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. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 11954236 |
| SCHEMBL ID | 17373214 |
| MeSH ID | M000605888 |
| Synonym |
|---|
| emtricitabine / tenofovir disoproxil fumarate |
| emtricitabine and tenofovir disoproxil fumarate |
| emtricitabine, tenofovir disoproxil fumarate drug combination |
| tenofovir disoproxil fumarate/emtricitabine |
| emtricitabine and tenofovir |
| 731772-45-5 |
| emtricitabine / tenofovir |
| tenofovir / emtricitabine |
| SCHEMBL17373214 |
| emtricitabine tenofovir df |
| VERWQPYQDXWOGT-LVJNJWHOSA-N |
| emtricitabine tenofovir disoproxil fumarate |
| Q2412859 |
| tenofovir/emtricitabine |
| 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 |
| Excerpt | Reference | Relevance |
|---|---|---|
| " Using in vitro kinetic parameters for TFV and the OAT1 and OAT3 inhibitor probenecid, a bottom-up physiologically-based pharmacokinetic model was successfully developed for the first time that accurately describes the probenecid-TFV interaction." | ( Probenecid-Boosted Tenofovir: A Physiologically-Based Pharmacokinetic Model-Informed Strategy for On-Demand HIV Preexposure Prophylaxis. Desta, Z; Gufford, BT; Liu, SN, 2020) | 0.56 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "Efficacy results were consistent with the ARTEN study demonstrating that NVP was non-inferior to ATV/r when taken in combination with TDF/FTC." | ( A randomised comparison of safety and efficacy of nevirapine vs. atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients. Bhatti, L; Conner, C; Dejesus, E; Mills, A; Storfer, S, 2011) | 0.37 |
| " A related issue is whether a drug-drug interaction (DDI) exists between gender affirming hormone therapy (GAHT) and PrEP." | ( Pharmacology and drug interactions with HIV PrEP in transgender persons receiving gender affirming hormone therapy. Anderson, PL; Yager, JL, 2020) | 0.56 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "To evaluate the relative bioavailability of a new formulation of emtricitabine (EMT) 200 mg and tenofovir disoproxil fumarate (TNF) 300 mg and to compare with reference formulation to meet regulatory criteria in Argentina." | ( Comparative bioavailability of two tablet formulations of emtricitabine/tenofovir in healthy, fasting volunteers: a single-dose, randomized-sequence, open-label crossover study. Bertuola, RA; Czerniuk, P; Di Girolamo, G; Gimenez, MI; Keller, GA; Mendez, M, 2016) | 0.43 |
| " The latter was further converted to two orally bioavailable prodrug forms, TDF and TAF, and both TDF and TAF were further combined with other antiviral drugs, thus giving rise to a broad array of antiviral drug combinations for the treatment of HIV infections." | ( The Elegance of the Acyclic Nucleoside Phosphonates (ANPs), Honorary Tribute to Antonín Holý, Who Passed Away on 16 July 2012, at the 10th Anniversary of His Death. De Clercq, E, 2022) | 0.72 |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 20 (8.37) | 29.6817 |
| 2010's | 191 (79.92) | 24.3611 |
| 2020's | 28 (11.72) | 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 moderate demand-to-supply ratio for research on this compound.
| This Compound (22.93) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 31 (12.20%) | 5.53% |
| Reviews | 25 (9.84%) | 6.00% |
| Case Studies | 14 (5.51%) | 4.05% |
| Observational | 4 (1.57%) | 0.25% |
| Other | 180 (70.87%) | 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 | ||
|---|---|---|---|---|---|---|---|
| Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in [NCT03706924] | Phase 1 | 140 participants (Actual) | Interventional | 2018-06-01 | Completed | ||
| A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™ [NCT00369941] | Phase 3 | 566 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
| A Prospective, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Raltegravir + Truvada Versus Kaletra + Truvada, for Post-exposure Prophylaxis in Health Care Workers [NCT01234116] | Phase 4 | 16 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs [NCT04140266] | Phase 3 | 394 participants (Actual) | Interventional | 2020-09-24 | 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.) | ||
| A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1 [NCT01345630] | Phase 3 | 813 participants (Actual) | Interventional | 2011-09-30 | Terminated(stopped due to See termination reason in detailed description.) | ||
| Optimal Combination Therapy After Nevirapine Exposure [NCT00089505] | Phase 3 | 745 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH [NCT01114425] | Phase 3 | 149 participants (Actual) | Interventional | 2010-11-01 | Completed | ||
| A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects [NCT01118871] | Phase 4 | 3 participants (Actual) | Interventional | 2010-05-31 | Terminated | ||
| Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation [NCT02968576] | 25 participants (Actual) | Interventional | 2016-12-31 | Completed | |||
| A Phase IV, Open-label Three-arm Study Investigating the Impact of a Combination of Tenofovir Disoproxil Fumarate/Emtricitabine With Raltegravir or Dolutegravir or Elvitegravir/Cobicistat on Renal Tubular Function and Renal Transporters in HIV-1 Antiretro [NCT02351908] | Phase 4 | 60 participants (Actual) | Interventional | 2015-03-31 | Completed | ||
| Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities [NCT02985996] | Phase 1 | 48 participants (Actual) | Interventional | 2017-02-06 | Completed | ||
| Defining Antiretroviral Pharmacology Within HIV-1 Reservoirs of Males and Females [NCT02924389] | Phase 4 | 22 participants (Actual) | Interventional | 2016-09-30 | Terminated(stopped due to This study terminated early due to the ongoing covid-19 pandemic making it unsafe to recruit participants for in-person visits. Participants are living with HIV who are antiretroviral therapy-naive and are at high risk of COVID-19 complications.) | ||
| Bioequivalence of Crushed and Whole Genvoya Tablets (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate) [NCT03717129] | Phase 4 | 12 participants (Actual) | Interventional | 2019-04-15 | Completed | ||
| A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects [NCT00118898] | Phase 3 | 1,864 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
| Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine [NCT00099632] | Phase 2 | 484 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
| A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B [NCT00116805] | Phase 3 | 266 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
| Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study. [NCT02203461] | Phase 1 | 30 participants (Actual) | Interventional | 2014-07-31 | Completed | ||
| Effects of the Anti-HIV Pill Truvada on Gene Transcription in the Gastrointestinal Tract of HIV-uninfected Individuals [NCT02621242] | 9 participants (Actual) | Interventional | 2015-12-31 | Completed | |||
| Demonstration Project of Early Antiretroviral Therapy and Pre-exposure Prophylaxis for HIV Prevention Among Female Sex Workers in Cotonou, Benin [NCT02237027] | Phase 4 | 361 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
| A Pilot Prospective Cohort Evaluation of Uptake and Adherence to PrEP in Young South African Women [NCT03142256] | Phase 4 | 200 participants (Actual) | Interventional | 2017-03-24 | Active, not 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 | ||
| Pre-exposure Option for Reducing HIV in the UK: an Open-label Randomisation to Immediate or Deferred Daily Truvada for HIV Negative Gay Men.(PROUD) [NCT02065986] | Phase 4 | 544 participants (Actual) | Interventional | 2012-10-31 | Completed | ||
| A Cohort for Evaluation of Open-label PrEP Delivery Among Kenyan and South African Women: The POWER Cohort [NCT03490058] | 2,255 participants (Actual) | Observational | 2017-06-14 | Completed | |||
| A Prosp., Multic., Randomized, Open-label Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Boosted Darunavir + Dolutegravir When Switching From SOC ART in HIV-patients With Sustained Virological Suppr. [NCT02486133] | Phase 3 | 269 participants (Actual) | Interventional | 2015-07-31 | 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 | ||
| The SETPOINT Study - A Randomized Study of the Effect of Immediate Treatment With Potent Antiretroviral Therapy Versus Observation With Treatment as Indicated in Newly Infected HIV-1 Infected Subjects: Does Early Therapy After the Virologic Setpoint? [NCT00090779] | Phase 2 | 130 participants (Actual) | Interventional | 2005-01-31 | Terminated(stopped due to The DSMB concluded that the findings regarding the primary analysis would persist and that no additional study goals would be achieved by continuing the study.) | ||
| "Prevention of HIV in Île-de-France" [NCT03113123] | 3,257 participants (Anticipated) | Interventional | 2017-05-03 | Recruiting | |||
| Post-prandial Lipid Effects of Raltegravir (RAL) vs Ritonavir-boosted Darunavir (DRV-r) in Anti-retroviral Therapy (ART)-Naive Adults or Adults Recommencing ART. [NCT01258439] | Phase 4 | 25 participants (Actual) | Interventional | 2010-11-30 | Completed | ||
| 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 Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients [NCT00762892] | Phase 4 | 33 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women [NCT00705679] | Phase 2 | 5,029 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France [NCT05813964] | Phase 3 | 524 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting | ||
| Antiretroviral Activity and Tolerability of Once Daily Etravirine in Treatment-Naïve Adults With HIV-1 Infection [NCT00959894] | Phase 2 | 80 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro [NCT05108935] | 17 participants (Actual) | Interventional | 2022-02-17 | Completed | |||
| A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR 652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV 1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Trop [NCT01338883] | Phase 2 | 143 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| A Single-dose, Open-label, Randomized, Crossover Study to Assess the Impact of Food on the Pharmacokinetics of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Administered as a Fixed-dose Combination Tablet, and the Relative Bioavailabilit [NCT02475135] | Phase 1 | 72 participants (Actual) | Interventional | 2015-06-01 | Completed | ||
| Effect of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide and Bictegravir/Emtricitabine/Tenofovir Alafenamide on the Circulatory microRNA Profile in Treatment naïve HIV Patients, and Its Correlation With Change in Body Weight [NCT05463783] | Phase 4 | 30 participants (Anticipated) | Interventional | 2023-03-14 | Recruiting | ||
| A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population [NCT03074786] | Phase 2 | 0 participants (Actual) | Interventional | 2017-11-30 | Withdrawn(stopped due to Study was transferred to partner who will conduct under its own IND) | ||
| Study of Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir [NCT02253901] | Phase 1 | 33 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
| The Role of Home Packs of HIV Post-Exposure Prophylaxis for Sexual Exposure (PEPSE) to Improve the Speed and Appropriate Uptake of PEPSE in High Risk Individuals [NCT04965662] | Phase 4 | 139 participants (Actual) | Interventional | 2018-01-01 | Completed | ||
| A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodef [NCT00105079] | Phase 3 | 337 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
| Randomized Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19 [NCT04890626] | Phase 3 | 2,193 participants (Anticipated) | Interventional | 2020-04-04 | Recruiting | ||
| Prophylaxis for HIV-1: Tenofovir/Emtricitabine (Truvada ®) + Lopinavir/Ritonavir (Kaletra ®) vs Tenofovir/Emtricitabine/Cobicistat/Elvitegravir (Stribild ®). Prospective, Randomized, Open. [NCT02198443] | Phase 4 | 160 participants (Actual) | Interventional | 2015-06-06 | Completed | ||
| Implementation of HIV Preexposure Prophylaxis With Antiretroviral Medications Among People at High Risk for HIV Infection: A Demonstration Project [NCT02206555] | Phase 4 | 327 participants (Actual) | Interventional | 2014-11-14 | Completed | ||
| Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples [NCT02572505] | 0 participants (Actual) | Interventional | 2015-11-30 | Withdrawn | |||
| International Trial of Modified Directly Observed Therapy Versus Self-Administered Therapy for Participants With First Virologic Failure on a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Antiretroviral Regimen [NCT00608569] | 529 participants (Actual) | Interventional | 2009-03-31 | Completed | |||
| Demonstrating Effective Delivery of Daily Oral HIV Pre-Exposure Prophylaxis as Part of HIV Combination Prevention Intervention Among Young Women at High HIV Risk, Female Sex Workers and Men Who Have Sex With Men in Kenya (IPCP-KENYA) [NCT02755350] | 2,100 participants (Anticipated) | Interventional | 2015-08-31 | Recruiting | |||
| Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study [NCT02732730] | Phase 4 | 451 participants (Actual) | Interventional | 2016-10-12 | Completed | ||
| Multicentric, Non-inferiority, Randomized, Non-blinded Phase 3 Trial Comparing Virological Response at 48 Weeks of 3 Antiretroviral Treatment Regimens in HIV-1-infected Patients With Treatment Failure After 1st Line Antiretroviral Therapy (Cameroon, Burki [NCT00928187] | Phase 3 | 454 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| An Open-label, Short-duration, Repeat-dose Study of Breastmilk Excretion and Infant Absorption of Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine When Used by HIV-uninfected Lactating Women [NCT02776748] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use [NCT03842436] | Phase 4 | 16 participants (Actual) | Interventional | 2018-10-01 | Completed | ||
| First-Phase Viral Decay Rates in Treatment-Naive Subjects Initiating Treatment With Raltegravir (RAL) and Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF): A Pilot Study [NCT00660972] | Phase 1 | 40 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep) [NCT01040091] | Phase 1 | 34 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| "The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-Nearly Naive Participants" [NCT00442962] | Phase 4 | 54 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
| Closing a Critical HIV Prevention Gap: Demonstrating Safety and Effective Delivery of Daily Oral Pre-exposure Prophylaxis (PrEP) as Part of an HIV Combination Preventive Intervention for Sex Workers in Kolkata and Mysore-Mandya, India [NCT02148094] | Early Phase 1 | 1,325 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
| Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants [NCT03386578] | Phase 2 | 390 participants (Actual) | Interventional | 2018-07-03 | Active, not recruiting | ||
| CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection [NCT00667433] | Phase 1 | 38 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| Effects of Antiviral Therapies on Epstein-Barr Virus Replication [NCT05957913] | Phase 2 | 50 participants (Anticipated) | Interventional | 2023-06-05 | Enrolling by invitation | ||
| A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects With C [NCT00737568] | Phase 3 | 280 participants (Actual) | Interventional | 2008-09-30 | Completed | ||
| A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily [NCT00711009] | Phase 3 | 206 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder [NCT05378399] | Phase 3 | 40 participants (Anticipated) | Interventional | 2022-12-20 | Recruiting | ||
| A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence of Darunavir 800 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg, in the Presence of Cobicistat 150 mg, Administered as Either a Fixed-Dose Combination Tablet or [NCT02578550] | Phase 1 | 126 participants (Actual) | Interventional | 2015-11-30 | Completed | ||
| Quantification of Estradiol's Impact on Nucleotides in Different Cellular Populations of the Lower Gastrointestinal Tract [NCT03917420] | Phase 1 | 10 participants (Actual) | Interventional | 2019-03-26 | Completed | ||
| Decay Kinetics of HIV With the Integrase Inhibitor Raltegravir [NCT00863668] | 0 participants (Actual) | Interventional | 2009-03-31 | Withdrawn | |||
| Efficacy of Simultaneous Versus Sequential Antiretroviral Therapy and Antituberculosis Treatment in Patients With AIDS and Active Tuberculosis. Open, Randomized and Controlled, Multisite Clinical Trial. [NCT00737724] | 63 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Other published trials showed definitive expected superiority of Group 1) | |||
| [NCT00669487] | Phase 3 | 150 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Antiretroviral Therapy and the Hepatitis C Virus [NCT00545558] | Phase 1 | 18 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| CCR5 Antagonism to Decrease the Incidence of the Immune Reconstitution Inflammatory Syndrome in HIV-Infected Patients [NCT00988780] | 276 participants (Anticipated) | Interventional | 2009-12-31 | Active, not recruiting | |||
| A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir (ATV/GS-9350) Compared to Ritonavir-boosted Atazanavir (ATV/r) in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in HIV-1 Infected [NCT00892437] | Phase 2 | 85 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Pilot Phase IV, Multicenter, Randomized, Open-label and Controlled Study to Assess the Evolution of Peripheral Body Fat Distribution After Switching From Zidovudine Containing Backbone to Truvada in HIV-1-infected Patients on HAART (RECOMB Study). [NCT00324649] | Phase 4 | 80 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At R [NCT02842086] | Phase 3 | 5,399 participants (Actual) | Interventional | 2016-09-02 | Active, not recruiting | ||
| The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment [NCT00811954] | Phase 3 | 1,814 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the P [NCT00298363] | Phase 2 | 112 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| Correcting Pre-Exposure Prophylaxis (PrEP) Dosing and Adherence Benchmarks in Pregnancy to Optimize HIV Prevention (PrEP-P): A Randomized Comparative Pharmacokinetic Trial [NCT03834909] | Phase 1 | 0 participants (Actual) | Interventional | 2022-04-30 | Withdrawn(stopped due to Study was not funded) | ||
| A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV In [NCT00745823] | Phase 3 | 775 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to Primary efficacy analysis at Week 48 did not demonstrate non-inferiority of raltegravir 800 mg once daily versus raltegravir 400 mg twice daily) | ||
| HIV Pre-Exposure Prophylaxis Priming of Immune Effectors [NCT02593409] | Phase 4 | 220 participants (Anticipated) | Interventional | 2017-05-25 | Recruiting | ||
| ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3 [NCT00820118] | Phase 2 | 45 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens [NCT00357552] | 123 participants (Actual) | Interventional | 2008-01-31 | Completed | |||
| A Randomised, Open-label, 96-week Study Comparing the Safety and Efficacy of Three Different Combination Antiretroviral Regimens as Initial Therapy for HIV Infection. [NCT00335322] | Phase 4 | 329 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
| Open-label Randomized Multicenter Trial to Evaluate the Impact on the Lipid Profile of the Substitution of the NRTIs of a HAART Regimen by a Once Daily Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus Maintained Treatment in HIV Infe [NCT00323492] | Phase 4 | 92 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
| A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B [NCT00117676] | Phase 3 | 382 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
| Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PE [NCT00084136] | Phase 4 | 1,571 participants (Actual) | Interventional | 2005-05-31 | Completed | ||
| Chemoprophylaxis for HIV Prevention in Men [NCT00458393] | Phase 3 | 2,499 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
| Boosted Atazanavir and Truvada Given Once-Daily (BATON Study): A Phase 4 Study of Safety, Efficacy & Adherence in HIV Infected, Antiretroviral Naïve Subjects Treated With a Simple Once-Daily Regimen [NCT00224445] | Phase 4 | 100 participants (Actual) | Interventional | 2005-09-30 | 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 | ||
| CHAMPS: Choices For Adolescent Prevention Methods For South Africa. Pilot Study B: 'PlusPills' [NCT02213328] | Phase 2 | 148 participants (Actual) | Interventional | 2015-04-30 | Completed | ||
| HPTN 091: Integrating HIV Prevention, Gender-Affirmative Medical Care, and Peer Health Navigation for Transgender Women in the Americas: A Vanguard Study [NCT04742491] | Phase 2/Phase 3 | 307 participants (Actual) | Interventional | 2021-03-26 | Active, not recruiting | ||
| A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study [NCT00936715] | Phase 2 | 24 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| Optimizing Access to Non-occupational Post Exposure Prophylaxis for HIV Using Contingency Management in Stimulant-Using Men Who Have Sex With Men [NCT01140880] | Phase 2 | 170 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| PrEPared-RN, CAN Nurse-Led Management of High-risk Patients for Pre-Exposure [NCT06030557] | 210 participants (Anticipated) | Observational | 2023-04-16 | Recruiting | |||
| A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for Non-occupational Prophylaxis Following Potential Exposure to [NCT01602822] | Phase 4 | 11 participants (Actual) | Interventional | 2012-02-29 | Terminated(stopped due to Grade 3 elevation in liver function tests) | ||
| A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment- [NCT01108510] | Phase 3 | 698 participants (Actual) | Interventional | 2010-04-30 | 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 1 Pharmacokinetic Study to Assess the Steady State Pharmacokinetic Profile and Short Term Safety of Maraviroc Dosed With Darunavir/Ritonavir All Once Daily, With and Without Nucleoside Analogues, in HIV-1 Infected Subjects [NCT01348763] | Phase 1 | 13 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| A Prospective, Randomized, Multicenter, Open-Label Study to Compare the Efficacy and Safety of Simplifying From a Regimen of Atazanavir (ATV) + Ritonavir (RTV) + Tenofovir/Emtricitabine to ATV + Abacavir/Lamivudine Without RTV in Virologically Suppressed, [NCT01102972] | Phase 4 | 297 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men [NCT02720094] | Phase 2/Phase 3 | 4,570 participants (Actual) | Interventional | 2016-12-31 | Active, not recruiting | ||
| A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of Fixed Dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Tr [NCT00772902] | Phase 4 | 85 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Phase I Exploratory Pharmacodynamic Study of Tenofovir-Based Products [NCT02722343] | Phase 1 | 25 participants (Actual) | Interventional | 2016-04-30 | Completed | ||
| Biobehavioral Interventions for HIV-negative Methamphetamine-using MSM [NCT00856323] | Phase 2 | 53 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| Cardiovascular, Anthropometric, and Skeletal Effects of Antiretroviral Therapy (ART) Initiation With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Plus Atazanavir/Ritonavir (ATV/r), Darunavir/Ritonavir (DRV/r), or Raltegravir (RAL): Metabolic Subs [NCT00851799] | 334 participants (Actual) | Observational | 2009-06-30 | Completed | |||
| Impact of the Rapid Expansion of Pre-exposure Prophylaxis (PrEP) on HIV Incidence, in a Setting With High HIV Testing and Antiretroviral Treatment Coverage, to Achieve the Virtual Elimination of HIV Transmission by 2020: a NSW HIV Strategy Implementation [NCT02870790] | Phase 3 | 9,733 participants (Actual) | Interventional | 2016-03-31 | Completed | ||
| A Phase IV Open-Label Evaluation of Safety, Tolerability and Patient Acceptance of Raltegravir (MK-0518) Combined With a Fixed-Dose Formulation of Tenofovir Following Potential Exposure to HIV-1 [NCT00594646] | Phase 4 | 100 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) [NCT01061151] | Phase 3 | 3,747 participants (Actual) | Interventional | 2011-03-01 | Completed | ||
| A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg When A [NCT04236453] | Phase 1 | 16 participants (Actual) | Interventional | 2020-01-23 | Terminated(stopped due to COVID-19 pandemic impacted the BE assessment of the trial. The clinical team decided to terminate the trial in order to start a new pivotal BE trial) | ||
| A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs [NCT06101342] | Phase 2 | 250 participants (Anticipated) | Interventional | 2023-12-13 | Recruiting | ||
| A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary Peo [NCT04925752] | Phase 3 | 3,295 participants (Actual) | Interventional | 2021-06-28 | Active, not recruiting | ||
| ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence [NCT03218592] | Phase 4 | 36 participants (Actual) | Interventional | 2017-06-28 | Completed | ||
| A Phase 3, Randomized, Active-Controlled, Double-blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Women at High Risk for HIV-1 Infection [NCT04644029] | Phase 3 | 730 participants (Actual) | Interventional | 2021-02-24 | Active, not recruiting | ||
| A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women [NCT05746065] | 3,000 participants (Anticipated) | Observational | 2022-05-20 | Active, not recruiting | |||
| A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepa [NCT03547908] | Phase 3 | 244 participants (Actual) | Interventional | 2018-05-30 | Active, not recruiting | ||
| Open Label Prospective Study of Strategies to Combine Pre-Exposure Prophylaxis (PrEP)With Prevention Efforts [NCT01832571] | 0 participants (Actual) | Interventional | 2013-06-30 | Withdrawn(stopped due to Study is closed early due to withdrawal of funding. No study procedures were implemented.) | |||
| On Demand Antiretroviral Pre-exposure Prophylaxis for HIV Infection in Men Who Have Sex With Men [NCT01473472] | Phase 3 | 400 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants [NCT00076791] | Phase 1 | 66 participants (Actual) | Interventional | 2004-03-31 | Completed | ||
| A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarat [NCT00121017] | Phase 2 | 200 participants | Interventional | Withdrawn | |||
| A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV [NCT04652700] | Phase 3 | 494 participants (Actual) | Interventional | 2021-03-15 | Completed | ||
| Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After sd Nevirapine for the Prevention of Mother-to-child Transmission (MTCT) [NCT00346567] | 566 participants (Actual) | Interventional | 2006-06-30 | Completed | |||
| A Phase 4, Single-Arm Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Tenofovir Disoproxil Fumarate in Combination With Emtricitabine in HIV-1 Infected Patients Experiencing Various Degrees of Renal Impairment [NCT00106379] | Phase 4 | 52 participants | Interventional | 2004-10-31 | Completed | ||
| A Randomized Comparison of Protease Inhibitor-based Versus Non-nucleoside Reverse Transcriptase Inhibitor-based Antiretroviral Therapy for Initial Treatment of Individuals With AIDS-related Kaposi's Sarcoma in Sub-Saharan Africa [NCT00444379] | Phase 4 | 224 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
| Pharmacokinetic and Efficacy of Saquinavir Mesylate Film Coated Tablet / Ritonavir 1500/100 Plus Tenofovir/Emtricitabine 300/200 mg Once Daily in HIV Pretreated Patients [NCT00476983] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | Withdrawn(stopped due to No funding) | |||
| A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW) [NCT04760691] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting | ||
| Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo [NCT04334928] | Phase 3 | 1,002 participants (Actual) | Interventional | 2020-04-15 | Completed | ||
| Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples [NCT03030768] | 74 participants (Actual) | Observational | 2016-02-29 | Completed | |||
| Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Effectiveness and Safety Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women [NCT00625404] | Phase 3 | 2,120 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy [NCT00632970] | Phase 4 | 6 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to no patients 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) | ||
| Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study) [NCT03826199] | Phase 4 | 200 participants (Actual) | Interventional | 2019-08-23 | Completed | ||
| Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG. [NCT00391638] | Phase 2/Phase 3 | 56 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| A Phase IV Study of Antiretroviral Therapy for HIV Infected Adults Presenting With Acute Opportunistic Infections: Immediate Versus Deferred Initiation of Antiretroviral Therapy [NCT00055120] | Phase 4 | 283 participants (Actual) | Interventional | 2003-03-31 | Completed | ||
| Combination of Efavirenz & Truvada (COMET Study): Phase 4 Evaluation of Switching Twice Daily Combivir to Once-Daily Regimen Co-Formulated Truvada in Virologically Suppressed HIV Infected Patients Taking Efavirenz. [NCT00224458] | Phase 4 | 400 participants | Interventional | 2004-09-30 | Completed | ||
| Biomarkers for Event-driven PrEP Adherence [NCT04298697] | Phase 4 | 48 participants (Actual) | Interventional | 2020-02-28 | Completed | ||
| Entecavir Intensification for Persistent Hepatitis B Virus (HBV) Viremia in HIV-HBV Infection [NCT00662545] | Phase 4 | 10 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study [NCT01450189] | 46 participants (Actual) | Interventional | 2011-10-31 | Completed | |||
| Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals [NCT02251236] | 14 participants (Actual) | Interventional | 2016-01-31 | Completed | |||
| 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 | ||
| Pilot Study of Dolutegravir Plus Tenofovir/Lamivudine or Emtricitabine in HIV-1 Infected Transgender Women [NCT03033836] | Phase 4 | 60 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| A Pilot Project to Assess the Safety and Tolerability of Truvada Plus Raltegravir as Post-exposure Prophylaxis (nPEP) Following Sexual Exposure to Human Immunodeficiency Virus (HIV) [NCT01214759] | Phase 4 | 103 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| A Pilot Study of the Safety, Acceptability, Behavior Impact, and HIV Seroincidence Among High Risk Men Who Have Sex With Men With Access to Isentress 400 mg BID + Truvada Once Daily for Peri-exposure Chemoprophylaxis for HIV Infection Chemoprophylaxis for [NCT01697046] | Phase 3 | 65 participants (Anticipated) | Interventional | 2012-11-30 | Not yet recruiting | ||
| Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection [NCT02401230] | Phase 4 | 86 participants (Actual) | Interventional | 2015-03-31 | Completed | ||
| ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients [NCT01605890] | Phase 2 | 30 participants (Actual) | Interventional | 2012-07-31 | Completed | ||
| Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women [NCT02333045] | 4 participants (Actual) | Interventional | 2015-01-31 | Terminated(stopped due to Minimal efficacy of maraviroc alone was found in preliminary data analysis of another study.) | |||
| 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 | ||
| Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women An Open-Label Randomised Control Study [NCT03227731] | Phase 2/Phase 3 | 540 participants (Actual) | Interventional | 2017-09-28 | Completed | ||
| Pharmacokinetics of Tenofovir in Blood, Plasma and Urine of Healthy Adults With Perfect, Median and Low Drug Adherence [NCT03012607] | 30 participants (Actual) | Interventional | 2017-01-31 | Completed | |||
| A Phase III, Open-label, Single Centre, Single-arm, Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Raltegravir [NCT01195467] | Phase 3 | 40 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combina [NCT02275780] | Phase 3 | 769 participants (Actual) | Interventional | 2014-12-01 | Completed | ||
| The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples [NCT03049176] | 46 participants (Actual) | Observational | 2017-03-13 | Completed | |||
| Prospective, Randomised, Crossover, Double-Blind, Placebo-Controlled Trial To Assess The Lipid-Lowering Effect Of Adding Tenofovir/Emtricitabine Co-Formulation Vs Placebo To Hiv-1-Infected Subjects With Dyslipidemia And Sustained Viral Load Suppression Un [NCT01458977] | Phase 4 | 48 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Pharmacology of TDF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women [NCT05057858] | Phase 2 | 72 participants (Actual) | Interventional | 2022-05-09 | Active, not recruiting | ||
| A Randomized, Crossover Study Comparing Adherence, Preference + Acceptability of a Dual Prevention Pill (DPP) Capsule Containing PrEP + an Oral Contraceptive Versus Two Separate Pills in Women at Risk of HIV in Johannesburg, South Africa [NCT04778527] | 96 participants (Anticipated) | Interventional | 2022-09-13 | Recruiting | |||
| Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women [NCT00729573] | 518 participants (Actual) | Observational | 2009-11-30 | Completed | |||
| Randomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary Cirrhosis [NCT01614405] | 13 participants (Actual) | Interventional | 2012-06-30 | Completed | |||
| "Switch to a Completely ONce Daily Regimen Containing Emtricitabine/Tenofovir - Fixed Dose Combination Plus Third QD Partner: SONETT" [NCT00323687] | Phase 4 | 50 participants (Anticipated) | Interventional | 2004-09-30 | Completed | ||
| An Open-Label, Proof of Concept, Randomized Trial Comparing a LPV/r-Based to an nNRTI-Based Antiretroviral Therapy Regimen for Clearance of Plasmodium Falciparum Subclinical Parasitemia in HIV-infected Adults With CD4+ Counts >200 and <500 Cells/mm^3 [NCT01632891] | Phase 1/Phase 2 | 52 participants (Actual) | Interventional | 2014-01-10 | Completed | ||
| Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients [NCT01632345] | Phase 2 | 342 participants (Actual) | Interventional | 2012-10-12 | Completed | ||
| A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in [NCT02131233] | Phase 3 | 802 participants (Actual) | Interventional | 2014-05-23 | Completed | ||
| Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE) [NCT01641367] | Phase 4 | 545 participants (Actual) | Interventional | 2013-02-22 | Completed | ||
| Phase 3b, Randomized, Open Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy [NCT03965923] | Phase 3 | 859 participants (Actual) | Interventional | 2020-01-09 | Active, not recruiting | ||
| A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 [NCT04661397] | Phase 1 | 37 participants (Actual) | Interventional | 2021-01-05 | Completed | ||
| GMB: Phase IV, Multicenter, Randomized, Open-Label Pilot Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients Who Need to Interrupt HAART and Who Are Infected With HIV Isolates Containing at Least 2 TA [NCT00362687] | Phase 4 | 50 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Parallel Comparison of Tenofovir and Emtricitabine/Tenofovir Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples [NCT00557245] | Phase 3 | 4,758 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| A Demonstration Project of HIV Pre-exposure Prophylaxis (PrEP) With Tenofovir DF/Emtricitabine (TDF/FTC Among Female Sex Workers in Dakar, Senegal [NCT02474303] | 267 participants (Actual) | Interventional | 2015-07-31 | Completed | |||
| Comprehensive HIV Prevention Package for MSM in Port Elizabeth [NCT02449733] | 101 participants (Actual) | Interventional | 2015-05-31 | Completed | |||
| ID Cap System: Next Generation Ingestible Sensors for Medication Adherence Measurement [NCT05592613] | Phase 3 | 30 participants (Anticipated) | Interventional | 2023-02-20 | Recruiting | ||
| Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) [NCT03512418] | Phase 3 | 60 participants (Anticipated) | Interventional | 2019-06-20 | Recruiting | ||
| Implementation of HIV Pre-exposure Prophylaxis (PrEP): A Demonstration Project [NCT01632995] | 557 participants (Actual) | Interventional | 2012-10-31 | Completed | |||
| Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) in the United States [NCT01769456] | Phase 2 | 78 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
| Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection [NCT00885664] | Phase 4 | 60 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Effect of Substituting Truvada for Combivir or Trizivir vs Continuing Combivir or Trizivir on Physiologic Correlates of Mitochondrial Function in Subjects Infected With Human Immunodeficiency Virus on Highly Active Antiretroviral Therapy [NCT00960622] | Phase 4 | 17 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
| IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya [NCT04898699] | 120 participants (Anticipated) | Interventional | 2021-10-31 | Not yet recruiting | |||
| A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States [NCT06101329] | Phase 2 | 250 participants (Anticipated) | Interventional | 2023-11-17 | Recruiting | ||
| 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 | ||
| Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses [NCT02859558] | Phase 2 | 195 participants (Actual) | Interventional | 2017-01-31 | Active, not recruiting | ||
| A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel [NCT01687218] | Phase 2 | 195 participants (Actual) | Interventional | 2013-09-25 | Completed | ||
| A Pharmacist-run, Community-based PrEP Program for High-risk women-the OPTIMIZE Study [NCT05755204] | 50 participants (Anticipated) | Observational | 2023-06-21 | Recruiting | |||
| A Phase II Acceptability Study of Oral Emtricitabine/Tenofovir Alafenamide (F/TAF) vs Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for the Prevention of HIV Acquisition in Adolescent Girls and Young Women (AGYW) [NCT05458765] | Phase 2 | 330 participants (Actual) | Interventional | 2022-06-21 | Active, not recruiting | ||
| Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States [NCT01772823] | Phase 2 | 200 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men. [NCT01769469] | 101 participants (Actual) | Observational | 2012-11-30 | Completed | |||
| A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Wo [NCT04994509] | Phase 3 | 5,639 participants (Actual) | Interventional | 2021-08-30 | Active, not recruiting | ||
| PrEP Adherence Monitoring Using Dried Blood Spots [NCT02022657] | Phase 1/Phase 2 | 52 participants (Actual) | Interventional | 2014-04-30 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
| Intervention | participants (Number) | |
|---|---|---|
| Week 24: Number with RNA <400 c/mL (N=495; N=500) | Week 48: Number with RNA <400 c/mL (N=482; N=487) | |
| TDF/FTC+EFV | 448 | 455 |
| ZDV/3TC+EFV | 459 | 442 |
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| ddI+FTC+ATV | 0 | 0 | 48 |
| ZDV/3TC+EFV | 0 | 16 | NA |
Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 using follow-up through study closure on May 31,2010
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| TDF/FTC+EFV | 0 | 0 | NA |
| ZDV/3TC+EFV | 0 | 0 | 32 |
Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| TDF/FTC+EFV | 0 | 24 | NA |
| ZDV/3TC+EFV | 0 | 16 | NA |
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| ddI+FTC+ATV | 16 | 24 | 120 |
| ZDV/3TC+EFV | 16 | 40 | NA |
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
| Intervention | cells/mm^3 (Median) | ||
|---|---|---|---|
| Change from screening to week 24 (N=490; N=498) | Change from screening to week 48 (N=480; N=485) | Change from screening to week 96 (N=458; N=471) | |
| TDF/FTC+EFV | 120.5 | 159 | 226 |
| ZDV/3TC+EFV | 112.5 | 151.5 | 220.5 |
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| ddI+FTC+ATV | 0 | 0 | 48 |
| ZDV/3TC+EFV | 0 | 0 | 32 |
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 using follow-up through study closure on May 31,2010
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| TDF/FTC+EFV | 0 | 0 | NA |
| ZDV/3TC+EFV | 0 | 0 | 32 |
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up through study closure on May 31,2010)
| Intervention | weeks (Number) | |
|---|---|---|
| 5th percentile | 10th percentile | |
| TDF/FTC+EFV | 0 | 24 |
| ZDV/3TC+EFV | 0 | 16 |
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| ddI+FTC+ATV | 48 | NA |
| ZDV/3TC+EFV | 48 | 112 |
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | |
| TDF/FTC+EFV | 48 | 104 | NA |
| ZDV/3TC+EFV | 48 | 128 | NA |
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until study closure (May 31, 2010)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 10th percentile | 25th percentile | 50th percentile | |
| TDF/FTC+EFV | 4 | 32 | 224 |
| ZDV/3TC+EFV | 4 | 12 | 112 |
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 10th percentile | 25th percentile | 50th percentile | |
| ddI+FTC+ATV | 4 | 32 | 144 |
| ZDV/3TC+EFV | 4 | 12 | 96 |
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| ddI+FTC+ATV | 7 | 18 | 76 |
| ZDV/3TC+EFV | 16 | 34 | NA |
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until study closed (May 31,2010)
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| TDF/FTC+EFV | 18 | 36 | 201 |
| ZDV/3TC+EFV | 16 | 34 | 163 |
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
| Intervention | participants (Number) | |
|---|---|---|
| Week 24: Number with RNA <400 c/mL (N=495; N=506) | Week 48: Number with RNA <400 c/mL (N=476; N=478) | |
| ddI+FTC+ATV | 431 | 424 |
| ZDV/3TC+EFV | 459 | 437 |
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| TDF/FTC+EFV | 16 | 40 | NA |
| ZDV/3TC+EFV | 16 | 40 | NA |
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
| Intervention | cells/mm^3 (Median) | ||
|---|---|---|---|
| Change from screening to week 24 (N=490; N=502) | Change from screening to week 48 (N=474; N=477) | Change from screening to week 96 (N= 188; N=188) | |
| ddI+FTC+ATV | 146.5 | 187.0 | 256.0 |
| ZDV/3TC+EFV | 112.5 | 152.0 | 216.0 |
Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 6 |
| NVP/LPV_r | 4 |
| NoNVP/NVP | 19 |
| NoNVP/LPV_r | 26 |
The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 15 |
| NVP/LPV_r | 0 |
| NoNVP/NVP | 35 |
| NoNVP/LPV_r | 0 |
Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 20 |
| NoNVP/NVP | 51 |
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.
| Intervention | cells/mm^3 (Median) | |
|---|---|---|
| Week 48 CD4 count change from randomization | Week 96 CD4 count change from randomization | |
| NoNVP/LPV_r | 172 | 256 |
| NoNVP/NVP | 172 | 223 |
| NVP/LPV_r | 201 | 278 |
| NVP/NVP | 191 | 291 |
Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.
| Intervention | Percent of participants (Number) | |
|---|---|---|
| week 48 percent of virologic failure or death | week 96 percent of virologic failure or death | |
| NoNVP/LPV_r | 14 | 20 |
| NoNVP/NVP | 14 | 17 |
| NVP/LPV_r | 4 | 12 |
| NVP/NVP | 23 | 31 |
Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.
| Intervention | percent of participants (Number) | |
|---|---|---|
| week 48 percent of full adherence in past month | week 96 percent of full adherence in past month | |
| NoNVP/LPV_r | 86 | 87 |
| NoNVP/NVP | 90 | 93 |
| NVP/LPV_r | 88 | 95 |
| NVP/NVP | 89 | 94 |
5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| NVP/LPV_r | 60 | 84 | NA |
| NVP/NVP | 12 | 12 | 60 |
5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | |
| NoNVP/LPV_r | 12 | 36 | 132 |
| NoNVP/NVP | 24 | 36 | NA |
Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.
| Intervention | participants (Number) |
|---|---|
| NVP/NVP | 32 |
| NVP/LPV_r | 10 |
| NoNVP/NVP | 42 |
| NoNVP/LPV_r | 50 |
(NCT00090779)
Timeframe: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)
| Intervention | Change in Log10 transformed CD4 Counts (Mean) | |||
|---|---|---|---|---|
| IT arm (wk 60- wk 36) vs. DT arm (wk 24- wk 0) | IT arm (wk 72- wk 36) vs. DT arm (wk 36- wk 0) | IT arm (wk 84- wk 36) vs. DT arm (wk 48- wk 0) | IT arm (wk 96- wk 36) vs. DT arm (wk 60- wk 0) | |
| DT Arm | -0.02 | -0.03 | -0.06 | -0.02 |
| IT Arm | -0.11 | -0.10 | -0.10 | -0.12 |
5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death (NCT00090779)
Timeframe: 5 years since randomization
| Intervention | weeks (Number) | ||||
|---|---|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile | |
| DT Arm | 13.9 | 20.9 | 43.7 | 97.3 | 157.7 |
| IT Arm | 36 | 36.9 | 67.1 | 96.4 | 163.3 |
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
| Intervention | weeks (Number) | |||||
|---|---|---|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile | 90th percentile | |
| DT Arm | 6.9 | 12.3 | 26.3 | 60.0 | 96.0 | 96.0 |
| IT Arm | 6.3 | 13.0 | 36.4 | 72.0 | NA | NA |
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
| Intervention | weeks (Number) | |||||
|---|---|---|---|---|---|---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile | 90th percentile | |
| DT Arm | 6.9 | 12.3 | 26.3 | 60.0 | 96.0 | 96.0 |
| IT Arm | 5.1 | 10.4 | 22.7 | 58.1 | NA | NA |
"The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)
| Intervention | rank (Median) |
|---|---|
| IT Arm | 26.0 |
| DT Arm | 48.5 |
"The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: At Weeks 72 and 76
| Intervention | rank (Median) |
|---|---|
| IT Arm | 26.0 |
| DT Arm | 49.3 |
The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
| Intervention | Participants (Number) |
|---|---|
| IT Arm | 7 |
| DT Arm | 23 |
The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm. (NCT00090779)
Timeframe: At Week 36
| Intervention | participants (Number) |
|---|---|
| IT Arm | 8 |
(NCT00090779)
Timeframe: 96 weeks since randomization
| Intervention | participants (Number) |
|---|---|
| IT Arm | 2 |
| DT Arm | 8 |
"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death" (NCT00099632)
Timeframe: From first day of study treatment to week 12
| Intervention | participants (Number) |
|---|---|
| 7-day Lamivudine/Zidovudine (3TC/ZDV) | 5 |
| 21-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
| 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
| 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 7-day Lopinavir/Ritonavir (LPV/r) | 2 |
| 21-day Lopinavir/Ritonavir (LPV/r) | 2 |
participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively. (NCT00099632)
Timeframe: From first day of study treatment to last day of study treatment (up to 21 days)
| Intervention | participants (Number) |
|---|---|
| 7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
| 21-day Lamivudine/Zidovudine (3TC/ZDV) | 2 |
| 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 7-day Lopinavir/Ritonavir (LPV/r) | 0 |
| 21-day Lopinavir/Ritonavir (LPV/r) | 5 |
"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis." (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
| Intervention | participants (Number) |
|---|---|
| 7-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
| 21-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
| 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 7-day Lopinavir/Ritonavir (LPV/r) | 3 |
| 21-day Lopinavir/Ritonavir (LPV/r) | 1 |
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
| Intervention | participants (Number) |
|---|---|
| 7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
| 21-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
| 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
| 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
| 7-day Lopinavir/Ritonavir (LPV/r) | 1 |
| 21-day Lopinavir/Ritonavir (LPV/r) | 0 |
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
| Intervention | participants (Number) |
|---|---|
| 7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
| 21-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
| 7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
| 7-day Lopinavir/Ritonavir (LPV/r) | 0 |
| 21-day Lopinavir/Ritonavir (LPV/r) | 0 |
Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline) (NCT00105079)
Timeframe: Baseline to Week 48
| Intervention | copies/mL (Mean) | ||
|---|---|---|---|
| Baseline | Week 48 (n=126,133) | Change from Baseline to Week 48 (n=126,133) | |
| Lopinavir/Ritonavir | 5.17 | 1.83 | -3.36 |
| Saquinavir/Ritonavir | 5.20 | 1.80 | -3.39 |
"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported." (NCT00105079)
Timeframe: Week 48
| Intervention | participants (Number) | |
|---|---|---|
| Patients with <50 Copies/mL | Patients with <400 Copies/mL | |
| Lopinavir/Ritonavir | 108 | 127 |
| Saquinavir/Ritonavir | 108 | 121 |
"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported." (NCT00105079)
Timeframe: Week 48
| Intervention | participants (Number) | |
|---|---|---|
| Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES | Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO | |
| Lopinavir/Ritonavir | 108 | 62 |
| Saquinavir/Ritonavir | 108 | 59 |
Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS. (NCT00105079)
Timeframe: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
| Intervention | participants (Number) |
|---|---|
| Saquinavir/Ritonavir | 163 |
| Lopinavir/Ritonavir | 168 |
Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported. (NCT00105079)
Timeframe: baseline and all study visits (Up to Week 52)
| Intervention | participants (Number) |
|---|---|
| Saquinavir/Ritonavir | 0 |
| Lopinavir/Ritonavir | 0 |
Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) - (CD4+ count at baseline). (NCT00105079)
Timeframe: Baseline to Week 48
| Intervention | cells/mm^3 (Median) | ||
|---|---|---|---|
| Baseline (n=166,169) | Week 48 (n=122,131) | Change from Baseline to Week 48 (n=121,130) | |
| Lopinavir/Ritonavir | 142.0 | 348.0 | 204.0 |
| Saquinavir/Ritonavir | 141.5 | 319.0 | 178.0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00116805)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | percentage of participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HBsAg Loss - Week 144 | Anti-HBs Seroconversion - Week 144 | HBsAg Loss - Week 192 | Anti-HBs Seroconversion - Week 192 | HBsAg Loss - Week 240 | Anti-HBs Seroconversion - Week 240 | HBsAg Loss - Week 288 | Anti-HBs Seroconversion - Week 288 | HBsAg Loss - Week 336 | Anti-HBs Seroconversion - Week 336 | HBsAg Loss - Week 384 | Anti-HBs Seroconversion - Week 384 | HBsAg Loss - Week 432 | Anti-HBs Seroconversion - Week 432 | HBsAg Loss - Week 480 | Anti-HBs Seroconversion - Week 480 | |
| ADV-TDF | 8.0 | 6.8 | 7.9 | 6.7 | 8.0 | 8.0 | 8.0 | 8.0 | 7.9 | 7.9 | 9.0 | 7.9 | 10.2 | 8.0 | 10.1 | 7.9 |
| TDF-TDF | 7.5 | 5.2 | 9.4 | 6.4 | 9.2 | 6.3 | 9.2 | 6.4 | 10.3 | 7.5 | 11.0 | 8.1 | 10.9 | 7.6 | 10.9 | 8.0 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Weeks 432 and 480
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 432 | Week 480 | |
| ADV-TDF | 78.6 | 82.8 |
| TDF-TDF | 79.6 | 75.0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 75 | 8 | 17 | 43 | 7 |
| TDF-TDF | 31 | 2 | 13 | 7 | 9 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, and 384
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
| ADV-TDF | 67.8 | 69.4 | 65.9 | 70.1 | 67.9 | 67.1 |
| TDF-TDF | 60.2 | 59.6 | 50.0 | 51.3 | 46.2 | 52.6 |
ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 68.0 |
| ADV-TDF | 54.4 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 49 to 96
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 16 | 2 | 1 | 12 | 1 |
| ADV-TDF With Addition of FTC | 10 | 3 | 2 | 3 | 2 |
| TDF-TDF | 18 | 2 | 3 | 10 | 3 |
| TDF-TDF With Addition of FTC | 13 | 0 | 1 | 5 | 7 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 65.2 |
| ADV-TDF | 74.4 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 433 to 480
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 1 | 0 | 0 | 1 | 0 |
| ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF With Addition of FTC | 3 | 0 | 1 | 2 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 385 to 432
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| ADV-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
| TDF-TDF | 1 | 0 | 1 | 0 | 0 |
| TDF-TDF With Addition of FTC | 3 | 0 | 0 | 3 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 337 to 384
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 2 | 1 | 1 | 0 | 0 |
| ADV-TDF With Addition of FTC | 2 | 0 | 1 | 1 | 0 |
| TDF-TDF | 1 | 0 | 0 | 0 | 1 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 289 to 336
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 1 | 0 | 0 | 1 | 0 |
| ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 1 | 0 | 0 | 0 | 1 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
(NCT00116805)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 77.6 |
| ADV-TDF | 77.9 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 241 to 288
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 3 | 0 | 0 | 2 | 1 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 145 to 192
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 1 | 0 | 1 | 0 | 0 |
| ADV-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
| TDF-TDF | 2 | 0 | 1 | 0 | 1 |
| TDF-TDF With Addition of FTC | 5 | 0 | 0 | 1 | 3 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 193 to 240
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| ADV-TDF With Addition of FTC | 1 | 1 | 0 | 0 | 0 |
| TDF-TDF | 3 | 0 | 2 | 1 | 0 |
| TDF-TDF With Addition of FTC | 3 | 0 | 0 | 2 | 1 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 97 to 144
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 5 | 2 | 3 | 0 | 0 |
| ADV-TDF With Addition of FTC | 5 | 0 | 0 | 3 | 1 |
| TDF-TDF | 2 | 1 | 0 | 1 | 0 |
| TDF-TDF With Addition of FTC | 7 | 2 | 3 | 2 | 0 |
(NCT00116805)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | log10 IU/mL (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -2.43 | -2.27 | -2.41 | -2.49 | -2.62 | -2.59 | -2.34 | -2.32 | -2.16 |
| TDF-TDF | -0.10 | -0.19 | -0.20 | -0.14 | -0.18 | -0.25 | -0.29 | -0.13 | -0.24 |
(NCT00116805)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | U/L (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -6.9 | -0.7 | -7.8 | -8.1 | -10.3 | -9.3 | -6.9 | -11.6 | -7.1 |
| TDF-TDF | -2.0 | -0.4 | -1.3 | 3.7 | -1.6 | -1.2 | -4.4 | -4.3 | -5.5 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
| ADV-TDF | -3.2 | -2.6 |
| TDF-TDF | -3.6 | -2.7 |
(NCT00116805)
Timeframe: Weeks 432 and 480
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 432 | Week 480 | |
| ADV-TDF | 100.0 | 96.6 |
| TDF-TDF | 93.0 | 98.0 |
(NCT00116805)
Timeframe: Weeks 144, 192, 240, 288, 336, and 384
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
| ADV-TDF | 70.5 | 71.6 | 66.3 | 64.8 | 62.1 | 60.5 |
| TDF-TDF | 71.7 | 67.9 | 63.4 | 61.3 | 59.4 | 56.1 |
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | HBeAg Seroconversion | |
| ADV-TDF | 17.5 | 17.5 |
| TDF-TDF | 22.2 | 20.9 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00116805)
Timeframe: Baseline; Week 240
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
| ADV-TDF | -5.1 | -4.5 |
| TDF-TDF | -4.8 | -4.1 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00116805)
Timeframe: Baseline; Week 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | Anti-HBs Seroconversion | |
| ADV-TDF | 5.8 | 4.7 |
| TDF-TDF | 5.3 | 4.1 |
(NCT00116805)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | log10 IU/mL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -3.93 | -6.38 | -6.31 | -6.49 | -6.45 | -6.49 | -6.46 | -6.28 | -6.45 | -6.37 |
| TDF-TDF | -6.17 | -6.26 | -6.32 | -6.30 | -6.22 | -6.27 | -6.35 | -6.38 | -6.13 | -6.18 |
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96. (NCT00116805)
Timeframe: Baseline; Week 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | Seroconversion to Anti-HBe | |
| ADV-TDF | 25.6 | 22.0 |
| TDF-TDF | 25.9 | 22.8 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | HBsAg Seroconversion | |
| ADV-TDF | 0 | 0 |
| TDF-TDF | 3.2 | 1.3 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00116805)
Timeframe: Baseline; Week 240
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| ADV-TDF | 89.6 | 10.4 |
| TDF-TDF | 88.2 | 11.8 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| ADV-TDF | 67.8 | 32.2 |
| TDF-TDF | 74.4 | 25.6 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00116805)
Timeframe: Baseline; Week 240
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | |
| ADV-TDF | 97.9 | 2.1 | 0 | 58.3 | 39.6 | 2.1 |
| TDF-TDF | 96.1 | 3.9 | 0 | 56.6 | 39.5 | 3.9 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Missing Data - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | Missing Data - Fibrosis | |
| ADV-TDF | 78.9 | 3.3 | 5.6 | 12.2 | 20.0 | 61.1 | 6.7 | 12.2 |
| TDF-TDF | 81.3 | 4.5 | 3.4 | 10.8 | 19.9 | 63.6 | 5.1 | 11.4 |
"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40." (NCT00116805)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 66.5 |
| ADV 10 mg | 12.2 |
(NCT00116805)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 76.1 |
| ADV-TDF | 13.3 |
(NCT00116805)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | U/L (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -106.1 | -120.4 | -126.2 | -139.6 | -134.8 | -130.9 | -132.3 | -133.7 | -162.1 | -157.5 |
| TDF-TDF | -107.2 | -107.8 | -100.7 | -101.4 | -95.9 | -102.3 | -101.9 | -108.1 | -105.0 | -92.3 |
(NCT00117676)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 93.2 |
| ADV-TDF | 63.2 |
(NCT00117676)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | units per liter (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -124.4 | -138.5 | -140.0 | -140.3 | -139.5 | -134.7 | -143.1 | -132.6 | -131.9 | -129.2 |
| TDF-TDF | -95.0 | -93.7 | -99.1 | -99.6 | -97.7 | -98.9 | -98.9 | -96.1 | -97.0 | -94.9 |
(NCT00117676)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 90.6 |
| ADV-TDF | 89.3 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 72.4 |
| ADV-TDF | 68.5 |
(NCT00117676)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | log10 copies/mL (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -4.07 | -4.74 | -4.77 | -4.75 | -4.77 | -4.81 | -4.81 | -4.79 | -4.69 | -4.75 |
| TDF-TDF | -4.57 | -4.54 | -4.61 | -4.56 | -4.59 | -4.61 | -4.61 | -4.56 | -4.60 | -4.57 |
ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| TDF-TDF | 76.3 |
| ADV-TDF | 77.1 |
(NCT00117676)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | units per liter (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -0.6 | -0.3 | -3.6 | -3.9 | -4.1 | -2.0 | -3.9 | -8.9 | -5.9 |
| TDF-TDF | 2.4 | -0.6 | 0.7 | -2.5 | -3.9 | -2.6 | -2.9 | -4.6 | -2.8 |
(NCT00117676)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | log10 copies/mL (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
| ADV-TDF | -0.60 | -0.63 | -0.61 | -0.61 | -0.64 | -0.65 | -0.66 | -0.67 | -0.72 |
| TDF-TDF | 0.02 | -0.03 | 0.01 | -0.04 | -0.04 | -0.05 | -0.02 | -0.04 | -0.05 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 97 to 144
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 4 | 0 | 1 | 2 | 1 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 145 to 192
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 3 | 0 | 1 | 1 | 1 |
| TDF-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00117676)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
| Intervention | percentage of participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HBsAg Loss - Week 144 | Anti-HBs Seroconversion - Week 144 | HBsAg Loss - Week 192 | Anti-HBs Seroconversion - Week 192 | HBsAg Loss - Week 240 | Anti-HBs Seroconversion - Week 240 | HBsAg Loss - Week 288 | Anti-HBs Seroconversion - Week 288 | HBsAg Loss - Week 336 | Anti-HBs Seroconversion - Week 336 | HBsAg Loss - Week 384 | Anti-HBs Seroconversion - Week 384 | HBsAg Loss - Week 432 | Anti-HBs Seroconversion - Week 432 | HBsAg Loss - Week 480 | Anti-HBs Seroconversion - Week 480 | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0.8 | 0 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 1.6 | 0.8 | 2.4 | 0.8 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 0.4 | 1.2 | 0.4 | 1.2 | 0.8 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 241 to 288
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 1 | 0 | 1 | 0 | 0 |
| TDF-TDF | 3 | 0 | 2 | 1 | 0 |
| TDF-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 289 to 336
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 1 | 0 | 0 | 0 | 1 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 337 to 384
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 1 | 0 | 0 | 0 | 1 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 385 to 432
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 1 | 0 | 1 | 0 | 0 |
| TDF-TDF | 2 | 0 | 0 | 2 | 0 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL. (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 42 | 7 | 14 | 20 | 1 |
| TDF-TDF | 8 | 0 | 3 | 4 | 1 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 433 to 480
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 49 to 96
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
| ADV-TDF | 0 | 0 | 0 | 0 | 0 |
| TDF-TDF | 6 | 0 | 2 | 4 | 0 |
| TDF-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, and 384
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
| ADV-TDF | 70.0 | 76.4 | 75.7 | 72.9 | 65.4 | 69.2 |
| TDF-TDF | 74.3 | 68.2 | 70.3 | 69.9 | 65.9 | 65.3 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Weeks 432 and 480
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 432 | Week 480 | |
| ADV-TDF | 87.2 | 88.9 |
| TDF-TDF | 86.5 | 80.0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96. (NCT00117676)
Timeframe: Baseline; Week 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | Anti-HBs Seroconversion | |
| ADV-TDF | 0 | 0 |
| TDF-TDF | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 193 to 240
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
| ADV-TDF | 2 | 0 | 0 | 0 | 2 |
| TDF-TDF | 1 | 1 | 0 | 0 | 0 |
| TDF-TDF With Addition of FTC | 2 | 0 | 2 | 0 | 0 |
"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40." (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| ADV-TDF | 48.8 | 51.2 |
| TDF-TDF | 70.8 | 29.2 |
(NCT00117676)
Timeframe: Weeks 144, 192, 240, 288, 336, and 384
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
| ADV-TDF | 88.4 | 86.8 | 83.9 | 82.9 | 78.0 | 76.3 |
| TDF-TDF | 86.7 | 84.0 | 82.8 | 80.5 | 77.0 | 74.3 |
(NCT00117676)
Timeframe: Weeks 432 and 480
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 432 | Week 480 | |
| ADV-TDF | 97.7 | 100.0 |
| TDF-TDF | 97.6 | 100.0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48. (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | Seroconversion to anti-HBs | |
| ADV-TDF | 0 | 0 |
| TDF-TDF | 0 | 0 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00117676)
Timeframe: Baseline; Week 240
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| ADV-TDF | 85.1 | 14.9 |
| TDF-TDF | 87.3 | 12.7 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| ADV-TDF | 68.8 | 31.2 |
| TDF-TDF | 72.4 | 27.6 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00117676)
Timeframe: Baseline; Week 240
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | |
| ADV-TDF | 94.6 | 1.4 | 4.1 | 59.5 | 33.8 | 6.8 |
| TDF-TDF | 96.7 | 2.7 | 0.7 | 62.0 | 34.0 | 4.0 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Missing Data - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | Missing Data - Fibrosis | |
| ADV-TDF | 81.6 | 8.0 | 0.8 | 9.6 | 25.6 | 54.4 | 10.4 | 9.6 |
| TDF-TDF | 82.0 | 6.8 | 4.8 | 6.4 | 22.0 | 63.2 | 8.4 | 6.4 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00117676)
Timeframe: Baseline; Week 240
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Knodell Score | Ishak Score | |
| ADV-TDF | -4.9 | -4.2 |
| TDF-TDF | -4.6 | -4.0 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00117676)
Timeframe: Baseline; Week 48
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
| ADV-TDF | -3.4 | -2.6 |
| TDF-TDF | -3.5 | -2.6 |
Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | participants (Number) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 27 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 41 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 5 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 12 |
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | Cells/mm3 (Median) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 163 | 220.5 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 188 | 250.5 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 175 | 251.5 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 177.5 | 250.3 |
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | mg/dL (Median) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 8 | 9 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 10 | 11 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 5 | 4 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 8 | 7 |
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | mg/dL (Median) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 14 | 13.5 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 23 | 18 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 8 | 10 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 20 | 18 |
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | mg/dL (Median) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 22 | 23 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 35 | 33 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 11 | 14 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 30 | 25 |
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | Weeks (Number) | ||
|---|---|---|---|
| 5th percentile time to treatment modification | 10th percentile time to treatment modification | 25th percentile time to treatment modification | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 3.4 | 15.0 | 83.7 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 1.4 | 2.1 | 27.4 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 7.9 | 24.9 | 108.9 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 1.6 | 5.0 | 43.6 |
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | Weeks (Number) | ||
|---|---|---|---|
| 5th percentile time to regimen failure | 10th percentile time to regimen failure | 25th percentile time to regimen failure | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 4 | 16 | 72 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 4 | 4 | 24 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 4 | 16 | 84 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 4 | 4 | 36 |
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | Weeks (Number) | |
|---|---|---|
| 5th percentile time to virologic failure | 10th percentile time to virologic failure | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 36 | 96 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 24 | 36 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 24 | 84 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 24 | 36 |
(NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Number of Participants with RNA data at Week 48 | Number with HIV-1 RNA <50 copies/ml at Week 48 | Number of Participants with RNA data at Week 96 | Number with HIV-1 RNA <50 copies/ml at Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 415 | 372 | 379 | 345 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 400 | 346 | 361 | 328 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 416 | 348 | 384 | 345 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 411 | 322 | 374 | 317 |
(NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Number of Participants with RNA data at Week 48 | Number with HIV-1 RNA <200 copies/ml at Week 48 | Number of Participants with RNA data at Week 96 | Number with HIV-1 RNA <200 copies/ml at Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 415 | 398 | 379 | 362 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 400 | 377 | 361 | 342 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 416 | 391 | 384 | 368 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 411 | 372 | 374 | 346 |
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 80 | 73 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 67 | 56 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 86 | 77 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 73 | 62 |
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | participants (Number) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 152 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 239 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 138 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 216 |
"AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.~http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm" (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Death | AIDS-defining illness | HIV-1 relatated event | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 6 | 14 | 56 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 11 | 25 | 61 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 6 | 20 | 57 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 8 | 23 | 63 |
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
| Intervention | mg/dL (Median) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 10 | 9 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 15 | 14 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 14 | 11 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 24 | 33 |
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 78 | 70 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 64 | 58 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 79 | 73 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 73 | 66 |
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 79 | 70 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 64 | 54 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 80 | 73 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 66 | 57 |
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Week 48 | Week 96 | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 94 | 90 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 88 | 85 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 92 | 89 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 88 | 83 |
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.
| Intervention | Weeks (Number) | ||
|---|---|---|---|
| 5th percentile time to a grade 3/4 safety event | 10th percentile time to a grade 3/4 safety event | 25th percentile time to a grade 3/4 safety event | |
| EFV, FTC/TDF, and Placebo ABC/3TC | 2.6 | 7.9 | 59.3 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 1.3 | 2.0 | 16.0 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 3.0 | 8.1 | 81.4 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 1.3 | 3.9 | 44.4 |
Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks
| Intervention | Weeks (Median) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 141.4 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 133.3 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 141.6 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 137.3 |
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks
| Intervention | participants (Number) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 145 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 182 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 137 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 156 |
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | participants (Number) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 162 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 246 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 157 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 233 |
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
| Intervention | participants (Number) |
|---|---|
| EFV, FTC/TDF, and Placebo ABC/3TC | 57 |
| EFV, Placebo FTC/TDF, and ABC/3TC | 72 |
| RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 57 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 83 |
Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percent probability (KM estimate) (Number) |
|---|---|
| Tenofovir DF | 15 |
| FTC/TDF | 14 |
| TDF or FTC/TDF | 14 |
| Entecavir | 10 |
Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percent probability (KM estimate) (Number) |
|---|---|
| Tenofovir DF | 18 |
| FTC/TDF | 4 |
| TDF or FTC/TDF | 11 |
| Entecavir | 14 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 25.9 |
| FTC/TDF | 51.9 |
| Entecavir | 45.5 |
| Overall | 40.0 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 24.0 |
| FTC/TDF | 45.8 |
| Entecavir | 45.5 |
| Overall | 36.7 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 25.9 |
| FTC/TDF | 48.0 |
| Entecavir | 41.7 |
| Overall | 37.5 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 23.1 |
| FTC/TDF | 52.0 |
| Entecavir | 50.0 |
| Overall | 39.3 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 0.0 |
| FTC/TDF | 2.6 |
| Entecavir | 0.0 |
| Overall | 1.0 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 0.0 |
| FTC/TDF | 2.5 |
| Entecavir | 0.0 |
| Overall | 1.0 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 2.4 |
| FTC/TDF | 0.0 |
| Entecavir | 0.0 |
| Overall | 1.0 |
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 0.0 |
| FTC/TDF | 0.0 |
| Entecavir | 0.0 |
| Overall | 0.0 |
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | units on a scale (Median) |
|---|---|
| Tenofovir DF | -2.0 |
| FTC/TDF | -1.5 |
| Entecavir | -2.0 |
| Overall | -2.0 |
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 144 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 144 weeks
| Intervention | log _10 copies/mL (Median) |
|---|---|
| Tenofovir DF | -3.07 |
| FTC/TDF | -3.82 |
| Entecavir | -3.76 |
| Overall | -3.49 |
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 168 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 168 weeks
| Intervention | log_10 copies/mL (Median) |
|---|---|
| Tenofovir DF | -3.16 |
| FTC/TDF | -4.06 |
| Entecavir | -3.77 |
| Overall | -3.66 |
ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 50 |
Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 46.2 |
| FTC/TDF | 64.0 |
| Entecavir | 41.2 |
| Overall | 51.5 |
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 34.6 |
| FTC/TDF | 64.0 |
| Entecavir | 37.5 |
| Overall | 46.3 |
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 29.2 |
| FTC/TDF | 60.0 |
| Entecavir | 37.5 |
| Overall | 43.1 |
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 50.0 |
| FTC/TDF | 58.3 |
| Entecavir | 31.3 |
| Overall | 48.5 |
ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100 |
| FTC/TDF | 100 |
LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 100 |
| FTC/TDF | 100 |
| Entecavir | 100 |
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized. (NCT00298363)
Timeframe: Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 50.0 |
| FTC/TDF | 77.5 |
| Entecavir | 52.4 |
| Overall | 61.0 |
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized. (NCT00298363)
Timeframe: Week 168
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 50.0 |
| FTC/TDF | 75.7 |
| Entecavir | 52.4 |
| Overall | 60.0 |
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized. (NCT00298363)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 70.5 |
| FTC/TDF | 87.8 |
| Entecavir | 72.7 |
| Overall | 77.6 |
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized. (NCT00298363)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 59.1 |
| FTC/TDF | 79.5 |
| Entecavir | 57.1 |
| Overall | 66.3 |
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | HBeAg Seroconversion | |
| Entecavir | 16.7 | 0.0 |
| FTC/TDF | 33.3 | 13.3 |
| Overall | 22.9 | 11.4 |
| Tenofovir DF | 14.3 | 14.3 |
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | HBeAg Seroconversion | |
| Entecavir | 16.7 | 0.0 |
| FTC/TDF | 35.7 | 21.4 |
| Overall | 27.3 | 18.2 |
| Tenofovir DF | 23.1 | 23.1 |
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | HBeAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 33.3 | 13.3 |
| Overall | 20.0 | 11.4 |
| Tenofovir DF | 14.3 | 14.3 |
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | HBsAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 0.0 | 0.0 |
| Overall | 0.0 | 0.0 |
| Tenofovir DF | 0.0 | 0.0 |
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | HBsAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 0.0 | 0.0 |
| Overall | 0.0 | 0.0 |
| Tenofovir DF | 0.0 | 0.0 |
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | HBsAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 0.0 | 0.0 |
| Overall | 0.0 | 0.0 |
| Tenofovir DF | 0.0 | 0.0 |
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBeAg Loss | HBeAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 26.7 | 13.3 |
| Overall | 19.4 | 13.9 |
| Tenofovir DF | 21.4 | 21.4 |
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | percentage of participants (Number) | |
|---|---|---|
| HBsAg Loss | HBsAg Seroconversion | |
| Entecavir | 0.0 | 0.0 |
| FTC/TDF | 0.0 | 0.0 |
| Overall | 0.0 | 0.0 |
| Tenofovir DF | 0.0 | 0.0 |
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | units on a scale (Median) |
|---|---|
| Tenofovir DF | -2.0 |
| FTC/TDF | -2.0 |
| Entecavir | -2.0 |
| Overall | -2.0 |
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 96
| Intervention | units on a scale (Median) |
|---|---|
| Tenofovir DF | -2.0 |
| FTC/TDF | -3.0 |
| Entecavir | -3.0 |
| Overall | -2.0 |
MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. (NCT00298363)
Timeframe: Baseline to Week 48
| Intervention | units on a scale (Median) |
|---|---|
| Tenofovir DF | -2.0 |
| FTC/TDF | -2.0 |
| Entecavir | -2.0 |
| Overall | -2.0 |
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 96 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 96 weeks
| Intervention | log_10 copies/mL (Median) |
|---|---|
| Tenofovir DF | -3.06 |
| FTC/TDF | -4.06 |
| Entecavir | -3.32 |
| Overall | -3.40 |
Change from baseline was evaluated by subtracting baseline HBV DNA log_10 copies/mL from Week 48 HBV DNA log_10 copies/mL. DAVG is defined as the area of the trapezoid under the response-time curve divided by time to the last available evaluation of the patient minus the baseline value. (NCT00298363)
Timeframe: Baseline to 48 weeks
| Intervention | log_10 copies/mL (Median) |
|---|---|
| Tenofovir DF | -2.93 |
| FTC/TDF | -3.45 |
| Entecavir | -3.61 |
| Overall | -3.19 |
(NCT00298363)
Timeframe: Baseline to Week 168
| Intervention | Days (Number) |
|---|---|
| Tenofovir DF | NA |
| FTC/TDF | NA |
| Entecavir | NA |
| Overall | NA |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | Ratio (Median) |
|---|---|
| Truvada | 0.0 |
| Maintain Baseline Regimen | 0.0 |
Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | cells/mm^3 (Median) |
|---|---|
| Truvada | 17.5 |
| Maintain Baseline Regimen | 16.0 |
(NCT00323492)
Timeframe: 12 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 96 |
| Maintain Baseline Regimen | 98 |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | mmol/L (Median) |
|---|---|
| Truvada | -0.1 |
| Maintain Baseline Regimen | 0.0 |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | mmol/L (Median) |
|---|---|
| Truvada | -0.4 |
| Maintain Baseline Regimen | -0.1 |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | mmol/L (Median) |
|---|---|
| Truvada | -0.5 |
| Maintain Baseline Regimen | -0.1 |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | Ratio (Median) |
|---|---|
| Truvada | -0.5 |
| Maintain Baseline Regimen | -0.1 |
Centralized laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | mmol/L (Median) |
|---|---|
| Truvada | -0.8 |
| Maintain Baseline Regimen | -0.1 |
Local laboratory assessment. Change = Week 12 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 12
| Intervention | mg/L (Median) |
|---|---|
| Truvada | 0.4 |
| Maintain Baseline Regimen | 0.7 |
Change = Week 48 value minus baseline value. (NCT00323492)
Timeframe: Baseline to Week 48
| Intervention | cells/mm^3 (Median) |
|---|---|
| Truvada | 35.0 |
| Maintain Baseline Regimen | 40.0 |
Centralized laboratory assessment (NCT00323492)
Timeframe: 12 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 0 |
| Maintain Baseline Regimen | 0 |
(NCT00323492)
Timeframe: 48 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 80 |
| Maintain Baseline Regimen | 80 |
(NCT00323492)
Timeframe: 12 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 0 |
| Maintain Baseline Regimen | 0 |
Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL. (NCT00324649)
Timeframe: 48 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 0 |
| Zidovudine/Lamivudine | 0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | Ratio (Median) |
|---|---|
| Truvada | 36.0 |
| Zidovudine/Lamivudine | 43.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | cells/mm^3 (Median) |
|---|---|
| Truvada | 60.5 |
| Zidovudine/Lamivudine | 9.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Median) |
|---|---|
| Truvada | -2.0 |
| Zidovudine/Lamivudine | 2.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Median) |
|---|---|
| Truvada | 1.5 |
| Zidovudine/Lamivudine | 4.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Median) |
|---|---|
| Truvada | 4.5 |
| Zidovudine/Lamivudine | 1.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | g/dL (Median) |
|---|---|
| Truvada | 0.9 |
| Zidovudine/Lamivudine | 0.3 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | mmol/L (Median) |
|---|---|
| Truvada | -0.23 |
| Zidovudine/Lamivudine | 0.09 |
Limb fat was measured by DEXA. Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | grams (g) (Median) |
|---|---|
| Truvada | 392 |
| Zidovudine/Lamivudine | -257 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | mg/dL (Median) |
|---|---|
| Truvada | 7.0 |
| Zidovudine/Lamivudine | 5.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | Ratio (Median) |
|---|---|
| Truvada | 62.0 |
| Zidovudine/Lamivudine | 97.0 |
Change = Week 48 value minus baseline value. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | Ratio (Median) |
|---|---|
| Truvada | -0.01 |
| Zidovudine/Lamivudine | 0.01 |
Change = Week 48 value minus baseline value expressed as median percent change. (NCT00324649)
Timeframe: Baseline to Week 48
| Intervention | Percent change in hematocrit (Median) |
|---|---|
| Truvada | 2.7 |
| Zidovudine/Lamivudine | 1.0 |
Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire (SMAQ)])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated. (NCT00324649)
Timeframe: Baseline to Week 72
| Intervention | Percentage of days with compliance (Median) |
|---|---|
| Truvada | 100.0 |
| Zidovudine/Lamivudine | 100.0 |
(NCT00324649)
Timeframe: 48 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 3 |
| Zidovudine/Lamivudine | 10 |
(NCT00324649)
Timeframe: 48 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 92.3 |
| Zidovudine/Lamivudine | 78.0 |
"Participants with treatment-emergent adverse events were analyzed. Adverse events were defined as any untoward medical occurrence in a clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with study treatment, and were categorized using the Medical Dictionary for Regulatory Activities (MedDRA) Version 11.~Treatment-emergent adverse events were events that met one of the following criteria:~Began or worsened in severity or relationship to study drug, on or after the date of the first dose of study drug and on or before the date of the last dose of study drug plus 30 days.~Had no recorded start date." (NCT00324649)
Timeframe: 72 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 77 |
| Zidovudine/Lamivudine | 85 |
(NCT00324649)
Timeframe: 48 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Truvada | 0 |
| Zidovudine/Lamivudine | 5 |
(NCT00335322)
Timeframe: 48 weeks
| Intervention | log copies/mL (Mean) |
|---|---|
| TDF/FTC+EFV | -2.59 |
| TDF/FTC+r/ATV | -2.69 |
| TDF/FTC+AZT+ABC | -2.39 |
(NCT00335322)
Timeframe: 144 weeks
| Intervention | log copies/mL (Mean) |
|---|---|
| TDF/FTC+EFV | -2.77 |
| TDF/FTC+ r/ATV | -2.88 |
| TDF/FTC + AZT+ABC | -2.54 |
(NCT00357552)
Timeframe: Study entry and week 104
| Intervention | cells/mm^3 (Median) |
|---|---|
| LPV/r Monotherapy | 213 |
Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair. (NCT00357552)
Timeframe: Study entry to week 104
| Intervention | participants (Number) |
|---|---|
| LPV/r Monotherapy | 39 |
Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL. (NCT00357552)
Timeframe: From study entry to week 24
| Intervention | percentage of enrolled subjects (Number) |
|---|---|
| LPV/r Monotherapy | 87 |
Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From study entry to week 24
| Intervention | cumulative probability of grade 3 or 4 (Number) |
|---|---|
| LPV/r Monotherapy | 0.23 |
25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From LPV/r intensification to week 104
| Intervention | weeks (Number) |
|---|---|
| LPV/r Monotherapy | 26.0 |
25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy. (NCT00357552)
Timeframe: Study entry to Week 104
| Intervention | weeks (Number) |
|---|---|
| LPV/r Monotherapy | 48.0 |
The percentage of subjects reporting never missing medications in the last month. (NCT00357552)
Timeframe: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24
| Intervention | percentage of subjects with data (Number) | ||||||
|---|---|---|---|---|---|---|---|
| week 2 (N=120) | week 4 (N=121) | week 8 (N=123) | week 12 (N=123) | week 16 (N=122) | week 20 (N=120) | week 24 (N=122) | |
| LPV/r Monotherapy | 90 | 86.8 | 87.8 | 86.2 | 86.1 | 90.9 | 89.4 |
Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature). (NCT00357552)
Timeframe: At study entry and weeks 24 and 48
| Intervention | proportion of samples (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| study entry DBS <= 400 cp/mL | study entry plasma <= 400 cp/mL | study entry DBS & plasma concordance | week 24 DBS <= 400 cp/mL | week 24 plasma <= 400 cp/mL | week 24 DBS & plasma concordance | week 48 DBS <= 400 cp/mL | week 48 plasma <= 400 cp/mL | week 48 DBS & plasma concordance | |
| LPV/r Monotherapy | 0.17 | 0.00 | 0.83 | 0.82 | 0.80 | 0.80 | 0.94 | 0.91 | 0.97 |
Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm. (NCT00357552)
Timeframe: Screening
| Intervention | number of screened subjects (Number) | |
|---|---|---|
| At least one NNRTI-associated mutation | At least one NRTI-associated mutation | |
| All Screened Subjects With Available Sequences | 201 | 197 |
(NCT00357552)
Timeframe: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104
| Intervention | proportion of participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| week 0 (N=123) | week 12 (N=122) | week 16 (N=121) | week 20 (N=115) | week 24 (N=122) | week 32 (N=121) | week 40 (N=118) | week 48 (N=118) | week 56 (N=120) | week 68 (N=116) | week 80 (N=117) | week 92 (N=116) | week 104 (N=117) | |
| LPV/r Monotherapy | 0.02 | 0.75 | 0.87 | 0.84 | 0.84 | 0.83 | 0.84 | 0.87 | 0.86 | 0.91 | 0.85 | 0.87 | 0.89 |
Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm. (NCT00357552)
Timeframe: At time of virologic failure
| Intervention | participants (Number) |
|---|---|
| Virologic Failures by Week 24. | 2 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Drug-related LAEs | Without Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 29 | 253 |
| MK-0518 400 mg b.i.d. | 18 | 263 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With LAEs | Without LAEs | |
| Efavirenz 600 mg q.h.s. | 41 | 241 |
| MK-0518 400 mg b.i.d. | 27 | 254 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With LAEs | Without LAEs | |
| Efavirenz 600 mg q.h.s. | 63 | 219 |
| MK-0518 400 mg b.i.d. | 41 | 240 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With LAEs | Without LAEs | |
| Efavirenz 600 mg q.h.s. | 77 | 205 |
| MK-0518 400 mg b.i.d. | 56 | 225 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With LAEs | Without LAEs | |
| Efavirenz 600 mg q.h.s. | 53 | 229 |
| MK-0518 400 mg b.i.d. | 33 | 248 |
Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression (NCT00369941)
Timeframe: 8 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Nervous System Symptoms | Without Nervous System Symptoms | |
| Efavirenz 600 mg q.h.s. | 147 | 135 |
| MK-0518 400 mg b.i.d. | 57 | 224 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious CAEs | Without Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 46 | 236 |
| MK-0518 400 mg b.i.d. | 46 | 235 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious CAEs | Without Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 57 | 225 |
| MK-0518 400 mg b.i.d. | 57 | 224 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious CAEs | Without Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 27 | 255 |
| MK-0518 400 mg b.i.d. | 28 | 253 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious CAEs | Without Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 33 | 249 |
| MK-0518 400 mg b.i.d. | 37 | 244 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 6 | 276 |
| MK-0518 400 mg b.i.d. | 6 | 275 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 7 | 275 |
| MK-0518 400 mg b.i.d. | 8 | 273 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 5 | 277 |
| MK-0518 400 mg b.i.d. | 4 | 277 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 5 | 277 |
| MK-0518 400 mg b.i.d. | 6 | 275 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related LAEs | Without Serious Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related LAEs | Without Serious Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 0 | 282 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious Drug-related CAEs | Without Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 0 | 282 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious LAEs | Without Serious LAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious LAEs | Without Serious LAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious LAEs | Without Serious LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Serious LAEs | Without Serious LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With CAEs | Without CAEs | |
| Efavirenz 600 mg q.h.s. | 276 | 6 |
| MK-0518 400 mg b.i.d. | 271 | 10 |
Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 156
| Intervention | CD4 Cell Count (cells/mm3) (Mean) |
|---|---|
| MK-0518 400 mg b.i.d. | 331.7 |
| Efavirenz 600 mg q.h.s. | 295.2 |
Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 240
| Intervention | CD4 Cell Count (cells/mm3) (Mean) |
|---|---|
| MK-0518 400 mg b.i.d. | 373.7 |
| Efavirenz 600 mg q.h.s. | 311.6 |
Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 96
| Intervention | CD4 Cell Count (cells/mm3) (Mean) |
|---|---|
| MK-0518 400 mg b.i.d. | 239.6 |
| Efavirenz 600 mg q.h.s. | 224.8 |
Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 48
| Intervention | CD4 Cell Count (cells/mm3) (Mean) |
|---|---|
| MK-0518 400 mg b.i.d. | 189.1 |
| Efavirenz 600 mg q.h.s. | 163.3 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 224 |
| Efavirenz 600 mg q.h.s. | 203 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 206 |
| Efavirenz 600 mg q.h.s. | 181 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 252 |
| Efavirenz 600 mg q.h.s. | 241 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 240 |
| Efavirenz 600 mg q.h.s. | 229 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 212 |
| Efavirenz 600 mg q.h.s. | 192 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 198 |
| Efavirenz 600 mg q.h.s. | 171 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 228 |
| Efavirenz 600 mg q.h.s. | 222 |
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) |
|---|---|
| MK-0518 400 mg b.i.d. | 241 |
| Efavirenz 600 mg q.h.s. | 230 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-related LAEs | Did Not Discontinue With Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-related LAEs | Did Not Discontinue With Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse events (AEs) in this study were defined as drug-related if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued with Drug-related LAEs | Did Not Discontinue with Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-related LAEs | Did Not Discontinue With Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With LAEs | Did Not Discontinue With LAEs | |
| Efavirenz 600 mg q.h.s. | 3 | 279 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With LAEs | Did Not Discontinue With LAEs | |
| Efavirenz 600 mg q.h.s. | 3 | 279 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued with LAEs | Did Not Discontinue with LAEs | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With LAEs | Did Not Discontinue With LAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 0 | 281 |
All participant deaths in the span of 156 weeks on study were recorded. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Died | Did Not Die | |
| Efavirenz 600 mg q.h.s. | 1 | 281 |
| MK-0518 400 mg b.i.d. | 4 | 277 |
All participant deaths in the span of 240 weeks on study were recorded. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Died | Did Not Die | |
| Efavirenz 600 mg q.h.s. | 5 | 277 |
| MK-0518 400 mg b.i.d. | 5 | 276 |
All participant deaths in the span of 48 weeks on study were recorded. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Died | Did Not Die | |
| Efavirenz 600 mg q.h.s. | 0 | 282 |
| MK-0518 400 mg b.i.d. | 2 | 279 |
All participant deaths in the span of 96 weeks on study were recorded. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Died | Did Not Die | |
| Efavirenz 600 mg q.h.s. | 0 | 282 |
| MK-0518 400 mg b.i.d. | 3 | 278 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With CAEs | Did Not Discontinue With CAEs | |
| Efavirenz 600 mg q.h.s. | 21 | 261 |
| MK-0518 400 mg b.i.d. | 13 | 268 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With CAEs | Did Not Discontinue With CAEs | |
| Efavirenz 600 mg q.h.s. | 25 | 257 |
| MK-0518 400 mg b.i.d. | 14 | 267 |
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued with CAEs | Did Not Discontinue with CAEs | |
| Efavirenz 600 mg q.h.s. | 17 | 265 |
| MK-0518 400 mg b.i.d. | 9 | 272 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With CAEs | Did Not Discontinue With CAEs | |
| Efavirenz 600 mg q.h.s. | 17 | 265 |
| MK-0518 400 mg b.i.d. | 10 | 271 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-related CAEs | Did Not Discontinue With Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 14 | 268 |
| MK-0518 400 mg b.i.d. | 3 | 278 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-related CAEs | Did Not Discontinue With Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 14 | 268 |
| MK-0518 400 mg b.i.d. | 3 | 278 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued with Drug-related CAEs | Did not Discontinue with Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 11 | 271 |
| MK-0518 400 mg b.i.d. | 3 | 278 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Drug-Related CAEs | Did Not Discontinue With Drug-Related CAEs | |
| Efavirenz 600 mg q.h.s. | 12 | 270 |
| MK-0518 400 mg b.i.d. | 3 | 278 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 6 | 276 |
| MK-0518 400 mg b.i.d. | 10 | 271 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 10 | 272 |
| MK-0518 400 mg b.i.d. | 11 | 270 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued with Serious CAEs | Did Not Discontinue with Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 4 | 278 |
| MK-0518 400 mg b.i.d. | 7 | 274 |
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs | |
| Efavirenz 600 mg q.h.s. | 5 | 277 |
| MK-0518 400 mg b.i.d. | 8 | 273 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious Drug-related CAEs | Did Not Discontinue With Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 1 | 280 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious Drug-related CAEs | Did Not Discontinue With Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 1 | 280 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontiued with Serious Drug-related CAEs | Did Not Discontinue with Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 1 | 280 |
"Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Discontinued With Serious Drug-related CAEs | Did Not Discontinue With Serious Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 2 | 280 |
| MK-0518 400 mg b.i.d. | 1 | 280 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With CAEs | Without CAEs | |
| Efavirenz 600 mg q.h.s. | 276 | 6 |
| MK-0518 400 mg b.i.d. | 267 | 14 |
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With CAEs | Without CAEs | |
| Efavirenz 600 mg q.h.s. | 274 | 8 |
| MK-0518 400 mg b.i.d. | 265 | 16 |
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With CAEs | Without CAEs | |
| Efavirenz 600 mg q.h.s. | 272 | 10 |
| MK-0518 400 mg b.i.d. | 253 | 28 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With drug-related CAEs | Without drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 225 | 57 |
| MK-0518 400 mg b.i.d. | 139 | 142 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With drug-related CAEs | Without drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 226 | 56 |
| MK-0518 400 mg b.i.d. | 146 | 135 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Drug-related CAEs | Without Drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 217 | 65 |
| MK-0518 400 mg b.i.d. | 124 | 157 |
"Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 96 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With drug-related CAEs | Without drug-related CAEs | |
| Efavirenz 600 mg q.h.s. | 220 | 62 |
| MK-0518 400 mg b.i.d. | 132 | 149 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 156 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Drug-related LAEs | Without Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 33 | 249 |
| MK-0518 400 mg b.i.d. | 22 | 259 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 240 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Drug-related LAEs | Without Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 43 | 239 |
| MK-0518 400 mg b.i.d. | 26 | 255 |
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Adverse experiences (AEs) in this study were defined as drug-related if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment." (NCT00369941)
Timeframe: 48 Weeks
| Intervention | Participants (Number) | |
|---|---|---|
| With Drug-related LAEs | Without Drug-related LAEs | |
| Efavirenz 600 mg q.h.s. | 24 | 258 |
| MK-0518 400 mg b.i.d. | 14 | 267 |
Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL. (NCT00442962)
Timeframe: Throughout study
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 50th percentile | 75th percentile | 95th percentile | |
| EFV + FTC/TDF | 2 | 8 | 24 |
Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00442962)
Timeframe: Throughout study
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 15th percentile | |
| EFV + FTC/TDF | 4.1 | 24.4 | 33.1 |
Time from starting study treatment to first dose/drug modification. (NCT00442962)
Timeframe: Throughout study
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 10th percentile | 15th percentile | 20th percentile | |
| EFV + FTC/TDF | 1.9 | 24.9 | 25.7 |
Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline. (NCT00442962)
Timeframe: At weeks 0(baseline), 4, 8, 16, 24
| Intervention | cells/mm^3 (Mean) | |||
|---|---|---|---|---|
| Change from baseline to week 4 | Change from baseline to week 8 | Change from baseline to week 16 | Change from baseline to week 24 | |
| EFV + FTC/TDF | 105 | 118 | 138 | 147 |
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Weeks 24
| Intervention | percentage of participants (Number) |
|---|---|
| EFV + FTC/TDF | 72.0 |
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| EFV + FTC/TDF | 80.8 |
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Week 48
| Intervention | percentage (Number) |
|---|---|
| EFV + FTC/TDF | 70.5 |
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 48
| Intervention | percentage (Number) |
|---|---|
| EFV + FTC/TDF | 80.43 |
(NCT00442962)
Timeframe: Throughout study
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 10th percentile | 15th percentile | 20th percentile | |
| EFV + FTC/TDF | 16 | 24 | 24 |
Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment. (NCT00442962)
Timeframe: Throughout study
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 5th percentile | 10th percentile | 15th percentile | |
| EFV + FTC/TDF | 16 | 16 | 24 |
Change in CD4+ lymphocyte counts between week 48 study visit and baseline. (NCT00442962)
Timeframe: At week 48
| Intervention | cells/mm^3 (Mean) |
|---|---|
| EFV + FTC/TDF | 194 |
Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Duration of follow-up, median 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 32 |
| Placebo | 24 |
Confirmed HIV infection (NCT00458393)
Timeframe: Monthly follow-up through a median of 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 48 |
| Placebo | 83 |
Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL) (NCT00458393)
Timeframe: The entire follow-up period, median 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 13 |
| Placebo | 10 |
Diagnosis of gonorrhea during the follow-up period by PCR (NCT00458393)
Timeframe: All of follow-up period, median of 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 18 |
| Placebo | 30 |
Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Entire follow-up, median 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 70 |
| Placebo | 79 |
Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Entire follow-up, median 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 157 |
| Placebo | 162 |
CD4 cell count for HIV infected participants during the trial (NCT00458393)
Timeframe: at the time infection was detected
| Intervention | cells per cubic mm (Mean) |
|---|---|
| TDF/FTC | 495 |
| Placebo | 502 |
Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status. (NCT00458393)
Timeframe: At 24 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 332 |
| Placebo | 348 |
"A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.~More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/" (NCT00458393)
Timeframe: Quarterly lab tests through a median follow-up of 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 0 |
| Placebo | 0 |
Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period (NCT00458393)
Timeframe: at the time of HIV acquisition
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Infected at Enrollment (prior to randomization) | Infected after Randomization | |
| Placebo | 1 | 0 |
| TDF/FTC | 2 | 0 |
% Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry (NCT00458393)
Timeframe: baseline and week 24.
| Intervention | percent change from baseline (Mean) | |
|---|---|---|
| L1-L4 Spine bone mineral density | Hip bone mineral density | |
| Placebo | 0.32 | 0.29 |
| TDF/FTC | -0.59 | -0.34 |
Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample. (NCT00458393)
Timeframe: Baseline and Week 24
| Intervention | percent change from baseline (Median) |
|---|---|
| TDF/FTC | 0.0 |
| Placebo | 0.0 |
HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection (NCT00458393)
Timeframe: At the time closest to HIV detection
| Intervention | log RNA copies per ml (Mean) |
|---|---|
| TDF/FTC | 5.2 |
| Placebo | 5.1 |
Self-reported total number of sexual partners in the previous 12 weeks. (NCT00458393)
Timeframe: 24 weeks
| Intervention | Count (Median) |
|---|---|
| TDF/FTC | 3 |
| Placebo | 3 |
Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles) (NCT00458393)
Timeframe: At 24 weeks
| Intervention | proportion of pills not returned (Mean) |
|---|---|
| TDF/FTC | 0.92 |
| Placebo | 0.93 |
Percentage of missed doses by estimate during computer assisted structured interview (NCT00458393)
Timeframe: Week 24
| Intervention | percentage of doses taken (Mean) |
|---|---|
| TDF/FTC | 91.0 |
| Placebo | 91.2 |
Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry (NCT00458393)
Timeframe: Baseline and Week 24
| Intervention | percent change from baseline (Median) |
|---|---|
| TDF/FTC | 0.0 |
| Placebo | 3.8 |
Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline (NCT00458393)
Timeframe: Baseline and Week 24
| Intervention | percent change from baseline (Median) |
|---|---|
| TDF/FTC | -3.2 |
| Placebo | -1.1 |
Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex (NCT00458393)
Timeframe: At 24 weeks
| Intervention | count (Median) |
|---|---|
| TDF/FTC | 0 |
| Placebo | 0 |
Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline (NCT00458393)
Timeframe: Total study follow-up, a median of 1.2 years
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 65 |
| Placebo | 60 |
Number of participants who have at least 1 confirmed syphilis infection during the study (NCT00458393)
Timeframe: All Follow-Up median of 1.2 years of follow-up
| Intervention | Participants (Count of Participants) |
|---|---|
| TDF/FTC | 147 |
| Placebo | 132 |
Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | percentage of visits (Number) | |
|---|---|---|
| Missed any doses | Missed 2+ consecutive doses | |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 15 | 4 |
| Placebo | 15 | 4 |
| Tenofovir Disoproxil Fumarate (TDF) | 15 | 4 |
Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | percentage of doses taken of dispensed (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 97 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 97 |
| Placebo | 97 |
"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)." (NCT00557245)
Timeframe: Up to 36 months
| Intervention | Participants (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 1 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
| Placebo | 0 |
Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | percentage of visits (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 14 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 13 |
| Placebo | 13 |
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | Participants (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 118 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 115 |
| Placebo | 118 |
"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)." (NCT00557245)
Timeframe: Up to 36 months
| Intervention | participants (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 102 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 76 |
| Placebo | 85 |
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
| Intervention | z-score difference per study month (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | -0.057 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | -0.005 |
| Placebo | -0.079 |
Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | Number of live-born infants (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 4 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 4 |
| Placebo | 5 |
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms. (NCT00557245)
Timeframe: Up to 36 months
| Intervention | events per 100 person years (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | 0.65 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.50 |
| Placebo | 1.99 |
The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
| Intervention | z-score difference per study month (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | -0.006 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.036 |
| Placebo | -0.033 |
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
| Intervention | z-score difference per study month (Number) |
|---|---|
| Tenofovir Disoproxil Fumarate (TDF) | -0.021 |
| Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.009 |
| Placebo | -0.056 |
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected (NCT00594646)
Timeframe: 90 days
| Intervention | participants (Number) |
|---|---|
| Group 1 | 0 |
Pill counts performed at 14 and 28 days (NCT00594646)
Timeframe: 28 days
| Intervention | participants (Number) | ||
|---|---|---|---|
| Completed as prescribed | Stopped or Modified regimen | Lost to follow-up | |
| Group 1 | 57 | 28 | 15 |
Number of participants with self-reported 100% adherence over the week prior to study visit (NCT00608569)
Timeframe: At weeks 4, 8, 12, 24, 36, 48 and 52
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 24 | Week 48 | Week 52 | |
| mDOT Arm | 105 | 108 | 114 | 107 | 103 | 104 |
| Non-mDOT Arm | 117 | 115 | 116 | 116 | 109 | 109 |
CD4 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At Weeks 4, 12, 24, 36, and 48
| Intervention | cells/mm3 (Median) | ||||
|---|---|---|---|---|---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 | |
| mDOT Arm | 212 | 225 | 268 | 281 | 301 |
| Non-mDOT Arm | 219 | 235 | 266 | 294 | 347 |
CD8 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At week 4, 12, 24, 36, and 48
| Intervention | cells/mm3 (Median) | ||||
|---|---|---|---|---|---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 | |
| mDOT Arm | 776 | 895 | 816 | 787 | 815 |
| Non-mDOT Arm | 859 | 916 | 818 | 833 | 823 |
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. (NCT00608569)
Timeframe: At or prior to Week 24
| Intervention | participants (Number) | |
|---|---|---|
| No Failure | Experienced Failure | |
| mDOT Arm | 105 | 24 |
| Non-mDOT Arm | 111 | 17 |
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. (NCT00608569)
Timeframe: At or prior to Week 48
| Intervention | participants (Number) | |
|---|---|---|
| No Failure | Experienced Failure | |
| mDOT Arm | 95 | 34 |
| Non-mDOT Arm | 105 | 23 |
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event (NCT00608569)
Timeframe: 52 weeks since randomization
| Intervention | weeks (Number) | |
|---|---|---|
| 5th percentile | 10th percentile | |
| mDOT Arm | 24 | NA |
| Non-mDOT Arm | NA | NA |
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event (NCT00608569)
Timeframe: 52 weeks since randomization
| Intervention | weeks (Number) | |
|---|---|---|
| 5th percentile | 10th percentile | |
| mDOT Arm | 6.4 | 24 |
| Non-mDOT Arm | 24 | 32.6 |
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom (NCT00608569)
Timeframe: 52 weeks since randomization
| Intervention | weeks (Number) | |
|---|---|---|
| 5th percentile | 10th percentile | |
| mDOT Arm | 13.7 | NA |
| Non-mDOT Arm | 26.7 | 48.9 |
Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 3 |
| Placebo Arm | 1 |
Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 6 |
| Placebo Arm | 8 |
Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 45 |
| Placebo Arm | 40 |
Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal (NCT00625404)
Timeframe: cumulative toxicity through 52 weeks of product use and 4 weeks post product
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 4 |
| Placebo Arm | 2 |
CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks (NCT00625404)
Timeframe: Up to 16 weeks
| Intervention | cells/mL (Mean) |
|---|---|
| Truvada Arm | 579.3 |
| Placebo Arm | 601.4 |
The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration. (NCT00625404)
Timeframe: 10-26 months per site
| Intervention | Number of adverse events (Number) |
|---|---|
| Truvada Arm | 2257 |
| Placebo Arm | 2384 |
"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time." (NCT00625404)
Timeframe: up to 52 weeks
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 3 |
| Placebo Arm | 1 |
HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens. (NCT00625404)
Timeframe: Cumulative HIV infection between enrollment and 52 weeks
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 33 |
| Placebo Arm | 35 |
Difference in mean number of reported sexual partners between final study visit and enrollment visit (NCT00625404)
Timeframe: Up to 52 weeks
| Intervention | mean number of sexual partners (Mean) |
|---|---|
| Truvada Arm | -0.14 |
| Placebo Arm | -0.13 |
Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts (NCT00625404)
Timeframe: Up to 52 weeks
| Intervention | percentage of days (Mean) |
|---|---|
| Truvada Arm | 87 |
| Placebo Arm | 89 |
Viral load at the time of HIV detection, HIV conversion and through 16 weeks (NCT00625404)
Timeframe: up to 16 weeks
| Intervention | log copies/mL (Log Mean) |
|---|---|
| Truvada Arm | 4.40 |
| Placebo Arm | 4.37 |
Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications (NCT00625404)
Timeframe: up to 60 weeks
| Intervention | participants (Number) |
|---|---|
| Truvada Arm | 20 |
| Placebo Arm | 10 |
(NCT00632970)
Timeframe: 24 and 48 weeks
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Raltegravir | 50 |
| Lopinavir/Ritonavir | 50 |
"HBV DNA carries the genetic blueprint of the virus. How many HBV DNA particles or copies are found in the blood indicates how rapidly the virus is reproducing in the liver." (NCT00662545)
Timeframe: week 24
| Intervention | log 10 IU/ml (Median) |
|---|---|
| Entecavir Intensification | 2.4 |
| Standard of Care | 0.8 |
(NCT00662545)
Timeframe: entry, week 12, and week 24
| Intervention | participants (Number) |
|---|---|
| Entecavir Intensification | 5 |
| Standard of Care | 5 |
ALT flare: sudden increase in blood level of alanine transaminase (ALT) (NCT00662545)
Timeframe: every 4 weeks for 24 weeks
| Intervention | participants (Number) |
|---|---|
| Entecavir Intensification | 0 |
| Standard of Care | 0 |
(NCT00662545)
Timeframe: 24 weeks
| Intervention | participants (Number) |
|---|---|
| Entecavir Intensification | 0 |
| Standard of Care | 0 |
(NCT00662545)
Timeframe: every 4 weeks for 24 weeks
| Intervention | participants (Number) |
|---|---|
| Entecavir Intensification | 0 |
| Standard of Care | 0 |
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | participants (Number) |
|---|---|
| Oral TDF | 52 |
| Oral Placebo | 35 |
This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years
| Intervention | participants (Number) |
|---|---|
| Oral TDF | 4 |
| Oral TDF-FTC | 13 |
| Oral Placebo | 2 |
| TFV Gel | 9 |
| Gel Placebo | 3 |
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | cases per 100 person-years (Number) |
|---|---|
| Oral TDF | 6.3 |
| Oral Placebo | 4.2 |
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | cases per 100 person-years (Number) |
|---|---|
| Oral TDF-FTC | 4.7 |
| Oral Placebo | 4.6 |
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | cases per 100 person-years (Number) |
|---|---|
| TFV Gel | 6.0 |
| Placebo Gel | 6.8 |
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | participants (Number) |
|---|---|
| Oral TDF-FTC | 61 |
| Oral Placebo | 60 |
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | participants (Number) |
|---|---|
| TFV Gel | 61 |
| Placebo Gel | 70 |
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group. (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | person-years (Number) |
|---|---|
| Oral TDF | 823 |
| Oral Placebo | 838 |
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | person-years (Number) |
|---|---|
| Oral TDF-FTC | 1284 |
| Oral Placebo | 1308 |
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up
| Intervention | person-years (Number) |
|---|---|
| TFV Gel | 1024 |
| Placebo Gel | 1030 |
The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years
| Intervention | participants (Number) | |
|---|---|---|
| M184V mutation | No M184V mutation | |
| Gel Placebo | 0 | 68 |
| Oral Placebo | 0 | 60 |
| Oral TDF | 0 | 58 |
| Oral TDF-FTC | 1 | 54 |
| TFV Gel | 0 | 60 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.332 |
| LPV/r + RAL | 0.368 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | ratio (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.056 |
| LPV/r + RAL | -0.040 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.535 |
| LPV/r + RAL | 0.715 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 4.674 |
| LPV/r + RAL | -1.898 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | nanograms/milliliter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 3.623 |
| LPV/r + RAL | 2.927 |
The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction. (NCT00711009)
Timeframe: Week 96
| Intervention | Scores on a scale (Mean) |
|---|---|
| LPV/r + FTC/TDF | 75.5 |
| LPV/r + RAL | 76.0 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | millimoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.281 |
| LPV/r + RAL | 0.444 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | nanograms/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -1.584 |
| LPV/r + RAL | -53.286 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | picomoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -6.724 |
| LPV/r + RAL | 4.441 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.046 |
| LPV/r + RAL | -0.028 |
Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cm (Mean) |
|---|---|
| LPV/r + FTC/TDF | 2.45 |
| LPV/r + RAL | 4.70 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.257 |
| LPV/r + RAL | 0.346 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 5.4 |
| LPV/r + RAL | 5.1 |
Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | % by volume of packed RBCs in blood (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.038 |
| LPV/r + RAL | 0.036 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | millimoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.011 |
| LPV/r + RAL | 0.109 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.012 |
| LPV/r + RAL | 0.015 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.33 |
| LPV/r + RAL | 1.52 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | -1.49 |
| LPV/r + RAL | -1.25 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 7.28 |
| LPV/r + RAL | 21.53 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 3.48 |
| LPV/r + RAL | 6.34 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.67 |
| LPV/r + RAL | 2.56 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 13.75 |
| LPV/r + RAL | 27.01 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 2.9 |
| LPV/r + RAL | 5.4 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.08 |
| LPV/r + RAL | 1.56 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 12.71 |
| LPV/r + RAL | 25.31 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 4.32 |
| LPV/r + RAL | 6.96 |
The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 15.32 |
| LPV/r + RAL | 28.82 |
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams/cm^2 (Mean) |
|---|---|
| LPV/r + FTC/TDF | -2.48 |
| LPV/r + RAL | 0.68 |
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | -3.69 |
| LPV/r + RAL | 0.52 |
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.97 |
| LPV/r + RAL | 2.27 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 5.7 |
| LPV/r + RAL | 1.6 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 398.9 |
| LPV/r + RAL | 157.2 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.808 |
| LPV/r + RAL | 1.113 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.4 |
| LPV/r + RAL | 0.2 |
Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cm (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.13 |
| LPV/r + RAL | 4.06 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | milliliters/second (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.122 |
| LPV/r + RAL | -0.024 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.040 |
| LPV/r + RAL | -0.016 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.00 |
| LPV/r + RAL | 0.37 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.5 |
| LPV/r + RAL | -0.8 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.005 |
| LPV/r + RAL | 0.003 |
The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction. (NCT00711009)
Timeframe: Week 96
| Intervention | Scores on a scale (Mean) |
|---|---|
| LPV/r + FTC/TDF | 82.5 |
| LPV/r + RAL | 85.5 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.8 |
| LPV/r + RAL | -9.6 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 14.5 |
| LPV/r + RAL | 1.7 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.4 |
| LPV/r + RAL | 1.3 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -6.1 |
| LPV/r + RAL | -13.4 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micrograms/milliliter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 2.112 |
| LPV/r + RAL | 2.064 |
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Scores on a scale (Mean) |
|---|---|
| LPV/r + FTC/TDF | -1.0 |
| LPV/r + RAL | -1.1 |
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Scores on a scale (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.3 |
| LPV/r + RAL | 1.3 |
The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction. (NCT00711009)
Timeframe: Week 96
| Intervention | Scores on a scale (Mean) |
|---|---|
| LPV/r + FTC/TDF | 84.6 |
| LPV/r + RAL | 86.2 |
Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Percentage of Participants (Number) |
|---|---|
| LPV/r + FTC/TDF | 79.1 |
| LPV/r + RAL | 77.8 |
Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Lopinavir resistance | Emtricitabine resistance | Tenofovir resistance | Raltegravir resistance | |
| LPV/r + FTC/TDF | 0 | 1 | 0 | NA |
| LPV/r + RAL | 0 | 0 | 0 | 3 |
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Percentage of Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 | Week 4 | Week 8 | Week 16 | Week 24 | Week 32 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | |
| LPV/r + FTC/TDF | 7.6 | 17.1 | 36.2 | 67.6 | 80.0 | 85.7 | 84.8 | 84.8 | 82.9 | 78.1 | 74.3 | 68.6 |
| LPV/r + RAL | 33.7 | 63.4 | 75.2 | 81.2 | 83.2 | 85.1 | 87.1 | 83.2 | 75.2 | 71.3 | 70.3 | 66.3 |
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Any adverse event | Diarrhoea | Hyperchloresterolaemia | Hypertriglyceridaemia | Hyperlipidaemia | Blood triglycerides increased | Alanine aminotransferase increased | Aspartate aminotransferase increased | Asthenia | |
| LPV/r + FTC/TDF | 34.3 | 16.2 | 4.8 | 2.9 | 1.0 | 1.9 | 1.0 | 0 | 2.9 |
| LPV/r + RAL | 30.7 | 7.9 | 8.9 | 5.9 | 3.0 | 3.0 | 3.0 | 2.0 | 0 |
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Percentage of participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Alananine aminotransferase >5x upper limit normal | Aspartate aminotransferase >5x upper limit normal | Creatinine phosphokinase >4x upper limit of normal | Calcium <1.75 millimoles/liter | Cholesterol >7.77 millimoles/liter | Triglycerides >8.475 millimoles/liter | Calc. creatinine clearance <50 milliliters/minute | Lipase >2x upper limit of normal | Neutrophils < 0.75 x 10^9/liter | Magnesium < 0.5 millimoles/liter | |
| LPV/r + FTC/TDF | 2.9 | 2.9 | 8.7 | 0 | 13.5 | 4.8 | 3.8 | 7.7 | 3.8 | 0 |
| LPV/r + RAL | 5.0 | 5.0 | 19.8 | 2.0 | 16.8 | 9.9 | 1.0 | 4.0 | 0 | 2.0 |
Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cm (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.76 |
| LPV/r + RAL | 4.71 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cells/microliter (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 16 | Week 24 | Week 32 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | |
| LPV/r + FTC/TDF | 97.2 | 107.9 | 158.7 | 154.9 | 180.0 | 204.6 | 245.0 | 243.4 | 277.4 | 309.6 | 296.4 |
| LPV/r + RAL | 113.4 | 124.5 | 141.6 | 174.5 | 188.2 | 223.0 | 241.9 | 250.6 | 269.9 | 280.2 | 281.0 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | units/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -21.157 |
| LPV/r + RAL | -28.926 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | millimoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.019 |
| LPV/r + RAL | -0.009 |
Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cm (Mean) |
|---|---|
| LPV/r + FTC/TDF | 2.09 |
| LPV/r + RAL | 5.13 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.065 |
| LPV/r + RAL | 0.112 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.509 |
| LPV/r + RAL | 0.705 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 46.8 |
| LPV/r + RAL | 34.2 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.13 |
| LPV/r + RAL | 0.03 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^12/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.12 |
| LPV/r + RAL | 0.16 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | mm Hg (Mean) |
|---|---|
| LPV/r + FTC/TDF | -2.4 |
| LPV/r + RAL | -1.8 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | beats per minute (Mean) |
|---|---|
| LPV/r + FTC/TDF | -4.6 |
| LPV/r + RAL | -6.3 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | mm Hg (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.7 |
| LPV/r + RAL | -2.4 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.1 |
| LPV/r + RAL | 0.7 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | picograms/milliliter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -138.602 |
| LPV/r + RAL | -166.403 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | picograms/milliliter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -1257.9 |
| LPV/r + RAL | -1594.7 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | °F (Mean) |
|---|---|
| LPV/r + FTC/TDF | -0.152 |
| LPV/r + RAL | -0.183 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.9 |
| LPV/r + RAL | 1.9 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | grams/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -6.3 |
| LPV/r + RAL | -7.2 |
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.846 |
| LPV/r + RAL | 1.103 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | micromoles/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | -29.0 |
| LPV/r + RAL | -6.1 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | pH (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.00 |
| LPV/r + RAL | 0.03 |
Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | ratio of urine density to water density (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.0042 |
| LPV/r + RAL | 0.0052 |
Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | cm (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.88 |
| LPV/r + RAL | 4.93 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | kg (Mean) |
|---|---|
| LPV/r + FTC/TDF | 1.83 |
| LPV/r + RAL | 3.77 |
(NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | number of cells x 10^9/liter (Mean) |
|---|---|
| LPV/r + FTC/TDF | 0.90 |
| LPV/r + RAL | 1.20 |
Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S. (NCT00711009)
Timeframe: Baseline to Week 96
| Intervention | Participants (Number) |
|---|---|
| LPV/r + FTC/TDF | 0 |
| LPV/r + RAL | 1 |
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 48
| Intervention | Percentage of Participants (Number) |
|---|---|
| LPV/r + FTC/TDF | 84.8 |
| LPV/r + RAL | 83.2 |
The development of DRMs was summarized, either as development of new DRMs or enrichment of existing DRMs. (NCT00737568)
Timeframe: Baseline to Week 240
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| New tenofovir DF DRMs | Enrichment of tenofovir DF DRMs | New FTC DRMs | Enrichment of FTC DRMs | |
| FTC/Tenofovir DF | 0 | 0 | 0 | 1 |
| Tenofovir DF | 0 | 0 | 0 | 0 |
The percentage of participants with seroconversion to anti-HBs at the given time point was summarized. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00737568)
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 0.0 | 0.0 | 0.7 | 0.7 | 0.7 |
| Tenofovir DF | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Normal ALT was defined as having a value less than or equal to the ULN. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00737568)
Timeframe: Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 69.8 | 69.8 | 75.5 | 76.3 | 71.9 |
| Tenofovir DF | 67.4 | 70.2 | 70.2 | 75.9 | 71.6 |
The percentage of participants who were HBeAg positive at baseline and who had seroconversion to anti-HBe at the given time point was summarized. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00737568)
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 4.4 | 10.3 | 11.8 | 10.3 | 10.3 |
| Tenofovir DF | 6.2 | 10.8 | 12.3 | 10.8 | 12.3 |
(NCT00737568)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| Tenofovir DF | 89.4 |
| FTC/Tenofovir DF | 86.3 |
(NCT00737568)
Timeframe: Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 77.7 | 83.5 | 84.9 | 84.2 | 82.0 |
| Tenofovir DF | 76.6 | 85.8 | 86.5 | 85.1 | 81.6 |
The percentage of participants who were HBeAg positive at baseline and who had HBeAg Loss at the given time point was summarized. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. (NCT00737568)
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 5.9 | 13.2 | 17.6 | 14.7 | 19.1 |
| Tenofovir DF | 9.2 | 15.4 | 23.1 | 21.5 | 24.6 |
The percentage of participants with virologic breakthrough at the given time point was summarized. Virologic breakthrough was defined as having two consecutive 1.0 log10 or greater increases in serum HBV DNA from on-treatment nadir, or two consecutive HBV DNA values ≥ 400 copies/mL after being < 400 copies/mL. (NCT00737568)
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 (TDF: n=130; FTC/TDF: n=133) | Week 96 (TDF: n=132; FTC/TDF: n=127) | Week 144 (TDF: n=128; FTC/TDF: n=123) | Week 192 (TDF: n=126; FTC/TDF: n=119) | Week 240 (TDF: n=118; FTC/TDF: n=116) | |
| FTC/Tenofovir DF | 0.8 | 0.0 | 0.8 | 0.0 | 0.0 |
| Tenofovir DF | 0.0 | 0.0 | 0.8 | 0.8 | 0.0 |
(NCT00737568)
Timeframe: Weeks 48, 96, 144, 192, and 240
| Intervention | log10 copies/mL (Mean) | ||||
|---|---|---|---|---|---|
| Week 48 (TDF: n=130; FTC/TDF: n=133) | Week 96 (TDF: n=132; FTC/TDF: n=127) | Week 144 (TDF: n=128; FTC/TDF: n=123) | Week 192 (TDF: n=126; FTC/TDF: n=119) | Week 240 (TDF: n=118; FTC/TDF: n=116) | |
| FTC/Tenofovir DF | 2.48 | 2.28 | 2.29 | 2.23 | 2.26 |
| Tenofovir DF | 2.42 | 2.29 | 2.26 | 2.25 | 2.23 |
BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. (NCT00737568)
Timeframe: Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240
| Intervention | percentage change (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| % Change at Week 24 (TDF: n=130; FTC/TDF: n=127) | % Change at Week 48 (TDF: n=126; FTC/TDF: n=118) | % Change at Week 72 (TDF: n=121; FTC/TDF: n=115) | % Change at Week 96 (TDF: n=125; FTC/TDF: n=112) | % Change at Week 144 (TDF: n=120; FTC/TDF: n=107) | % Change at Week 192 (TDF: n=116; FTC/TDF: n=105) | % Change at Week 240 (TDF: n=111; FTC/TDF: n=100) | |
| FTC/Tenofovir DF | -0.59 | -1.00 | -1.61 | -1.77 | -1.91 | -2.41 | -2.63 |
| Tenofovir DF | -0.71 | -1.15 | -1.59 | -1.70 | -2.02 | -2.33 | -2.46 |
BMD is calculated as grams per cubic centimeter (g/cm^2); the mean (SD) percentage change is presented. (NCT00737568)
Timeframe: Baseline; Weeks 24, 48, 72, 96, 144, 192, and 240
| Intervention | percentage change (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| % Change at Week 24 (TDF: n=132; FTC/TDF: n=127) | % Change at Week 48 (TDF: n=126; FTC/TDF: n=121) | % Change at Week 72 (TDF: n=123; FTC/TDF: n=119) | % Change at Week 96 (TDF: n=126; FTC/TDF: n=114) | % Change at Week 144 (TDF: n=123; FTC/TDF: n=110) | % Change at Week 192 (TDF: n=120; FTC/TDF: n=106) | % Change at Week 240 (TDF: n=115; FTC/TDF: n=102) | |
| FTC/Tenofovir DF | -1.83 | -1.73 | -1.95 | -1.72 | -1.63 | -1.60 | -1.15 |
| Tenofovir DF | -1.74 | -1.68 | -1.35 | -1.24 | -1.36 | -1.32 | -0.83 |
The percentage of participants with HBsAg Loss at the given time point was summarized. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. (NCT00737568)
Timeframe: Baseline; Weeks 48, 96, 144, 192, and 240
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 0.7 | 0.7 | 1.4 | 2.9 | 2.9 |
| Tenofovir DF | 0.0 | 0.0 | 0.7 | 0.7 | 1.4 |
(NCT00737568)
Timeframe: Weeks 48, 144, 192, and 240
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 48 | Week 144 | Week 192 | Week 240 | |
| FTC/Tenofovir DF | 84.2 | 84.9 | 85.6 | 82.7 |
| Tenofovir DF | 81.6 | 87.2 | 86.5 | 83.0 |
(NCT00745823)
Timeframe: Week 48
| Intervention | Participants (Number) |
|---|---|
| Raltegravir 800 mg q.d. | 4 |
| Raltegravir 400 mg b.i.d. | 3 |
(NCT00745823)
Timeframe: Baseline and Week 48
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Raltegravir 800 mg q.d. | 209.76 |
| Raltegravir 400 mg b.i.d. | 196.20 |
(NCT00745823)
Timeframe: 48 weeks
| Intervention | Participants (Number) |
|---|---|
| Raltegravir 800 mg q.d. | 338 |
| Raltegravir 400 mg b.i.d. | 361 |
(NCT00745823)
Timeframe: Week 48
| Intervention | Participants (Number) |
|---|---|
| Raltegravir 800 mg q.d. | 318 |
| Raltegravir 400 mg b.i.d. | 343 |
(NCT00745823)
Timeframe: Week 48
| Intervention | Participants (Number) |
|---|---|
| Raltegravir 800 mg q.d. | 331 |
| Raltegravir 400 mg b.i.d. | 337 |
(NCT00762892)
Timeframe: Baseline and 48 weeks
| Intervention | umol/L (Mean) |
|---|---|
| Raltegravir | 0.53 |
| Atazanavir | 0.10 |
(NCT00762892)
Timeframe: Baseline and 48 weeks
| Intervention | pg/mL (Mean) |
|---|---|
| Raltegravir | -2.71 |
| Atazanavir | -4.47 |
(NCT00762892)
Timeframe: Baseline and 48 weeks
| Intervention | copies/mL (Mean) |
|---|---|
| Raltegravir | -3.05 |
| Atazanavir | -3.29 |
(NCT00762892)
Timeframe: Baseline and 48 weeks
| Intervention | mg/dL (Mean) | |||
|---|---|---|---|---|
| Total cholesterol | Triglycerides | HDL cholesterol | LDL cholesterol | |
| Atazanavir | 8.13 | 16.88 | -1.38 | 5.88 |
| Raltegravir | -0.25 | -15.50 | -1.5 | 4.13 |
(NCT00762892)
Timeframe: Baseline and 48 weeks
| Intervention | cells/uL (Mean) |
|---|---|
| Raltegravir | 192 |
| Atazanavir | 205 |
Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | cm (Mean) | ||
|---|---|---|---|
| week 48 (nA=555, nB=551, nC=547) | week 96 (nA=512, nB=526, nC=517) | week 144 (nA=425, nB=419, nC=409) | |
| Arm A: ATV/RTV + FTC/TDF | 2.3 | 3.3 | 3.6 |
| Arm B: RAL + FTC/TDF | 3.1 | 4.0 | 4.0 |
| Arm C: DRV/RTV + FTC/TDF | 2.1 | 2.8 | 3.4 |
Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144. (NCT00811954)
Timeframe: At Weeks 4, 24, 48, 96, and 144
| Intervention | percentage of prescribed medication (Mean) | ||||
|---|---|---|---|---|---|
| week 4 (nA=584, nB=590, nC=583) | week 24 (nA=570, nB=568, nC=562) | week 48 (nA=555, nB=547, nC=536) | week 96 (nA=508, nB=525, nC=507) | week 144 (nA=361, nB=376, nC=350) | |
| Arm A: ATV/RTV + FTC/TDF | 98 | 97 | 96 | 96 | 97 |
| Arm B: RAL + FTC/TDF | 97 | 97 | 97 | 96 | 97 |
| Arm C: DRV/RTV + FTC/TDF | 98 | 96 | 96 | 96 | 98 |
The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable
| Intervention | events per 100 person-years (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 1.55 |
| Arm B: RAL + FTC/TDF | 1.64 |
| Arm C: DRV/RTV + FTC/TDF | 2.14 |
Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| week 48 (nA=522, nB=542, nC=507) | week 96 (nA=490, nB=505, nC=490) | week 144 (nA=364, nB=397, nC=363) | |
| Arm A: ATV/RTV + FTC/TDF | 18 | 19 | 12 |
| Arm B: RAL + FTC/TDF | -9 | -9 | -4 |
| Arm C: DRV/RTV + FTC/TDF | 16 | 16 | 20 |
The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable
| Intervention | events per 100 person-years (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 2.38 |
| Arm B: RAL + FTC/TDF | 2.24 |
| Arm C: DRV/RTV + FTC/TDF | 2.69 |
The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
| Intervention | participants (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 0 |
| Arm B: RAL + FTC/TDF | 0 |
| Arm C: DRV/RTV + FTC/TDF | 0 |
The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
| Intervention | participants (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 1 |
| Arm B: RAL + FTC/TDF | 1 |
| Arm C: DRV/RTV + FTC/TDF | 1 |
The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
| Intervention | participants (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 8 |
| Arm B: RAL + FTC/TDF | 7 |
| Arm C: DRV/RTV + FTC/TDF | 3 |
The absolute levels of CD4+ T-cell counts (cells/mm3) (NCT00811954)
Timeframe: At Weeks 24, 48, 96, and 144
| Intervention | cells/mm^3 (Mean) | |||
|---|---|---|---|---|
| week 24 (nA=582, nB=574, nC=579) | week 48 (nA=564, nB=565, nC=559) | week 96 (nA=523, nB=541, nC=525) | week 144 (nA=395, nB=418, nC=394) | |
| Arm A: ATV/RTV + FTC/TDF | 462 | 524 | 587 | 622 |
| Arm B: RAL + FTC/TDF | 460 | 526 | 596 | 631 |
| Arm C: DRV/RTV + FTC/TDF | 457 | 509 | 564 | 596 |
Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count (NCT00811954)
Timeframe: Study entry to weeks 24, 48, 96, and 144
| Intervention | cells/mm^3 (Mean) | |||
|---|---|---|---|---|
| week 24 (nA=582, nB=574, nC=579) | week 48 (nA=564, nB=565, nC=559) | week 96 (nA=523, nB=541, nC=525) | week 144 (nA=395, nB=418, nC=394) | |
| Arm A: ATV/RTV + FTC/TDF | 157 | 218 | 284 | 324 |
| Arm B: RAL + FTC/TDF | 153 | 218 | 288 | 325 |
| Arm C: DRV/RTV + FTC/TDF | 147 | 201 | 256 | 288 |
"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry." (NCT00811954)
Timeframe: From study entry to week 96
| Intervention | cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 13 |
| Arm B: RAL + FTC/TDF | 10 |
| Arm C: DRV/RTV + FTC/TDF | 15 |
"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up." (NCT00811954)
Timeframe: From study entry to week 96
| Intervention | cumulative events per 100 persons (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 81 |
| Arm B: RAL + FTC/TDF | 59 |
| Arm C: DRV/RTV + FTC/TDF | 65 |
Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| week 48 (nA=522, nB=542, nC=506) | week 96 (nA=490, nB=505, nC=488) | week 144 (nA=364, nB=397, nC=363) | |
| Arm A: ATV/RTV + FTC/TDF | 6 | 7 | 8 |
| Arm B: RAL + FTC/TDF | 5 | 6 | 6 |
| Arm C: DRV/RTV + FTC/TDF | 5 | 5 | 7 |
The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. (NCT00811954)
Timeframe: From study entry to week 96
| Intervention | cumulative events per 100 persons (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 14 |
| Arm B: RAL + FTC/TDF | 1 |
| Arm C: DRV/RTV + FTC/TDF | 5 |
Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| week 48 (nA=517, nB=535, nC=506) | week 96 (nA=489, nB=499, nC=481) | week 144 (nA=353, nB=392, nC=358) | |
| Arm A: ATV/RTV + FTC/TDF | 2.2 | 3.0 | 2.2 |
| Arm B: RAL + FTC/TDF | 1.3 | 0.9 | 0.9 |
| Arm C: DRV/RTV + FTC/TDF | 2.1 | 2.5 | 3.6 |
Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| week 48 (nA=521, nB=542, nC=507) | week 96 (nA=490, nB=505, nC=490) | week 144 (nA=364, nB=397, nC=363) | |
| Arm A: ATV/RTV + FTC/TDF | 13 | 16 | 20 |
| Arm B: RAL + FTC/TDF | 1 | 3 | 6 |
| Arm C: DRV/RTV + FTC/TDF | 15 | 14 | 19 |
"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit." (NCT00811954)
Timeframe: From study entry to week 96
| Intervention | cumulative probability per 100 persons (Number) |
|---|---|
| Arm A: ATV/RTV + FTC/TDF | 31 |
| Arm B: RAL + FTC/TDF | 16 |
| Arm C: DRV/RTV + FTC/TDF | 24 |
"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk." (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | percent risk (Mean) | ||
|---|---|---|---|
| week 48 (nA=509, nB=537, nC=492) | week 96 (nA=479, nB=493, nC=470) | week 144 (nA=347, nB=383, nC=349) | |
| Arm A: ATV/RTV + FTC/TDF | 0.4 | 0.5 | 0.6 |
| Arm B: RAL + FTC/TDF | 0.0 | 0.2 | 0.4 |
| Arm C: DRV/RTV + FTC/TDF | 0.4 | 0.4 | 0.9 |
Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
| Intervention | cm:cm (Mean) | ||
|---|---|---|---|
| week 48 (nA=555, nB=551, nC=547) | week 96 (nA=512, nB=526, nC=517) | week 144 (nA=425, nB=419, nC=409) | |
| Arm A: ATV/RTV + FTC/TDF | 0.01 | 0.02 | 0.02 |
| Arm B: RAL + FTC/TDF | 0.02 | 0.02 | 0.02 |
| Arm C: DRV/RTV + FTC/TDF | 0.01 | 0.02 | 0.02 |
Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | -3.7 |
| Cohort B: RAL + FTC/TDF | -2.2 |
| Cohort C: DRV/RTV + FTC/TDF | -3.3 |
Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | -4.0 |
| Cohort B: RAL + FTC/TDF | -1.6 |
| Cohort C: DRV/RTV + FTC/TDF | -3.1 |
Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | -1.9 |
| Cohort B: RAL + FTC/TDF | -0.9 |
| Cohort C: DRV/RTV + FTC/TDF | -1.0 |
Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 1.8 |
| Cohort B: RAL + FTC/TDF | 1.7 |
| Cohort C: DRV/RTV + FTC/TDF | 0.1 |
Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 10.3 |
| Cohort B: RAL + FTC/TDF | 11.8 |
| Cohort C: DRV/RTV + FTC/TDF | 11.4 |
Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 9.8 |
| Cohort B: RAL + FTC/TDF | 6.3 |
| Cohort C: DRV/RTV + FTC/TDF | 7.9 |
Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 10.8 |
| Cohort B: RAL + FTC/TDF | 13.5 |
| Cohort C: DRV/RTV + FTC/TDF | 9.7 |
Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 10.7 |
| Cohort B: RAL + FTC/TDF | 16.2 |
| Cohort C: DRV/RTV + FTC/TDF | 9.5 |
The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. (NCT00851799)
Timeframe: Study entry, weeks 4, 24 and 48
| Intervention | mm (Mean) | ||
|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.002 | -0.002 | 0.002 |
| Cohort B: RAL + FTC/TDF | 0.012 | -0.004 | 0.005 |
| Cohort C: DRV/RTV + FTC/TDF | -0.005 | 0.008 | -0.001 |
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, weeks 4 and 48
| Intervention | percent (Mean) | |
|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 48 | |
| Cohort A: ATV/RTV + FTC/TDF | -0.04 | -0.04 |
| Cohort B: RAL + FTC/TDF | 0.22 | -0.08 |
| Cohort C: DRV/RTV + FTC/TDF | -0.15 | -0.11 |
Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). (NCT00851799)
Timeframe: Study entry to weeks 24, 48, 96, and 144
| Intervention | cell/mm^3 (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | Change from study entry to week 144 | |
| Cohort A: ATV/RTV + FTC/TDF | 161 | 209 | 280 | 305 |
| Cohort B: RAL + FTC/TDF | 133 | 191 | 247 | 279 |
| Cohort C: DRV/RTV + FTC/TDF | 118 | 194 | 248 | 227 |
Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | mg/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0 | 2 | 1 | 2 |
| Cohort B: RAL + FTC/TDF | -3 | -2 | -1 | -1 |
| Cohort C: DRV/RTV + FTC/TDF | 1 | 3 | 5 | 6 |
Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | mg/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 3 | 4 | 4 | 3 |
| Cohort B: RAL + FTC/TDF | 3 | 4 | 4 | 6 |
| Cohort C: DRV/RTV + FTC/TDF | 2 | 4 | 2 | 2 |
HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | mg/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | -1 | 3 | 2 | 4 |
| Cohort B: RAL + FTC/TDF | -2 | 3 | 2 | 4 |
| Cohort C: DRV/RTV + FTC/TDF | -3 | 0 | 1 | 4 |
Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | uIU/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 4.0 | 4.0 | 4.0 | 3.5 |
| Cohort B: RAL + FTC/TDF | 3.0 | 3.0 | 3.0 | 3.0 |
| Cohort C: DRV/RTV + FTC/TDF | 3.0 | 2.0 | 3.0 | 2.0 |
Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | mg/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 4 | 9 | 8 | 12 |
| Cohort B: RAL + FTC/TDF | -7 | -4 | -1 | 1 |
| Cohort C: DRV/RTV + FTC/TDF | 3 | 7 | 12 | 14 |
Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
| Intervention | mg/dL (Median) | |||
|---|---|---|---|---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 14 | 6 | 9 | 10 |
| Cohort B: RAL + FTC/TDF | -12 | -16 | -13 | -7 |
| Cohort C: DRV/RTV + FTC/TDF | 15 | 2 | 8 | 0 |
D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.57 | 0.52 |
| Cohort B: RAL + FTC/TDF | 0.73 | 0.72 |
| Cohort C: DRV/RTV + FTC/TDF | 0.65 | 0.65 |
hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.75 | 0.85 |
| Cohort B: RAL + FTC/TDF | 0.88 | 0.78 |
| Cohort C: DRV/RTV + FTC/TDF | 0.78 | 1.31 |
IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.62 | 0.89 |
| Cohort B: RAL + FTC/TDF | 0.71 | 0.82 |
| Cohort C: DRV/RTV + FTC/TDF | 0.75 | 0.89 |
Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 24 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.49 | 0.38 |
| Cohort B: RAL + FTC/TDF | 0.51 | 0.34 |
| Cohort C: DRV/RTV + FTC/TDF | 0.52 | 0.37 |
Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 24 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.51 | 0.35 |
| Cohort B: RAL + FTC/TDF | 0.56 | 0.36 |
| Cohort C: DRV/RTV + FTC/TDF | 0.59 | 0.38 |
Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 1.01 | 0.98 |
| Cohort B: RAL + FTC/TDF | 0.91 | 0.90 |
| Cohort C: DRV/RTV + FTC/TDF | 1.00 | 0.98 |
Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
| Intervention | Fold change (Median) | |
|---|---|---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 | |
| Cohort A: ATV/RTV + FTC/TDF | 0.54 | 0.51 |
| Cohort B: RAL + FTC/TDF | 0.62 | 0.56 |
| Cohort C: DRV/RTV + FTC/TDF | 0.61 | 0.58 |
The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. (NCT00851799)
Timeframe: Study entry, weeks 24, 48, 96 and 144
| Intervention | cell/mm^3 (Median) | ||||
|---|---|---|---|---|---|
| Study Entry | Week 24 | Week 48 | Week 96 | Week 144 | |
| Cohort A: ATV/RTV + FTC/TDF | 350 | 509 | 573 | 634 | 658 |
| Cohort B: RAL + FTC/TDF | 343 | 445 | 496 | 569 | 613 |
| Cohort C: DRV/RTV + FTC/TDF | 355 | 464 | 528 | 567 | 560 |
"Right common carotid artery intima-media thickness was measured by ultrasound scan at study entry and weeks 48, 96 and 144.~The annual rate of change in right common carotid artery intima-media thickness (CIMT) was estimated over 144 weeks from study entry using mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors." (NCT00851799)
Timeframe: Study entry, week 144
| Intervention | micron/year (Mean) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | 8.2 |
| Cohort B: RAL + FTC/TDF | 10.7 |
| Cohort C: DRV/RTV + FTC/TDF | 12.9 |
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, week 24
| Intervention | percent (Median) |
|---|---|
| Cohort A: ATV/RTV + FTC/TDF | -0.05 |
| Cohort B: RAL + FTC/TDF | -0.27 |
| Cohort C: DRV/RTV + FTC/TDF | 0.15 |
Mean number of days (of the past 30) of methamphetamine use. (NCT00856323)
Timeframe: 3-months after baseline
| Intervention | days (Mean) |
|---|---|
| PEP/CM | 1.6 |
Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia. (NCT00856323)
Timeframe: Baseline and 3-months
| Intervention | Proportion of Participants (Mean) |
|---|---|
| PEP/CM | .074 |
Self-reported episodes of Unprotected Anal Intercourse in the previous 30 days. (NCT00856323)
Timeframe: 3-months after baseline
| Intervention | episodes (Mean) |
|---|---|
| PEP/CM | .44 |
Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed). (NCT00856323)
Timeframe: 28-days
| Intervention | proportional medication adherence (Median) |
|---|---|
| PEP/CM | 0.96 |
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale. (NCT00885664)
Timeframe: Week 4
| Intervention | units on a scale (Median) |
|---|---|
| CD4<100 | 10 |
| CD4>/=100 | 8 |
Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 21.32 |
| CD4>/=100 | 10.30 |
Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 0.03 |
| CD4>/=100 | 0.03 |
Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 17.50 |
| CD4>/=100 | 10.53 |
Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 13.07 |
| CD4>/=100 | 9.07 |
Measure of physical function out of 100. Lower score means less physical capacity. (NCT00885664)
Timeframe: 4 weeks
| Intervention | units on a scale (Median) |
|---|---|
| CD4<100 | 43 |
| CD4>/=100 | 54 |
Measure of mental functioning where lower is better out of a scale of 100. (NCT00885664)
Timeframe: 4 weeks
| Intervention | score on a scale (Median) |
|---|---|
| CD4<100 | 46 |
| CD4>/=100 | 50 |
Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 2.24 |
| CD4>/=100 | 1.06 |
Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 7.58 |
| CD4>/=100 | 5.18 |
Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 4.41 |
| CD4>/=100 | 4.01 |
Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
| Intervention | pg/mL (Median) |
|---|---|
| CD4<100 | 0.07 |
| CD4>/=100 | 0.07 |
The change from baseline in CD4 cell count at Week 24 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 24
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 200 |
| ATV+RTV+FTC/TDF | 202 |
The change from baseline in CD4 cell count at Week 48 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 48
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 243 |
| ATV+RTV+FTC/TDF | 213 |
The change from baseline in log_10 HIV-1 RNA at Week 24 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 24
| Intervention | log_10 copies/mL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | -2.80 |
| ATV+RTV+FTC/TDF | -2.97 |
The change from baseline in log_10 HIV-1 RNA at Week 48 was analyzed. (NCT00892437)
Timeframe: Baseline to Week 48
| Intervention | log_10 copies/mL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | -2.79 |
| ATV+RTV+FTC/TDF | -2.96 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint. (NCT00892437)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 84.0 |
| ATV+RTV+FTC/TDF | 89.7 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method. (NCT00892437)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 82.0 |
| ATV+RTV+FTC/TDF | 89.7 |
Gastrointestinal complaints (grade 1 to 4) between baseline and W48. (NCT00928187)
Timeframe: between baseline and 48 weeks
| Intervention | participants (Number) |
|---|---|
| Arm A | 50 |
| Arm B | 48 |
| Arm C | 26 |
evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value (NCT00928187)
Timeframe: between baseline and W48
| Intervention | participants (Number) |
|---|---|
| Arm A | 28 |
| Arm B | 14 |
| Arm C | 19 |
number of patients with plasma HIV RNA below 200 copies/ml (NCT00928187)
Timeframe: 48 weeks
| Intervention | participants (Number) |
|---|---|
| Arm A | 130 |
| Arm B | 118 |
| Arm C | 127 |
patients having a diagnosis of HIV related event classified as stage 3 or 4 (NCT00928187)
Timeframe: between baseline and 48 weeks
| Intervention | participants (Number) |
|---|---|
| Arm A | 17 |
| Arm B | 23 |
| Arm C | 30 |
number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) (NCT00928187)
Timeframe: between W12 and W48
| Intervention | participants (Number) |
|---|---|
| Arm A | 0 |
| Arm B | 0 |
| Arm C | 0 |
number of patients having a plasma viral load below 200 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A | 127 |
| Arm B | 117 |
| Arm C | 129 |
Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A | 90 |
| Arm B | 81 |
| Arm C | 97 |
median gain in circulating CD4 cells between baseline and W48 (NCT00928187)
Timeframe: between baseline and 48 weeks
| Intervention | cell/mm3 (Median) |
|---|---|
| Arm A | 133 |
| Arm B | 136 |
| Arm C | 115 |
number of patients developing metabolic syndrome over a period of 48 weeks (NCT00928187)
Timeframe: from baseline to week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Arm A | 12 |
| Arm B | 21 |
| Arm C | 9 |
(NCT00928187)
Timeframe: 48 weeks
| Intervention | participants (Number) |
|---|---|
| Arm A | 105 |
| Arm B | 92 |
| Arm C | 97 |
number of patients discounting treatment because of adverse events (NCT00928187)
Timeframe: between baseline and W48
| Intervention | participants (Number) |
|---|---|
| Arm A | 0 |
| Arm B | 4 |
| Arm C | 1 |
number of patients in different categories of adherence as measured by questionnaire (NCT00928187)
Timeframe: between baseline and W48
| Intervention | participants (Number) | ||
|---|---|---|---|
| Always above 95% | At least once 80-95% | At least once < 80% | |
| Arm A | 50 | 89 | 11 |
| Arm B | 54 | 72 | 14 |
| Arm C | 67 | 78 | 4 |
any symptom of peripheral neuropathy (NCT00928187)
Timeframe: between baseline and W48
| Intervention | participants (Number) |
|---|---|
| Arm A | 5 |
| Arm B | 11 |
| Arm C | 8 |
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. (NCT00936715)
Timeframe: Up to 240 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| FTC/TDF | 24 |
Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks
| Intervention | ratio of trunk fat % : lower limb fat % (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 0.02 |
Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
| Intervention | ratio of trunk fat % : lower limb fat % (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 0.06 |
Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 24 weeks
| Intervention | µU/ml*mmol/L (Median) |
|---|---|
| Etravirine 400 mg Once Daily | -0.08 |
Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 48 weeks
| Intervention | µU/ml*mmol/L (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 0.71 |
The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
| Intervention | cells/uL (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 224 |
The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI). (NCT00959894)
Timeframe: Baseline to 24 weeks
| Intervention | cells/uL (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 156 |
Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks
| Intervention | ng*hr/mL (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 8024.40 |
This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine. (NCT00959894)
Timeframe: 4 weeks
| Intervention | ratio of semen:plasma drug concentration (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 0.192 |
Metabolic data analyses were conducted as-treated. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. Changes from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 96 weeks
| Intervention | µU/ml*mmol/L (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 0.23 |
Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 24 weeks
| Intervention | mg/dL (Median) | ||||
|---|---|---|---|---|---|
| Total cholesterol | HDL-cholesterol | LDL-cholesterol | Triglycerides | Fasting glucose | |
| Etravirine 400 mg Once Daily | -7 | 1 | -9 | -16 | 1 |
Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
| Intervention | percentage of body fat (Median) | ||
|---|---|---|---|
| Total body fat | Limb fat | Trunk fat | |
| Etravirine 400 mg Once Daily | 1.44 | 0.82 | 1.93 |
Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks
| Intervention | percentage of body fat (Median) | ||
|---|---|---|---|
| Total body fat | Limb fat | Trunk fat | |
| Etravirine 400 mg Once Daily | 0.43 | 0.48 | 0.32 |
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.71 |
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.77 |
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.77 |
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.82 |
Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. (NCT00959894)
Timeframe: Baseline to 48 weeks
| Intervention | mg/dL (Median) | ||||
|---|---|---|---|---|---|
| Total cholesterol | HDL-cholesterol | LDL-cholesterol | Triglycerides | Fasting glucose | |
| Etravirine 400 mg Once Daily | 6 | 5 | -1 | -10 | 2 |
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 24 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.89 |
Metabolic data analyses were conducted as-treated. Changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and fasting blood glucose from baseline to follow-up were calculated using the value closest to schedule and within the analysis window, and were quantified with the median and inter-quartile range. Insulin resistance was estimated by the homeostasis model assessment of insulin resistance (HOMA-IR), and was calculated as [fasting insulin (µU/mL) × fasting glucose (mmol/L)]/22.5. (NCT00959894)
Timeframe: Baseline to 96 weeks
| Intervention | mg/dL (Median) | ||||
|---|---|---|---|---|---|
| Total cholesterol | HDL-cholesterol | LDL-cholesterol | Triglycerides | Fasting glucose | |
| Etravirine 400 mg Once Daily | 6 | 4 | -5 | 3 | 2 |
Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks
| Intervention | ng/mL (Median) | |
|---|---|---|
| Etravirine trough plasma concentration | Etravirine peak plasma concentration | |
| Etravirine 400 mg Once Daily | 217.47 | 480.99 |
Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY) (NCT00959894)
Timeframe: 96 weeks
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Y181C | E138K | E138K, Y181C, M230L, M184I, K219E, V75I | No resistance-associated mutations detected | |
| Etravirine 400 mg Once Daily | 1 | 1 | 1 | 3 |
"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)." (NCT00959894)
Timeframe: 96 weeks
| Intervention | participants (Number) | ||
|---|---|---|---|
| At least one safety/tolerability event | Signs or Symptoms | Laboratory Abnormalities | |
| Etravirine 400 mg Once Daily | 23 | 13 | 10 |
The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry). (NCT00959894)
Timeframe: 24 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.87 |
The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring). (NCT00959894)
Timeframe: 96 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Etravirine 400 mg Once Daily | 0.69 |
The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 48 weeks
| Intervention | cells/uL (Median) |
|---|---|
| Etravirine 400 mg Once Daily | 163 |
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months
| Intervention | ml/Kg/min (Mean) |
|---|---|
| Truvada 200/300 mg, Daily, by Mouth. | 2.2 |
| Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. | 2.8 |
Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | events per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 4.0 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 4.6 |
The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 15.3 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 13.9 |
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Postpartum Arm A (Maternal Prophylaxis) | 0.56 |
| Postpartum Arm B (Infant Prophylaxis) | 0.55 |
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Postpartum Arm A (Maternal Prophylaxis) | 14.4 |
| Postpartum Arm B (Infant Prophylaxis) | 14.1 |
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through 24 months post-delivery
| Intervention | Probability (Number) |
|---|---|
| Postpartum Arm A (Maternal Prophylaxis) | 0.971 |
| Postpartum Arm B (Infant Prophylaxis) | 0.977 |
Composite outcome (NCT01061151)
Timeframe: Measured at birth
| Intervention | Participants (Count of Participants) |
|---|---|
| Period 2 | |
| Antepartum Arm C | 111 |
Composite outcome (NCT01061151)
Timeframe: Measured at birth
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Periods 1 and 2 | Period 2 | |
| Antepartum Arm A | 389 | 91 |
| Antepartum Arm B | 563 | 123 |
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
| Intervention | Participants (Count of Participants) |
|---|---|
| Period 2 | |
| Antepartum Arm C | 60 |
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Periods 1 and 2 | Period 2 | |
| Antepartum Arm A | 261 | 59 |
| Antepartum Arm B | 318 | 61 |
"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
| Intervention | Participants (Count of Participants) |
|---|---|
| Period 2 | |
| Antepartum Arm C | 23 |
"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Periods 1 and 2 | Period 2 | |
| Antepartum Arm A | 89 | 20 |
| Antepartum Arm B | 75 | 12 |
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age
| Intervention | Proportional probability (Number) | |
|---|---|---|
| Overall survival, period 2 group | HIV-free survival, period 2 group | |
| Antepartum Arm C | 0.942 | 0.921 |
"Adherence is by maternal report; adherence through hair analysis is not included here.~The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study." (NCT01061151)
Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 6 visit72329524 | Week 6 visit72329525 | Week 14 visit72329524 | Week 14 visit72329525 | Week 26 visit72329524 | Week 26 visit72329525 | Week 50 visit72329524 | Week 50 visit72329525 | Week 74 visit72329524 | Week 74 visit72329525 | |||||||||||||||||||||||||||||||
| Missed dose over 1 month ago | Never missed a dose | Missed dose 2-4 weeks ago | Missed dose within last 2 weeks | |||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 1003 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 1104 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 12 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 17 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 4 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 140 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 74 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 956 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 1081 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 20 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 0 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 35 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 112 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 50 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 888 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 1035 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 48 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 31 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 8 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 103 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 47 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 716 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 841 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 37 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 34 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 7 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 64 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 30 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 311 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 377 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm A (Maternal Prophylaxis) | 15 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 2 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 1 | |||||||||||||||||||||||||||||||||||||||
| Postpartum Arm B (Infant Prophylaxis) | 9 | |||||||||||||||||||||||||||||||||||||||
Detected by HIV NAT positivity (NCT01061151)
Timeframe: Measured at the birth (<= 3 days postpartum) visit
| Intervention | Participants (Count of Participants) |
|---|---|
| Antepartum Arm A | 22 |
| Antepartum Arm B | 4 |
| Antepartum Arm C | 2 |
Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point (NCT01061151)
Timeframe: Measured at birth or Week 1 study visit
| Intervention | Participants (Count of Participants) |
|---|---|
| Antepartum Arm A | 25 |
| Antepartum Arm B | 7 |
| Antepartum Arm C | 2 |
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age
| Intervention | Proportional probability (Number) | |||
|---|---|---|---|---|
| Overall survival, Periods 1 & 2 group (arms A & B only) | Overall survival, period 2 group | HIV-free survival, Periods 1&2 group (arms A&B only) | HIV-free survival, period 2 group | |
| Antepartum Arm A | 0.959 | 0.951 | 0.937 | 0.936 |
| Antepartum Arm B | 0.967 | 0.982 | 0.947 | 0.940 |
"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 0.08 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 0.25 |
Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 0.24 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 0.43 |
"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 1.30 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 1.43 |
"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 3.47 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 5.61 |
"HIV/AIDS-related event refers to the WHO Clinical Stage 4 illnesses, pulmonary tuberculosis, and other serious bacterial infections listed in Appendix IV of the protocol. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 1.14 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 1.24 |
AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 0.24 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 0.49 |
Incidence of tuberculosis. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | New cases per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 0.40 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 0.31 |
"Cardiovascular or metabolic events of particular concern were included in this analysis. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates.~Metabolic events considered were diabetes mellitus, lipodystrophy, or dyslipidemia. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | events per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 2.9 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 5.7 |
Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) (NCT01061151)
Timeframe: Measured at 12 and 24 months post-delivery
| Intervention | Probability (Number) | |
|---|---|---|
| 12 months post delivery | 24 months post delivery | |
| Postpartum Arm A (Maternal Prophylaxis) | 0.988 | 0.978 |
| Postpartum Arm B (Infant Prophylaxis) | 0.989 | 0.987 |
Analysis used the principle of intent to treat. (NCT01061151)
Timeframe: Measured at the time of delivery
| Intervention | Participants (Count of Participants) | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Periods 1 and 272329519 | Periods 1 and 272329520 | Period 272329520 | Period 272329519 | Period 272329521 | ||||||
| HIV RNA < 400 copies/mL | HIV RNA >= 400 copies/mL | |||||||||
| Antepartum Arm A | 415 | |||||||||
| Antepartum Arm B | 1092 | |||||||||
| Antepartum Arm A | 929 | |||||||||
| Antepartum Arm B | 275 | |||||||||
| Antepartum Arm A | 102 | |||||||||
| Antepartum Arm B | 259 | |||||||||
| Antepartum Arm C | 225 | |||||||||
| Antepartum Arm A | 210 | |||||||||
| Antepartum Arm B | 62 | |||||||||
| Antepartum Arm C | 79 | |||||||||
Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | events per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 9.0 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 14.0 |
"This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 (Severe). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
| Intervention | events per 100 person-years (Number) |
|---|---|
| Maternal Health Arm A (Continue Triple ARVs) | 0.5 |
| Maternal Health Arm B (Discontinue Triple ARVs) | 0.9 |
The number of participants that failed to remain virologically suppressed through 24 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL. (NCT01102972)
Timeframe: From Baseline to Week 24
| Intervention | participants (Number) |
|---|---|
| ABC/3TC + ATV | 2 |
| TDF/FTC + ATV/RTV | 1 |
Death and clinical disease progression (as per CDC classification) were assessed from Baseline through Week 48. Disease progression is defined as progression from CDC Class A to B, Class A to C, or from Class B to C. AIDS CDC classifications are: Class A, Asymptomatic/lymphadenopathy/acute HIV; Class B, Symptomatic, not AIDS; Class C, AIDS indicator conditions. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions. (NCT01102972)
Timeframe: From Baseline to Week 48
| Intervention | participants (Number) |
|---|---|
| ABC/3TC + ATV | 0 |
| TDF/FTC + ATV/RTV | 0 |
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE. (NCT01102972)
Timeframe: From Baseline to Week 48
| Intervention | participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Event | Upper respiratory tract infection | Diarrhoea | Depression | Back pain | Bronchitis | Insomnia | Muscle strain | Rash | Sinusitis | Muscle spasms | |
| ABC/3TC + ATV | 90 | 11 | 7 | 6 | 4 | 4 | 6 | 3 | 6 | 2 | 2 |
| TDF/FTC + ATV/RTV | 44 | 7 | 4 | 3 | 3 | 3 | 0 | 3 | 0 | 4 | 3 |
The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 is a descriptive terminology that can be utilized for AE reporting. A grading (severity) scale is provided for each AE. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild AE; Grade 2, moderate AE; Grade 3, severe AE; Grade 4, life-threatening or disabling AE; Grade 5, death related to the AE. (NCT01102972)
Timeframe: From Baseline to Week 24
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Upper respiratory tract infection | Diarrhoea | Bronchitis | Rash | Muscle strain | Muscle spasms | Sinusitis | |
| ABC/3TC + ATV | 7 | 5 | 4 | 6 | 2 | 1 | 1 |
| TDF/FTC + ATV/RTV | 6 | 3 | 3 | 0 | 3 | 3 | 3 |
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline. (NCT01102972)
Timeframe: From Baseline to Week 48
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| HIV PAR with reduced abacavir susceptibility | HIV PAR with reduced lamivudine susceptibility | HIV PAR with reduced tenofovir susceptibility | HIV PAR with reduced emtricitabine susceptibility | HIV PAR with reduced atazanavir susceptibility | HIV PAR with reduced ritonavir susceptibility | |
| ABC/3TC + ATV | 1 | 2 | 0 | 2 | 2 | 2 |
| TDF/FTC + ATV/RTV | 0 | 0 | 0 | 0 | 0 | 0 |
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at Baseline. (NCT01102972)
Timeframe: From Baseline to Week 24
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| HIV PAR with reduced abacavir susceptibility | HIV PAR with reduced lamivudine susceptibility | HIV PAR with reduced tenofovir susceptibility | HIV PAR with reduced emtricitabine susceptibility | HIV PAR with reduced atazanavir susceptibility | HIV PAR with reduced ritonavir susceptibility | |
| ABC/3TC + ATV | 1 | 1 | 0 | 1 | 1 | 1 |
| TDF/FTC + ATV/RTV | 0 | 0 | 0 | 0 | 0 | 0 |
A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT01102972)
Timeframe: From Baseline to Week 48
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| PAR with treatment-emergent mutations | PAR with NRTI mutations | PAR with major NNRTI mutations | PAR with major PI mutations | PAR with minor PI mutations | |
| ABC/3TC + ATV | 4 | 2 | 1 | 2 | 4 |
| TDF/FTC + ATV/RTV | 1 | 0 | 0 | 0 | 1 |
A blood sample was drawn for particiapants with confirmed VF >=400 c/mL. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at Baseline. New resistance-associated viral mutations defined by the International Acquired Immunodeficiency Syndrome Society-United States of America guidelines present at the time of failure were tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT01102972)
Timeframe: From Baseline to Week 24
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| PAR with treatment-emergent mutations | PAR with NRTI mutations | PAR with NNRTI mutations | PAR with major PI mutations | PAR with minor PI mutations | |
| ABC/3TC + ATV | 2 | 1 | 1 | 1 | 2 |
| TDF/FTC + ATV/RTV | 1 | 0 | 0 | 0 | 1 |
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured or calculated at Week 48. A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 48
| Intervention | milligrams per deciliter (mg/dL) (Mean) | |||
|---|---|---|---|---|
| Triglycerides, n=152, 76 | Total cholesterol, n=152, 76 | HDL cholesterol, n=152, 76 | LDL cholesterol (Calculation), n=148, 71 | |
| ABC/3TC + ATV | -9.28 | 7.62 | 3.11 | 5.28 |
| TDF/FTC + ATV/RTV | 7.71 | 0.62 | 0.53 | -0.62 |
The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. (NCT01102972)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| ABC/3TC + ATV | 88.4 |
| TDF/FTC + ATV/RTV | 86.6 |
Triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol levels were measured at Week 24. A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 24
| Intervention | milligrams per deciliter (mg/dL) (Mean) | |||
|---|---|---|---|---|
| Triglycerides, n=170, 81 | Total cholesterol, n=170, 81 | HDL cholesterol, n=170, 81 | LDL cholesterol (Calculation), n=166, 80 | |
| ABC/3TC + ATV | -17.23 | 4.49 | 4.50 | 3.34 |
| TDF/FTC + ATV/RTV | -4.35 | 0.14 | -0.20 | 0.94 |
Change from Baseline was calculated as the Week 48 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT01102972)
Timeframe: Baseline and Week 48
| Intervention | log10 copies/mL (Mean) |
|---|---|
| ABC/3TC + ATV | 0.071 |
| TDF/FTC + ATV/RTV | -0.018 |
The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had an unconfirmed HIV RNA of at least 50 c/mL at the last visit. (NCT01102972)
Timeframe: Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| ABC/3TC + ATV | 86.9 |
| TDF/FTC + ATV/RTV | 86.6 |
The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load <400 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA <400 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 400 c/mL, or had an unconfirmed HIV RNA of at least 400 c/mL at the last visit. (NCT01102972)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| ABC/3TC + ATV | 81 |
| TDF/FTC + ATV/RTV | 84 |
The number of participants that failed to remain virologically suppressed from baseline through 48 weeks on treatment was assessed. Viral failure is defined per protocol as confirmed HIV-1 RNA >=400 c/mL. (NCT01102972)
Timeframe: From Baseline to Week 48
| Intervention | participants (Number) |
|---|---|
| ABC/3TC + ATV | 4 |
| TDF/FTC + ATV/RTV | 1 |
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 24 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 24
| Intervention | cells per cubic millimeter (mm^3) (Mean) |
|---|---|
| ABC/3TC + ATV | 47.7 |
| TDF/FTC + ATV/RTV | 8.3 |
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from Baseline was calculated as the Week 48 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 48
| Intervention | cells per cubic millimeter (mm^3) (Mean) |
|---|---|
| ABC/3TC + ATV | 95.8 |
| TDF/FTC + ATV/RTV | 57.2 |
A Fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 24 value minus the Baseline value. (NCT01102972)
Timeframe: Baseline and Week 24
| Intervention | ratio (Mean) |
|---|---|
| ABC/3TC + ATV | -0.20 |
| TDF/FTC + ATV/RTV | -0.01 |
A fasting blood sample was drawn to analyze for lipids. Change from Baseline was calculated as the Week 48 value minus the Baseline value for each parameter. (NCT01102972)
Timeframe: Baseline and Week 48
| Intervention | ratio (Mean) |
|---|---|
| ABC/3TC + ATV | 0.00 |
| TDF/FTC + ATV/RTV | 0.00 |
Change from Baseline was calculated as the Week 24 value minus the Baseline value. Blood was drawn to analyze for plasma HIV viral load. (NCT01102972)
Timeframe: Baseline and Week 24
| Intervention | log10 copies/mL (Mean) |
|---|---|
| ABC/3TC + ATV | 0.014 |
| TDF/FTC + ATV/RTV | 0.008 |
The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| TLOVR, n=199, 97 | Observed, n=169, 82 | M/D=F, n=199, 97 | SNAPSHOT, n=199, 97 | |
| ABC/3TC + ATV | 76.4 | 91.1 | 76.9 | 77.4 |
| TDF/FTC + ATV/RTV | 79.4 | 96.3 | 79.4 | 81.4 |
The percentage of PAR with HIV-1 RNA virus <50 c/mL determined from blood samples drawn through Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Observed, n=181, 89 | M/D=F, n=199, 97 | SNAPSHOT, n=199, 97 | |
| ABC/3TC + ATV | 94.5 | 84.9 | 84.9 |
| TDF/FTC + ATV/RTV | 97.7 | 87.6 | 88.7 |
The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 48 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Observed, n=169, 82 | M/D=F, n=199, 97 | SNAPSHOT, n=199, 97 | |
| ABC/3TC + ATV | 96 | 81 | 82 |
| TDF/FTC + ATV/RTV | 100 | 82 | 85 |
The percentage of PAR with HIV-1 RNA virus <400 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment using specific analysis methods. (NCT01102972)
Timeframe: Week 24
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Observed, n=181, 89 | M/D=F, n=199, 97 | SNAPSHOT, n=199, 97 | |
| ABC/3TC + ATV | 98.9 | 88.9 | 89.4 |
| TDF/FTC + ATV/RTV | 98.9 | 88.7 | 89.7 |
(NCT01108510)
Timeframe: Baseline to Week 48
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 213 |
| ATV+RTV+FTC/TDF | 219 |
(NCT01108510)
Timeframe: Baseline to Week 192
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 350 |
| ATV+RTV+FTC/TDF | 343 |
(NCT01108510)
Timeframe: Baseline to Week 144
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 310 |
| ATV+RTV+FTC/TDF | 332 |
(NCT01108510)
Timeframe: Baseline to Week 96
| Intervention | cells/μL (Mean) |
|---|---|
| ATV+COBI+FTC/TDF | 277 |
| ATV+RTV+FTC/TDF | 287 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 144
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 72.1 |
| ATV+RTV+FTC/TDF | 74.1 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 192 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 192
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 71.6 |
| ATV+RTV+FTC/TDF | 79.7 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status. (NCT01108510)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 85.2 |
| ATV+RTV+FTC/TDF | 87.4 |
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm. (NCT01108510)
Timeframe: Week 96
| Intervention | percentage of participants (Number) |
|---|---|
| ATV+COBI+FTC/TDF | 77.9 |
| ATV+RTV+FTC/TDF | 79.3 |
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen. (NCT01140880)
Timeframe: 6-month follow-up
| Intervention | hours (Mean) |
|---|---|
| Contingency Management | 32.8 |
| Yoked Contingency Management | 33.0 |
Adherence to Truvada medication (if initiated) as assessed by self-report and pill count. (NCT01140880)
Timeframe: Daily throughout medication course
| Intervention | proportion (Number) |
|---|---|
| Contingency Management | 0.75 |
| Yoked Contingency Management | 0.45 |
PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion. (NCT01140880)
Timeframe: 28-days post initiation
| Intervention | participants (Number) |
|---|---|
| Contingency Management | 12 |
| Yoked Contingency Management | 4 |
Abstinence will be measured using thrice weekly urine drug screens and self-report (NCT01140880)
Timeframe: Thrice-weekly for 8 weeks
| Intervention | Stimulant-free urinalyses (Mean) |
|---|---|
| Contingency Management | 8.9 |
| Yoked Contingency Management | 6.0 |
To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) (NCT01195467)
Timeframe: 4 weeks
| Intervention | percentage improvement in CNS score (Number) |
|---|---|
| Single Arm | 26 |
"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)" (NCT01195467)
Timeframe: baseline to week 12
| Intervention | percentage of improvement in sleep score (Number) |
|---|---|
| Single Arm | 25 |
This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. (NCT01214759)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|---|
| Truvada and Raltegravir | 0 |
(NCT01214759)
Timeframe: 28 days
| Intervention | participants (Number) |
|---|---|
| Truvada and Raltegravir | 85 |
Number of participants with laboratory abnormalities are reported (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) | |
|---|---|---|
| Normal Baseline | Abnormal Baseline | |
| FTC/TDF+DRV/r | 205 | 101 |
| MVC+DRV/r | 210 | 111 |
Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012). (NCT01345630)
Timeframe: Week 48
| Intervention | Number of participants (Number) | |
|---|---|---|
| Confirmed PDTF | Evaluable PDTF | |
| FTC/TDF+DRV/r | 13 | 3 |
| MVC+DRV/r | 40 | 17 |
For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF. (NCT01345630)
Timeframe: Week 48
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| R5 (Randomized Assay) | NON R5 (Randomized Assay) | NR (Randomized Assay) | R5 (Alternate Assay) | NON R5 (Alternate Assay) | NR (Alternate Assay) | |
| FTC/TDF+DRV/r - Baseline | 2 | 0 | 1 | 3 | 0 | 0 |
| FTC/TDF+DRV/r - Failure | 1 | 0 | 2 | 2 | 1 | 0 |
| MVC+DRV/r - Baseline | 14 | 1 | 2 | 10 | 2 | 5 |
| MVC+DRV/r - Failure | 13 | 1 | 3 | 10 | 3 | 4 |
Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant. (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alanine Aminotransferase (ALT) (n=396, 400) | Alkaline Phosphatase (n=396, 400) | Amylase (n=396, 400) | Aspartate Aminotransferase (AST) (n=396, 400) | Blood Urea Nitrogen (BUN) (n=396, 400) | Calcium (n=396, 400) | Creatine Kinase (n=396, 400) | Hemoglobin (n=396, 400) | LDL Cholesterol (n=396, 400) | Lipase (n=116, 122) | Lymphocytes (Abs) (n=396, 400) | Phosphate (n=396, 400) | Platelets (n=396, 400) | Potassium (n=396, 400) | Sodium (n=396, 400) | Total Bilirubin (n=396, 400) | Total Neutrophils (Abs) (n=396, 400) | Triglycerides (n=396, 400) | Uric Acid (n=396, 400) | White Blood Cell Count (n=396, 400) | Creatinine (n=396, 400) | |
| FTC/TDF+DRV/r | 6 | 0 | 13 | 7 | 5 | 10 | 22 | 2 | 24 | 10 | 2 | 12 | 1 | 2 | 0 | 1 | 2 | 6 | 2 | 0 | 1 |
| MVC+DRV/r | 9 | 1 | 5 | 11 | 3 | 7 | 18 | 4 | 50 | 3 | 2 | 5 | 5 | 3 | 2 | 3 | 6 | 4 | 0 | 1 | 0 |
The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
| Intervention | Percentage of lymphocytes (Mean) | ||
|---|---|---|---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) | |
| FTC/TDF+DRV/r | 55.8 | 43.0 | -12.6 |
| MVC+DRV/r | 57.0 | 46.0 | -10.9 |
The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
| Intervention | Percentage of lymphocytes (Mean) | ||
|---|---|---|---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) | |
| FTC/TDF+DRV/r | 24.5 | 33.7 | 9.2 |
| MVC+DRV/r | 24.2 | 31.3 | 7.0 |
For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism. (NCT01345630)
Timeframe: Week 48
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Not eligible for analysis (failed tropism test) | Not eligible for analysis (non-R5 tropism) | Eligible for analysis (R5 virus using ESTA) | Results reported | Maximal percent inhibition <95% | IC50 FC ≥3.0 | |
| FTC/TDF+DRV/r | 1 | 1 | 1 | 1 | 0 | 0 |
| MVC+DRV/r | 4 | 1 | 12 | 12 | 0 | 0 |
The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
| Intervention | Ratio (Mean) | ||
|---|---|---|---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) | |
| FTC/TDF+DRV/r | 0.48 | 0.87 | 0.39 |
| MVC+DRV/r | 0.47 | 0.75 | 0.28 |
The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
| Intervention | cell/mm^3 (Mean) | ||
|---|---|---|---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) | |
| FTC/TDF+DRV/r | 914.5 | 751.1 | -157.9 |
| MVC+DRV/r | 954.4 | 900.0 | -49.9 |
The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
| Intervention | cell/mm^3 (Mean) | ||
|---|---|---|---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) | |
| FTC/TDF+DRV/r | 379.5 | 574.6 | 194.2 |
| MVC+DRV/r | 382.0 | 576.9 | 194.9 |
The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method. (NCT01345630)
Timeframe: Week 48
| Intervention | proportion of participants (Number) |
|---|---|
| MVC+DRV/r | 0.8047 |
| FTC/TDF+DRV/r | 0.8797 |
"The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure." (NCT01345630)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| MVC+DRV/r | 77.3 |
| FTC/TDF+DRV/r | 86.8 |
Number of treatment-related AEs are presented here. (NCT01345630)
Timeframe: Week 96
| Intervention | events (Number) |
|---|---|
| MVC+DRV/r | 316 |
| FTC/TDF+DRV/r | 361 |
Total number of participants with treatment-emergent serious adverse events are reported (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) |
|---|---|
| MVC+DRV/r | 41 |
| FTC/TDF+DRV/r | 40 |
Number of participants with grade 3 or 4 AEs are presented here. (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) |
|---|---|
| MVC+DRV/r | 65 |
| FTC/TDF+DRV/r | 71 |
Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants. (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) |
|---|---|
| MVC+DRV/r | 22 |
| FTC/TDF+DRV/r | 23 |
Number of participants with treatment-emergent non serious AEs (NCT01345630)
Timeframe: Week 96
| Intervention | participants (Number) |
|---|---|
| MVC+DRV/r | 360 |
| FTC/TDF+DRV/r | 365 |
A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48
| Intervention | ratio (Least Squares Mean) |
|---|---|
| MVC+DRV/r | 0.017 |
| FTC/TDF+DRV/r | -0.014 |
A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48
| Intervention | gram (Least Squares Mean) |
|---|---|
| MVC+DRV/r | -181.6 |
| FTC/TDF+DRV/r | -257.5 |
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
| Intervention | g/cm^2 (Least Squares Mean) |
|---|---|
| MVC+DRV/r | -0.014 |
| FTC/TDF+DRV/r | -0.028 |
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
| Intervention | g/cm^2 (Least Squares Mean) |
|---|---|
| MVC+DRV/r | -0.021 |
| FTC/TDF+DRV/r | -0.029 |
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
| Intervention | g/cm^2 (Least Squares Mean) |
|---|---|
| MVC+DRV/r | -0.020 |
| FTC/TDF+DRV/r | -0.025 |
Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48
| Intervention | pg/mL (Mean) |
|---|---|
| MVC+DRV/r | 121.13 |
| FTC/TDF+DRV/r | 223.52 |
Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48
| Intervention | ng/mL (Mean) |
|---|---|
| MVC+DRV/r | 5.61 |
| FTC/TDF+DRV/r | 6.77 |
For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm. (NCT01345630)
Timeframe: Week 48
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NRTI - All (Baseline, n=15, 3) | NNRTI Delavirdine (Baseline, n=15, 3) | NNRTI Nevirapine (Baseline, n=15, 3) | NNRTI Efavirenz (Baseline, n=15, 3) | PRI - All (Baseline, n=15, 3) | NRTI - All (PDTF, n=15, 3) | NNRTI Delavirdine (PDTF, n=15, 3) | NNRTI Nevirapine (PDTF, n=15, 3) | NNRTI Efavirenz (PDTF, n=15, 3) | PRI - All (PDTF, n=15, 3) | |
| FTC/TDF+DRV/r | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| MVC+DRV/r | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes. (NCT01348763)
Timeframe: 35 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada, Darunavir/r and Maraviroc | 0 |
On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured . (NCT01348763)
Timeframe: 10 day, 20 days
| Intervention | ratio (Mean) |
|---|---|
| Truvada, Darunavir/r and Maraviroc | 0.99 |
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 |
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 |
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 |
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 |
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 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-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 |
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 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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
"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 |
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 |
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 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, 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 |
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 |
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) |
|---|---|
| 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) |
|---|---|
| ET+ART | 7.8 |
| PTX+ART | 0.0 |
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 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 |
In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms. (NCT01450189)
Timeframe: 1 year
| Intervention | proportion of participants (Number) |
|---|---|
| Combined Behavioral Intervention Arms | 0.216 |
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that (NCT01450189)
Timeframe: 1 year
| Intervention | proportion of BIA participants (Number) |
|---|---|
| Behavioral Intervention Plus Antiretrovirals (BIA) | 0.917 |
Number of partners per index reporting for HIV testing at any time during follow-up (NCT01450189)
Timeframe: 52 weeks
| Intervention | partners per index participant (Mean) |
|---|---|
| Standard Counseling Arm | 0.4 |
| Behavioral Intervention Arm Only | 0.4 |
| Behavioral Intervention Plus ARV | 0.4 |
Mean number of adverse events per group (NCT01450189)
Timeframe: one year
| Intervention | number of events (Mean) |
|---|---|
| Standard Counseling Arm | 0.78 |
| Behavioral Intervention Arm Only | 1.3 |
| Behavioral Intervention Plus ARV | 1.3 |
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 52 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 0 |
| Behavioral Intervention Arm Only | 219 |
| Behavioral Intervention Plus ARV | 2111 |
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 52 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 13088 |
| Behavioral Intervention Arm Only | 66 |
| Behavioral Intervention Plus ARV | 0 |
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 26 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 11.5 |
| Behavioral Intervention Arm Only | 0 |
| Behavioral Intervention Plus ARV | 164 |
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 26 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 9456 |
| Behavioral Intervention Arm Only | 292 |
| Behavioral Intervention Plus ARV | 0 |
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 12 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 82.5 |
| Behavioral Intervention Arm Only | 0 |
| Behavioral Intervention Plus ARV | 38.5 |
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 12 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 25364 |
| Behavioral Intervention Arm Only | 446 |
| Behavioral Intervention Plus ARV | 0 |
cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 52 weeks
| Intervention | Proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.5 |
| Behavioral Intervention Arm Only | 1.0 |
| Behavioral Intervention Plus ARV | 0.3 |
Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 26 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.14 |
| Behavioral Intervention Arm Only | 0.33 |
| Behavioral Intervention Plus ARV | 0.12 |
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. (NCT01450189)
Timeframe: 1 year
| Intervention | proportion of participants (Number) |
|---|---|
| Overall | 0.0073 |
cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 26 weeks
| Intervention | Proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.5 |
| Behavioral Intervention Arm Only | 0.5 |
| Behavioral Intervention Plus ARV | 0.25 |
(NCT01450189)
Timeframe: 52 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 3248.5 |
| Behavioral Intervention Arm Only | 6467.5 |
| Behavioral Intervention Plus ARV | 10876 |
(NCT01450189)
Timeframe: 26 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 8661 |
| Behavioral Intervention Arm Only | 58504 |
| Behavioral Intervention Plus ARV | 6788 |
(NCT01450189)
Timeframe: 12 weeks
| Intervention | copies/ml (Median) |
|---|---|
| Standard Counseling Arm | 19411 |
| Behavioral Intervention Arm Only | 22734 |
| Behavioral Intervention Plus ARV | 20 |
The mean number of unprotected sex acts in previous one week, assessed at 12 weeks (NCT01450189)
Timeframe: 12 weeks
| Intervention | unprotected sex acts/week (Mean) |
|---|---|
| Standard Counseling Arm | 0 |
| Behavioral Intervention Arm Only | 0.5 |
| Behavioral Intervention Plus ARV | 1.2 |
The mean number of unprotected sex acts in previous one week, assessed at 52 weeks (NCT01450189)
Timeframe: 52 weeks
| Intervention | unprotected sex acts/week (Mean) |
|---|---|
| Standard Counseling Arm | 0.8 |
| Behavioral Intervention Arm Only | 0.2 |
| Behavioral Intervention Plus ARV | 0 |
At least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 52 weeks
| Intervention | proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.14 |
| Behavioral Intervention Arm Only | 0.42 |
| Behavioral Intervention Plus ARV | 0.15 |
The mean number of unprotected sex acts in previous one week, assessed at 26 weeks (NCT01450189)
Timeframe: 26 weeks
| Intervention | unprotected sex acts/week (Mean) |
|---|---|
| Standard Counseling Arm | 0.25 |
| Behavioral Intervention Arm Only | 0.1 |
| Behavioral Intervention Plus ARV | 0.5 |
The mean number of unprotected sex acts in previous one month, assessed at 52 weeks (NCT01450189)
Timeframe: 52 weeks
| Intervention | unprotected sex acts/month (Mean) |
|---|---|
| Standard Counseling Arm | 0.8 |
| Behavioral Intervention Arm Only | 0.5 |
| Behavioral Intervention Plus ARV | 0 |
The mean number of unprotected sex acts in previous one month, assessed at 26 weeks (NCT01450189)
Timeframe: 26 weeks
| Intervention | unprotected sex acts/month (Mean) |
|---|---|
| Standard Counseling Arm | 0.25 |
| Behavioral Intervention Arm Only | 0.2 |
| Behavioral Intervention Plus ARV | 0.4 |
The mean number of unprotected sex acts in previous one month, assessed at 12 weeks (NCT01450189)
Timeframe: 12 weeks
| Intervention | unprotected sex acts/month (Mean) |
|---|---|
| Standard Counseling Arm | 0 |
| Behavioral Intervention Arm Only | 0.8 |
| Behavioral Intervention Plus ARV | 0 |
median time to viral load suppression (<1000 c/ml) (NCT01450189)
Timeframe: From date of randomization until viral load suppression, up to 52 weeks
| Intervention | weeks (Median) |
|---|---|
| Standard Counseling Arm | 39 |
| Behavioral Intervention Arm Only | 26 |
| Behavioral Intervention Plus ARV | 16 |
Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks (NCT01450189)
Timeframe: 12 weeks
| Intervention | Proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.5 |
| Behavioral Intervention Arm Only | 0.25 |
| Behavioral Intervention Plus ARV | 0.72 |
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization. (NCT01450189)
Timeframe: 1 year
| Intervention | Proportion of persons with AHI recruited (Number) |
|---|---|
| Overall | 0.69 |
(NCT01450189)
Timeframe: 1 year
| Intervention | Proportion of participants (Number) |
|---|---|
| Standard Counseling Arm | 0.44 |
| Behavioral Intervention Arm | 0.44 |
| Behavioral Intervention Plus Antiretrovirals (BIA) | 0.37 |
(NCT01450189)
Timeframe: 1 year
| Intervention | proportion of participants screened (Number) |
|---|---|
| Overall | 0.622 |
Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants (NCT01450189)
Timeframe: 52 weeks
| Intervention | proportion of sex partners (Number) |
|---|---|
| Standard Counseling Arm | 0.1 |
| Behavioral Intervention Arm Only | 0.1 |
| Behavioral Intervention Plus ARV | 0.1 |
(NCT01605890)
Timeframe: between Week 0 and Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 96.4 |
"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee" (NCT01605890)
Timeframe: at Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 40 |
(NCT01605890)
Timeframe: between Week 0 and Week 12
| Intervention | cells/µL (Median) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 73 |
"The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:~Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated." (NCT01605890)
Timeframe: from Week 0 to Week 48
| Intervention | Score on a scale (Median) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 45 |
(NCT01605890)
Timeframe: from Week 4 to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 76 |
(NCT01605890)
Timeframe: from Week 0 to Week 48
| Intervention | clinical and biological events (Number) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 61 |
(NCT01605890)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 5 |
(NCT01605890)
Timeframe: at Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 3 |
"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death." (NCT01605890)
Timeframe: from Week 0 to Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 0 |
Overall (regardless of the molecule) (NCT01605890)
Timeframe: from Week 0 to Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 4 |
Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. (NCT01605890)
Timeframe: from Week 0 to Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 1 |
(NCT01605890)
Timeframe: between Week 0 and Week 48
| Intervention | cells/µL (Median) |
|---|---|
| Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 87 |
Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I. (NCT01632345)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 25 mg: Part I | 85.0 |
| Doravirine 50 mg: Part I | 83.7 |
| Doravirine 100 mg: Part I | 92.9 |
| Doravirine 200 mg: Part I | 90.2 |
| Efavirenz 600 mg: Part I | 81.0 |
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 89.7 |
| Efavirenz 600 mg: Part I/II (Combined) | 87.0 |
Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 85.2 |
| Efavirenz 600 mg: Part I/II (Combined) | 85.0 |
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 79.6 |
| Efavirenz 600 mg: Part I/II (Combined) | 75.9 |
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 72.9 |
| Efavirenz 600 mg: Part I/II (Combined) | 73.1 |
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 77.8 |
| Efavirenz 600 mg: Part I/II (Combined) | 79.4 |
Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. (NCT01632345)
Timeframe: Baseline, Week 24
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 152.3 |
| Efavirenz 600 mg: Part I/II (Combined) | 146.0 |
Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. (NCT01632345)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 75.0 |
| Efavirenz 600 mg: Part I/II (Combined) | 75.9 |
Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I. (NCT01632345)
Timeframe: Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 25 mg: Part I | 80.0 |
| Doravirine 50 mg: Part I | 74.4 |
| Doravirine 100 mg: Part I | 71.4 |
| Doravirine 200 mg: Part I | 80.5 |
| Efavirenz 600 mg: Part I | 64.3 |
Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. (NCT01632345)
Timeframe: Baseline, Week 48
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 191.9 |
| Efavirenz 600 mg: Part I/II (Combined) | 194.5 |
A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. (NCT01632345)
Timeframe: Baseline, Week 96
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 259.2 |
| Efavirenz 600 mg: Part I/II (Combined) | 263.6 |
Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24. (NCT01632345)
Timeframe: Up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 25 mg: Part I | 2.5 |
| Doravirine 50 mg: Part I | 7.0 |
| Doravirine 100 mg: Part I | 2.4 |
| Doravirine 200 mg: Part I | 0.0 |
| Efavirenz 600 mg: Part I | 4.8 |
Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24. (NCT01632345)
Timeframe: Up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 25 mg: Part I | 90.0 |
| Doravirine 50 mg: Part I | 93.0 |
| Doravirine 100 mg : Part I | 71.4 |
| Doravirine 200 mg: Part I | 85.4 |
| Efavirenz 600 mg: Part I | 83.3 |
Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. (NCT01632345)
Timeframe: Baseline, Week 24
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Doravirine 25 mg: Part I | 154.1 |
| Doravirine 50 mg: Part I | 112.9 |
| Doravirine 100 mg: Part I | 133.6 |
| Doravirine 200 mg: Part I | 140.7 |
| Efavirenz 600 mg: Part I | 121.1 |
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24. (NCT01632345)
Timeframe: Up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 75.0 |
| Efavirenz 600 mg: Part I/II (Combined) | 85.2 |
A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48. (NCT01632345)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 87.0 |
| Efavirenz 600 mg: Part I/II (Combined) | 89.8 |
A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96. (NCT01632345)
Timeframe: Up to Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 89.8 |
| Efavirenz 600 mg: Part I/II (Combined) | 96.3 |
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24. (NCT01632345)
Timeframe: Up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 26.9 |
| Efavirenz 600 mg: Part I/II (Combined) | 47.2 |
Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8. (NCT01632345)
Timeframe: Up to Week 8
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg: Part I/II (Combined) | 24.1 |
| Efavirenz 600 mg: Part I/II (Combined) | 44.4 |
Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication. (NCT01632891)
Timeframe: From study entry to day 30
| Intervention | Participants (Count of Participants) |
|---|---|
| LPV/R-based ART | 2 |
| nNRTI-based ART | 1 |
"Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.~Change is evaluated in four groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to nNRTI-based ART with clearance of Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with clearance of Pf SCP at day 15" (NCT01632891)
Timeframe: Entry, Day 30
| Intervention | log10(parasites/µL) (Median) |
|---|---|
| nNRTI-based ART, Not Cleared | -2.26 |
| nNRTI-based ART, Cleared | -1.65 |
| LPV/R-based ART, Not Cleared | -1.82 |
| LPV/R-based ART, Cleared | -3.61 |
"Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30." (NCT01632891)
Timeframe: Entry, Day 30
| Intervention | log10(gametocyte/µL) (Number) |
|---|---|
| nNRTI-based ART, Not Cleared | -0.46 |
| LPV/R-based ART, Not Cleared | 0.17 |
"Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.~If a participant had missing data on day 15, they were considered as not having clearance." (NCT01632891)
Timeframe: Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)
| Intervention | Proportion of participants (Number) | |
|---|---|---|
| Proportion Cleared | Proportion Not Cleared | |
| LPV/R-based ART | 0.23 | 0.77 |
| nNRTI-based ART | 0.27 | 0.73 |
Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Entry | Day 3 | Day 6 | Day 9 | Day 12 | Day 15 | Day 20 | Day 25 | Day 30 | |
| LPV/R-based ART | 11 | 10 | 9 | 11 | 6 | 10 | 11 | 12 | 11 |
| nNRTI-based ART | 12 | 15 | 12 | 13 | 11 | 14 | 14 | 16 | 13 |
Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30
| Intervention | log10(parasites/µL) (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Entry | Day 3 | Day 6 | Day 9 | Day 12 | Day 15 | Day 20 | Day 25 | Day 30 | |
| LPV/R-based ART | 2.48 | 1.92 | 1.77 | 1.65 | 1.59 | 1.59 | 0.65 | 0.28 | 0.14 |
| nNRTI-based ART | 2.09 | 1.57 | 1.49 | 1.63 | 1.56 | 1.43 | 0.67 | 0.49 | 0.30 |
Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite. (NCT01632891)
Timeframe: From study entry up to day 30
| Intervention | Days (Median) |
|---|---|
| LPV/R-based ART | 12 |
| nNRTI-based ART | 14 |
(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | events (Number) | |
|---|---|---|
| Serious adverse events | Creatinine elevations | |
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 19 | 23 |
(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | participant with acquired HIV resistance (Number) |
|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 1 |
Number of study drug interruptions (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | interruptions (Number) |
|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 86 |
Mean duration of interruptions (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | Days (Number) |
|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 65 |
(NCT01632995)
Timeframe: Measured through enrollment (Week 0)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Potentially eligible clients | Declined participation | |
| Participants Assessed for Participation | 921 | 364 |
(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | Percent of Participants (Number) | ||||
|---|---|---|---|---|---|
| % with protective TFV-DP levels at week 4 | % with protective TFV-DP levels at week 12 | % with protective TFV-DP levels at week 24 | % with protective TFV-DP levels at week 36 | % with protective TFV-DP levels at week 48 | |
| Participants With DBS Testing | 86 | 85 | 82 | 85 | 80 |
(NCT01632995)
Timeframe: Measured through enrollment (Week 0)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Potentially eligible clients | Participants enrolled | |
| Participants Assessed for Participation | 921 | 557 |
Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | percent (Number) |
|---|---|
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 85.9 |
(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | partners (Mean) | |
|---|---|---|
| Mean Anal sex partners at baseline | Mean Anal sex partners at week 48 | |
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 10.9 | 9.3 |
(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination
| Intervention | participants (Number) | |
|---|---|---|
| Acute HIV infection at baseline | HIV seroconversion during follow-up | |
| Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) | 3 | 2 |
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||||
|---|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile | |
| Experimental: Cohort A | 2.4 | 13.4 | 32.6 | 120.1 | 168.9 |
| Experimental: Cohort C | 2.0 | 7.7 | 77.9 | NA | NA |
| Experimental: Cohort D | 2.3 | 5.6 | 96.1 | NA | NA |
| Experimental: Sub-cohort B1 | 2.3 | 20.3 | 80.7 | NA | NA |
| Experimental: Sub-cohort B2 | 3.0 | 28.0 | 49.7 | NA | NA |
| Experimental: Sub-cohort B3 | 16.4 | 16.4 | 16.4 | NA | NA |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | cells/mm^3 (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 72 | 112 | 145 |
| Standard of Care (SOC) | 74 | 107 | 134 |
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.3 | 11.3 | 44.6 | 168.9 |
| Standard of Care (SOC) | 2.3 | 20.3 | 45.3 | NA |
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | NA | NA |
| Standard of Care (SOC) | 25.0 | NA |
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| Experimental: Cohort A | NA | NA |
| Experimental: Cohort C | NA | NA |
| Experimental: Cohort D | 13.0 | NA |
| Experimental: Sub-cohort B1 | NA | NA |
| Experimental: Sub-cohort B2 | 25.0 | NA |
| Experimental: Sub-cohort B3 | NA | NA |
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 11.3 | NA | NA |
| Standard of Care (SOC) | 15.9 | 82.1 | NA |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 15.3 | 2.2 | 13.7 |
| Standard of Care (SOC) | 18.7 | 19.6 | 7.1 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 15.4 | 12.2 | 17.5 |
| Experimental: Cohort C | 15.4 | 9.9 | 11.8 |
| Experimental: Cohort D | 28.9 | 24.4 | 6.7 |
| Experimental: Sub-cohort B1 | -3.6 | -11.5 | -31.3 |
| Experimental: Sub-cohort B2 | 27.6 | 19.9 | 18.9 |
| Experimental: Sub-cohort B3 | 36.0 | 22.2 | 20.7 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 10.1 | 15.1 | 17.4 |
| Standard of Care (SOC) | 14.4 | 14.1 | 18.7 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 5.7 | 4.4 | 7.6 |
| Experimental: Cohort C | 16.5 | 20.0 | 22.1 |
| Experimental: Cohort D | 7.9 | 19.1 | 24.5 |
| Experimental: Sub-cohort B1 | 16.7 | 19.7 | 22.6 |
| Experimental: Sub-cohort B2 | 32.5 | 40.4 | 40.4 |
| Experimental: Sub-cohort B3 | 12.4 | 9.9 | 28.2 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.9 | 5.6 | 6.0 |
| Standard of Care (SOC) | 3.6 | 3.7 | 6.6 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 2.8 | 3.5 | 4.7 |
| Experimental: Cohort C | 1.0 | 2.3 | 5.8 |
| Experimental: Cohort D | -2.2 | 1.8 | 3.4 |
| Experimental: Sub-cohort B1 | 3.2 | 5.3 | 4.4 |
| Experimental: Sub-cohort B2 | 11.4 | 13.4 | 15.7 |
| Experimental: Sub-cohort B3 | 2.1 | 3.8 | 4.6 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.7 | 3.6 | 3.6 |
| Standard of Care (SOC) | 3.7 | 5.1 | 1.5 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 1.9 | 2.1 | 3.0 |
| Experimental: Cohort C | 2.1 | 3.0 | -0.9 |
| Experimental: Cohort D | 3.2 | 4.2 | 7.8 |
| Experimental: Sub-cohort B1 | 8.8 | 9.3 | 6.8 |
| Experimental: Sub-cohort B2 | 6.1 | 6.2 | -5.2 |
| Experimental: Sub-cohort B3 | 6.6 | 1.7 | 4.3 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 5.5 | 12.0 | 11.9 |
| Standard of Care (SOC) | 9.5 | 10.1 | 12.8 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
| Intervention | mg/dL (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 1.3 | 3.4 | 3.9 |
| Experimental: Cohort C | 12.2 | 15.3 | 13.6 |
| Experimental: Cohort D | 9.9 | 14.4 | 19.7 |
| Experimental: Sub-cohort B1 | 13.3 | 16.3 | 22.4 |
| Experimental: Sub-cohort B2 | 21.5 | 28.2 | 27.8 |
| Experimental: Sub-cohort B3 | -0.5 | 0.3 | 16.6 |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Experimental: Cohort A | 145 |
| Experimental: Sub-cohort B1 | 6 |
| Experimental: Sub-cohort B2 | 4 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 5 |
| Experimental: Cohort D | 6 |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 66 |
| Standard of Care (SOC) | 89 |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Experimental: Cohort A | 48 |
| Experimental: Sub-cohort B1 | 1 |
| Experimental: Sub-cohort B2 | 2 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 1 |
| Experimental: Cohort D | 5 |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 20 |
| Standard of Care (SOC) | 32 |
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
| Intervention | weeks (Median) |
|---|---|
| Experimental: Cohort A | 72 |
| Experimental: Sub-cohort B1 | 96 |
| Experimental: Sub-cohort B2 | 84 |
| Experimental: Sub-cohort B3 | 96 |
| Experimental: Cohort C | 72 |
| Experimental: Cohort D | 96 |
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
| Intervention | weeks (Median) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 72 |
| Standard of Care (SOC) | 72 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 3.9 |
| Experimental: Sub-cohort B1 | 1.4 |
| Experimental: Sub-cohort B2 | 1.4 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 0 |
| Experimental: Cohort D | 2.9 |
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 45.7 | NA |
| Standard of Care (SOC) | NA | NA |
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| Experimental: Cohort A | 45.7 | NA |
| Experimental: Cohort C | NA | NA |
| Experimental: Cohort D | NA | NA |
| Experimental: Sub-cohort B1 | 63.3 | NA |
| Experimental: Sub-cohort B2 | NA | NA |
| Experimental: Sub-cohort B3 | NA | NA |
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | |
| Experimental: Cohort A | 11.3 | 62.4 | NA |
| Experimental: Cohort C | 77.9 | NA | NA |
| Experimental: Cohort D | 2.4 | NA | NA |
| Experimental: Sub-cohort B1 | 3.1 | NA | NA |
| Experimental: Sub-cohort B2 | 44.6 | NA | NA |
| Experimental: Sub-cohort B3 | NA | NA | NA |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Experimental: Cohort A | 24 | 24 | 24 | 144 |
| Experimental: Cohort C | 48 | NA | NA | NA |
| Experimental: Cohort D | 24 | 24 | 24 | NA |
| Experimental: Sub-cohort B1 | 24 | NA | NA | NA |
| Experimental: Sub-cohort B2 | 24 | NA | NA | NA |
| Experimental: Sub-cohort B3 | NA | NA | NA | NA |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||||
|---|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24 | 24 | 24 | 60 | NA |
| Standard of Care (SOC) | 24 | 24 | 24 | 24 | NA |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||||
|---|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile | |
| Experimental: Cohort A | 24 | 24 | 24 | 24 | 60 |
| Experimental: Cohort C | 24 | 48 | 120 | NA | NA |
| Experimental: Cohort D | 24 | 24 | 24 | NA | NA |
| Experimental: Sub-cohort B1 | 24 | 48 | NA | NA | NA |
| Experimental: Sub-cohort B2 | 24 | 72 | 144 | NA | NA |
| Experimental: Sub-cohort B3 | NA | NA | NA | NA | NA |
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||||
|---|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile | |
| Experimental: Cohort A | 1.0 | 8.4 | 25.3 | 58.6 | NA |
| Experimental: Cohort C | 0.1 | 4.1 | 29.7 | NA | NA |
| Experimental: Cohort D | 2.4 | 5.1 | 47.6 | 98.9 | NA |
| Experimental: Sub-cohort B1 | 3.1 | 33.4 | 59.0 | NA | NA |
| Experimental: Sub-cohort B2 | 4.4 | 36.0 | 38.6 | 165.6 | NA |
| Experimental: Sub-cohort B3 | 4.4 | 4.4 | 4.4 | NA | NA |
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |
|---|---|---|
| 1st percentile | 5th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.1 | NA |
| Standard of Care (SOC) | 9.0 | NA |
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | ||
|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | |
| Experimental: Cohort A | 2.1 | 106.1 | NA |
| Experimental: Cohort C | 0.1 | NA | NA |
| Experimental: Cohort D | NA | NA | NA |
| Experimental: Sub-cohort B1 | 15.0 | NA | NA |
| Experimental: Sub-cohort B2 | 6.4 | 134.0 | NA |
| Experimental: Sub-cohort B3 | NA | NA | NA |
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 1.0 | 5.1 | 23.6 | 84.0 |
| Standard of Care (SOC) | 2.4 | 22.3 | 38.9 | 111.1 |
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24 | 24 | NA | NA |
| Standard of Care (SOC) | 24 | 24 | 48 | NA |
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 4.0 | 27.6 | 60.6 | NA |
| Standard of Care (SOC) | 4.0 | 42.3 | 77.9 | NA |
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
| Intervention | weeks (Number) | |||
|---|---|---|---|---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | |
| Experimental: Cohort A | 4.0 | 27.6 | 57.9 | NA |
| Experimental: Cohort C | 3.3 | 36.0 | 77.9 | 142.4 |
| Experimental: Cohort D | 2.4 | 24.0 | 48.4 | 96.3 |
| Experimental: Sub-cohort B1 | 3.1 | 36.0 | 84.0 | NA |
| Experimental: Sub-cohort B2 | 16.3 | 50.3 | 120.0 | NA |
| Experimental: Sub-cohort B3 | NA | NA | NA | NA |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.9 |
| Standard of Care (SOC) | 1.5 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 8.8 |
| Experimental: Sub-cohort B1 | 5.4 |
| Experimental: Sub-cohort B2 | 4.2 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 5.8 |
| Experimental: Cohort D | 5.9 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 8.2 |
| Standard of Care (SOC) | 6.5 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 0.7 |
| Experimental: Sub-cohort B1 | 0 |
| Experimental: Sub-cohort B2 | 1.4 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 0 |
| Experimental: Cohort D | 3.0 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.4 |
| Standard of Care (SOC) | 1.1 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 1.0 |
| Experimental: Sub-cohort B1 | 0 |
| Experimental: Sub-cohort B2 | 0 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 0 |
| Experimental: Cohort D | 0 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 1.2 |
| Standard of Care (SOC) | 0 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 48.9 |
| Experimental: Sub-cohort B1 | 8.2 |
| Experimental: Sub-cohort B2 | 2.9 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 5.8 |
| Experimental: Cohort D | 18.6 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24.9 |
| Standard of Care (SOC) | 32.2 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 16.6 |
| Experimental: Sub-cohort B1 | 1.4 |
| Experimental: Sub-cohort B2 | 1.4 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 1.5 |
| Experimental: Cohort D | 15.4 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 7.8 |
| Standard of Care (SOC) | 12.1 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 12.3 |
| Experimental: Sub-cohort B1 | 8.1 |
| Experimental: Sub-cohort B2 | 9.7 |
| Experimental: Sub-cohort B3 | 12.5 |
| Experimental: Cohort C | 5.7 |
| Experimental: Cohort D | 5.9 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 10.6 |
| Standard of Care (SOC) | 10.6 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 19.9 |
| Experimental: Sub-cohort B1 | 6.8 |
| Experimental: Sub-cohort B2 | 19.4 |
| Experimental: Sub-cohort B3 | 12.5 |
| Experimental: Cohort C | 14.3 |
| Experimental: Cohort D | 11.8 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 19.1 |
| Standard of Care (SOC) | 13.6 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Experimental: Cohort A | 3.2 |
| Experimental: Sub-cohort B1 | 2.7 |
| Experimental: Sub-cohort B2 | 1.4 |
| Experimental: Sub-cohort B3 | 0 |
| Experimental: Cohort C | 4.3 |
| Experimental: Cohort D | 0 |
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.8 |
| Standard of Care (SOC) | 2.3 |
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 24 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Overall Study | 0.64 |
| Experimental: Cohort A | 0.43 |
| Experimental: Sub-cohort B1 | 0.89 |
| Experimental: Sub-cohort B2 | 0.88 |
| Experimental: Sub-cohort B3 | 1.00 |
| Experimental: Cohort C | 0.90 |
| Experimental: Cohort D | 0.74 |
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 24 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.68 |
| Standard of Care (SOC) | 0.61 |
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 48 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Overall Study | 0.64 |
| Experimental: Cohort A | 0.44 |
| Experimental: Sub-cohort B1 | 0.88 |
| Experimental: Sub-cohort B2 | 0.88 |
| Experimental: Sub-cohort B3 | 1.00 |
| Experimental: Cohort C | 0.90 |
| Experimental: Cohort D | 0.74 |
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 48 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.66 |
| Standard of Care (SOC) | 0.62 |
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 72 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Overall Study | 0.64 |
| Experimental: Cohort A | 0.44 |
| Experimental: Sub-cohort B1 | 0.92 |
| Experimental: Sub-cohort B2 | 0.87 |
| Experimental: Sub-cohort B3 | 1.00 |
| Experimental: Cohort C | 0.85 |
| Experimental: Cohort D | 0.77 |
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 72 weeks after the date of entry
| Intervention | proportion of participants (Number) |
|---|---|
| Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.69 |
| Standard of Care (SOC) | 0.62 |
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
| Intervention | cells/mm^3 (Mean) | ||
|---|---|---|---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 | |
| Experimental: Cohort A | 39 | 65 | 87 |
| Experimental: Cohort C | 100 | 160 | 185 |
| Experimental: Cohort D | 90 | 135 | 165 |
| Experimental: Sub-cohort B1 | 109 | 157 | 182 |
| Experimental: Sub-cohort B2 | 116 | 158 | 197 |
| Experimental: Sub-cohort B3 | 142 | 86 | 238 |
Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mL (Mean) | |
|---|---|---|
| Mid-Period TFV Concentration | End Period TFV Concentration | |
| Product 1 | 1.85 | 1.77 |
| Product 2 | 0.42 | 0.37 |
| Product 3 | -0.01 | -0.02 |
Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mg (Mean) | ||
|---|---|---|---|
| Initiate Period TFV Concentration | Mid-Period TFV Concentration | End Period TFV Concentration | |
| Product 1 | -1.53 | 0.71 | 0.66 |
| Product 2 | -1.65 | 0.97 | 1.00 |
| Product 3 | -1.29 | -0.03 | 0.01 |
Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mL (Mean) | |
|---|---|---|
| Mid-Period FTC Concentration | End Period FTC Concentration | |
| Product 1 | 2.34 | 2.25 |
| Product 2 | -0.35 | -0.37 |
| Product 3 | -0.37 | -0.33 |
Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mg (Mean) | ||
|---|---|---|---|
| Initiate Period FTC Concentration | Mid-Period FTC Concentration | End Period FTC Concentration | |
| Product 1 | -1.75 | 0.31 | 0.14 |
| Product 2 | -1.76 | -1.76 | -1.80 |
| Product 3 | -1.57 | -1.67 | -1.69 |
Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Less Than 80% | At or Greater than 80% | |
| Product 1 | 12 | 173 |
| Product 2 | 31 | 153 |
| Product 3 | 13 | 170 |
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | participants (Number) | |
|---|---|---|
| Disliked Very Much/A Little | Liked Very Much/A Little | |
| Product 1 | 16 | 163 |
| Product 2 | 47 | 134 |
| Product 3 | 38 | 145 |
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | participants (Number) | |
|---|---|---|
| Very Unlikely/Unlikely | Very Likely/Likely | |
| Product 1 | 24 | 159 |
| Product 2 | 52 | 132 |
| Product 3 | 31 | 145 |
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | participants (Number) | |
|---|---|---|
| Very Difficult/Difficult | Very Easy/Easy | |
| Product 1 | 14 | 169 |
| Product 2 | 24 | 160 |
| Product 3 | 18 | 165 |
Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold). (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | participants (Number) |
|---|---|
| Product 1 | 64 |
| Product 2 | 61 |
| Product 3 | 56 |
Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mg (Mean) |
|---|---|
| Product 1 | 1.52 |
| Product 2 | 2.06 |
| Product 3 | 1.54 |
Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mg (Mean) |
|---|---|
| Product 1 | -0.35 |
| Product 2 | -1.26 |
| Product 3 | -1.26 |
Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
| Intervention | log10 ng/mg (Mean) |
|---|---|
| Product 1 | 0.18 |
| Product 2 | 0.84 |
| Product 3 | 0.02 |
"This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.~Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48)." (NCT01769456)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| PCC Behavioral Intervention Group | 0 |
"The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
| Intervention | percent change (Mean) |
|---|---|
| PCC Behavioral Intervention Group | 2.59 |
"The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
| Intervention | percent change (Mean) |
|---|---|
| PCC Behavioral Intervention Group | 1.16 |
"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:~Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey? An event is defined as an answer of greater than 0.~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| PCC Behavioral Intervention Group | 25 |
"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:~Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48
| Intervention | male sexual partners (Mean) |
|---|---|
| PCC Behavioral Intervention Group | 1.64 |
"This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions." (NCT01769456)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Size of the pill71989854 | Taste of the pill71989854 | Color of the pill71989854 | Taking the pill every day71989854 | Taking part in the study71989854 | HIV test at every visit71989854 | Risk Reduction Counseling at every visit71989854 | Questions about sexual behavior at every visit71989854 | Physician exam by a doctor71989854 | Health clinic for study visits71989854 | |||||||||||||||||||||||||||||||
| Did not like it at all | Liked | Did not like | Liked a lot | |||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 14 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 36 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 6 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 27 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 22 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 3 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 2 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 8 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 42 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 9 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 1 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 17 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 34 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 7 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 0 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 26 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 35 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 4 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 25 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 32 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 30 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 10 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 15 | |||||||||||||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 41 | |||||||||||||||||||||||||||||||||||||||
"This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.~The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).~The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)" (NCT01769456)
Timeframe: Week 4, Week 12, Week 24, Week 36, Week 48
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBS RBC TFV-DP (fmol/punch), Week 471989854 | DBS RBC TFV-DP (fmol/punch), Week 871989854 | DBS RBC TFV-DP (fmol/punch), Week 1271989854 | DBS RBC TFV-DP (fmol/punch), Week 2471989854 | DBS RBC TFV-DP (fmol/punch), Week 3671989854 | DBS RBC TFV-DP (fmol/punch), Week 4871989854 | |||||||||||||||||||||||||
| 2 days | 4 days | Daily | Below level of quantification | <2 days | ||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 24 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 13 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 14 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 21 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 12 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 3 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 17 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 7 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 22 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 11 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 15 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 18 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 5 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 6 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 19 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 8 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 2 | |||||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 4 | |||||||||||||||||||||||||||||
"This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.~Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:" (NCT01769456)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Were away from home71989854 | Were too busy with other things71989854 | Simply forgot71989854 | Had too many study pills to take71989854 | Wanted to avoid side effects71989854 | Did not want others to notice you taking meds71989854 | Had a change in daily routine71989854 | ||||||||||||||||||||||
| Rarely | Sometimes | Often | Never | |||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 12 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 15 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 10 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 7 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 8 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 21 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 37 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 2 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 36 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 3 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 0 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 1 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 27 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 5 | |||||||||||||||||||||||||||
| PCC Behavioral Intervention Group | 4 | |||||||||||||||||||||||||||
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders. (NCT01769456)
Timeframe: Baseline through Week 48
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Signed up for text message reminders | Discontinued reminders while on study agent | Discontinued reminders while still on study | |
| PCC Behavioral Intervention Group | 22 | 2 | 1 |
"The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease in absolute BMD >=1% baseline to Wk48 | Decrease in absolute BMD >=5% baseline to Wk48 | Decrease in absolute BMD >10% baseline to Wk48 | |
| PCC Behavioral Intervention Group | 16 | 2 | 0 |
"The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
| Intervention | percent change (Mean) |
|---|---|
| PCC Behavioral Intervention Group | 1.27 |
"The percent change in total body BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
| Intervention | percent change (Mean) |
|---|---|
| PCC Behavioral Intervention Group | 1.29 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | ratio*weeks (Median) |
|---|---|
| High Exposure Group | 0.00 |
| Low Exposure Group | -0.01 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | mg*wks/dL (Median) |
|---|---|
| High Exposure Group | -0.02 |
| Low Exposure Group | 0.01 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | mcg*wks/g (Median) |
|---|---|
| High Exposure Group | -2281.71 |
| Low Exposure Group | 808.53 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pmol*wks/L (Median) |
|---|---|
| High Exposure Group | -12.55 |
| Low Exposure Group | -8.60 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pM*wks (Median) |
|---|---|
| High Exposure Group | 50.64 |
| Low Exposure Group | -20.72 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | z-score (Median) |
|---|---|
| High Exposure Group | -0.10 |
| Low Exposure Group | 0.10 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pg*wks/mL (Median) |
|---|---|
| High Exposure Group | 1.66 |
| Low Exposure Group | 0.60 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | z-score (Median) |
|---|---|
| High Exposure Group | -0.20 |
| Low Exposure Group | -0.10 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mcg*wks/L (Median) |
|---|---|
| High Exposure Group | 1.12 |
| Low Exposure Group | -0.10 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pg*wks/mL (Median) |
|---|---|
| High Exposure Group | -0.09 |
| Low Exposure Group | 3.59 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mg*wks/dL (Median) |
|---|---|
| High Exposure Group | 0.01 |
| Low Exposure Group | -0.02 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | % of phosphorus reabsorbed*wks (Median) |
|---|---|
| High Exposure Group | 0.03 |
| Low Exposure Group | -1.28 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ng*wks/mL (Median) |
|---|---|
| High Exposure Group | -0.21 |
| Low Exposure Group | -79.82 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ratio*weeks (Median) |
|---|---|
| High Exposure Group | 0.00 |
| Low Exposure Group | 0.00 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mg*wks/dL (Median) |
|---|---|
| High Exposure Group | -0.01 |
| Low Exposure Group | 0.02 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mcg*wks/g (Median) |
|---|---|
| High Exposure Group | -710.86 |
| Low Exposure Group | 1606.38 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -0.80 |
| Low Exposure Group | 0.62 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -0.40 |
| Low Exposure Group | -0.24 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -1.89 |
| Low Exposure Group | 1.14 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -0.32 |
| Low Exposure Group | 0.88 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -0.60 |
| Low Exposure Group | -1.24 |
Serum calcium Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mg/dL (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.07 |
Serum Phosphate (SPO4) Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mmol/L (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ratio (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
SCr Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mg/dL (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
UB2MG Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ng/mL (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -34.78 |
UGluc Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mg/dL (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
UProt/ UCr Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ratio (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
URBP/UCr Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mcg/g (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -601.14 |
The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.99 |
The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.72 |
The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.94 |
The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.01 |
The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.81 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.09 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 2.59 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.56 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.36 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.80 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mg/dL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.01 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (ng/mL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.45 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mg/dL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | Weeks^-1 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mcg/g)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 270.70 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 24.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 24.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.95 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.33 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (pmol/L)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 4.27 |
CTX Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pM (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 25.90 |
OC Week 48 difference from baseline (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | mcg/L (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.05 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (pg/mL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.39 |
(NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pg/ML (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -1.50 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | % change*wks (Median) |
|---|---|
| High Exposure Group | -0.33 |
| Low Exposure Group | 0.00 |
(NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | pmol/L (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -8.61 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | pmol*wks/L (Median) |
|---|---|
| High Exposure Group | 10.80 |
| Low Exposure Group | 7.07 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | pM*wks (Median) |
|---|---|
| High Exposure Group | 105.89 |
| Low Exposure Group | -25.90 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | z-score (Median) |
|---|---|
| High Exposure Group | -0.10 |
| Low Exposure Group | 0.00 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | pg*wks/mL (Median) |
|---|---|
| High Exposure Group | -6.88 |
| Low Exposure Group | 0.79 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | z-score (Median) |
|---|---|
| High Exposure Group | -0.10 |
| Low Exposure Group | 0.00 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | mcg*wks/L (Median) |
|---|---|
| High Exposure Group | 0.87 |
| Low Exposure Group | -1.03 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | pg*wks/mL (Median) |
|---|---|
| High Exposure Group | 0.46 |
| Low Exposure Group | 0.47 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | mg*wks/dL (Median) |
|---|---|
| High Exposure Group | 0.02 |
| Low Exposure Group | 0.00 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | % of phosphorus reabsorbed*wks (Median) |
|---|---|
| High Exposure Group | 0.57 |
| Low Exposure Group | 1.14 |
"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24." (NCT01769469)
Timeframe: Baseline and wk 24
| Intervention | ng*wks/mL (Median) |
|---|---|
| High Exposure Group | -7.28 |
| Low Exposure Group | -23.29 |
The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.96 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.18 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.02 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.10 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 24.00 |
(NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | ml/min/1.73m^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 3.06 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.37 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.14 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.35 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (pg/mL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.51 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 24.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 8.00 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48
| Intervention | (pM)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 17.98 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mcg/L)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.07 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.99 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36 and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.05 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (% phosphorus reabsorbed)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.21 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 24.00 |
(NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | percentage of phosphorus reabsorbed (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.57 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)" (NCT01769469)
Timeframe: Baseline and wk 72
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)" (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 72
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)" (NCT01769469)
Timeframe: Baseline and wk 96
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)" (NCT01769469)
Timeframe: W 48 (or last available measurement on study), Wk 96
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Baseline and wk 72
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.10 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Week 48 (or last available measurement on study), Week 72
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Baseline, Week 96
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.10 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 96
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.05 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)" (NCT01769469)
Timeframe: Baseline and wk 72
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)" (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 72
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)" (NCT01769469)
Timeframe: Baseline and wk 96
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)" (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 96
| Intervention | g/cm^2 (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -0.01 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Baseline and wk 72
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.10 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 72
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Baseline and wk 96
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.20 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 96
| Intervention | z-score (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)" (NCT01769469)
Timeframe: Baseline and wk 72
| Intervention | g (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 7.90 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)" (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 72
| Intervention | g (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -27.80 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)" (NCT01769469)
Timeframe: Baseline and wk 96
| Intervention | g (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -17.49 |
"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)" (NCT01769469)
Timeframe: Wk 48 (or last available measurement on study), Wk 96
| Intervention | g (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | -46.83 |
The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and Week (wk) 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.08 |
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.00 |
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.00 |
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.00 |
"The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure." (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.04 |
The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline). (NCT01769469)
Timeframe: Baseline and wk 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.00 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.03 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.14 |
Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | fold change (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 1.95 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mg/dL)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.02 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mmol/L)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.01 |
"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]" (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | (mg/mg)/ weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 0.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline. (NCT01769469)
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48
| Intervention | weeks (Median) |
|---|---|
| Subjects Enrolled in ATN 110 or ATN 113 | 12.00 |
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total body." (NCT01772823)
Timeframe: Baseline, Week 48
| Intervention | g/cm2 (Mean) | |
|---|---|---|
| Total body BMD at baseline | Total body BMD Week 48 | |
| All Study Participants | 1.20 | 1.18 |
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total hip." (NCT01772823)
Timeframe: Baseline, Week 48
| Intervention | g/cm2 (Mean) | |
|---|---|---|
| Total hip BMD at baseline | Total hip BMD Week 48 | |
| All Study Participants | 1.10 | 1.08 |
"This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily)." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 471977136 | Week 871977136 | Week 1271977136 | Week 2471977136 | Week 3671977136 | Week 4871977136 | |||||||||||||||||||||||||
| Below level of quantification | <2 days | 2 days | 4 days | Daily | ||||||||||||||||||||||||||
| All Study Participants | 13 | |||||||||||||||||||||||||||||
| All Study Participants | 35 | |||||||||||||||||||||||||||||
| All Study Participants | 58 | |||||||||||||||||||||||||||||
| All Study Participants | 59 | |||||||||||||||||||||||||||||
| All Study Participants | 8 | |||||||||||||||||||||||||||||
| All Study Participants | 7 | |||||||||||||||||||||||||||||
| All Study Participants | 30 | |||||||||||||||||||||||||||||
| All Study Participants | 69 | |||||||||||||||||||||||||||||
| All Study Participants | 12 | |||||||||||||||||||||||||||||
| All Study Participants | 32 | |||||||||||||||||||||||||||||
| All Study Participants | 26 | |||||||||||||||||||||||||||||
| All Study Participants | 55 | |||||||||||||||||||||||||||||
| All Study Participants | 34 | |||||||||||||||||||||||||||||
| All Study Participants | 36 | |||||||||||||||||||||||||||||
| All Study Participants | 14 | |||||||||||||||||||||||||||||
| All Study Participants | 42 | |||||||||||||||||||||||||||||
| All Study Participants | 27 | |||||||||||||||||||||||||||||
| All Study Participants | 23 | |||||||||||||||||||||||||||||
| All Study Participants | 28 | |||||||||||||||||||||||||||||
| All Study Participants | 37 | |||||||||||||||||||||||||||||
| All Study Participants | 24 | |||||||||||||||||||||||||||||
| All Study Participants | 18 | |||||||||||||||||||||||||||||
| All Study Participants | 15 | |||||||||||||||||||||||||||||
"This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
| Intervention | fmol/punch (Mean) | |||||
|---|---|---|---|---|---|---|
| DBS RBC TFV-DP at Week 4 | DBS RBC TFV-DP at Week 8 | DBS RBC TFV-DP at Week 12 | DBS RBC TFV-DP at Week 24 | DBS RBC TFV-DP at Week 36 | DBS RBC TFV-DP at Week 48 | |
| All Study Participants | 584.56 | 783.18 | 793.37 | 657.66 | 671.72 | 528.24 |
Number of subjects who discontinued receiving text message reminders while they were still on the study agent (NCT01772823)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| All Study Participants | 3 |
Total number of subjects who signed up for text message reminders (NCT01772823)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| All Study Participants | 76 |
"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's age at enrollment." (NCT01772823)
Timeframe: 48 weeks
| Intervention | years (Mean) |
|---|---|
| On Prep | 20.28 |
| Off Prep | 19.93 |
"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)" (NCT01772823)
Timeframe: 48 weeks
| Intervention | copies/ml (Mean) |
|---|---|
| On Prep | 1.22 |
| Off Prep | 1.14 |
"This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM~Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal." (NCT01772823)
Timeframe: 48 Weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| All Study Participants | 1 |
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for femoral neck." (NCT01772823)
Timeframe: Baseline, Week 48
| Intervention | g/cm2 (Mean) | |
|---|---|---|
| Femoral neck BMD at baseline | Femoral neck Week 48 | |
| All Study Participants | 1.04 | 1.03 |
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for lumbar spine." (NCT01772823)
Timeframe: Baseline, Week 48
| Intervention | g/cm2 (Mean) | |
|---|---|---|
| Lumbar spine BMD at baseline | Lumbar spine BMD Week 48 | |
| All Study Participants | 1.09 | 1.08 |
PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations. (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
| Intervention | pmol/punch (Mean) | |||||
|---|---|---|---|---|---|---|
| DBS RBC FTC-TP at Week 4 | DBS RBC FTC-TP at Week 8 | DBS RBC FTC-TP at Week 12 | DBS RBC FTC-TP at Week 24 | DBS RBC FTC-TP at Week 36 | DBS RBC FTC-TP at Week 48 | |
| All Study Participants | 0.20 | 0.19 | 0.18 | 0.16 | 0.17 | 0.15 |
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48." (NCT01772823)
Timeframe: 48 weeks
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease in absolute BMD >=1% | Decrease in absolute BMD >=5% | Decrease in absolute BMD >10% | |
| All Study Participants | 97 | 16 | 1 |
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to male partners in the past month/since the last survey:~Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0." (NCT01772823)
Timeframe: Baseline and 48 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Had unprotected oral/anal w/male (BL) | Had unprotected oral/anal w/ male (Wk48) | |
| All Study Participants | 143 | 103 |
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:~During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48)~And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:~Of those you had unprotected sex with, how many did you know were HIV positive?" (NCT01772823)
Timeframe: Baseline and 48 weeks
| Intervention | sexual partners (Mean) | |||
|---|---|---|---|---|
| Male sexual partners last month (baseline) | Male sexual partners since last survey (Wk 48) | Number HIV+ male partners last month (baseline) | Number HIV+ male partners since last survey(Wk48) | |
| All Study Participants | 5.41 | 2.46 | 1.65 | 0.15 |
TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02022657)
Timeframe: Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.
| Intervention | fmol/punch (Mean) |
|---|---|
| DOT-DBS Dosing 33% | 530 |
| DOT-DBS Dosing 67% | 997 |
| DOT-DBS Dosing 100% | 1605 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE (NCT02131233)
Timeframe: Up to Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 1.3 |
| Raltegravir | 2.3 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 26.4 |
| Raltegravir | 28.6 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related. (NCT02131233)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 25.0 |
| Raltegravir | 27.1 |
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 9.6 |
| Raltegravir | 15.8 |
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. (NCT02131233)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 6.2 |
| Raltegravir | 9.4 |
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 0.2 |
| Raltegravir | 0.8 |
A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related. (NCT02131233)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 0.2 |
| Raltegravir | 0.8 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02131233)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 83.2 |
| Raltegravir | 88.0 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02131233)
Timeframe: Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 90.8 |
| Raltegravir | 94.0 |
CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values. (NCT02131233)
Timeframe: Baseline and Week 96
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Reformulated Raltegravir | 261.6 |
| Raltegravir | 262.2 |
"From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason." (NCT02131233)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 81.5 |
| Raltegravir | 80.1 |
"From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason." (NCT02131233)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 88.9 |
| Raltegravir | 88.3 |
CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values. (NCT02131233)
Timeframe: Baseline and Week 48
| Intervention | cells/mm^3 (Mean) |
|---|---|
| Reformulated Raltegravir | 232.0 |
| Raltegravir | 234.1 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE (NCT02131233)
Timeframe: Up to Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Reformulated Raltegravir | 1.1 |
| Raltegravir | 2.3 |
Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline visit
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| No. of participants reporting alcohol use | No. of participants reporting drug use | |
| Truvada | 83 | 25 |
Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48 (NCT02213328)
Timeframe: Measured though Week 48
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| total enrolled participants | week 12 | week 24 | week 36 | week 48 | |
| Truvada | 148 | 107 | 74 | 31 | 22 |
Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011. (NCT02213328)
Timeframe: Measured through Week 48
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Grade 2 | Grade 3 | Grade 4 | |
| Truvada | 14 | 4 | 2 |
Count of participants who had been enrolled in the study and successfully completed the study (NCT02213328)
Timeframe: Measured through Week 52
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Number of participants enrolled | Number of participants completing the study | |
| Truvada | 148 | 120 |
Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada | 100 |
Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later. (NCT02213328)
Timeframe: Measured through Week 52
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada | 1 |
Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit (NCT02213328)
Timeframe: Measured at Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada | 97 |
Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point (NCT02213328)
Timeframe: Measured through Week 48
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada | 141 |
Participants reporting multiple partners during interviewer administered questionnaires (NCT02213328)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) |
|---|---|
| Truvada | 49 |
The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study (NCT02213328)
Timeframe: Measured through Week 48
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Percentage of partcipants who reported willingness to use the study regimen | Percentage of participants who took up PrEP | Percentage of participants who remained on PrEP at 12 weeks | Percentage of participants who remained on PrEP at 24 weeks | Percentage of participants who remained on PrEP at 36 weeks | Percentage of participants who remained on PrEP at week 48 | |
| Truvada | 148 | 148 | 122 | 87 | 85 | 85 |
Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48 (NCT02213328)
Timeframe: Measured through Week 48
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Participants with truvada in DBS at week 24 | Participants with truvada in DBS at week 36 | Participants with truvada in DBS at week 48 | |
| Truvada | 74 | 31 | 22 |
(NCT02251236)
Timeframe: Baseline
| Intervention | ng/mL (Median) |
|---|---|
| Stribild Arm | 3.03 |
| Genvoya Arm | 0.49 |
(NCT02251236)
Timeframe: Week 24
| Intervention | ng/mL (Median) |
|---|---|
| Stribild Arm | 0.507 |
| Genvoya Arm | 0.481 |
(NCT02251236)
Timeframe: Week 24
| Intervention | ng/mL (Median) |
|---|---|
| Stribild Arm | 5.90 |
| Genvoya Arm | 3.09 |
(NCT02251236)
Timeframe: Baseline
| Intervention | ng/mL (Median) |
|---|---|
| Stribild Arm | 4.3 |
| Genvoya Arm | 2.72 |
The percentage of participants with any drug-related SAE was assessed. (NCT02275780)
Timeframe: Up to 98 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Doravirine 100 mg | 0.3 |
| Daurunavir 800 mg + Ritonavir 100 mg | 0.3 |
A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. (NCT02275780)
Timeframe: Up to 98 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Doravirine 100 mg | 7.0 |
| Daurunavir 800 mg + Ritonavir 100 mg | 8.6 |
Serum HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Daurunavir 800 mg + Ritonavir 100 mg | 43.27 | 4.15 |
| Doravirine 100 mg | 43.58 | 3.94 |
Serum LDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid-lowering therapy. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Daurunavir 800 mg + Ritonavir 100 mg | 91.76 | 9.92 |
| Doravirine 100 mg | 91.10 | -4.51 |
Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Daurunavir 800 mg + Ritonavir 100 mg | 114.44 | 13.75 |
| Doravirine 100 mg | 113.34 | -5.30 |
Serum total cholesterol was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Daurunavir 800 mg + Ritonavir 100 mg | 157.71 | 17.90 |
| Doravirine 100 mg | 156.92 | -1.37 |
Serum triglyceride was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | mg/dL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Daurunavir 800 mg + Ritonavir 100 mg | 117.02 | 21.97 |
| Doravirine 100 mg | 111.16 | -3.14 |
"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 96 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 and all missing data were considered treatment failures, regardless of the reason." (NCT02275780)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg | 72.0 |
| Daurunavir 800 mg + Ritonavir 100 mg | 64.4 |
CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. (NCT02275780)
Timeframe: Baseline and Week 96
| Intervention | Cells/mm^3 (Mean) |
|---|---|
| Doravirine 100 mg | 224.1 |
| Daurunavir 800 mg + Ritonavir 100 mg | 206.7 |
CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. (NCT02275780)
Timeframe: Baseline and Week 48
| Intervention | Cells/mm^3 (Mean) |
|---|---|
| Doravirine 100 mg | 192.7 |
| Daurunavir 800 mg + Ritonavir 100 mg | 185.6 |
The percentage of participants who discontinued study treatment due to an AE was assessed. (NCT02275780)
Timeframe: Up to 96 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Doravirine 100 mg | 1.6 |
| Daurunavir 800 mg + Ritonavir 100 mg | 3.4 |
"The percentage of participants in each arm achieving HIV-1 RNA levels <40 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 and all missing data were considered treatment failures, regardless of the reason." (NCT02275780)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg | 83.3 |
| Daurunavir 800 mg + Ritonavir 100 mg | 79.1 |
"The percentage of participants in each arm achieving 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 and all missing data were considered treatment failures, regardless of the reason." (NCT02275780)
Timeframe: Week 48
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg | 83.8 |
| Daurunavir 800 mg + Ritonavir 100 mg | 79.9 |
"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 96 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 and all missing data were considered treatment failures, regardless of the reason." (NCT02275780)
Timeframe: Week 96
| Intervention | Percentage of participants (Number) |
|---|---|
| Doravirine 100 mg | 73.1 |
| Daurunavir 800 mg + Ritonavir 100 mg | 66.0 |
An adverse event (AE) is defined as any untoward medical occurrence in a study participant and which does not necessarily have to have a causal relationship to treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study treatment is also an AE. The percentage of participants with any AE was assessed. (NCT02275780)
Timeframe: Up to 98 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Doravirine 100 mg | 84.6 |
| Daurunavir 800 mg + Ritonavir 100 mg | 82.8 |
The investigator was to determine if an AE had a reasonable possibility of a relationship to the study drug. The percentage of participants with any drug-related AE was assessed. (NCT02275780)
Timeframe: Up to 98 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Doravirine 100 mg | 32.1 |
| Daurunavir 800 mg + Ritonavir 100 mg | 32.1 |
The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract. (NCT02333045)
Timeframe: Baseline, Day 7, Day 14, Day 21
| Intervention | cells (Mean) | |||
|---|---|---|---|---|
| Baseline | Day 7 | Day 14 | Day 21 | |
| Maraviroc | 20,000,000 | 18,700,000 | 28,300,000 | 21,800,000 |
| Truvada | 42,000,000 | 15,000,000 | 20,000,000 | 30,000,000 |
Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | fmol/million cells (Median) |
|---|---|
| Truvada | 45 |
| Rectal Gel Lubricant + Truvada | 48 |
Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | fmol/mg tissue (Median) |
|---|---|
| Truvada | 510 |
| Rectal Gel Lubricant + Truvada | 280 |
Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | fmol/mg tissue (Median) |
|---|---|
| Truvada | 104 |
| Rectal Gel Lubricant + Truvada | 112 |
Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | ng/swab (Median) |
|---|---|
| Truvada | 812 |
| Rectal Gel Lubricant + Truvada | 780 |
Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | ng/swab (Median) |
|---|---|
| Truvada | 320 |
| Rectal Gel Lubricant + Truvada | 382 |
Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | ng/ml (Median) |
|---|---|
| Truvada | 52 |
| Rectal Gel Lubricant + Truvada | 64 |
Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | ng/ml (Median) |
|---|---|
| Truvada | 248 |
| Rectal Gel Lubricant + Truvada | 340 |
Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Post-Intervention (Day 8)
| Intervention | fmol/million cells (Median) |
|---|---|
| Truvada | 4980 |
| Rectal Gel Lubricant + Truvada | 4020 |
Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)
| Intervention | fmol/mg tissue (Median) | |
|---|---|---|
| Baseline | Post-Intervention (Day 8) | |
| Rectal Gel Lubricant + Truvada | 74 | 66 |
| Truvada | 131 | 60 |
The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)
| Intervention | pg/mL (Median) | |
|---|---|---|
| Baseline | Day 8 | |
| Rectal Gel Lubricant | 250 | 363 |
| Rectal Gel Lubricant + Truvada | 276 | 284 |
| Truvada | 287 | 133 |
HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)
| Intervention | percentage positive T-cells (Median) | |
|---|---|---|
| Baseline | Day 8 | |
| Rectal Gel Lubricant | 62 | 66 |
| Rectal Gel Lubricant + Truvada | 58 | 51 |
| Truvada | 70 | 58 |
Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)
| Intervention | fmol/million cells (Median) | |
|---|---|---|
| Baseline | Post-Intervention (Day 8) | |
| Rectal Gel Lubricant + Truvada | 140 | 122 |
| Truvada | 149 | 204 |
Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution. (NCT02401230)
Timeframe: Baseline, Post-Intervention (Day 8)
| Intervention | fmol/mg tissue (Median) | |
|---|---|---|
| Baseline | Post-Intervention (Day 8) | |
| Rectal Gel Lubricant + Truvada | 58 | 36 |
| Truvada | 246 | 43 |
Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit. (NCT02720094)
Timeframe: Reported week 57 (injection visit #8) and week 105 (injection visit #14)
| Intervention | umol/L (Median) | |
|---|---|---|
| Week 57 (Injection #8) | Week 105 (Injection #14) | |
| Cabotegravir | 0.90 | 0.90 |
| TDF/FTC | 1.70 | 2.30 |
Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus. (NCT02720094)
Timeframe: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Cabotegravir | 73 |
| TDF/FTC | 96 |
Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population (NCT02720094)
Timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 oror the date of DSMB decision to unblind all participants, whichever is earliest.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cabotegravir | 8 |
| TDF/FTC | 37 |
All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC). (NCT02720094)
Timeframe: HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.
| Intervention | Participants (Count of Participants) |
|---|---|
| Cabotegravir | 13 |
| TDF/FTC | 39 |
The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2. (NCT02720094)
Timeframe: Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).
| Intervention | Participants (Count of Participants) |
|---|---|
| Cabotegravir | 2106 |
| TDF/FTC | 2116 |
Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations. (NCT02720094)
Timeframe: Assessed at weeks 57 and 105.
| Intervention | mg/dL (Median) | |
|---|---|---|
| Week 57 | Week 105 | |
| Cabotegravir | 1.0 | 1.0 |
| TDF/FTC | 0.0 | 1.8 |
Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations. (NCT02720094)
Timeframe: Assessed at weeks 57 and 105.
| Intervention | mg/dL (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Total Cholesterol Week 57 | Total Cholesterol Week 105 | Trigylcerides Week 57 | Trigylcerides Week 105 | LDL Week 57 | LDL Week 105 | HDL Week57 | HDL Week 105 | |
| Cabotegravir | 1.0 | 4.0 | 2.7 | 7.5 | 1.0 | 3.0 | -0.2 | -0.9 |
| TDF/FTC | -10.0 | -7.5 | 0.0 | 2.0 | -6.0 | -4.0 | -3.0 | -3.0 |
Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit. (NCT02720094)
Timeframe: Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).
| Intervention | Kg (Median) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 5 (Injection #1) | Week 9 (Injection #2) | Week 17 (Injection #3) | Week 25 (Injection #4) | Week 33 (Injection #5) | Week 41 (Injection #6) | Week 49 (Injection #7) | Week 57 (Injection #8) | Week 65 (Injection #9) | Week #73 (Injection #10) | Week 81 (Injection #11) | Week 89 (Injection #12) | Week 97 (Injection #13) | Week #105 (Injection #14) | Week 113 (Injection #15) | Week 121 (Injection #16) | Week 129 (Injection #17) | Week 137 (Injection #18) | Week 145 (Injection #19) | Week 153 (Injection #20) | |
| Cabotegravir | 0.4 | 0.5 | 0.7 | 0.9 | 1.0 | 1.2 | 1.5 | 1.2 | 1.7 | 1.8 | 2.0 | 2.2 | 2.1 | 2.1 | 2.6 | 2.8 | 2.9 | 2.7 | 2.7 | 2.9 |
| TDF/FTC | 0.1 | 0.0 | 0.0 | -0.2 | 0.0 | 0.0 | 0.0 | 0.2 | 0.5 | 0.5 | 0.5 | 0.5 | 1.0 | 0.9 | 1.4 | 1.0 | 1.3 | 1.2 | 1.9 | 0.7 |
(NCT02842086)
Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Descovy (DVY) | 93.7 |
| Truvada (TVD) | 93.6 |
(NCT02842086)
Timeframe: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)
| Intervention | percentage of participants (Number) |
|---|---|
| Descovy (DVY) | 76.1 |
| Truvada (TVD) | 79.1 |
"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 48
| Intervention | Percent Change (Median) |
|---|---|
| Descovy (DVY) | 0.1 |
| Truvada (TVD) | 20.0 |
"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 96
| Intervention | Percent Change (Median) |
|---|---|
| Descovy (DVY) | 0.3 |
| Truvada (TVD) | 21.4 |
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 48
| Intervention | Percent Change (Mean) |
|---|---|
| Descovy (DVY) | 0.218 |
| Truvada (TVD) | -0.968 |
"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)" (NCT02842086)
Timeframe: When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)
| Intervention | HIV-1 infections per 100 PY (Number) |
|---|---|
| Descovy (DVY) | 0.160 |
| Truvada (TVD) | 0.342 |
(NCT02842086)
Timeframe: Baseline, Week 96
| Intervention | mg/dL (Mean) |
|---|---|
| Descovy (DVY) | 0.01 |
| Truvada (TVD) | 0.03 |
(NCT02842086)
Timeframe: Baseline, Week 48
| Intervention | mg/dL (Mean) |
|---|---|
| Descovy (DVY) | -0.01 |
| Truvada (TVD) | 0.01 |
"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 96
| Intervention | Percent Change (Median) |
|---|---|
| Descovy (DVY) | -14.5 |
| Truvada (TVD) | 14.1 |
"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios." (NCT02842086)
Timeframe: Baseline, Week 48
| Intervention | Percent Change (Median) |
|---|---|
| Descovy (DVY) | -10.6 |
| Truvada (TVD) | 15.4 |
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 96
| Intervention | Percent Change (Mean) |
|---|---|
| Descovy (DVY) | 0.831 |
| Truvada (TVD) | -1.426 |
Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 48
| Intervention | Percent Change (Mean) |
|---|---|
| Descovy (DVY) | 0.512 |
| Truvada (TVD) | -1.061 |
Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%. (NCT02842086)
Timeframe: Baseline, Week 96
| Intervention | Percent Change (Mean) |
|---|---|
| Descovy (DVY) | 0.565 |
| Truvada (TVD) | -1.048 |
"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)" (NCT02842086)
Timeframe: When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)
| Intervention | HIV-1 infections per 100 PY (Number) |
|---|---|
| Descovy (DVY) | 0.159 |
| Truvada (TVD) | 0.297 |
"Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At week 48
| Intervention | Percentage of CD4+ T-cells (Median) | |||
|---|---|---|---|---|
| CD4+ T-cell Response to Env | CD4+ T-cell Response to Gag | CD4+ T-cell Response to Nef | CD4+ T-cell Response to Pol | |
| Arm 1: Fiebig I/II | 0.00 | 0.06 | 0.04 | 0.00 |
| Arm 2: Fiebig III/IV | 0.00 | 0.19 | 0.10 | 0.04 |
| Arm 3: Fiebig V | 0.08 | 0.14 | 0.10 | 0.04 |
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 48
| Intervention | Proportion of participants (Number) | ||
|---|---|---|---|
| Joint Assay (Integrase + Gag) | Integrase Assay | Gag Assay | |
| Arm 1: Fiebig I/II | 0.00 | 0.10 | 0.03 |
| Arm 2: Fiebig III/IV | 0.00 | 0.06 | 0.02 |
| Arm 3: Fiebig V | 0.00 | 0.10 | 0.00 |
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 0
| Intervention | Proportion of participants (Number) | ||
|---|---|---|---|
| Joint Assay (Integrase + Gag) | Integrase Assay | Gag Assay | |
| Arm 1: Fiebig I/II | 0.00 | 0.04 | 0.00 |
| Arm 2: Fiebig III/IV | 0.01 | 0.03 | 0.01 |
| Arm 3: Fiebig V | 0.00 | 0.07 | 0.00 |
"Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At 48 weeks
| Intervention | Percentage of CD8+ T-cells (Median) | |||
|---|---|---|---|---|
| CD8+ T-cell Response to Env | CD8+ T-cell Response to Gag | CD8+ T-cell Response to Nef | CD8+ T-cell Response to Pol | |
| Arm 1: Fiebig I/II | 0.00 | 0.15 | 0.03 | 0.00 |
| Arm 2: Fiebig III/IV | 0.00 | 0.33 | 0.15 | 0.05 |
| Arm 3: Fiebig V | 0.00 | 0.28 | 0.33 | 0.08 |
Dolutegravir concentrations in blood plasma are assessed as the maximum dolutegravir concentration (Cmax) and 24 hour trough (lowest) concentration (C24h) of dolutegravir in micrograms per milliliter (µg/mL). Blood samples for pharmacokinetics were obtained prior to dosing (hour 0) and 1, 2, 3, 4, 6, 8, and 24 hours after dosing. (NCT02924389)
Timeframe: Day 84 (hour 0 through 24)
| Intervention | µg/mL (Median) | ||
|---|---|---|---|
| First-dose pharmacokinetics (Cmax) | Steady state pharmacokinetics (Cmax) | Trough dolutegravir concentration (C24h) | |
| Anti-retroviral (ARV) Naïve Males and Females | 2.01 | 2.34 | 0.56 |
Rectal dolutegravir concentrations in rectal tissue stratified by virologic suppressors vs non-suppressors. (NCT02924389)
Timeframe: Week 2, Week 6, Week 12
| Intervention | ng/mL (Median) | ||
|---|---|---|---|
| Week 2 | Week 6 | Week 12 | |
| HIV RNA Non-suppressors | 749 | 625 | 373 |
| HIV RNA Suppressors | 1606 | 724 | 473 |
Time of maximum dolutegravir concentration is assessed in hours for the time periods of after the first dose and during steady state. Blood samples for pharmacokinetics were obtained prior to dosing (hour 0) and 1, 2, 3, 4, 6, 8, and 24 hours after dosing. (NCT02924389)
Timeframe: Day 84 (hour 0 through 24)
| Intervention | hours (Median) | |
|---|---|---|
| First-dose pharmacokinetics (Tmax) | Steady state pharmacokinetics (Tmax) | |
| Anti-retroviral (ARV) Naïve Males and Females | 1.5 | 3.0 |
The area under the dolutegravir plasma concentration vs time curve in a 24 hour period (AUC24h) is assessed in hours times micrograms per millimeters (h* µg/mL) for the time periods of after the first dose and during steady state. Blood samples for pharmacokinetics were obtained prior to dosing (hour 0) and 1, 2, 3, 4, 6, 8, and 24 hours after dosing. (NCT02924389)
Timeframe: Day 84 (hour 0 through 24)
| Intervention | h* µg/mL (Median) | |
|---|---|---|
| First-dose pharmacokinetics (AUC24h) | Steady state pharmacokinetics (AUC24h) | |
| Anti-retroviral (ARV) Naïve Males and Females | 22.30 | 27.24 |
Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
| Intervention | ng*h/mL (Geometric Mean) | |||
|---|---|---|---|---|
| TFV AUC-unencapsulated | TFV AUC-coencapsulated | FTC AUC-unencapsulated | FTC AUC-coencapsulated | |
| All Participants | 1978 | 2042 | 9342 | 9512 |
Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
| Intervention | ng/mL (Geometric Mean) | |||
|---|---|---|---|---|
| TFV Cmax-unencapsulated | TFV Cmax-coencapsulated | FTC Cmax-unencapsulated | FTC Cmax-coencapsulated | |
| All Participants | 222 | 229 | 1567 | 1684 |
"Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | fmol/mg tissue (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 0 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 27 |
| Phase III/Truvada | 41 |
"Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Short Course | 32 |
| Phase III/Steady State | 30 |
| Phase III/Genvoya | 175 |
| Phase III/Truvada | 54 |
"Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/mg tissue (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 2.7 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 6.8 |
| Phase III/Truvada | 0 |
"Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 0 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 0 |
| Phase III/Truvada | 0 |
"Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | fmol/mg tissue (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 17 |
| Phase II/Truvada | 11 |
| Phase III/Genvoya | 0 |
| Phase III/Truvada | 0 |
"Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 405 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 219 |
| Phase III/Truvada | 0 |
"Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | fmol/1000000 PBMC (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 213 |
| Phase II/Truvada | 28 |
| Phase III/Genvoya | 453 |
| Phase III/Truvada | 80 |
"Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/mL (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Short Course | 0 |
| Phase III/Steady State | 28 |
| Phase III/Genvoya | 0 |
| Phase III/Truvada | 59 |
"Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 58 |
| Phase II/Truvada | 45 |
| Phase III/Genvoya | 533 |
| Phase III/Truvada | 1325 |
"Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/mL (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 30 |
| Phase II/Truvada | 34 |
| Phase III/Genvoya | 152 |
| Phase III/Truvada | 280 |
"Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/mL (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 102 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 384 |
| Phase III/Truvada | 0 |
"Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.~For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Up to 10 months post-baseline
| Intervention | ng p24 (Median) |
|---|---|
| Phase I/Pre-Drug | 740 |
| Phase II/Genvoya | 225 |
| Phase II/Truvada | 298 |
| Phase III/Genvoya | 348 |
| Phase III/Truvada | 327 |
"Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 0 |
| Phase II/Truvada | 0 |
| Phase III/Genvoya | 0 |
| Phase III/Truvada | 17 |
"Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | ng/swab (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 288 |
| Phase II/Truvada | 419 |
| Phase III/Genvoya | 371 |
| Phase III/Truvada | 109 |
"Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration." (NCT02985996)
Timeframe: Baseline, Visit 4 (Up to ten days post drug)
| Intervention | fmol/1000000 PBMC (Median) |
|---|---|
| Phase I/Pre-Drug | 0 |
| Phase II/Genvoya | 3380 |
| Phase II/Truvada | 2580 |
| Phase III/Genvoya | 6470 |
| Phase III/Truvada | 7660 |
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 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 |
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 |
"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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 |
Concentrations of emtricitabine-triphosphate, tenofovir-diphosphate will be measured in peripheral blood mononuclear cells in the Truvada arm only. Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose
| Intervention | fmol/10^6 cells (Median) | ||||
|---|---|---|---|---|---|
| Phase 1 Single Dose | Phase 2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: Zero Doses per week | |
| Emtricitabine (Truvada) | 27.09 | 4460 | 2388.69 | 267.82 | 27.48 |
| Tenfovir (Truvada) | 2.1 | 127.1 | 60 | 15.7 | 10.4 |
Signal Strength concentrations will be measured in hair for all study drugs, inclusive of FTC (emtricitabine), tenofovir (TFV), maraviroc (MRV), and dolutegravir (DTG) using Matrix-assisted Laser Desorption Electrospray Ionization (IR-MALDESI) to be reported by signal abundance (au). Signal abundance is the industry standard unit, and higher values represent greater signal with capability to relate to comparative concentrations. (NCT03218592)
Timeframe: Up to 28 days post dose
| Intervention | Signal Abundance (au) (Median) | ||||
|---|---|---|---|---|---|
| Phase 3: Zero Doses Per Week | Phase 3: 1 Dose Per week | Phase 3: 3 Doses Per Week | Phase 2: Daily Dosing | Phase 1: Single Dose | |
| Dolutegravir | 1092.130868 | 2377.868226 | 5504.883169 | 14251.46653 | NA |
| Maraviroc | 156.4826656 | 3942.692396 | 27814.98823 | 46013.29104 | NA |
| Truvada | 0.501209 | 156.1127125 | 466.7986895 | 824.721385 | NA |
Concentrations will be measured in dried blood spots of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir). Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose
| Intervention | fmol / 3mm punch (Median) | ||||
|---|---|---|---|---|---|
| Phase 1: Single Dose | Phase 2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: 0 Doses per week | |
| Dolutegravir | 10 | 718.5 | 60.95 | 10 | 10 |
| Emtricitabine | 50 | 280 | 150.5 | 50 | 50 |
| Maraviroc | 3 | 9.185 | 3 | 3 | 3 |
| Tenofovir | 50 | 809.5 | 811 | 644.5 | 621 |
Concentrations will be measured in hair of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir) (NCT03218592)
Timeframe: Up to 28 days post-dose
| Intervention | ng/mL (Median) | ||||
|---|---|---|---|---|---|
| Phase 1: Single dose | Phase2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: 0 Doses per week | |
| Dolutegravir | 1 | 1240 | 69.3 | 3.095 | 1 |
| Emtricitabine | 0.5 | 72.3 | 17.2 | 1.2 | 0.5 |
| Maraviroc | 1 | 9.715 | 1.71 | 1 | 1 |
| Tenofovir | 0.5 | 61.9 | 9.4 | 0.5 | 0.5 |
(NCT03547908)
Timeframe: Baseline; Week 48
| Intervention | percentage of CD4 cells (Mean) |
|---|---|
| B/F/TAF | 8.43 |
| DTG + F/TDF | 7.75 |
This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing on-treatment data were treated as HBV DNA ≥ 29 IU/mL. (NCT03547908)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| B/F/TAF | 63.0 |
| DTG + F/TDF | 43.4 |
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03547908)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| B/F/TAF | 95.0 |
| DTG + F/TDF | 91.0 |
HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. (NCT03547908)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| B/F/TAF | 12.6 |
| DTG + F/TDF | 5.8 |
ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. (NCT03547908)
Timeframe: Week 48
| Intervention | percentage of participants (Number) |
|---|---|
| B/F/TAF | 73.3 |
| DTG + F/TDF | 55.3 |
(NCT03547908)
Timeframe: Baseline; Week 48
| Intervention | cells/µL (Mean) |
|---|---|
| B/F/TAF | 200 |
| DTG + F/TDF | 175 |
AUC 0 to Infinity for Emtricitabine (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
| Intervention | ng*h/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 11603 |
| Genvoya Crushed Dose | 10969 |
Terminal elimination half-life for TFV (hours). (NCT03717129)
Timeframe: 72 hours
| Intervention | hours (Mean) |
|---|---|
| Genvoya Oral Dose | 42.5 |
| Genvoya Crushed Dose | 40.7 |
AUC 0 to Infinity for TFV (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
| Intervention | ng*h/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 253 |
| Genvoya Crushed Dose | 241 |
Maximum Plasma Concentration (Cmax) for Elvitegravir (ng/mL) (NCT03717129)
Timeframe: 72 Hr
| Intervention | ng/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 1650 |
| Genvoya Crushed Dose | 1946 |
Terminal elimination half-life for EVG (hours). (NCT03717129)
Timeframe: 72 hours
| Intervention | hours (Mean) |
|---|---|
| Genvoya Oral Dose | 5 |
| Genvoya Crushed Dose | 5.1 |
Maximum Plasma Concentration (Cmax) for Tenofovir (ng/mL) (NCT03717129)
Timeframe: 72 hr
| Intervention | ng/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 11 |
| Genvoya Crushed Dose | 9.5 |
Maximum Plasma Concentration (Cmax) for Emtricitabine (ng/mL) (NCT03717129)
Timeframe: 72 hr
| Intervention | ng/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 2095 |
| Genvoya Crushed Dose | 1968 |
Terminal elimination half-life for FTC (hours). (NCT03717129)
Timeframe: 72 hours
| Intervention | hours (Mean) |
|---|---|
| Genvoya Oral Dose | 15.2 |
| Genvoya Crushed Dose | 16.1 |
AUC 0 to Infinity for Elvitegravir (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
| Intervention | ng*h/mL (Mean) |
|---|---|
| Genvoya Oral Dose | 24219 |
| Genvoya Crushed Dose | 26948 |
number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective) (NCT03826199)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregnant Women Offered PrEP | 118 |
number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective) (NCT03826199)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|---|
| Pregnant Women Offered PrEP | 25 |
number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual) (NCT03826199)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregnant Women Offered PrEP | 25 |
number of women who initiate PrEP over time/ total number of women in active cohort (NCT03826199)
Timeframe: 18 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregnant Women Offered PrEP | 180 |
number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP (NCT03826199)
Timeframe: 18 months
| Intervention | participants (Number) |
|---|---|
| Pregnant Women Offered PrEP | 100 |
Accuracy of the digital pill system (DPS) in measuring PrEP adherence. To analyze the performance of the DPS, the ground truth of PrEP ingestion events was defined as the pill counts obtained each month (i.e., the number of unused pills returned, subtracted from the number of pills previously dispensed). The number of DPS-recorded ingestions - which included the number of both Reader-detected and manually-reported ingestions - was compared with the aggregate pill count at each monthly timepoint; this was defined as the overall performance metric for the DPS. Cumulative data collected at months 1, 2, and 3 are reported in the data table below. (NCT03842436)
Timeframe: Months 1, 2, and 3
| Intervention | percentage of ingestions DPS recorded (Number) |
|---|---|
| Digital Pills | 92 |
Acceptability was assessed via individual, semi-structured, qualitative exit interviews conducted at the end of the 90-day study period. The qualitative interview guide was grounded in the Technology Acceptance Model. Questions explored participants' experiences using the digital pill system (DPS), including facilitators and barriers to use, engagement with the technology, and willingness to use the DPS long-term. (NCT03842436)
Timeframe: Month 3
| Intervention | Participants (Count of Participants) |
|---|---|
| Digital Pills | 15 |
The total number recorded ingestions recorded by the digital pill system (DPS) - which included both the number of Reader-detected and manually-reported ingestions - was collected. The Reader-detected ingestions count was used to reflect the number of times the DPS was operated correctly. Successful DPS operation was defined as ingestion of a digital pill, proper use of the wearable Reader, and confirmation of the ingestion on both the Reader and the app. Cumulative data collected at months 1, 2, and 3 are reported in the data table below. (NCT03842436)
Timeframe: Months 1, 2, and 3
| Intervention | Recorded ingestions (Count of Units) | |
|---|---|---|
| Reader-detected ingestions | Manually reported ingestions | |
| Digital Pills | 922 | 177 |
We dichotomized TFV-DP levels using a cutoff of ≥700 fmol/punch to indicate at least four doses of PrEP ingested per week. Using TFV-DP in DBS <700 vs ≥700 fmol/punch as a dichotomous variable, and considering the granular continuous adherence data from the digital pill, we then calculated a point biserial correlation between TFV-DP in DBS and digital pill adherence. Additionally, drug concentrations of tenofovir diphosphate as measured in dried blood spot collection at months one and three were compared to DPS-recorded PrEP adherence. (NCT03842436)
Timeframe: Months 1 and 3
| Intervention | correlation coefficient (Number) | ||
|---|---|---|---|
| Point-biserial correlation | Pearson's correlation for month one | Pearson's correlation for month three | |
| Digital Pills | 0.58 | 0.85 | 0.75 |
Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared. (NCT03842436)
Timeframe: Months 1, 2, and 3
| Intervention | Expected ingestions per pill counts (Count of Units) | ||
|---|---|---|---|
| Month 1: Total ingestions recorded by DPS | Month 2: Total ingestions recorded by DPS | Month 3: Total ingestions recorded by DPS | |
| Digital Pills | 411 | 368 | 320 |
Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 12-15
| Intervention | fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 74.822 |
Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5
| Intervention | fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 13.005 |
Average emtricitabine concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5
| Intervention | Fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 5601.95 |
Average emtricitabine concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
| Intervention | ng/ml (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 78.07 |
Average testosterone concentrations in serum measured in ng/mL (NCT03917420)
Timeframe: Day 5
| Intervention | ng/ml (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 55.45 |
Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells (NCT03917420)
Timeframe: Days 12-15
| Intervention | fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 480.4 |
Average tenofovir diphosphate concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5
| Intervention | Fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 96.40 |
Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5
| Intervention | fmol/million cells (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 406.14 |
Average tenofovir concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
| Intervention | ng/ml (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 61.02 |
Average progesterone concentrations in serum measured in ng/mL. (NCT03917420)
Timeframe: Day 5
| Intervention | ng/ml (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 2.46 |
Average estradiol concentrations in serum reported in pg/mL (NCT03917420)
Timeframe: Day 5
| Intervention | pg/ml (Mean) |
|---|---|
| Tenofovir/Emtricitabine | 101.06 |
As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Infants - Group A: DPV VR | 4 |
| Infants - Group B: Truvada Tablet | 0 |
This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | pg/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 529.4 | 492.0 | 457.0 | 418.9 | 402.8 | 20.0 |
The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs <= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations < 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study. (NCT04140266)
Timeframe: Measured through Month 3
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Month 1 | Month 2 | Month 3 | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 14 | 28 | 29 |
| Mothers - Group B: Truvada Tablet | 2 | 0 | 0 |
The residual DPV concentrations from the returned VRs are summarized. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | mg (Median) | ||
|---|---|---|---|
| Month 1 | Month 2 | Month 3 | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 22.1 | 22.4 | 22.1 |
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 47 | 48 | 45 | 44 | 47 | 45 |
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 139 | 136 | 139 | 138 | 136 | 48 |
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 45 | 46 | 38 | 34 | 38 | 1 |
This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 47 | 44 | 42 | 38 | 38 | 3 |
This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 47 | 45 | 44 | 39 | 40 | 1 |
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | fmol/punch (Geometric Mean) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Infants - Group B: Truvada Tablet | 15.6 | 15.6 | 15.6 | 15.6 | 15.6 |
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit | |
| Infants - Group B: Truvada Tablet | 0 | 0 | 0 | 0 | 0 |
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit | |
| Infants - Group A: DPV VR | 21 | 20 | 14 | 7 | 0 |
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit | |
| Infants - Group B: Truvada Tablet | 4 | 2 | 2 | 1 | 0 |
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | fmol/punch (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 254.6 | 424.2 | 524.7 | 551.9 | 591.5 | 330.8 |
This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | ng/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 5.6 | 4.3 | 3.3 | 3.2 | 2.7 | 0.6 |
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | pmol/punch (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 0.3 | 0.3 | 0.3 | 0.2 | 0.2 | 0.1 |
This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | mg/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group B: Truvada Tablet | 552.6 | 447.6 | 319.9 | 313.0 | 296.6 | 2.8 |
This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 137 | 137 | 138 | 138 | 135 | 94 |
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | pmol/punch (Geometric Mean) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Infants - Group B: Truvada Tablet | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | pg/mL (Geometric Mean) | ||||
|---|---|---|---|---|---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Infants - Group A: DPV VR | 11.7 | 11.5 | 11.0 | 10.5 | 10 |
"Based on participant report on the question Overall, how much did you like using the study product? on the Product End Use Visit Behavioral Assessment." (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 141 |
| Mothers - Group B: Truvada Tablet | 46 |
"Based on participant report to the question Would you be willing to use the study product for HIV prevention while breastfeeding in the future?" (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 142 |
| Mothers - Group B: Truvada Tablet | 48 |
As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 2 |
| Mothers - Group B: Truvada Tablet | 0 |
As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 3 |
| Group B: Truvada Tablet | 2 |
As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | Participants (Count of Participants) |
|---|---|
| Infants - Group A: DPV VR | 10 |
| Infants - Group B: Truvada Tablet | 1 |
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
| Intervention | pg/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit | |
| Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 327.9 | 314.9 | 275.4 | 263.8 | 260.4 | 16.7 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| adenine [no description available] | 9.15 | 26 | 2 | 6-aminopurines; purine nucleobase | Daphnia magna metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| albendazole [no description available] | 2.25 | 1 | 0 | aryl sulfide; benzimidazoles; benzimidazolylcarbamate fungicide; carbamate ester | anthelminthic drug; microtubule-destabilising agent; tubulin modulator |
| 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. | 5.13 | 5 | 2 | cyclopropanes; dipyridodiazepine | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| probenecid Probenecid: The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.. probenecid : A sulfonamide in which the nitrogen of 4-sulfamoylbenzoic acid is substituted with two propyl groups. | 4.04 | 2 | 1 | benzoic acids; sulfonamide | uricosuric drug |
| pyrimethamine Maloprim: contains above 2 cpds | 2.25 | 1 | 0 | aminopyrimidine; monochlorobenzenes | antimalarial; antiprotozoal drug; EC 1.5.1.3 (dihydrofolate reductase) inhibitor |
| prednisolone Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. | 2.11 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; drug metabolite; environmental contaminant; immunosuppressive agent; xenobiotic |
| alanine Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2. | 5.92 | 6 | 1 | alanine zwitterion; alanine; L-alpha-amino acid; proteinogenic amino acid; pyruvate family amino acid | EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor; fundamental metabolite |
| 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. | 2.46 | 2 | 0 | monohydroxyquinoline; quinolone | bacterial xenobiotic metabolite |
| methamphetamine Methamphetamine: A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.. methamphetamine : A member of the class of amphetamines in which the amino group of (S)-amphetamine carries a methyl substituent. | 2.69 | 2 | 0 | amphetamines; secondary amine | central nervous system stimulant; environmental contaminant; neurotoxin; psychotropic drug; xenobiotic |
| deoxycytidine [no description available] | 14.19 | 102 | 4 | pyrimidine 2'-deoxyribonucleoside | Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| stavudine Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase | 2.08 | 1 | 0 | dihydrofuran; nucleoside analogue; organic molecular entity | antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| cetylpyridinium chloride anhydrous tserigel: according to first source contains polyvinylbutyral & cetylpyridinium chloride; UD only lists cetylpyridinium chloride as constituent. cetylpyridinium chloride : A pyridinium salt that has N-hexadecylpyridinium as the cation and chloride as the anion. It has antiseptic properties and is used in solutions or lozenges for the treatment of minor infections of the mouth and throat. | 2.06 | 1 | 0 | chloride salt; organic chloride salt | antiseptic drug; surfactant |
| 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. | 6.87 | 7 | 1 | azide; pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| cidofovir anhydrous Cidofovir: An acyclic nucleoside phosphonate that acts as a competitive inhibitor of viral DNA polymerases. It is used in the treatment of RETINITIS caused by CYTOMEGALOVIRUS INFECTIONS and may also be useful for treating HERPESVIRUS INFECTIONS.. cidofovir anhydrous : Cytosine substituted at the 1 position by a 3-hydroxy-2-(phosphonomethoxy)propyl group (S configuration). A nucleoside analogue, it is an injectable antiviral used for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. | 2.41 | 1 | 0 | phosphonic acids; pyrimidone | anti-HIV agent; antineoplastic agent; antiviral drug; photosensitizing agent |
| lamivudine [no description available] | 8.51 | 14 | 2 | 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. | 8.96 | 21 | 2 | 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. | 6.42 | 5 | 3 | 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. | 4.49 | 2 | 2 | 1,2,3-triazole | |
| lopinavir [no description available] | 6.22 | 6 | 2 | amphetamines; dicarboxylic acid diamide | anticoronaviral agent; antiviral drug; HIV protease inhibitor |
| 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. | 4.96 | 4 | 2 | organic sulfate salt | |
| combivir lamivudine, zidovudine drug combination: contains half the typical daily doses of both drugs in one tablet | 6.59 | 5 | 1 | ||
| organophosphonates hydrogenphosphite : A divalent inorganic anion resulting from the removal of a proton from two of the hydroxy groups of phosphorous acid. | 6.02 | 20 | 0 | divalent inorganic anion; phosphite ion | |
| 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. | 4.21 | 3 | 1 | carbamate ester; furofuran; sulfonamide | antiviral drug; HIV protease inhibitor |
| 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. | 7.6 | 14 | 4 | 1,3-thiazoles; carbamate ester; carboxamide; L-valine derivative; ureas | antiviral drug; environmental contaminant; HIV protease inhibitor; xenobiotic |
| linezolid [no description available] | 2.25 | 1 | 0 | acetamides; morpholines; organofluorine compound; oxazolidinone | antibacterial drug; protein synthesis 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. | 12.5 | 40 | 7 | nucleoside analogue; phosphonic acids | antiviral drug; drug metabolite; HIV-1 reverse transcriptase inhibitor |
| maraviroc [no description available] | 4.49 | 2 | 2 | tropane alkaloid | |
| abacavir, lamivudine drug combination abacavir, lamivudine drug combination: combination of Epivir and Ziagen | 6.55 | 5 | 1 | ||
| jtk-303 [no description available] | 2.46 | 2 | 0 | aromatic ether; monochlorobenzenes; organofluorine compound; quinolinemonocarboxylic acid; quinolone | HIV-1 integrase inhibitor |
| fumarates Fumarates: Compounds based on fumaric acid.. fumarate(2-) : A C4-dicarboxylate that is the E-isomer of but-2-enedioate(2-) | 2.41 | 1 | 0 | butenedioate; C4-dicarboxylate | human metabolite; metabolite; Saccharomyces cerevisiae metabolite |
| rilpivirine [no description available] | 2.78 | 3 | 0 | aminopyrimidine; nitrile | EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor |
| gs-7340 tenofovir alafenamide: component of Biktarvy. tenofovir alafenamide : An L-alanine derivative that is isopropyl L-alaninate in which one of the amino hydrogens is replaced by an (S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)(phenoxy)phosphoryl group. A prodrug for tenofovir, it is used (as the fumarate salt) in combination therapy for the treatment of HIV-1 infection. | 5.92 | 6 | 1 | 6-aminopurines; ether; isopropyl ester; L-alanine derivative; phosphoramidate ester | antiviral drug; HIV-1 reverse transcriptase inhibitor; prodrug |
| efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: Inhibitor of reverse transcriptases or of RNA-directed DNA polymerases. | 2.75 | 3 | 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. | 7.59 | 11 | 3 | ||
| ro13-9904 Ceftriaxone: A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.. ceftriaxone : A third-generation cephalosporin compound having 2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetylamino and [(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl side-groups. | 2.21 | 1 | 0 | ||
| combivent respimat Albuterol, Ipratropium Drug Combination: A combined pharmaceutical preparation of Ipratropium Bromide and Albuterol Sulfate that is used to treat the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE. | 3.56 | 1 | 1 | ||
| cobicistat [no description available] | 4.04 | 2 | 1 | 1,3-thiazoles; carbamate ester; monocarboxylic acid amide; morpholines; ureas | P450 inhibitor |
| quad pill Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination: A pharmaceutical preparation of the ANTI-HIV AGENTS elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate that is used in the treatment of HIV INFECTIONS. | 2.66 | 2 | 0 | ||
| sofosbuvir Sofosbuvir: A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.. sofosbuvir : A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. | 2.25 | 1 | 0 | isopropyl ester; L-alanyl ester; nucleotide conjugate; organofluorine compound; phosphoramidate ester | antiviral drug; hepatitis C protease inhibitor; prodrug |
| gsk1265744 [no description available] | 4.04 | 4 | 0 | difluorobenzene; monocarboxylic acid amide; organic heterotricyclic compound; secondary carboxamide | HIV-1 integrase inhibitor |
| dolutegravir [no description available] | 2.15 | 1 | 0 | difluorobenzene; monocarboxylic acid amide; organic heterotricyclic compound; secondary carboxamide | HIV-1 integrase inhibitor |
| levoleucovorin Levoleucovorin: A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.. (6S)-5-formyltetrahydrofolic acid : The pharmacologically active (6S)-stereoisomer of 5-formyltetrahydrofolic acid. | 2.15 | 1 | 0 | 5-formyltetrahydrofolic acid | antineoplastic agent; metabolite |
| sildenafil citrate Sildenafil Citrate: A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.. sildenafil citrate : The citrate salt of sildenafil. | 2.17 | 1 | 0 | citrate salt | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| HIV Coinfection [description not available] | 0 | 18.63 | 219 | 30 |
| 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 | 18.63 | 219 | 30 |
| Hepatitis B Virus Infection [description not available] | 0 | 4.65 | 5 | 0 |
| Hepatitis B INFLAMMATION of the LIVER in humans caused by a member of the ORTHOHEPADNAVIRUS genus, HEPATITIS B VIRUS. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. | 0 | 4.65 | 5 | 0 |
| 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 | 8.54 | 12 | 2 |
| Esophagitis INFLAMMATION, acute or chronic, of the ESOPHAGUS caused by BACTERIA, chemicals, or TRAUMA. | 0 | 2.41 | 1 | 0 |
| Acquired Immune Deficiency Syndrome [description not available] | 0 | 5 | 8 | 1 |
| 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 | 5 | 8 | 1 |
| Chemical Dependence [description not available] | 0 | 5.43 | 2 | 2 |
| Substance-Related Disorders Disorders related to substance use or abuse. | 0 | 5.43 | 2 | 2 |
| Co-infection [description not available] | 0 | 2.82 | 3 | 0 |
| Great Pox [description not available] | 0 | 2.21 | 1 | 0 |
| Skin Syphilis [description not available] | 0 | 2.21 | 1 | 0 |
| Syphilis A contagious venereal disease caused by the spirochete TREPONEMA PALLIDUM. | 0 | 2.21 | 1 | 0 |
| Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. | 0 | 3.37 | 6 | 0 |
| AIDS, Simian [description not available] | 0 | 4.8 | 11 | 0 |
| Infections, Coronavirus [description not available] | 0 | 2.25 | 1 | 0 |
| 2019 Novel Coronavirus Disease [description not available] | 0 | 2.25 | 1 | 0 |
| Pneumonia, Viral Inflammation of the lung parenchyma that is caused by a viral infection. | 0 | 2.25 | 1 | 0 |
| Coronavirus Infections Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE). | 0 | 2.25 | 1 | 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 | 2.63 | 2 | 0 |
| 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 | 2.63 | 2 | 0 |
| AIDS Seroconversion [description not available] | 0 | 7.11 | 6 | 1 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 5.01 | 4 | 0 |
| Central Nervous System Toxoplasmosis [description not available] | 0 | 2.15 | 1 | 0 |
| 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 | 2.15 | 1 | 0 |
| Toxoplasmosis, Cerebral Infections of the BRAIN caused by the protozoan TOXOPLASMA gondii that primarily arise in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES (see also AIDS-RELATED OPPORTUNISTIC INFECTIONS). The infection may involve the brain diffusely or form discrete abscesses. Clinical manifestations include SEIZURES, altered mentation, headache, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. (From Joynt, Clinical Neurology, 1998, Ch27, pp41-3) | 0 | 2.15 | 1 | 0 |
| Genital Herpes [description not available] | 0 | 3.56 | 1 | 1 |
| Bacterial Vaginitides [description not available] | 0 | 3.56 | 1 | 1 |
| Herpes Genitalis Infection of the genitals (GENITALIA) with HERPES SIMPLEX VIRUS in either the males or the females. | 0 | 3.56 | 1 | 1 |
| Vaginosis, Bacterial Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli. | 0 | 3.56 | 1 | 1 |
| Sexually Transmitted Diseases Diseases due to or propagated by sexual contact. | 0 | 3.42 | 2 | 0 |
| Complications, Infectious Pregnancy [description not available] | 0 | 3.94 | 2 | 0 |
| Bone Diseases Diseases of BONES. | 0 | 2.17 | 1 | 0 |
| Kidney Diseases Pathological processes of the KIDNEY or its component tissues. | 0 | 3.94 | 2 | 1 |
| Infectious Diseases [description not available] | 0 | 2.25 | 1 | 0 |
| Communicable Diseases An illness caused by an infectious agent or its toxins that occurs through the direct or indirect transmission of the infectious agent or its products from an infected individual or via an animal, vector or the inanimate environment to a susceptible animal or human host. | 0 | 2.25 | 1 | 0 |
| Bacterial Sexually Transmitted Disease [description not available] | 0 | 2.21 | 1 | 0 |
| Sexually Transmitted Diseases, Bacterial Bacterial diseases transmitted or propagated by sexual conduct. | 0 | 2.21 | 1 | 0 |
| Injuries, Needlestick [description not available] | 0 | 2.81 | 3 | 0 |
| Biliary Cirrhosis [description not available] | 0 | 2.11 | 1 | 0 |
| Infections, Retroviridae [description not available] | 0 | 2.11 | 1 | 0 |
| Fibroma, Shope [description not available] | 0 | 2.11 | 1 | 0 |
| Cholangitis Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both. | 0 | 2.11 | 1 | 0 |
| Liver Cirrhosis, Biliary FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cholangitis involves the destruction of small intra-hepatic bile ducts and decreased bile secretion. Secondary biliary cholangitis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes. | 0 | 2.11 | 1 | 0 |
| Retroviridae Infections Virus diseases caused by the RETROVIRIDAE. | 0 | 2.11 | 1 | 0 |
| Arrhythmia [description not available] | 0 | 2.11 | 1 | 0 |
| Muscle Disorders [description not available] | 0 | 2.11 | 1 | 0 |
| Carditis [description not available] | 0 | 2.49 | 2 | 0 |
| Edema, Pulmonary [description not available] | 0 | 2.11 | 1 | 0 |
| Arrhythmias, Cardiac Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction. | 0 | 2.11 | 1 | 0 |
| Muscular Diseases Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE. | 0 | 2.11 | 1 | 0 |
| Myocarditis Inflammatory processes of the muscular walls of the heart (MYOCARDIUM) which result in injury to the cardiac muscle cells (MYOCYTES, CARDIAC). Manifestations range from subclinical to sudden death (DEATH, SUDDEN). Myocarditis in association with cardiac dysfunction is classified as inflammatory CARDIOMYOPATHY usually caused by INFECTION, autoimmune diseases, or responses to toxic substances. Myocarditis is also a common cause of DILATED CARDIOMYOPATHY and other cardiomyopathies. | 0 | 2.49 | 2 | 0 |
| Pulmonary Edema Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening. | 0 | 2.11 | 1 | 0 |
| Chronic Hepatitis B [description not available] | 0 | 3.91 | 2 | 1 |
| Hepatitis B, Chronic INFLAMMATION of the LIVER in humans caused by HEPATITIS B VIRUS lasting six months or more. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. | 0 | 3.91 | 2 | 1 |
| Viremia The presence of viruses in the blood. | 0 | 2.78 | 3 | 0 |
| Eczema, Atopic [description not available] | 0 | 2.11 | 1 | 0 |
| Acquired-Immune Deficiency Syndrome Dementia Complex [description not available] | 0 | 2.11 | 1 | 0 |
| Dermatitis, Atopic A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema. | 0 | 2.11 | 1 | 0 |
| AIDS Dementia Complex A neurologic condition associated with the ACQUIRED IMMUNODEFICIENCY SYNDROME and characterized by impaired concentration and memory, slowness of hand movements, ATAXIA, incontinence, apathy, and gait difficulties associated with HIV-1 viral infection of the central nervous system. Pathologic examination of the brain reveals white matter rarefaction, perivascular infiltrates of lymphocytes, foamy macrophages, and multinucleated giant cells. (From Adams et al., Principles of Neurology, 6th ed, pp760-1; N Engl J Med, 1995 Apr 6;332(14):934-40) | 0 | 2.11 | 1 | 0 |
| Coma A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION. | 0 | 2.11 | 1 | 0 |
| Infections, Chlamydia [description not available] | 0 | 2.13 | 1 | 0 |
| Trichomoniasis, Human [description not available] | 0 | 2.13 | 1 | 0 |
| Chlamydia Infections Infections with bacteria of the genus CHLAMYDIA. | 0 | 2.13 | 1 | 0 |
| Trichomonas Vaginitis Inflammation of the vagina, marked by a purulent discharge. This disease is caused by the protozoan TRICHOMONAS VAGINALIS. | 0 | 2.13 | 1 | 0 |
| Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted [description not available] | 0 | 3.74 | 3 | 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 | 3.74 | 3 | 0 |
| Cognition Disorders Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment. | 0 | 3.51 | 1 | 1 |
| Ebola Hemorrhagic Fever [description not available] | 0 | 3.04 | 1 | 0 |
| Congenital Zika Syndrome [description not available] | 0 | 3.04 | 1 | 0 |
| Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME. | 0 | 3.04 | 1 | 0 |
| Hemorrhagic Fever, Ebola A highly fatal, acute hemorrhagic fever caused by EBOLAVIRUS. | 0 | 3.04 | 1 | 0 |
| Diseases, Occupational [description not available] | 0 | 2.15 | 1 | 0 |
| Acute Disease Disease having a short and relatively severe course. | 0 | 2.15 | 1 | 0 |
| Lipodystrophy A collection of heterogenous conditions resulting from defective LIPID METABOLISM and characterized by ADIPOSE TISSUE atrophy. Often there is redistribution of body fat resulting in peripheral fat wasting and central adiposity. They include generalized, localized, congenital, and acquired lipodystrophy. | 0 | 2.04 | 1 | 0 |
| Cancer of Ovary [description not available] | 0 | 2.07 | 1 | 0 |
| Ovarian Neoplasms Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS. | 0 | 2.07 | 1 | 0 |
| Autoimmune Disease [description not available] | 0 | 2.06 | 1 | 0 |
| Libman-Sacks Disease [description not available] | 0 | 2.06 | 1 | 0 |
| Abnormalities, Congenital, Nervous System [description not available] | 0 | 2.06 | 1 | 0 |
| Autoimmune Diseases of the Nervous System Disorders caused by cellular or humoral immune responses primarily directed towards nervous system autoantigens. The immune response may be directed towards specific tissue components (e.g., myelin) and may be limited to the central nervous system (e.g., MULTIPLE SCLEROSIS) or the peripheral nervous system (e.g., GUILLAIN-BARRE SYNDROME). | 0 | 2.06 | 1 | 0 |
| Autoimmune Diseases Disorders that are characterized by the production of antibodies that react with host tissues or immune effector cells that are autoreactive to endogenous peptides. | 0 | 2.06 | 1 | 0 |
| Lupus Erythematosus, Systemic A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow. | 0 | 2.06 | 1 | 0 |
| Chronic Illness [description not available] | 0 | 2.99 | 1 | 0 |
| Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). | 0 | 2.99 | 1 | 0 |
| Chronic Hepatitis C [description not available] | 0 | 2.08 | 1 | 0 |
| Acute Liver Injury, Drug-Induced [description not available] | 0 | 2.08 | 1 | 0 |
| Hepatitis C, Chronic INFLAMMATION of the LIVER in humans that is caused by HEPATITIS C VIRUS lasting six months or more. Chronic hepatitis C can lead to LIVER CIRRHOSIS. | 0 | 2.08 | 1 | 0 |
| Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment. | 0 | 2.08 | 1 | 0 |
| Allergy, Drug [description not available] | 0 | 2.43 | 2 | 0 |
| Drug Hypersensitivity Immunologically mediated adverse reactions to medicinal substances used legally or illegally. | 0 | 2.43 | 2 | 0 |
| Cholera Infantum [description not available] | 0 | 2.03 | 1 | 0 |
| Chronic Insomnia [description not available] | 0 | 2.04 | 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 | 2.04 | 1 | 0 |