF | -1 |
Hip BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 96
| Intervention | percentage change (Mean) |
|---|---|
| FTC/RPV/TAF | 1.831 |
| EFV/FTC/TDF | -0.617 |
Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT02345226)
Timeframe: Baseline; Week 48
| Intervention | percentage change (Mean) |
|---|---|
| FTC/RPV/TAF | 1.279 |
| EFV/FTC/TDF | -0.134 |
Spine BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 48
| Intervention | percentage change (Mean) |
|---|---|
| FTC/RPV/TAF | 1.645 |
| EFV/FTC/TDF | -0.045 |
Spine BMD was assessed by DXA scan. (NCT02345226)
Timeframe: Baseline; Week 96
| Intervention | percentage change (Mean) |
|---|---|
| FTC/RPV/TAF | 1.701 |
| EFV/FTC/TDF | 0.126 |
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TAF | 90.0 |
| EFV/FTC/TDF | 92.0 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TAF | 85.2 |
| EFV/FTC/TDF | 85.1 |
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02345226)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| FTC/RPV/TAF | 1.1 |
| EFV/FTC/TDF | 0.9 |
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | 198.4 |
| ATRIPLA™ | 188.4 |
"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)." (NCT02403674)
Timeframe: Up to Week 48
| Intervention | Percentage of Participants (Number) | ||
|---|---|---|---|
| Dizziness | Sleep disorders and disturbances | Altered sensorium | |
| ATRIPLA™ | 37.1 | 25.5 | 8.2 |
| MK-1439A | 8.8 | 12.1 | 4.4 |
The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | -1.97 |
| ATRIPLA™ | 21.77 |
The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | -12.40 |
| ATRIPLA™ | 22.01 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| MK-1439A | 3.0 |
| ATRIPLA™ | 6.6 |
The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | -3.83 |
| ATRIPLA™ | 13.26 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| MK-1439A | 82.7 |
| ATRIPLA™ | 90.7 |
"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48
| Intervention | Percentage of Participants (Number) |
|---|---|
| MK-1439A | 84.3 |
| ATRIPLA™ | 80.8 |
"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48
| Intervention | Percentage of Participants (Number) |
|---|---|
| MK-1439A | 83.8 |
| ATRIPLA™ | 79.7 |
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed. (NCT02403674)
Timeframe: Week 48
| Intervention | Percentage of Participants (Number) |
|---|---|
| MK-1439A | 59.6 |
| ATRIPLA™ | 55.5 |
"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders." (NCT02403674)
Timeframe: Up to Week 48
| Intervention | Percentage of Participants (Number) | |
|---|---|---|
| Depression and suicide/self-injury | Psychosis and psychotic disorders | |
| ATRIPLA™ | 6.6 | 1.1 |
| MK-1439A | 4.1 | 0.3 |
Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose. (NCT02403674)
Timeframe: 0 hours post-dose and 2 hours post-dose on Week 48
| Intervention | nM (Mean) | |
|---|---|---|
| Pre-dose | 0.5 to 2 hours post-dose | |
| MK-1439A | 1290 | 2330 |
The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | -1.58 |
| ATRIPLA™ | 8.74 |
The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
| Intervention | Percent Change from Baseline (Mean) |
|---|---|
| MK-1439A | 1.86 |
| ATRIPLA™ | 8.51 |
Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| < 50 copies/mL | < 40 copies/mL | |
| Combined Treatment Groups | 95.3 | 95.3 |
Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
| Intervention | mg/dL (Mean) | ||||
|---|---|---|---|---|---|
| LDL Cholesterol | Non-HDL Cholesterol | Cholesterol | HDL Cholesterol | Triglyceride | |
| Combined Treatment Groups | -10.97 | -13.18 | -20.91 | -7.72 | -12.99 |
Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. (NCT02652260)
Timeframe: Baseline (study Day 1) and study week 12
| Intervention | mg/dL (Mean) | ||||
|---|---|---|---|---|---|
| LDL Cholesterol | Non-HDL Cholesterol | Cholesterol | HDL Cholesterol | Triglyceride | |
| Deferred Switch to MK-1439A | -1.88 | -0.37 | 0.00 | 0.37 | 7.10 |
| Immediate Switch to MK-1439A | -10.78 | -14.08 | -22.14 | -8.05 | -21.19 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 4
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Switch to MK-1439A | 46.5 |
| Deferred Switch to MK-1439A | 65.1 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
| Intervention | Percentage of participants (Number) |
|---|---|
| Combined Treatment Groups: Time of Switch | 68.6 |
| Combined Treatment Groups: Week 24 Post-Switch | 30.2 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Immediate Switch to MK-1439A | 41.9 |
| Deferred Switch to MK-1439A | 37.2 |
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Treatment Groups | 0 |
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. (NCT02652260)
Timeframe: Up to Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Immediate Switch to MK-1439A | 14 |
| Deferred Switch to MK-1439A | 9 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Treatment Groups | 18 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Treatment Groups | 71 |
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Immediate Switch to MK-1439A | 34 |
| Deferred Switch to MK-1439A | 34 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Immediate Switch to MK-1439A | 0 |
| Deferred Switch to MK-1439A | 0 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Treatment Groups | 0 |
Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Combined Treatment Groups | 70.4 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 4
| Intervention | Percentage of maximum score (Mean) |
|---|---|
| Immediate Switch to MK-1439A | -17.6 |
| Deferred Switch to MK-1439A | -15.6 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 12
| Intervention | Percentage of maximum score (Mean) |
|---|---|
| Immediate Switch to MK-1439A | -18.1 |
| Deferred Switch to MK-1439A | -21.7 |
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
| Intervention | Percentage of maximum score (Mean) |
|---|---|
| Combined Treatment Groups: Time of Switch | 24.2 |
| Combined Treatment Groups: Week 24 Post-Switch | 10.7 |
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. (NCT02652260)
Timeframe: Up to Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Immediate Switch to MK-1439A | 0 |
| Deferred Switch to MK-1439A | 0 |
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Treatment Groups | 1 |
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. (NCT02652260)
Timeframe: Up to Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Immediate Switch to MK-1439A | 0 |
| Deferred Switch to MK-1439A | 0 |
Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.378 |
| Arm 2: Maternal DTG+FTC/TDF | 0.319 |
| Arm 3: Maternal EFV/FTC/TDF | 0.291 |
The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 1.0 |
| Arm 2 Infants | 2.0 |
| Arm 3 Infants | 6.9 |
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 88.9 |
| Arm 2: Maternal DTG+FTC/TDF | 92.6 |
| Arm 3: Maternal EFV/FTC/TDF | 81.0 |
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 75.6 |
| Arm 2: Maternal DTG+FTC/TDF | 77.7 |
| Arm 3: Maternal EFV/FTC/TDF | 76.3 |
Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 94.4 |
| Arm 3: Maternal EFV/FTC/TDF | 78.8 |
Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 96.3 |
| Arm 3: Maternal EFV/FTC/TDF | 96.4 |
Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.92 |
| Arm 2: Maternal DTG+FTC/TDF | 1.86 |
| Arm 3: Maternal EFV/FTC/TDF | 6.16 |
Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 5.8 |
| Arm 2: Maternal DTG+FTC/TDF | 9.4 |
| Arm 3: Maternal EFV/FTC/TDF | 12.1 |
Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 24.1 |
| Arm 2: Maternal DTG+FTC/TDF | 32.9 |
| Arm 3: Maternal EFV/FTC/TDF | 33.2 |
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 28.4 |
| Arm 3: Maternal EFV/FTC/TDF | 32.7 |
Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth
| Intervention | percentage of participants (Number) |
|---|---|
| Arm 1 Infants | 16.3 |
| Arm 2 Infants | 22.5 |
| Arm 3 Infants | 20.5 |
Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
| Intervention | mL/min (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | -0.980 |
| Arm 2: Maternal DTG+FTC/TDF | -0.887 |
| Arm 3: Maternal EFV/FTC/TDF | -0.935 |
"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 25.1 |
| Arm 2: Maternal DTG+FTC/TDF | 30.8 |
| Arm 3: Maternal EFV/FTC/TDF | 27.9 |
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 27.9 |
| Arm 3: Maternal EFV/FTC/TDF | 27.9 |
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 25.3 |
| Arm 2 Infants | 28.6 |
| Arm 3 Infants | 30.9 |
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arms 1 and 2 Infants | 26.8 |
| Arm 3 Infants | 30.9 |
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
| Intervention | percentage of mother-infant pairs (Number) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 24.1 |
| Arm 2: Maternal DTG+FTC/TDF | 32.9 |
| Arm 3: Maternal EFV/FTC/TDF | 32.7 |
The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
| Intervention | Cumulative probability per 100 persons (Number) |
|---|---|
| Arm 1 Infants | 0.98 |
| Arm 2 Infants | 0.50 |
| Arm 3 Infants | 0.55 |
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Intention-to-Treat Analysis | Per-Protocol Analysis | |
| Arm 3: Maternal EFV/FTC/TDF | 91.0 | 91.4 |
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 97.5 | 97.5 |
Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm 1 Infants | 1 |
| Arm 2 Infants | 0 |
| Arm 3 Infants | 1 |
Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | 0.014 |
| Arm 2: Maternal DTG+FTC/TDF | -0.008 |
| Arm 3: Maternal EFV/FTC/TDF | -0.032 |
Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
| Intervention | kg/week (Mean) |
|---|---|
| Arm 1: Maternal DTG+FTC/TAF | -0.027 |
| Arm 2: Maternal DTG+FTC/TDF | -0.050 |
| Arm 3: Maternal EFV/FTC/TDF | -0.084 |
Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum
| Intervention | mL/min (Mean) | |
|---|---|---|
| Delivery | 26 Weeks Postpartum | |
| Arm 1 Infants | 52.7 | 134.8 |
| Arm 2 Infants | 53.1 | 123.6 |
| Arm 3 Infants | 49.0 | 135.0 |
Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery
| Intervention | weeks (Mean) |
|---|---|
| Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 4.26 |
| Arm 3: Maternal EFV/FTC/TDF | 6.49 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| adenine [no description available] | 12.82 | 44 | 6 | 6-aminopurines; purine nucleobase | Daphnia magna metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| carbamates [no description available] | 6.33 | 4 | 2 | amino-acid anion | |
| pyrazinamide pyrazinecarboxamide : A monocarboxylic acid amide resulting from the formal condensation of the carboxy group of pyrazinoic acid (pyrazine-2-carboxylic acid) with ammonia. A prodrug for pyrazinoic acid, pyrazinecarboxamide is used as part of multidrug regimens for the treatment of tuberculosis. | 3.47 | 1 | 1 | monocarboxylic acid amide; N-acylammonia; pyrazines | antitubercular agent; prodrug |
| fluconazole Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis. | 2.04 | 1 | 0 | conazole antifungal drug; difluorobenzene; tertiary alcohol; triazole antifungal drug | environmental contaminant; P450 inhibitor; xenobiotic |
| 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). | 3.47 | 1 | 1 | carbohydrazide | antitubercular agent; drug allergen |
| 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. | 2.51 | 2 | 0 | cyclopropanes; dipyridodiazepine | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| 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. | 6.32 | 4 | 2 | monohydroxyquinoline; quinolone | bacterial xenobiotic metabolite |
| thiazoles [no description available] | 6.1 | 3 | 2 | 1,3-thiazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| hydrazine diamine : Any polyamine that contains two amino groups. | 2.07 | 1 | 0 | azane; hydrazines | EC 4.3.1.10 (serine-sulfate ammonia-lyase) inhibitor |
| limestone Calcium Carbonate: Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.. calcium carbonate : A calcium salt with formula CCaO3. | 3.64 | 1 | 1 | calcium salt; carbonate salt; inorganic calcium salt; one-carbon compound | antacid; fertilizer; food colouring; food firming agent |
| deoxycytidine [no description available] | 12.82 | 44 | 6 | pyrimidine 2'-deoxyribonucleoside | Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| ethambutol Ethambutol: An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863). ethambutol : An ethylenediamine derivative that is ethane-1,2-diamine in which one hydrogen attached to each of the nitrogens is sutstituted by a 1-hydroxybutan-2-yl group (S,S-configuration). It is a bacteriostatic antimycobacterial drug, effective against Mycobacterium tuberculosis and some other mycobacteria. It is used (as the dihydrochloride salt) in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol is used alone. | 3.47 | 1 | 1 | ethanolamines; ethylenediamine derivative | antitubercular agent; environmental contaminant; xenobiotic |
| 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 | 2.13 | 1 | 0 | dihydrofuran; nucleoside analogue; organic molecular entity | antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| 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. | 2.13 | 1 | 0 | azide; pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| lamivudine [no description available] | 3.03 | 4 | 0 | monothioacetal; 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 |
| 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. | 6.71 | 6 | 1 | monothioacetal; 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. | 6.54 | 9 | 2 | acetylenic compound; benzoxazine; cyclopropanes; organochlorine compound; organofluorine compound | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| 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. | 2.11 | 1 | 0 | 1,2,3-triazole | |
| lopinavir [no description available] | 2.05 | 1 | 0 | amphetamines; dicarboxylic acid diamide | anticoronaviral agent; antiviral drug; HIV protease inhibitor |
| 1-hexadecyl-2-acetyl-glycero-3-phosphocholine Platelet Activating Factor: A phospholipid derivative formed by PLATELETS; BASOPHILS; NEUTROPHILS; MONOCYTES; and MACROPHAGES. It is a potent platelet aggregating agent and inducer of systemic anaphylactic symptoms, including HYPOTENSION; THROMBOCYTOPENIA; NEUTROPENIA; and BRONCHOCONSTRICTION.. 2-O-acetyl-1-O-hexadecyl-sn-glycero-3-phosphocholine : A 2-acetyl-1-alkyl-sn-glycero-3-phosphocholine betaine which has hexadecyl as the alkyl group. PAF is a potent phospholipid activator and mediator of many leukocyte functions, including platelet aggregation, inflammation, and anaphylaxis. | 2.07 | 1 | 0 | 2-acetyl-1-alkyl-sn-glycero-3-phosphocholine | antihypertensive agent; beta-adrenergic antagonist; bronchoconstrictor agent; hematologic agent; vasodilator 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. | 2.08 | 1 | 0 | sulfonamide | prodrug |
| 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. | 2.75 | 3 | 0 | organic sulfate salt | |
| organophosphonates hydrogenphosphite : A divalent inorganic anion resulting from the removal of a proton from two of the hydroxy groups of phosphorous acid. | 12.82 | 44 | 6 | divalent inorganic anion; phosphite ion | |
| etravirine [no description available] | 4.06 | 1 | 0 | aminopyrimidine; 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. | 6.95 | 4 | 2 | carbamate ester; furofuran; sulfonamide | antiviral drug; HIV protease inhibitor |
| 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. | 2.04 | 1 | 0 | ||
| 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. | 4.73 | 3 | 2 | 1,3-thiazoles; carbamate ester; carboxamide; L-valine derivative; ureas | antiviral drug; environmental contaminant; HIV protease inhibitor; xenobiotic |
| 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. | 2.13 | 1 | 0 | 2,6-diaminopurines | antiviral drug; drug allergen; HIV-1 reverse transcriptase inhibitor |
| 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. | 6.71 | 6 | 1 | nucleoside analogue; phosphonic acids | antiviral drug; drug metabolite; HIV-1 reverse transcriptase inhibitor |
| maraviroc [no description available] | 2.11 | 1 | 0 | tropane alkaloid | |
| orlistat Orlistat: A lactone derivative of LEUCINE that acts as a pancreatic lipase inhibitor to limit the absorption of dietary fat; it is used in the management of obesity.. orlistat : A carboxylic ester resulting from the formal condensation of the carboxy group of N-formyl-L-leucine with the hydroxy group of (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one. A pancreatic lipase inhibitor, it is used as an anti-obesity drug. | 2.07 | 1 | 0 | beta-lactone; carboxylic ester; formamides; L-leucine derivative | anti-obesity agent; bacterial metabolite; EC 2.3.1.85 (fatty acid synthase) inhibitor; EC 3.1.1.3 (triacylglycerol lipase) inhibitor |
| abacavir, lamivudine drug combination abacavir, lamivudine drug combination: combination of Epivir and Ziagen | 2.5 | 2 | 0 | ||
| jtk-303 [no description available] | 2.05 | 1 | 0 | aromatic ether; monochlorobenzenes; organofluorine compound; quinolinemonocarboxylic acid; quinolone | HIV-1 integrase inhibitor |
| topiramate Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. | 2.31 | 1 | 0 | cyclic ketal; ketohexose derivative; sulfamate ester | anticonvulsant; sodium channel blocker |
| rilpivirine [no description available] | 3.17 | 1 | 0 | aminopyrimidine; nitrile | EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor |
| 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. | 2.75 | 3 | 0 | ||
| chitosan [no description available] | 2.15 | 1 | 0 | ||
| raltegravir potassium Raltegravir Potassium: A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION. | 5.62 | 3 | 2 | ||
| quad pill Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: A pharmaceutical preparation of the ANTI-HIV AGENTS elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate that is used in the treatment of HIV INFECTIONS. | 6.88 | 5 | 3 | ||
| bryostatin 1 bryostatin 1: a protein kinase C activator; macrocyclic lactone from marine Bryozoan Bugula neritina; RN given refers to (1S*-(1R*,3R*,5Z,7S*,8E,11R*,12R*(2E,4E),13E,15R*,17S*(S*),21S*,23S*,25R*))-isomer; structure given in first source; activates protein kinase c. bryostatin 1 : A member of the class of bryostatins that is (17E)-2-oxooxacyclohexacos-17-ene which is substituted by hydroxy groups at positions 4, 10, and 20; an acetoxy group at position 8; methyl groups at positions 9, 9, 18, and 19; 2-methoxy-2-oxoethylidene groups at positions 14 and 24; an (E,E)-octa-2,4-dienoyloxy group at position 21; and with oxygen bridges linking positions 6 to 10, 12 to 16, and 20 to 24. It is one of the most abundant member of the class of bryostatins. | 2.11 | 1 | 0 | ||
| 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. | 2.04 | 1 | 0 | sulfonamide | antiviral drug; HIV protease inhibitor |
| tigecycline [no description available] | 2.25 | 1 | 0 | ||
| dolutegravir [no description available] | 2.13 | 1 | 0 | difluorobenzene; monocarboxylic acid amide; organic heterotricyclic compound; secondary carboxamide | HIV-1 integrase inhibitor |
| 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) | 3.86 | 2 | 1 | cyclic 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 |
| amg531 [no description available] | 2.07 | 1 | 0 | ||
| trifazid [no description available] | 3.47 | 1 | 1 | ||
| pyrimidinones Pyrimidinones: Heterocyclic compounds known as 2-pyrimidones (or 2-hydroxypyrimidines) and 4-pyrimidones (or 4-hydroxypyrimidines) with the general formula C4H4N2O. | 2.05 | 1 | 0 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Cognitive Decline [description not available] | 0 | 2.63 | 2 | 0 |
| Alloxan Diabetes [description not available] | 0 | 2.31 | 1 | 0 |
| Diabetes Mellitus, Adult-Onset [description not available] | 0 | 2.31 | 1 | 0 |
| Asymmetric Diabetic Proximal Motor Neuropathy [description not available] | 0 | 2.31 | 1 | 0 |
| 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. | 0 | 2.31 | 1 | 0 |
| Diabetic Neuropathies Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325) | 0 | 2.31 | 1 | 0 |
| Cognitive Dysfunction Diminished or impaired mental and/or intellectual function. | 0 | 2.63 | 2 | 0 |
| HIV Coinfection [description not available] | 0 | 13.95 | 57 | 13 |
| 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). | 0 | 13.95 | 57 | 13 |
| Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted [description not available] | 0 | 2.41 | 1 | 0 |
| 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. | 0 | 2.41 | 1 | 0 |
| Infections, Klebsiella [description not available] | 0 | 2.25 | 1 | 0 |
| Infection, Postoperative Wound [description not available] | 0 | 2.25 | 1 | 0 |
| Cerebral Ventriculitis Inflammation of CEREBRAL VENTRICLES. | 0 | 2.25 | 1 | 0 |
| Klebsiella Infections Infections with bacteria of the genus KLEBSIELLA. | 0 | 2.25 | 1 | 0 |
| Bone Loss, Osteoclastic [description not available] | 0 | 3.64 | 1 | 1 |
| Innate Inflammatory Response [description not available] | 0 | 4.5 | 2 | 2 |
| 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. | 0 | 4.5 | 2 | 2 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 2.83 | 3 | 0 |
| Acquired Immune Deficiency Syndrome [description not available] | 0 | 2.77 | 3 | 0 |
| Kaposi Sarcoma [description not available] | 0 | 2.17 | 1 | 0 |
| Cancer of Skin [description not available] | 0 | 2.17 | 1 | 0 |
| Cancer of Stomach [description not available] | 0 | 2.17 | 1 | 0 |
| 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. | 0 | 2.77 | 3 | 0 |
| Conjunctival Neoplasms Tumors or cancer of the CONJUNCTIVA. | 0 | 2.17 | 1 | 0 |
| Sarcoma, Kaposi A multicentric, malignant neoplastic vascular proliferation characterized by the development of bluish-red cutaneous nodules, usually on the lower extremities, most often on the toes or feet, and slowly increasing in size and number and spreading to more proximal areas. The tumors have endothelium-lined channels and vascular spaces admixed with variably sized aggregates of spindle-shaped cells, and often remain confined to the skin and subcutaneous tissue, but widespread visceral involvement may occur. Kaposi's sarcoma occurs spontaneously in Jewish and Italian males in Europe and the United States. An aggressive variant in young children is endemic in some areas of Africa. A third form occurs in about 0.04% of kidney transplant patients. There is also a high incidence in AIDS patients. (From Dorland, 27th ed & Holland et al., Cancer Medicine, 3d ed, pp2105-7) HHV-8 is the suspected cause. | 0 | 2.17 | 1 | 0 |
| Skin Neoplasms Tumors or cancer of the SKIN. | 0 | 2.17 | 1 | 0 |
| Stomach Neoplasms Tumors or cancer of the STOMACH. | 0 | 2.17 | 1 | 0 |
| Adverse Drug Event [description not available] | 0 | 6.26 | 4 | 3 |
| 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. | 0 | 6.26 | 4 | 3 |
| 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. | 0 | 2.81 | 3 | 0 |
| 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. | 0 | 3.47 | 1 | 1 |
| 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. | 0 | 3.47 | 1 | 1 |
| 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. | 0 | 2.11 | 1 | 0 |
| Complications, Infectious Pregnancy [description not available] | 0 | 2.13 | 1 | 0 |
| Behavior Disorders [description not available] | 0 | 2.13 | 1 | 0 |
| Allergy, Drug [description not available] | 0 | 2.13 | 1 | 0 |
| 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. | 0 | 2.13 | 1 | 0 |
| Drug Hypersensitivity Immunologically mediated adverse reactions to medicinal substances used legally or illegally. | 0 | 2.13 | 1 | 0 |
| Acute Kidney Failure [description not available] | 0 | 2.15 | 1 | 0 |
| 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. | 0 | 2.15 | 1 | 0 |
| Diffuse Large B-Cell Lymphoma [description not available] | 0 | 2.04 | 1 | 0 |
| 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. | 0 | 2.04 | 1 | 0 |
| Bartonella bacilliformis Infection [description not available] | 0 | 2.05 | 1 | 0 |
| Neuroretinitis [description not available] | 0 | 2.05 | 1 | 0 |
| Retinitis Inflammation of the RETINA. It is rarely limited to the retina, but is commonly associated with diseases of the choroid (CHORIORETINITIS) and of the OPTIC DISK (neuroretinitis). | 0 | 2.05 | 1 | 0 |
| AIDS Seroconversion [description not available] | 0 | 2.48 | 2 | 0 |
| 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). | 0 | 2.07 | 1 | 0 |
| Central Nervous System Disease [description not available] | 0 | 2.07 | 1 | 0 |
| Chronic Insomnia [description not available] | 0 | 2.07 | 1 | 0 |
| Central Nervous System Diseases Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord. | 0 | 2.07 | 1 | 0 |
| Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. | 0 | 2.07 | 1 | 0 |
| 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. | 0 | 2.07 | 1 | 0 |
| Psychoses, Drug [description not available] | 0 | 2.07 | 1 | 0 |
| Thrombopenia [description not available] | 0 | 2.07 | 1 | 0 |
| Immune Reconstitution Disease [description not available] | 0 | 2.07 | 1 | 0 |
| Thrombocytopenia A subnormal level of BLOOD PLATELETS. | 0 | 2.07 | 1 | 0 |
| Pulmonary Consumption [description not available] | 0 | 3.47 | 1 | 1 |
| Tuberculosis, Pulmonary MYCOBACTERIUM infections of the lung. | 0 | 3.47 | 1 | 1 |
| Hepatic Failure [description not available] | 0 | 2.07 | 1 | 0 |
| 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) | 0 | 2.07 | 1 | 0 |