Trial | Phase | Enrollment | Study Type | Start Date | Status |
A Randomized, Pilot Estimation Study to Compare the Safety and Efficacy of Raltegravir+TDF+3TC Versus TDF+3TC+EFV in HBV/HIV Co-infected Patients [NCT01318096] | | 60 participants (Anticipated) | Interventional | 2011-03-31 | Not yet recruiting |
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum [NCT05355467] | Phase 4 | 40 participants (Actual) | Interventional | 2019-08-21 | Completed |
A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose [NCT01489046] | Phase 2 | 297 participants (Actual) | Interventional | 2011-02-28 | Terminated |
A Phase 1b/2a, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Patients With Chronic Hepatitis B [NCT03109730] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2017-06-15 | Completed |
Changes in Coagulation and Platelet Reactivity in HIV-1 Infected Patients Switching Between Abacavir and Tenofovir Containing Antiretroviral Regimens [NCT02093585] | Phase 4 | 43 participants (Actual) | Interventional | 2014-01-31 | Completed |
"A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Response-Guided-Therapy (RGT) Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients" [NCT02560649] | Phase 4 | 324 participants (Anticipated) | Interventional | 2015-05-31 | Active, not recruiting |
Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety and Activity of MK0518 Plus Tenofovir and Lamivudine (3TC) Versus Efavirenz Plus Tenofovir and Lamivudine (3TC) in ART-Naive, HIV-Infected Patients [NCT00100048] | Phase 2 | 206 participants (Actual) | Interventional | 2005-01-31 | Completed |
Treatment Cohort of HIV-infected Children With Resistance or Intolerance to Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI) First Line and PI Second Line Antiretroviral Therapy [NCT01225406] | | 56 participants (Actual) | Observational | 2010-08-31 | Completed |
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure [NCT03920618] | | 150 participants (Anticipated) | Interventional | 2019-02-01 | Recruiting |
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 |
[NCT01274780] | Phase 4 | 180 participants (Actual) | Interventional | 2011-05-31 | Completed |
Microbicide Safety and Acceptability in Young Men [NCT01283360] | Phase 1 | 249 participants (Actual) | Interventional | 2010-10-31 | Completed |
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA [NCT05177926] | Phase 4 | 330 participants (Anticipated) | Interventional | 2021-04-04 | Recruiting |
Bictegravir in the Elderly Living With HIV: Impact of Polypharmacy and Multimorbidity (BICEP) [NCT05064020] | | 162 participants (Anticipated) | Observational | 2020-08-01 | Active, not recruiting |
Clinical Trial of CNS Penetrating ART to Prevent NeuroAIDS in China [NCT01340950] | Phase 4 | 250 participants (Actual) | Interventional | 2010-07-31 | Completed |
Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial [NCT03759782] | Phase 3 | 24 participants (Anticipated) | Interventional | 2019-01-10 | Recruiting |
UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi [NCT06158126] | | 621 participants (Anticipated) | Observational [Patient Registry] | 2024-01-01 | Not yet recruiting |
A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients [NCT05275023] | Phase 2 | 37 participants (Actual) | Interventional | 2022-06-30 | Active, not recruiting |
A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Vi [NCT05123599] | Phase 1 | 24 participants (Actual) | Interventional | 2021-12-06 | Active, not recruiting |
A Phase 2 Randomized, Open-label, Parallel-group, Multicenter Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Response to Combination Regimens Containing JNJ-73763989 and Nucleos(t)Ide Analog With or Without JNJ [NCT04585789] | Phase 2 | 24 participants (Actual) | Interventional | 2021-03-11 | Active, not recruiting |
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hep [NCT04535544] | Phase 2 | 52 participants (Actual) | Interventional | 2020-09-17 | Active, not recruiting |
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patie [NCT04439539] | Phase 2 | 54 participants (Actual) | Interventional | 2020-09-14 | Active, not recruiting |
Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Efavirenz Once Daily Over 10 Days Following Drug Intake Cessation in Healthy Volunteers [NCT01108926] | Phase 1 | 19 participants (Actual) | Interventional | 2010-06-30 | Completed |
Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers [NCT01125696] | Phase 2 | 45 participants (Actual) | Interventional | 2012-05-31 | 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 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 |
Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC [NCT05159531] | Phase 4 | 142 participants (Anticipated) | Interventional | 2023-05-01 | Recruiting |
F/TAF Switch Study for Transgender Individuals for HIV Pre-exposure Prophylaxis (TAF4TRANS) [NCT04616963] | Phase 4 | 64 participants (Actual) | Interventional | 2019-10-24 | Active, not recruiting |
Immediate Initiation of Antiretroviral Therapy During Acute HIV Infection [NCT02656511] | Phase 4 | 74 participants (Anticipated) | Interventional | 2015-12-31 | Active, not recruiting |
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B [NCT01369212] | Phase 3 | 201 participants (Actual) | Interventional | 2012-11-30 | Completed |
Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression [NCT01174914] | Phase 2 | 171 participants (Actual) | Interventional | 2008-03-31 | Completed |
Tenofovir Disoproxil Fumarat 300 mg - Phyllanthus Urinaria 300mg - Adenosma Glutinosum 150mg - Eclipta Prostrata 150mg, Ascorbic Acid 500 mg Daily is Effective in the Long-term Treatment of Chronic and Acute Hepatitis B. [NCT01198860] | | 0 participants | Expanded Access | | Approved for marketing |
A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China [NCT03752658] | | 500 participants (Anticipated) | Observational | 2019-01-25 | Recruiting |
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 |
A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B [NCT03576066] | Phase 2 | 73 participants (Actual) | Interventional | 2018-06-11 | Completed |
Randomized, Open-Label, Active Comparator, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Hepatitis B Virus (HBV) Activity of NCO-48 Fumarate in Treatment-Naive Adults With Chronic HBV Infection [NCT04629976] | Phase 1 | 21 participants (Actual) | Interventional | 2021-01-12 | Completed |
A Single Arm, Phase 3 Study, Exploring the Safety of Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV, a Pilot Switch Study Strategy in South Africa [NCT04433780] | Phase 3 | 133 participants (Actual) | Interventional | 2021-01-04 | Completed |
A Study of the Safety and Efficacy of Entecavir Plus Tenofovir in Adults With Chronic Hepatitis B Virus Infection With Previous Nucleoside/Nucleotide Treatment Failure [NCT01063036] | Phase 3 | 144 participants (Actual) | Interventional | 2010-05-31 | Completed |
A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab From Viread Tab in Chronic Hepatitis B Patients on Treatment With Tenofovir Disop [NCT05282407] | Phase 4 | 118 participants (Actual) | Interventional | 2017-11-20 | Completed |
Bioequivalence of Tenofovir and Emtricitabine Following Overencapsulation [NCT02968576] | | 25 participants (Actual) | Interventional | 2016-12-31 | Completed |
Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar [NCT04781426] | | 200 participants (Actual) | Observational | 2020-10-28 | Completed |
A Phase 4, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Antiretroviral Treatment-experienced Human Immunodeficie [NCT04388904] | Phase 4 | 75 participants (Actual) | Interventional | 2021-09-01 | Active, not recruiting |
An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex [NCT03284164] | Phase 1 | 16 participants (Actual) | Interventional | 2017-09-28 | Completed |
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomiz [NCT03236584] | Phase 3 | 76 participants (Actual) | Interventional | 2015-09-01 | Active, not recruiting |
The Study of Starting to Use Tenofovir Disoproxil Fumarate(TDF) Antiviral Treatment From the 32 Weeks of Gestation to Block Mother-to-child Transmission of Hepatitis B Virus(HBV MTCT) and Withdrawal Time [NCT03209908] | | 380 participants (Anticipated) | Observational | 2017-01-01 | Recruiting |
A Randomized, Double-Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B [NCT00507507] | Phase 2 | 126 participants (Actual) | Interventional | 2007-09-30 | Completed |
I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones [NCT04050371] | Phase 4 | 48 participants (Actual) | Interventional | 2017-08-03 | Completed |
A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection [NCT05005507] | Phase 2 | 1 participants (Actual) | Interventional | 2021-11-03 | Terminated(stopped due to A strategic decision was made to not further execute the study. This decision was not based on a safety concern.) |
Simplified Model of Linkage and Retention to Healthcare System, Using a Mobil Unit and a Same-day Test and Treat Approach Among Excluded Population. [NCT05405751] | Phase 4 | 100 participants (Actual) | Interventional | 2022-07-04 | Active, not recruiting |
Two Randomized, Open-labeled, Parallel Designed Multiple-dose Clinical Trials to Evaluate Pharmacokinetics of Ritonavir-unboosted and Ritonavir-boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunte [NCT01368783] | Phase 1 | 32 participants (Anticipated) | Interventional | 2011-06-30 | Not yet recruiting |
Dose Proportionality of TFV-DP in Mucosal Tissue, and Endogenous Nucleotide Quantification, After a Single Dose of GS-7340 in Women [NCT02357602] | Phase 1 | 24 participants (Actual) | Interventional | 2015-03-31 | 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 |
Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL [NCT02039362] | Phase 4 | 37 participants (Actual) | Interventional | 2012-07-31 | Completed |
An Open Label Study Evaluating the Safety and Efficacy of Switching From Rilpivirine/Emtricitabine/Tenofovir Alafenamide in Combination With Dolutegravir, to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Combination With Doravirine, in Male HIV+ Subj [NCT04538040] | Phase 4 | 20 participants (Actual) | Interventional | 2019-12-19 | Completed |
An Open-label, Randomized Study to Compare the Efficacy and Safety of P1101 Plus Tenofovir Alafenamide With or Without Ursodeoxycholic Acid in Patients With Chronic Hepatitis B and Hepatitis D Virus Co-Infection [NCT05467553] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-02-24 | Not yet recruiting |
Assessing Virologic Success and Metabolic Changes in Patients Switching From a TDF to TAF Containing Antiretroviral Therapy Regimen [NCT03646370] | | 110 participants (Actual) | Observational | 2018-07-25 | Completed |
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 |
A Phase 1, Open-label, 2-cohort, Multiple Dose, Drug-drug Interaction, Safety and Tolerability, Fixed-sequence Study to Investigate the Potential Interaction Between ATI-2173 When Coadministered With Tenofovir Disoproxil Fumarate in Healthy Subjects [NCT05137548] | Phase 1 | 32 participants (Actual) | Interventional | 2021-10-27 | Completed |
A Phase 2, Exploratory Study Evaluating the Safety and Antiviral Efficacy of Inarigivir Soproxil in Non-cirrhotic Treatment-Naive Subjects Infected With Chronic Hepatitis B Virus [NCT04059198] | Phase 2 | 5 participants (Actual) | Interventional | 2019-10-10 | Terminated(stopped due to Evidence of liver injury in a separate Inarigavir study) |
A Open-label, Single Center Drug Interaction Study of Morphothiadine Mesilate/Ritonavir , Entecavir and Tenofovir Disoproxil Fumarate in Healthy Subjects [NCT03662568] | Phase 1 | 56 participants (Actual) | Interventional | 2018-06-26 | Completed |
"Assessment of a New Boosting Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers" [NCT03202511] | Early Phase 1 | 15 participants (Actual) | Interventional | 2017-06-23 | Completed |
Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver [NCT03604016] | Phase 4 | 76 participants (Anticipated) | Interventional | 2018-09-23 | Not yet recruiting |
A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis [NCT02238860] | Phase 4 | 100 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
A Sequential Phase 1a/1b Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ARC-521 in Normal Adult Volunteers and Patients With Chronic Hepatitis B [NCT02797522] | Phase 1 | 47 participants (Actual) | Interventional | 2016-06-30 | Terminated(stopped due to Company decision to discontinue trial) |
A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants [NCT04233879] | Phase 3 | 599 participants (Actual) | Interventional | 2020-02-28 | Active, not recruiting |
Extracellular and Intracellular TFV/FTC Residues After a Single Dose in HIV-Negative Men and Women: Implications for Pre-exposure HIV Prophylaxis Dosing of Truvada® [NCT01326221] | | 12 participants (Actual) | Observational | 2008-10-31 | Completed |
A Multi-centre, One-arm Prospective Study to Evaluate Efficacy and Safety of Switching From Entecavir (ETV) to Tenofovir Disoproxil Fumarate (TDF) in Japanese Chronic Hepatitis B HBeAg-positive and HBV-DNA Undetectable Subjects [NCT03258710] | Phase 4 | 75 participants (Actual) | Interventional | 2017-10-02 | Completed |
A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108 [NCT01334567] | Phase 2 | 30 participants (Actual) | Interventional | 2010-08-31 | Completed |
Real-life Data of Switching From Tenofovir Disoproxi Fumarate (TDF) to Tenofovir Alafenamide (TAF) in Virologically Suppressed Chronic Hepatitis B Patients With Antiviral Resistance [NCT03566030] | | 300 participants (Anticipated) | Observational | 2018-09-01 | Not yet recruiting |
The Incidence and Severity of Drug Interactions Before and After Switching Antiretroviral Therapy to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Treatment Experienced Patients [NCT03789968] | | 411 participants (Actual) | Observational | 2019-09-01 | Completed |
Treatment Efficacy and Safety of Tenofovir Alafenamide (TAF) Switch Therapy in Patients Who Have Been Treated With Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B: a Real Life Multicenter Cohort Study in Korea [NCT03559790] | | 400 participants (Anticipated) | Observational | 2018-07-18 | Recruiting |
Efficacy of Addition of Fecal Microbiota Transplant (FMT) and Plasma Exchange to Tenofovir in Comparison to Monotherapy With Tenofovir in ACLF-HBV [NCT04431375] | | 70 participants (Anticipated) | Interventional | 2020-06-22 | Recruiting |
Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the Bat 24 Regimen Versus Daily and Pericoital Dosing [NCT01369303] | Phase 1 | 194 participants (Actual) | Interventional | 2012-01-31 | Completed |
"Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir in Virologically-suppressed HIV-infected Rwandans (Near-Rwanda)" [NCT02104700] | Phase 2/Phase 3 | 150 participants (Actual) | Interventional | 2014-04-30 | Completed |
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 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates [NCT04465916] | Phase 2 | 26 participants (Actual) | Interventional | 2020-05-12 | Terminated(stopped due to DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.) |
Body Composition Sub-study of the D2EFT Trial [NCT03675815] | Phase 4 | 155 participants (Actual) | Interventional | 2019-12-05 | Active, not recruiting |
An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients [NCT01260610] | | 0 participants (Actual) | Interventional | 2011-06-30 | Withdrawn(stopped due to lack of funds) |
Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir With and Without Levonorgestrel Among Women in Western Kenya [NCT03762382] | Phase 2 | 50 participants (Anticipated) | Interventional | 2018-12-12 | Active, not recruiting |
Study of the Safety and Efficacy of Daily Tenofovir to Prevent HIV Infection Among Injection Drug Users in Bangkok, Thailand [NCT00119106] | Phase 2/Phase 3 | 2,413 participants (Actual) | Interventional | 2005-06-30 | 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 |
Reversibility of Mitochondrial Toxicity in HIV Lipoatrophy [NCT00119379] | Phase 2 | 50 participants (Actual) | Interventional | 2005-04-30 | Completed |
A Phase 3, Randomized, Multicenter Study of the Treatment of Antiretroviral-Naive HIV-1 Infected Subjects Comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination With Efavirenz vs Combivir (Lamivudine/Zidovudine) and Efavirenz [NCT00112047] | Phase 3 | 517 participants (Actual) | Interventional | 2003-07-31 | Completed |
Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study [NCT03567382] | Phase 4 | 179 participants (Actual) | Interventional | 2018-09-24 | Completed |
An Evaluation of the Uptake and Safety of, and Adherence to Antiretroviral Treatment Among Individuals With CD4 ≥ 250 Cells/mm3 and HIV Virus Load ≥ 50,000 cp/mL [NCT01583439] | | 11 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to Low Accrual.) |
Advanced HIV: Outcomes for Rapid ART [NCT05526118] | | 50 participants (Anticipated) | Observational | 2022-08-30 | Not yet recruiting |
The Clinical Efficacy of Tenofovir Alafenamide-switching Therapy in Patients With Chronic Hepatitis B Experiencing Clinical Flare-up After Discontinuation of Nucleos[t]Ide Analogues Therapy [NCT04496882] | Phase 4 | 260 participants (Anticipated) | Interventional | 2020-09-09 | Recruiting |
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B [NCT03120494] | Phase 4 | 75 participants (Actual) | Interventional | 2016-11-30 | Enrolling by invitation |
COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry [NCT00705419] | | 180 participants (Actual) | Observational | 2007-07-31 | Completed |
DOR/TDF/3TC Maintenance Therapy Among Patients Harboring M184V/I Mutation: a Pilot Open-label Study [NCT06034938] | Phase 2 | 32 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
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 |
Bioequivalence Study of Efavirenz, Emtricitabine and Tenofovir in Healthy Volunteers, After Administering a Single Dose of a Fixed Dose Combination of the Test Formulation With Respect to the Reference Product, Atripla ® From Gador S.A [NCT03309566] | Phase 4 | 24 participants (Actual) | Interventional | 2016-09-04 | Completed |
OPTIMA: A Randomized, Open-label, 156-week Treatment Study to Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept [NCT01379508] | Phase 4 | 241 participants (Actual) | Interventional | 2011-03-21 | Completed |
Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT) [NCT01352715] | Phase 3 | 515 participants (Actual) | Interventional | 2012-03-13 | Completed |
Switching Tenofovir/Emtricitabine/Efavirenz to Tenofovir/Emtricitabine/Rilpivirine Versus Continuing Tenofovir/Emtricitabine/Efavirenz in HIV1-infected Patients With Complete Virological Suppression [NCT03251690] | | 246 participants (Actual) | Interventional | 2016-10-27 | Completed |
A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of Peginterferon Alfa-2a on the Relapse Rate of the Subjects With Hepatocellular Carcinoma Who Have Been Treated by Resection [NCT03253250] | Phase 4 | 432 participants (Anticipated) | Interventional | 2017-09-01 | Recruiting |
To Study the Efficacy of 'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT - A Randomized Control Trial [NCT02454764] | | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to lack of funds) |
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 |
[NCT02287857] | | 360 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men [NCT02411630] | | 167 participants (Actual) | Observational | 2013-06-30 | Completed |
Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction [NCT03115736] | Phase 2 | 24 participants (Actual) | Interventional | 2017-05-23 | Completed |
"Efficacy, Safety, and Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1 Infection." [NCT03502005] | Phase 4 | 100 participants (Actual) | Interventional | 2018-03-01 | Completed |
A Prospective, Randomized, Blank Control, Multicenter Study to Evaluate the Efficacy and Safety of Alanine Aminotransferase(TMF)in the Treatment of Chronic Hepatitis B Patients With Normal Alanine Aminotransferase. [NCT05797714] | | 200 participants (Anticipated) | Interventional | 2022-06-23 | Recruiting |
A Maternal Short Course of Tenofovir Disoproxil Fumarate and Infant Vaccine to Prevent Mother-to-child Transmission of Hepatitis B Virus [NCT03343431] | Phase 3 | 504 participants (Actual) | Interventional | 2018-08-02 | Active, not recruiting |
The Cellular Pharmacology of F-TAF in Dried Blood Spots [NCT02962739] | Phase 1 | 38 participants (Actual) | Interventional | 2016-03-31 | 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 |
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 |
Phase I One-Month Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Intravaginal Rings Releasing Tenofovir and Levonorgestrel or Tenofovir Alone [NCT02235662] | Phase 1 | 86 participants (Actual) | Interventional | 2014-10-31 | Completed |
Efficacy of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults Without Baseline Genotyping Test (D2ARLING Study) [NCT04549467] | Phase 4 | 244 participants (Actual) | Interventional | 2020-11-17 | Active, not recruiting |
Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF) [NCT04054089] | Phase 4 | 66 participants (Anticipated) | Interventional | 2019-09-30 | Not yet recruiting |
Intensive Pharmacokinetic Studies of Antiretroviral Drug Combinations in Children [NCT00260078] | Phase 1/Phase 2 | 75 participants (Actual) | Interventional | 2006-02-28 | Completed |
A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection [NCT04820686] | Phase 2 | 65 participants (Actual) | Interventional | 2021-05-07 | Terminated(stopped due to Sponsor decision) |
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Switch Followed by Sofosbuvir/Velpatasvir (SOF/VEL) Antiviral HCV Therapy Followed by Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Simplification in HIV-HCV [NCT03549312] | Phase 4 | 25 participants (Anticipated) | Interventional | 2018-02-01 | Recruiting |
Phase III Multicenter Randomized Trial Evaluating in Patients at the Time of the Primary HIV-1 Infection, the Impact on the Viral Reservoir of a Combination Including Tenofovir/Emtricitabine and Dolutegravir or Tenofovir/Emtricitabine and Darunavir/Cobici [NCT02987530] | Phase 3 | 101 participants (Actual) | Interventional | 2017-04-11 | Completed |
The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children [NCT02301650] | | 400 participants (Anticipated) | Observational | 2014-10-31 | Enrolling by invitation |
Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon [NCT04998838] | | 110 participants (Anticipated) | Interventional | 2018-07-01 | Recruiting |
DOT Diary Longitudinal Pilot: A Mobile App for Pre-Exposure Prophylaxis Adherence in Young Men [NCT03771638] | Phase 4 | 100 participants (Actual) | Interventional | 2019-02-01 | Completed |
A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-n [NCT02831764] | Phase 3 | 722 participants (Actual) | Interventional | 2016-07-18 | Completed |
A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leu [NCT02186574] | Phase 3 | 184 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations [NCT02629822] | Phase 2 | 10 participants (Actual) | Interventional | 2016-01-14 | Completed |
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus [NCT03695029] | Phase 4 | 120 participants (Anticipated) | Interventional | 2010-12-29 | Recruiting |
A Prospective, Cohort Study of Renal and Bone Outcome After Changing Tenofovir in Patients With Renal Toxicity According to Antiretroviral Strategy [NCT02209740] | | 245 participants (Actual) | Observational | 2014-07-31 | Completed |
A Phase III, Randomised, Double Blind, Multicentre, Parallel Group, Non Inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in Human Immunodeficiency Vir [NCT02831673] | Phase 3 | 719 participants (Actual) | Interventional | 2016-07-21 | Completed |
TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load - a Randomized Controlled Trial [NCT05195450] | | 200 participants (Anticipated) | Interventional | 2022-02-23 | Recruiting |
A Phase 1, Open-label Study in Healthy Participants to Investigate the Effect of Multiple-dose JNJ-56136379 on the Single-dose Pharmacokinetics of Bictegravir, Emtricitabine, and Tenofovir Alafenamide [NCT04853524] | Phase 1 | 0 participants (Actual) | Interventional | 2021-05-06 | Withdrawn(stopped due to Sponsor Decision) |
Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial [NCT04850950] | Phase 4 | 240 participants (Anticipated) | Interventional | 2021-04-26 | Not yet recruiting |
A Multinational, Multicenter, Open-label, Randomized Controlled Trial to Investigate the Effectiveness of Tenofovir Alafenamide in Reducing Clinical Events in Chronic Hepatitis B Patients Beyond Treatment Indications by Current Guidelines [NCT03753074] | Phase 4 | 780 participants (Anticipated) | Interventional | 2019-02-18 | Recruiting |
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 |
HIV Drug Resistance Profiles Among Individuals Failing Tenofovir/Lamivudine and Dolutegravir First Line Regimen in Brazil [NCT04453436] | | 2,500 participants (Anticipated) | Observational [Patient Registry] | 2020-09-01 | Not yet recruiting |
A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604) [NCT00726336] | Phase 1 | 16 participants (Anticipated) | Interventional | 2008-08-31 | Completed |
A Phase III, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety Endpoints for the Treatment of Besifovir 150mg Compared to Tenofovir 300mg in Chronic Hepatitis B Patients Who Have Resistance to Nucleoside [NCT02792088] | Phase 3 | 146 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 |
HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy [NCT02097381] | | 10 participants (Actual) | Interventional | 2010-04-30 | Active, not recruiting |
Implementation and Evaluation of an HIV-2 Viral Load and ARV Resistance Informed Algorithm for 2nd-line ART in HIV-2 Infected Patients in the Initiative Sénégalaise d'Accès Aux Antirétroviraux (ISAARV) Program [NCT03394196] | | 152 participants (Actual) | Interventional | 2018-07-04 | Terminated(stopped due to COVID-19 and Funding) |
ANRS HB 05 : A Randomized, Double Blind, Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepa [NCT00823342] | Phase 3 | 150 participants (Anticipated) | Interventional | 2008-12-14 | Terminated(stopped due to safety aspects) |
Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of Birinapant in Subjects With Chronic Hepatitis B [NCT02288208] | Phase 1 | 7 participants (Actual) | Interventional | 2014-11-30 | Terminated(stopped due to Due to cranial nerve palsies observed) |
Prevention of Liver Fibrosis and Cancer in Africa. Observational Study of Screening, Assessment and Treatment for Chronic Hepatitis B Virus Infection [NCT02129829] | | 1,079 participants (Actual) | Observational | 2011-10-31 | Completed |
Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning, ESCAPE Study [NCT02308332] | Phase 4 | 58 participants (Actual) | Interventional | 2015-02-28 | Completed |
A Phase 2, Open-label, Randomized, Two-part, Multiple Dose Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected With Chronic Hepatitis B Virus [NCT02751996] | Phase 2 | 80 participants (Actual) | Interventional | 2016-05-31 | Completed |
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.) |
A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis [NCT02224456] | Phase 4 | 197 participants (Actual) | Interventional | 2015-03-25 | Completed |
An Open, Multi-center Clinical Study of Combination Therapy With Tenofovir Disoproxil Fumarate and Peginterferon Alpha 2a in Nucleos(t)Ide Analogs Experienced Patients With HBV Related Hepatic Fibrosis. [NCT03957629] | | 186 participants (Anticipated) | Interventional | 2019-11-06 | Recruiting |
Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum [NCT00042289] | | 1,578 participants (Actual) | Observational | 2003-06-09 | Completed |
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensifi [NCT00038506] | Phase 4 | 100 participants | Interventional | 2002-03-31 | Completed |
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine With or Without Tenofovir on the Pharmacokinetics of Atazanavir When Given With Ritonavir in HIV-Infected Subjects [NCT00384904] | Phase 4 | 40 participants (Actual) | Interventional | 2006-12-31 | Completed |
Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study) [NCT01014481] | Phase 4 | 156 participants (Actual) | Interventional | 2009-10-31 | Terminated(stopped due to this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.) |
A Phase III, Randomized, 2x2 Factorial Trial to Assess the Efficacy of Antiviral Therapy in Women and Infants in Reducing Vertical Transmission of Hepatitis B in Africa [NCT04704024] | Phase 3 | 450 participants (Anticipated) | Interventional | 2021-09-03 | Recruiting |
An Open Label, Comparative, Randomized , Phase IV Pilot Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load [NCT05898841] | Phase 4 | 75 participants (Anticipated) | Interventional | 2023-05-26 | Recruiting |
A Phase IV Open-label, Multi-centre, Randomised, Dual-arm, Pilot Study to Assess the Feasibility of Switching Individuals Receiving Efavirenz With Continuing Central Nervous System (CNS) Toxicity, to Dolutegravir [NCT02285374] | Phase 4 | 40 participants (Anticipated) | Interventional | 2014-11-30 | Not yet recruiting |
A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) [NCT03272347] | Phase 2 | 123 participants (Actual) | Interventional | 2017-11-27 | Completed |
Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Experienced Patients With Hepatitis b Virus Related Liver Fibrosis [NCT03920605] | | 100 participants (Anticipated) | Interventional | 2019-02-01 | Recruiting |
A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel [NCT01232803] | Phase 1 | 65 participants (Actual) | Interventional | 2010-10-31 | Completed |
Induction of HBsAg Decline Using an add-on Treatment of Peginterferon Alfa-2a in HBeAg-negative Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogous (PAS) [NCT01373684] | Phase 4 | 90 participants (Actual) | Interventional | 2012-05-25 | Completed |
A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Mono [NCT00804622] | Phase 2 | 15 participants (Actual) | Interventional | 2008-12-31 | Completed |
DOT Diary (D2): Developing a Mobile App With Combined Automated DOT and Daily Sexual Diary for Monitoring and Improving PrEP Adherence: DOT Diary Optimization Pilot [NCT03387462] | Phase 4 | 20 participants (Actual) | Interventional | 2018-02-28 | Completed |
Decreasing Risk of Recurrence by TAF in HCC Patients After Curative Treatment With Low HBV Viral Load [NCT04290936] | Phase 4 | 402 participants (Anticipated) | Interventional | 2020-10-16 | Recruiting |
Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population [NCT01180075] | | 85 participants (Actual) | Observational | 2010-05-31 | Completed |
Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus [NCT01291459] | Phase 2 | 40 participants (Anticipated) | Interventional | 2011-09-30 | Active, not recruiting |
A Multicenter, Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis B Virus (HBV) Infection [NCT02738008] | Phase 2 | 12 participants (Actual) | Interventional | 2016-03-31 | Terminated(stopped due to Company decision to discontinue trial) |
Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM) [NCT04686279] | Phase 1 | 8 participants (Actual) | Interventional | 2021-04-01 | Completed |
A Phase IV, Open-label, Multi Centre Pilot Study to Assess Changes in Cerebral Function Parameters in Patients Without Perceived Central Nervous System (CNS) Symptoms When Switched From a Fixed Dose Combination of Tenofovir/Emtricitabine/Efavirenz (Atripl [NCT02529059] | Phase 4 | 40 participants (Anticipated) | Interventional | 2015-11-30 | Completed |
Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis [NCT03919565] | | 120 participants (Anticipated) | Interventional | 2019-02-01 | Recruiting |
A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection [NCT05238844] | Phase 2 | 2 participants (Actual) | Interventional | 2022-04-11 | Terminated(stopped due to Sponsor stopped due to partner collaboration ending) |
Expanded Safety Investigation of Tenofovir 1% Gel in Pregnancy and Lactation [NCT01136759] | Phase 1 | 232 participants (Actual) | Interventional | 2011-03-31 | Completed |
"Prevention of HIV in Île-de-France" [NCT03113123] | | 3,257 participants (Anticipated) | Interventional | 2017-05-03 | Recruiting |
A Phase III, Multi-Centre, Randomized Controlled Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel in the Prevention of Human Immunodeficiency Virus Type 1 Infection in Women, and to Examine Effects of the Microbicid [NCT01386294] | Phase 3 | 2,059 participants (Actual) | Interventional | 2011-10-31 | Completed |
A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delt [NCT02888106] | Phase 2 | 90 participants (Actual) | Interventional | 2016-04-30 | Completed |
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 |
MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM TENOFOVIR TO ABACAVIR IN HIV-1-INFECTED SUBJECTS WITH LOSS OF BONE MINERAL DENSITY [NCT01153217] | Phase 3 | 54 participants (Actual) | Interventional | 2010-07-31 | Completed |
Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera [NCT03377608] | | 50 participants (Actual) | Observational | 2017-11-17 | Completed |
Pilot Single-Arm Clinical Trial to Evaluate the Efficacy, PK Interactions and Safety of Dolutegravir Plus 2 NRTIs in HIV-1-Infected Solid Organ Transplant Patients [NCT03360682] | Phase 4 | 20 participants (Anticipated) | Interventional | 2018-04-12 | Active, not recruiting |
Pharmacokinetics of EFV 400mg Once Daily During Pregnancy in HIV+ Women [NCT02499874] | Phase 1 | 26 participants (Actual) | Interventional | 2015-08-31 | Completed |
Efficacy and Safety of Switching to Tenofovir Alafenamide for Chronic Hepatitis B Patients With Advanced Fibrosis and Partial Virologic Responses to Oral Nucleos(t)Ide Analogues [NCT03798119] | Phase 4 | 80 participants (Anticipated) | Interventional | 2019-02-25 | Recruiting |
Single Observed Dose Administration of Truvada® to Establish Single Dose Pharmacokinetic Standards in Healthy Individuals [NCT03719053] | Phase 1 | 44 participants (Actual) | Interventional | 2018-10-25 | 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 |
Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals [NCT01293123] | | 2 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Did not meet enrollment goals) |
Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM) [NCT01033942] | Phase 2 | 68 participants (Actual) | Interventional | 2009-08-31 | Completed |
Open-Label, Multiple-Dose, Drug Interaction Study to Assess the Effect of Famotidine on the Pharmacokinetics of Atazanavir in HIV-Infected Subjects Receiving Atazanavir With Ritonavir and Tenofovir [NCT01232127] | Phase 4 | 25 participants (Actual) | Interventional | 2011-02-28 | Completed |
Atazanavir (BMS-232632) for HIV Infected Individuals Completing Atazanavir Clinical Trials: An Extended Access Study [NCT01003990] | Phase 3 | 710 participants (Actual) | Interventional | 2002-10-31 | Completed |
Real World Study of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate to Prevent Vertical Transmission of Hepatitis B in Mothers With High Viral Load [NCT04211805] | | 450 participants (Anticipated) | Observational | 2020-01-27 | Recruiting |
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 |
The Use of Tenofovir Disoproxil Fumarate (TDF) in the Management of Patients With Inactive Chronic Hepatitis B (CHB) Infection [NCT02600117] | Phase 3 | 50 participants (Actual) | Interventional | 2016-01-26 | Completed |
Efficacy and Safety of Tenofovir Alafenamide in Chronic Hepatitis B Patients With Suboptimal Response Following Nucleos(t)Ide Therapy [NCT04201808] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-05-01 | Recruiting |
A Multicenter, Randomized, Double-blind, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of CKD-390 Tablet and Viread® Tablet in Chronic Hepatitis B Patients [NCT02805738] | Phase 3 | 158 participants (Anticipated) | Interventional | 2016-04-30 | Recruiting |
A Randomized, Open-label Trial to Compare the Efficacy and Safety of Early Initiation of cART With or Without Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in Treatment-Naïve Acute HIV-1 Infected Adults [NCT02231281] | Phase 3 | 65 participants (Anticipated) | Interventional | 2014-08-31 | Active, not recruiting |
A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa [NCT02150993] | Phase 2/Phase 3 | 210 participants (Actual) | Interventional | 2016-01-26 | Completed |
A Long Term Follow-up Registry of Subjects Treated in A Gilead-Sponsored Trial in Subjects With Chronic Hepatitis B Infection [NCT02258581] | | 241 participants (Actual) | Observational | 2014-12-09 | Terminated |
Evaluation of the Capacity of a Weekly Strategy of 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV-1 Infected Patients With Undetectable Viral Load for at Least 12 Months, to Maintain a Virological Success With This Intermittent M [NCT02157311] | Phase 3 | 100 participants (Actual) | Interventional | 2014-07-31 | Completed |
Comparison of the Pharmacokinetics and Pharmacodynamics of Single Dose Tenofovir Vaginal Gel and Film Formulation [NCT02280109] | Early Phase 1 | 10 participants (Actual) | Interventional | 2014-11-30 | Completed |
Cellular Pharmacology and Platelet Effects of Abacavir and Lamivudine Anabolites [NCT04301661] | | 25 participants (Actual) | Observational | 2020-03-06 | Completed |
Effectiveness of the Use of Personal Protective Equipment in Addition to Tenofovir/Emtricitabine for the Prevention of the Transmission of SARS-COV-2 to Health Care Personnel. Randomized Clinical Trial [NCT04519125] | Phase 2/Phase 3 | 950 participants (Anticipated) | Interventional | 2020-08-30 | Not yet recruiting |
Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy: a Pilot Study [NCT02505009] | Phase 4 | 116 participants (Actual) | Interventional | 2015-05-01 | Completed |
Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppre [NCT02652260] | Phase 2 | 86 participants (Actual) | Interventional | 2016-03-04 | Active, not recruiting |
A Randomized Study to Compare the Efficacy of Vorinostat/Hydroxychloroquine/Maraviroc (VHM) in Controlling HIV After Treatment Interruption in Subjects Who Initiated ART During Acute HIV Infection [NCT02475915] | Phase 1/Phase 2 | 15 participants (Actual) | Interventional | 2015-01-31 | Completed |
Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 96w Open-label Multicenter Study [NCT04939441] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-04-20 | Active, not recruiting |
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 |
Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy [NCT02995005] | Phase 1/Phase 2 | 98 participants (Actual) | Interventional | 2018-05-24 | Completed |
Sustainable Healthcenter Implementation PrEP Pilot Study [NCT02074891] | | 1,200 participants (Anticipated) | Observational | 2014-10-31 | Recruiting |
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 |
The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China : a Mutil-center,Prospective,Single-arm,Open-label [NCT04997564] | Phase 4 | 120 participants (Anticipated) | Interventional | 2021-08-31 | 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) |
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 |
Switching From Tenofovir Disoproxil Fumarate(TDF) to Tenofovir AlaFenamide(TAF) vs. Maintaining TDF Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir or Entecavir [NCT03241641] | Phase 4 | 174 participants (Actual) | Interventional | 2017-10-26 | Completed |
The Pharmacokinetic and Pharmacodynamic Impacts of Depot Medroxyprogesterone Acetate on HIV Pre-exposure Prophylaxis (PrEP) [NCT03197961] | Early Phase 1 | 15 participants (Actual) | Interventional | 2017-11-17 | 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 |
An Open Label Randomized Clinical Trial, to Evaluate the Treatment With Darunavir/Ritonavir + Lamivudine Once Daily Versus Continuing With Darunavir/Ritonavir Once Daily + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject With Suppres [NCT02159599] | Phase 4 | 249 participants (Actual) | Interventional | 2014-07-31 | Completed |
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers [NCT03510468] | Phase 1 | 51 participants (Actual) | Interventional | 2018-06-12 | Completed |
A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Di [NCT02251145] | Phase 1 | 49 participants (Actual) | Interventional | 2002-05-31 | Completed |
A Multicenter, Randomized, Double-blind, Placebo-controlled Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, [NCT02604212] | Phase 2 | 32 participants (Actual) | Interventional | 2015-11-30 | Terminated(stopped due to Company decision to discontinue trial) |
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologica [NCT02603120] | Phase 3 | 567 participants (Actual) | Interventional | 2015-11-11 | Completed |
An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects [NCT06171880] | Phase 1 | 48 participants (Actual) | Interventional | 2022-02-15 | Completed |
A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infe [NCT02016924] | Phase 2/Phase 3 | 130 participants (Anticipated) | Interventional | 2014-01-16 | Recruiting |
Effect of Reducing Nucleotide Exposure on Bone Health (ReNew) [NCT03549689] | Phase 2 | 0 participants (Actual) | Interventional | 2019-08-01 | Withdrawn(stopped due to Withdrawn by drug manufacturer) |
Tenofovir Pharmacokinetics in HIV-infected Thai Adults With Moderate Renal Function Impairment Receiving Either a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based or Lopinavir/Ritonavir-based Antiretroviral Therapy [NCT01671982] | Phase 1 | 40 participants (Actual) | Interventional | 2012-08-31 | Completed |
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 |
Study of Once-Daily Abacavir/Lamivudine Versus Tenofovir/Emtricitabine, Administered With Efavirenz in Antiretroviral-Naive, HIV-1 Infected Adult Subjects [NCT00549198] | Phase 4 | 392 participants (Actual) | Interventional | 2007-06-30 | Completed |
Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples [NCT02572505] | | 0 participants (Actual) | Interventional | 2015-11-30 | Withdrawn |
An Open-label, Randomized, Active Controlled, Parallel Comparison Study of the Safety and Efficacy of REP 2139-Mg in Combination With Pegasys® and Viread® and REP 2165-Mg in Combination With Pegasys® and Viread® in Patients With HBeAg Negative Chronic Hep [NCT02565719] | Phase 2 | 40 participants (Actual) | Interventional | 2016-03-31 | Completed |
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy [NCT04619082] | Phase 4 | 150 participants (Anticipated) | Interventional | 2021-07-01 | Recruiting |
Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Co [NCT00958100] | Phase 2 | 40 participants (Actual) | Interventional | 2009-08-31 | Completed |
A Randomized, Prospective, Multicenter, Open-label Study to Evaluate the Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir in HBeAg-positive Chronic Hepatitis B Patients [NCT01588912] | Phase 4 | 104 participants (Anticipated) | Interventional | 2012-04-30 | Recruiting |
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study) [NCT04636437] | Phase 4 | 222 participants (Anticipated) | Interventional | 2021-05-20 | Recruiting |
Adherence to a One Pill, Once-a-day Antiretroviral Regimen [NCT00990600] | Phase 3 | 212 participants (Actual) | Interventional | 2008-04-30 | Completed |
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults [NCT00977756] | | 168 participants (Actual) | Observational | 2002-08-31 | Completed |
A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis [NCT01088659] | Phase 3 | 50 participants (Actual) | Interventional | 2010-02-16 | Completed |
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples [NCT00074581] | Phase 3 | 3,526 participants (Actual) | Interventional | 2005-02-28 | Completed |
The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB/HIV-1 Coinfected Participants [NCT04424264] | Phase 1 | 18 participants (Actual) | Interventional | 2019-12-05 | Completed |
Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir [NCT02588287] | | 14 participants (Actual) | Interventional | 2015-11-30 | Completed |
"A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of CYT107 (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients" [NCT01027065] | Phase 1/Phase 2 | 24 participants (Anticipated) | Interventional | 2009-12-31 | Active, not recruiting |
ADORE: A Single-arm, Phase 3, Pilot Study Investigating the Efficacy of Doravirine in Adults Living With HIV Experiencing Virological Failure on First-line Efavirenz-based Antiretroviral Therapy With Non-nucleoside Reverse Transcriptase Inhibitor Resistan [NCT04429152] | Phase 3 | 25 participants (Anticipated) | Interventional | 2021-02-09 | Recruiting |
Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV [NCT00035932] | Phase 3 | 571 participants (Actual) | Interventional | 2001-11-30 | Completed |
An Open-Label One-way Interaction Clinical Trial to Evaluate the Pharmacokinetic Interactions Between GSK3640254 and Tenofovir Alafenamide/Emtricitabine in Healthy Subjects [NCT03836729] | Phase 1 | 16 participants (Actual) | Interventional | 2019-02-11 | Completed |
Safety, Tolerability, and Adherence to a Raltegravir-based Antiretroviral Regimen for HIV Non-occupational Postexposure Prophylaxis [NCT01087840] | Phase 4 | 120 participants (Actual) | Interventional | 2010-07-31 | Completed |
An Open-Label Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration of a Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine Fixed-Dose Combination Tablet in Healthy Japanese Adult Male Subjec [NCT02530060] | Phase 4 | 8 participants (Actual) | Interventional | 2015-08-31 | Completed |
Pre-Exposure Prophylaxis With TDF/FTC to Prevent HIV-1 Acquisition in Young Men and Transgender Women of Color Who Have Sex With Men [NCT02367807] | | 50 participants (Actual) | Observational | 2015-02-28 | Completed |
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 |
Chronic HBV Infection in Pregnant Women Taking TAF to Prevent Mother-to-child Transmission in the Third Trimester: a Multicenter, Prospective Study [NCT04237376] | | 600 participants (Anticipated) | Observational | 2019-04-09 | Recruiting |
A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II) [NCT00932971] | Phase 2 | 70 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women [NCT03164564] | Phase 3 | 3,224 participants (Actual) | Interventional | 2017-11-07 | Active, not recruiting |
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 |
A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects [NCT02770508] | Phase 4 | 145 participants (Actual) | Interventional | 2015-11-30 | Completed |
A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection [NCT02719808] | | 500 participants (Anticipated) | Observational | 2015-03-31 | Recruiting |
A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects [NCT02710604] | Phase 2 | 62 participants (Actual) | Interventional | 2016-05-31 | Completed |
APT-POCT-01: An Open Label, Pharmacokinetic Study of Plasma/Urine/Salivary Drug Concentrations Over Fourteen Days Following Drug Intake Cessation, In HIV-Uninfected Healthy Volunteers Dosing to Steady-state to Further Development of Point of Care Diagnost [NCT04302896] | Early Phase 1 | 30 participants (Actual) | Interventional | 2020-08-31 | Completed |
Institute of HIV Research and Innovation (IHRI) [NCT04593680] | | 40 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF [NCT03356834] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2017-12-01 | Recruiting |
TMC125-TiDP2-C238: A Randomized, Exploratory, Open-label 48-week Trial to Investigate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of Etravirine (ETR) in Combination With Ritonavir-boosted Atazanavir (ATV/Rtv) and 1 NRTI in Treatment- [NCT00896051] | Phase 2 | 50 participants (Actual) | Interventional | 2009-08-31 | Completed |
Efficacy and Safety of Switching From AZT to Tenofovir [NCT00647244] | Phase 4 | 40 participants (Actual) | Interventional | 2008-06-30 | Completed |
A Phase II, Open-Label, Multicentre, Randomised, Comparator Study of Substitution With Tenofovir or Abacavir in HIV-1 Infected Individuals, With a Viral Load < 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of Their Highly [NCT00647946] | Phase 2 | 100 participants (Actual) | Interventional | 2003-02-28 | 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 |
An Exploratory Study to Evaluate The Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic Hepatitis B Patients [NCT04133259] | Phase 2 | 44 participants (Anticipated) | Interventional | 2019-12-31 | Recruiting |
A Randomized Prospective Open-label Trial for Comparing Combination Therapy Peg-Interferon Alfa-2a/Adefovir Dipivoxil and Peg-Interferon Alfa-2a/Tenofovir Disoproxil Fumarate Versus no Treatment in HBeAg Negative Chronic Hepatitis B Patients With Low Vira [NCT00973219] | | 151 participants (Actual) | Interventional | 2009-09-30 | Completed |
Open Label Study of Nucleus(t)Ide Treated Patients Randomised to Tenofovir, or Tenofovir + Telbivudine [NCT02774837] | Phase 4 | 146 participants (Actual) | Interventional | 2016-04-30 | Active, not recruiting |
The Different Effects of Nucleotide and Nucleoside Analogues on the Prognosis of Hepatitis B Virus-Related Hepatocellular Carcinoma Patients After Curative Resection:a Randomized Controlled Trial [NCT04032860] | Phase 4 | 104 participants (Actual) | Interventional | 2017-07-01 | Active, not recruiting |
A Study to Evaluate Clinical Benefits and Drawbacks of Antiretroviral Drugs as Pre-exposure Prophylaxis to Prevent HIV Infection Under Real-life Conditions Among Persons Who Pursue High-risk Sexual Practices: The Seville HIV PrEP Cohort [NCT05492565] | | 500 participants (Anticipated) | Observational [Patient Registry] | 2020-01-01 | Enrolling by invitation |
A Study Comparing Efficacy and Tolerance of Two Maintenance Strategies : a Monotherapy With Lopinavir/Ritonavir or a Single-tablet Triple Therapy by Efavirenz/Emtricitabin/Tenofovir in HIV-1 Infected Patients With HIV RNA Below 50 cp/mL [NCT00946595] | Phase 2/Phase 3 | 420 participants (Anticipated) | Interventional | 2009-11-30 | 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 |
A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adu [NCT00984971] | Phase 1 | 18 participants (Actual) | Interventional | 2009-09-30 | 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 |
A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study [NCT02149888] | Phase 4 | 52 participants (Actual) | Interventional | 2014-10-31 | Completed |
A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D [NCT03546621] | Phase 2 | 120 participants (Actual) | Interventional | 2016-02-16 | Completed |
A Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB) [NCT04891770] | Phase 2 | 103 participants (Actual) | Interventional | 2021-08-14 | Active, not recruiting |
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 |
The Stability and Bioequivalence of Tenofovir, Emtricitabine and Efavirenz (Atripla) in an Extemporaneously Prepared Oral Liquid Formulation Compared With the Commercially Available Tablet Formulation [NCT00862823] | Phase 4 | 14 participants (Actual) | Interventional | 2009-02-28 | Completed |
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women [NCT00869960] | Phase 4 | 24 participants (Actual) | Interventional | 2009-03-31 | Completed |
Nucleoside-Sparing Combination Therapy With Lopinavir/Ritonavir (LPV/r) + Raltegravir (RAL) vs. Efavirenz (EFV) + Tenofovir Disoproxil Fumarate + Emtricitabine (TDF/FTC) in Antiretroviral-Naïve Patients [NCT00752856] | Phase 2 | 51 participants (Actual) | Interventional | 2008-08-26 | Completed |
A Single-arm, Multinational, Two Year Study Evaluating the Efficacy and Safety of lead-in Telbivudine for 24 Weeks With or Without Tenofovir Treatment Intensification in Adult Patients With HBeAg-positive Chronic Hepatitis B. [NCT00651209] | Phase 4 | 105 participants (Actual) | Interventional | 2008-02-29 | Completed |
Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1 [NCT00827112] | Phase 2 | 129 participants (Actual) | Interventional | 2009-03-31 | Completed |
A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients [NCT04667104] | Phase 2 | 48 participants (Actual) | Interventional | 2021-02-01 | Completed |
An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Tenofovir in Naive Patients With Chronic Hepatitis b: a Multicenter, Randomized, Positive Controlled Clinical Trial [NCT04157699] | Phase 2 | 100 participants (Anticipated) | Interventional | 2019-07-26 | 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 |
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects [NCT00759070] | Phase 4 | 50 participants (Anticipated) | Interventional | 2008-09-30 | Active, not recruiting |
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis: A Multicenter, Real-world and Respective Study [NCT04160897] | | 4,000 participants (Anticipated) | Observational | 2019-10-22 | Enrolling by invitation |
A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers [NCT02557594] | Phase 1 | 36 participants (Actual) | Interventional | 2015-10-06 | Completed |
[NCT02920931] | Phase 1 | 50 participants (Actual) | Interventional | 2016-02-29 | Completed |
Randomized Controlled Trial Comparing the Efficacy and Safety of FMT in Hepatitis B Reactivation Leads to Acute on Chronic Liver Failure. [NCT02689245] | | 64 participants (Actual) | Interventional | 2016-02-26 | Completed |
Evaluation of Intrahepatic Immune and Virological Response to Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B: an Investigator-Initiated, Cohort Study [NCT04070079] | Phase 4 | 15 participants (Anticipated) | Interventional | 2019-01-29 | Recruiting |
Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT00448669] | Phase 2/Phase 3 | 1,219 participants (Actual) | Interventional | 2007-03-31 | Completed |
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents With Chronic Hepatitis B Infection [NCT00734162] | Phase 3 | 106 participants (Actual) | Interventional | 2008-12-31 | 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 |
A Phase IV Study to Evaluate the Efficacy, Safety and Tolerability of Tenofovir DF in Asian-American Adults With Chronic Hepatitis B Infection [NCT00736190] | Phase 4 | 90 participants (Actual) | Interventional | 2008-08-31 | Completed |
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg. [NCT02583464] | Phase 1 | 24 participants (Actual) | Interventional | 2014-09-30 | Completed |
Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - An Extended Safety Evaluation [NCT00122512] | Phase 2 | 500 participants | Interventional | | Terminated |
Direct Antiviral Agents for the Treatment of Chronic HCV/HBV Co-infection Patients [NCT02555943] | Phase 2/Phase 3 | 23 participants (Actual) | Interventional | 2015-02-28 | Completed |
CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis [NCT00924898] | Phase 4 | 92 participants (Actual) | Interventional | 2005-01-31 | Completed |
A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Two-Phase Crossover Study of the Metabolic Impact of Tenofovir Disoproxil Fumarate on HIV-1 Seronegative Healthy Adult Males [NCT00648817] | Phase 4 | 8 participants (Actual) | Interventional | 2006-07-31 | Completed |
Open Randomized Study to Assess the Evolution of Plasma Lipid Profile by Lipidomic in Patients Infected With Human Immunodeficiency Virus (HIV-1) With Viral Suppression That Change Atripla® to Eviplera® Compared to Continue With Atripla® [NCT02547844] | Phase 4 | 30 participants (Actual) | Interventional | 2015-09-30 | 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 |
A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV) [NCT04065230] | | 330 participants (Anticipated) | Observational [Patient Registry] | 2019-08-31 | Recruiting |
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in HBV Negative Recipients Received Orthotopic Liver Transplant With HBcAb+ Donors [NCT04703465] | | 30 participants (Anticipated) | Interventional | 2021-04-01 | Not yet recruiting |
Pharmacokinetics and Safety of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants [NCT04862975] | | 200 participants (Anticipated) | Observational | 2024-01-08 | Not yet recruiting |
A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretrea [NCT04202536] | Phase 4 | 152 participants (Anticipated) | Interventional | 2019-05-29 | Recruiting |
Decay Kinetics of HIV With the Integrase Inhibitor Raltegravir [NCT00863668] | | 0 participants (Actual) | Interventional | 2009-03-31 | Withdrawn |
CID 0708 - Sex, Aging and Antiretroviral Pharmacokinetics [NCT00666055] | | 11 participants (Actual) | Observational | 2008-03-31 | Completed |
Steady-state Pharmacokinetics of Efavirenz (Sustiva/Stocrin) 400 mg Once Daily in the Presence of Rifampicin and Isoniazid (Rifinah or the Local Generics) [NCT02832778] | Phase 1 | 35 participants (Anticipated) | Interventional | 2016-11-21 | Recruiting |
An Open-Label Phase 2 Study to Evaluate Safety and Efficacy of QL-007 Tablets in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis b Who Have Received Nucleoside (Acid) Therapy : a Multicenter, Randomized, Positive Controlled Clin [NCT04157257] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-07-26 | Recruiting |
Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b [NCT02883647] | | 100 participants (Anticipated) | Observational | 2014-01-31 | Recruiting |
A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) or Intolerant to Entecavir [NCT04034368] | Phase 4 | 8 participants (Anticipated) | Interventional | 2019-08-31 | Not yet recruiting |
Exploratory Study on Antiviral Therapy for Patients With Chronic Hepatitis B Virus Infection (Immune Tolerance Period) [NCT05382351] | Phase 2 | 238 participants (Anticipated) | Interventional | 2022-05-10 | Recruiting |
A Phase I, Open-label, Randomized, Crossover Trial in 20 Healthy Subjects to Investigate the Pharmacokinetic Interactions Between the Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir. [NCT00828789] | Phase 1 | 20 participants (Actual) | Interventional | 2009-02-28 | Completed |
Antiretroviral Therapy and the Hepatitis C Virus [NCT00545558] | Phase 1 | 18 participants (Actual) | Interventional | 2006-04-30 | Completed |
Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects [NCT00551018] | Phase 2 | 218 participants (Actual) | Interventional | 2007-12-31 | Completed |
Safety and Efficacy of Tenofovir Alafenamide for Chronic Hepatitis B Patients With Decompensated Liver Disease [NCT04683341] | Phase 4 | 100 participants (Anticipated) | Interventional | 2020-09-01 | Recruiting |
TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months [NCT04650828] | | 200 participants (Anticipated) | Observational [Patient Registry] | 2020-12-01 | Recruiting |
An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study [NCT02995252] | | 550 participants (Anticipated) | Observational | 2014-12-31 | Recruiting |
Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa [NCT06138600] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-11-01 | Active, not recruiting |
Randomized Trial of Tenofovir Disoproxil Fumerate Dose Adjustment VS. Switching to Tenofovir Alafenamide in Tenofovir Disoproxil Fumarate-experienced Chronic Hepatitis B Patients With Renal Impairment [NCT04391608] | Phase 4 | 80 participants (Anticipated) | Interventional | 2019-11-09 | Recruiting |
Safety and Efficacy of Emtricitabine/Tenofovir Alafenamide as Part of Salvage Antiretroviral Regimens in Patients With Uncontrolled Viremia and Drug-Resistant HIV Infection [NCT02556333] | Phase 2 | 1 participants (Actual) | Interventional | 2015-09-16 | Terminated |
A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B [NCT00994773] | Phase 1 | 32 participants (Actual) | Interventional | 2009-12-31 | Completed |
A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Act [NCT00528957] | Phase 3 | 97 participants (Actual) | Interventional | 2006-12-28 | Completed |
The Optimization of HAART for Chinese--a RCT Study [NCT02945163] | Phase 4 | 184 participants (Actual) | Interventional | 2018-03-05 | 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 |
Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine [NCT03218085] | | 50 participants (Anticipated) | Observational | 2017-07-14 | Recruiting |
Cell Cycle Independent Antiretroviral Therapy: Combination of Nevirapine, FTC, and Tenofovir [NCT00344461] | Phase 4 | 54 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients [NCT00757783] | Phase 4 | 68 participants (Actual) | Interventional | 2008-10-31 | Completed |
Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic He [NCT06150014] | Phase 1/Phase 2 | 64 participants (Anticipated) | Interventional | 2023-12-07 | Recruiting |
A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated With Adef [NCT00307489] | Phase 2 | 106 participants (Actual) | Interventional | 2006-03-31 | Completed |
A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment [NCT00768989] | Phase 2 | 167 participants (Actual) | Interventional | 2008-11-30 | Terminated(stopped due to Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.) |
The ARDENT Study: Atazanavir, Raltegravir, or Darunavir With Emtricitabine/Tenofovir for Naive Treatment [NCT00811954] | Phase 3 | 1,814 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Phase III Randomized, Open Label Trial to Evaluate Dolutegravir Versus Efavirenz 400 mg, Both Combined With Tenofovir Disoproxil Fumarate + Lamivudine for the Initial Management of HIV Infected Adults in Resource-limited Settings [NCT02777229] | Phase 3 | 616 participants (Actual) | Interventional | 2016-07-31 | Completed |
A Prospective, Randomized, Open Label Phase IV Study to Evaluate the Rationale of Switching From Fixed Dose Abacavir (ABC)/Lamivudine (3TC) to Fixed Dose Tenofovir DF (TDF)/Emtricitabine (FTC) in Virologically Suppressed, HIV-1 Infected Patients Maintaine [NCT00724711] | Phase 4 | 312 participants (Actual) | Interventional | 2008-07-31 | Completed |
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study to Compare the Safety and Pharmacokinetics of CKD-390 Tablet (Tenofovir Disoproxil Aspartate) With Viread® Tablet (Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers [NCT02589457] | Phase 1 | 40 participants (Actual) | Interventional | 2015-10-31 | Completed |
A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy [NCT02585947] | Phase 4 | 90 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
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 |
Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection [NCT01869010] | | 30 participants (Actual) | Observational | 2010-01-31 | Completed |
Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women [NCT05853718] | Phase 4 | 50 participants (Anticipated) | Interventional | 2021-05-06 | Recruiting |
A Randomized, Phase II, Open Label Study to Compare Twice Daily and Once Daily Potent Antiretroviral Therapy and to Compare Self-Administered Therapy and Therapy Administered Under Direct Observation [NCT00036452] | Phase 2 | 402 participants (Actual) | Interventional | | Completed |
A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients [NCT05550519] | Early Phase 1 | 0 participants (Actual) | Interventional | 2022-10-31 | Withdrawn(stopped due to Sponsor decision after reevaluation of strategy in the context of recruitment timelines projection) |
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) |
US Expanded Access Program of Tenofovir Disoproxil Fumarate in the Treatment of HIV-1 Infected Patients Who Have Limited Treatment Options [NCT00011089] | | 0 participants | Interventional | 2001-02-28 | Active, not recruiting |
Switching to Tenofovir Alafenamide Fumarate or Abacavir in Patients With Tenofovir Disoproxil Fumarate Associated eGFR Decline. A Randomized Trial. [NCT02957864] | Phase 4 | 80 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project [NCT03058835] | Phase 4 | 125 participants (Actual) | Interventional | 2016-09-30 | Active, not recruiting |
Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) [NCT03954327] | Phase 2 | 37 participants (Actual) | Interventional | 2021-03-01 | Active, not recruiting |
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study. [NCT00532168] | Phase 4 | 108 participants (Actual) | Interventional | 2007-09-30 | Completed |
Optimization of Antiretroviral Therapy [NCT02935075] | Phase 4 | 184 participants (Actual) | Interventional | 2018-03-05 | Completed |
A Phase 1 Pharmacokinetic Study of Varying Dosing Patterns on Tenofovir Concentrations in Hair [NCT00903084] | Phase 1 | 24 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Randomized Evaluation of Antiretroviral Therapy Alone or With Delayed Chemotherapy Versus Antiretroviral Therapy With Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) AMC 067 [NCT01352117] | Phase 3 | 192 participants (Actual) | Interventional | 2011-11-18 | Completed |
Effect of Tenofovir/Emtricitabine Short Course on Viral Clearance in Patients Recently Infected With SARS-COV2 (Covid-19) Not Requiring Hospitalization: a Phase IIB/III Multicenter Open-label Randomized Controlled Trial [NCT04685512] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2020-11-18 | Completed |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Tenofovir DF as Part of an Optimized Antiretroviral Regimen in HIV-1-Infected Adolescents [NCT00352053] | Phase 3 | 87 participants (Actual) | Interventional | 2006-06-30 | Completed |
A Comparative Study of Entecavir vs. Adefovir Plus Lamivudine vs Combination Entecavir Plus Adefovir in Lamivudine-resistant Chronic Hepatitis B Subjects: The DEFINE Study [NCT00410202] | Phase 3 | 629 participants (Actual) | Interventional | 2008-03-31 | Completed |
Optimisation of Primary HIV1 Infection Treatment (ANRS 147 OPTIPRIM) [NCT01033760] | Phase 3 | 90 participants (Actual) | Interventional | 2010-04-30 | Completed |
A Comparative Study of Chronic Hepatitis B Subjects Treated With Entecavir Plus Tenofovir Combination Therapy vs. Entecavir Monotherapy in Adults Who Are Treatment-Naive to Nucleosides and Nucleotides: The BE-LOW Study [NCT00410072] | Phase 3 | 669 participants (Actual) | Interventional | 2007-04-30 | 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 |
Nucleosides And Darunavir/Dolutegravir In Africa (NADIA): a Randomised Controlled Trial of Darunavir Versus Dolutegravir and Tenofovir Versus Zidovudine in Second-line Antiretroviral Therapy Regimens for the Public Health Approach in Sub-Saharan Africa [NCT03988452] | Phase 3 | 465 participants (Actual) | Interventional | 2019-07-30 | Active, not recruiting |
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 |
A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection [NCT01651403] | Phase 3 | 90 participants (Actual) | Interventional | 2012-12-06 | Active, not recruiting |
Tenofovir Reduces Morbidity and Mortality in Patients With Spontaneous Reactivation of Hepatitis B Presenting as Acute-on-chronic Liver Failure (ACLF): A Randomized Placebo Controlled Trial [NCT01074645] | Phase 4 | 27 participants (Actual) | Interventional | 2007-11-30 | Completed |
Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Marginalized Populations Who Are Virologically Suppressed [NCT04132674] | Phase 4 | 40 participants (Anticipated) | Interventional | 2018-11-26 | Recruiting |
Treatment Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in naïve Chronic Hepatitis B : a Real Life Multicenter Cohort Study in Korea [NCT02533544] | | 572 participants (Actual) | Observational | 2015-10-31 | Completed |
An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r + Tenofovir/Emtricitabine vs. Darunavir/r + Raltegravir (ANRS 143/NEAT 001) [NCT01066962] | Phase 3 | 800 participants (Actual) | Interventional | 2010-08-31 | 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 |
A Phase 1, Randomized Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir [NCT03670355] | Phase 1 | 49 participants (Actual) | Interventional | 2018-12-07 | Completed |
Switching HIV-positive Women on Tenofovir/Emtricitabine Plus Boosted Atazanavir to RALtegravir Plus Boosted ATazanavir: A Pilot Randomized Clinical Trial Investigating 48-weeks Changes in Bone Mineral Density [NCT01902186] | Phase 4 | 4 participants (Actual) | Interventional | 2014-09-30 | Terminated(stopped due to Low enrollment) |
Safety, Tolerability, and Adherence to Co-formulated Emtricitabine-rilpivirine-tenofovir Used as HIV Nonoccupational Post Exposure Prophylaxis in Men Who Have Sex With Men (EPEP) [NCT01715636] | Phase 4 | 100 participants (Actual) | Interventional | 2012-12-31 | Completed |
[NCT01918631] | | 36 participants (Actual) | Interventional | 2013-08-31 | Completed |
A Phase Ⅲ, Multi-center, Randomized, Double-blinded, Parallel Study to Assess the Antiviral Activity and Safety of Besifovir 150 mg Compared to Tenofovir 300 mg in Chronic Hepatitis B Patients for 48 Weeks [NCT01937806] | Phase 3 | 197 participants (Actual) | Interventional | 2013-10-31 | Active, not recruiting |
Addition of Single-dose, Maternal Tenofovir and Emtricitabine to Reduce Non-nucleoside Reverse Transcriptase Inhibitor Resistance Mutations in the Setting of Zidovudine and Nevirapine for Prevention of Mother-to-child HIV Transmission [NCT00204308] | Phase 2 | 400 participants (Actual) | Interventional | 2005-03-31 | Completed |
Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate [NCT03485534] | Phase 4 | 189 participants (Actual) | Interventional | 2018-01-23 | Completed |
Tenofovir, Emtricitabine, and Nevirapine for Recently HIV-Infected Subjects: Can Short-Course, Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection? [NCT00087464] | | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to study was withdrawn before any participants were recruited and enrolled) |
Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel [NCT00561496] | Phase 1 | 49 participants (Actual) | Interventional | 2007-03-31 | Completed |
Phase 2 Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV [NCT00122486] | Phase 2 | 1,200 participants | Interventional | 2004-07-31 | Completed |
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project. [NCT01989611] | | 400 participants (Anticipated) | Interventional | 2014-06-30 | Active, not recruiting |
A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04 [NCT01989663] | Phase 1 | 78 participants (Actual) | Interventional | 2013-11-30 | 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 |
A Prospective, Randomized, Three-period Crossover, Interaction Study to Evaluate the Pharmacokinetics of Doravirine and Tenofovir Disoproxil Fumarate Co-administered With Cross-sex Hormonal Therapy in Adult HIV-negative Transgender Women [NCT04283656] | Phase 1 | 7 participants (Actual) | Interventional | 2022-02-14 | 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 |
Randomized, Double-blinded, Controlled Trial of Intensive HAART Including Raltegravir, and Maraviroc, on HIV-1 Pro-viral DNA and Reservoir Decay in HIV-1-infected Individuals During the Acute/Early Infection [NCT01154673] | Phase 2/Phase 3 | 32 participants (Actual) | Interventional | 2011-11-30 | Completed |
A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3 [NCT00386659] | Phase 4 | 60 participants | Interventional | | Terminated |
A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers [NCT05652478] | Phase 2 | 120 participants (Anticipated) | Interventional | 2024-01-03 | Recruiting |
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals [NCT02251236] | | 14 participants (Actual) | Interventional | 2016-01-31 | Completed |
HIV Pre-exposure Prophylaxis Implementation Study in South Korea [NCT04583267] | | 200 participants (Anticipated) | Interventional | 2018-08-28 | Recruiting |
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 |
A Randomized, Single-Dose, Parallel-Group Study to Evaluate thePharmacokinetic Profiles of Two Formulations of Tenofovir Disoproxil Fumarate After Oral Administration in Healthy Volunteers Under Fasting Conditions [NCT04671563] | Phase 4 | 28 participants (Actual) | Interventional | 2019-04-22 | Completed |
A Phase IV Open-label Evaluation of Safety, Tolerability and Acceptability of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Disoproxil Fumarate Single-tablet Regimen for Non-occupational Prophylaxis Following Potential Exposure to HIV-1 [NCT01855867] | Phase 4 | 100 participants (Actual) | Interventional | 2013-05-31 | Completed |
The Tolerability of, and Adherence to, Dolutegravir With Co-formulated Tenofovir-emtricitabine for HIV Non-occupational Post-exposure Prophylaxis [NCT02211690] | Phase 4 | 100 participants (Actual) | Interventional | 2014-08-31 | Completed |
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Multi-center, Double-Blind, Randomized, Positive Control, Phase3 Study [NCT04543565] | Phase 3 | 900 participants (Anticipated) | Interventional | 2020-09-30 | Recruiting |
A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas [NCT04539119] | Phase 3 | 120 participants (Anticipated) | Interventional | 2020-07-03 | Recruiting |
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection [NCT02219672] | Phase 3 | 18 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
Transgender Men and HIV in Uganda: PrEP Uptake and Persistence [NCT04867798] | | 75 participants (Actual) | Observational | 2021-09-16 | Completed |
DREAM-01: Optimization of a Tenofovir Enema for HIV Prevention [NCT02750540] | Phase 1 | 21 participants (Actual) | Interventional | 2016-10-31 | Completed |
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) |
Phase 1 Evaluation of the Impact of Coitus on Pharmacokinetics and Pharmacodynamics of Tenofovir 1% Gel Following Pericoital or Daily Gel Dosing [NCT01687205] | Phase 1 | 31 participants (Actual) | Interventional | 2012-11-30 | Completed |
Effect of Multiple Dosing With 240 mg BID BI 201335 on the Steady State Pharmacokinetics of 300mg QD Tenofovir and Effect of Multiple Dosing With 300mg QD Tenofovir on Steady State BI 201335 Pharmacokinetics in Healthy Male and Female Volunteers [NCT01340196] | Phase 1 | 16 participants (Actual) | Interventional | 2011-04-30 | Completed |
Phase III Open-label Randomized Multicenter Trial to Assess the Non-inferiority of Raltegravir Compared With EFavirenz, Both in Combination With LAmivudine and TEnofovir, in ART-naïve HIV-1-infected Patients Receiving Rifampin for Active TuBerculosis [NCT02273765] | Phase 3 | 460 participants (Actual) | Interventional | 2015-09-11 | Completed |
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazan [NCT01332227] | Phase 4 | 132 participants (Actual) | Interventional | 2011-10-31 | Completed |
Safety and Efficacy of the Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations in Pregnant and Breastfeeding Women to Prevent mother-to Child Transmission of HIV-1 o, Resource-limited Settings: A Multicentre Randomized Phase 3 Clinical Trial [NCT00936195] | Phase 3 | 0 participants (Actual) | Interventional | 2010-01-31 | Withdrawn(stopped due to faillure to obtain insurance because of refusal from insurance companies) |
Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine. [NCT00808002] | Phase 3 | 30 participants (Actual) | Interventional | 2009-02-28 | Completed |
The Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children in Cameroon: The PREVENT-IT Study [NCT04070482] | | 400 participants (Anticipated) | Observational | 2017-10-01 | Active, not recruiting |
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 |
Open Label Extension (OLE) of the Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT04318210] | | 229 participants (Actual) | Interventional | 2012-10-31 | 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 |
Tenofovir Disoproxil Fumarate Alone Versus Its Combination With Emtricitabine for Treatment of Chronic Hepatitis B [NCT00524173] | Phase 2 | 35 participants (Actual) | Interventional | 2007-08-29 | Terminated |
The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function [NCT04155554] | Phase 3 | 100 participants (Anticipated) | Interventional | 2020-01-29 | Recruiting |
Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients [NCT00677300] | Phase 4 | 85 participants (Actual) | Interventional | 2009-01-31 | Completed |
A Phase II of Randomized, Double-blind, Placebo-controlled, Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients [NCT05244057] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-08-23 | Recruiting |
Phase 1 Safety and Pharmacokinetic Study of a Polyurethane Tenofovir Disoproxil Fumarate Vaginal Ring in Sexually Active Women (TDF IVR-002) [NCT02762617] | Phase 1 | 17 participants (Actual) | Interventional | 2017-02-24 | Terminated(stopped due to Safety-related) |
Adjunctive Therapy With Telmisartan Instituted With ART During Acute HIV Infection to Reduce the Establishment of CNS Reservoirs of HIV and Lymph Node Fibrosis [NCT02750059] | Phase 2 | 21 participants (Actual) | Interventional | 2015-01-31 | Completed |
Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa [NCT04341779] | | 540 participants (Anticipated) | Interventional | 2021-02-04 | Recruiting |
A Phase I, Open-label Multiple Dose Safety, Pharmacokinetic, Pharmacodynamic, and Acceptability Study of Tenofovir Rectal Douche [NCT04016233] | Phase 1 | 9 participants (Actual) | Interventional | 2020-01-10 | Completed |
Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection [NCT04329442] | | 0 participants (Actual) | Interventional | 2020-04-01 | Withdrawn(stopped due to COVID-19 caused substantial barriers to recruitment.) |
Use of Tenofovir/Emtricitabine With Immediate or Deferred Doxycycline 100mg PO Daily for Combination HIV and Syphilis Pre-exposure Prophylaxis in HIV-negative Men Who Have Sex With Men: a Pilot Study of Dual Daily HIV and Syphilis PrEP. (The DuDHS Trial). [NCT02844634] | Phase 4 | 52 participants (Actual) | Interventional | 2018-05-15 | Active, not recruiting |
A Randomised, Double-Blind, Multi-Centre, Parallel-Group Phase 3b Study to Demonstrate Non-inferiority of Stavudine (20 mg Twice Daily) Compared With Tenofovir Disoproxil Fumarate (300 mg Once Daily) When Administered in Combination With Lamivudine and Ef [NCT02670772] | Phase 3 | 1,077 participants (Actual) | Interventional | 2012-07-31 | Completed |
ART Drug Dosage Adjustment Using FSCII in Chinese HIV-infected Population [NCT02632474] | Phase 4 | 10 participants (Actual) | Interventional | 2015-04-30 | Completed |
Defining the PrEP Care Continuum Among Recently Incarcerated Men at High-Risk for HIV Infection [NCT04240509] | Phase 4 | 100 participants (Anticipated) | Interventional | 2019-11-01 | Enrolling by invitation |
A Randomized, Open-label, Controlled, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine 600 mg and Tenofovir Disproxil Fumarate 300 mg in Combination or Telbivudine 600 mg or Tenofovir Disproxil Fumarate 300 mg Mono [NCT00805675] | Phase 3 | 83 participants (Actual) | Interventional | 2008-11-30 | 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 |
Phase I Study of the Maternal Single-Dose Pharmacokinetics and Placental Transfer of Tenofovir 1% Vaginal Gel Among Healthy Term Gravidas [NCT00540605] | Phase 1 | 21 participants (Actual) | Interventional | | Completed |
A Randomized, Phase II, Controlled Trial Comparing the Efficacy of Adefovir Dipivoxil and Tenofovir Disoproxil Fumarate for the Treatment of Lamivudine-Resistant Hepatitis B Virus in Subjects Who Are Co-Infected With HIV [NCT00033163] | Phase 2 | 90 participants | Interventional | | Completed |
[NCT02902523] | Phase 1 | 50 participants (Actual) | Interventional | 2016-09-30 | Completed |
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women [NCT01394133] | | 0 participants (Actual) | Observational | 2011-07-31 | Withdrawn(stopped due to Lack of enrollment) |
Determination of Plasma and Intracellular Levels of Nucleoside Reverse Transcriptase Inhibitors (NRTI) and of Nucleotide Analog Tenofovir Disoproxil Fumarate (TDF) in Patients Treated With Abacavir and/or Lamivudine Given With or Without TDF. [NCT00335192] | Phase 4 | 32 participants (Actual) | Interventional | 2005-01-31 | Completed |
Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users [NCT01421368] | Phase 1 | 72 participants (Actual) | Interventional | 2012-03-31 | Completed |
An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function [NCT02510963] | | 300 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
Analysis of Lipodystrophy in HIV-Infected Individuals A Prospective, Non-randomised, 48 Week Study of the Effect of PI Containing and Non-PI Containing Antiretroviral Regimens on the Expression of Adipocyte Specific Genes, Protein Levels and Cellular Stru [NCT00192660] | Phase 4 | 80 participants (Actual) | Interventional | 2003-02-28 | Completed |
Virological and Clinical Anti-HBV Efficacy of Tenofovir and Emtricitabine in Antiretroviral Naïve Patients With HIV/HBV co-Infection [NCT00127959] | Phase 4 | 24 participants | Interventional | 2004-03-31 | Completed |
Clinical, Control, Double-blind, Randomized Experimentation With Tenofovir Disoproxyl Fumarate and Emtricitabine for COVID-19 [NCT04712357] | | 219 participants (Anticipated) | Interventional | 2020-11-09 | Recruiting |
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083 [NCT04692077] | Phase 2 | 9 participants (Actual) | Interventional | 2020-02-19 | Completed |
A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Antiretroviral Naive HIV-1 Infected Adolescents and Children Aged >= 6 to <18 Years [NCT00799864] | Phase 2 | 54 participants (Actual) | Interventional | 2011-01-07 | Completed |
A Randomized, Double-blind, Double-simulated, Active-controlled,Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients [NCT04303598] | Phase 3 | 720 participants (Anticipated) | Interventional | 2020-04-01 | Not yet recruiting |
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 |
Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal [NCT00158457] | Phase 3 | 40 participants (Actual) | Interventional | 2004-06-30 | Completed |
Study on Screening, Verification and Intervention of High-risk Patients With Liver Cancer [NCT05721300] | | 2,215 participants (Anticipated) | Interventional | 2023-02-10 | Recruiting |
A Prospective, Randomized, Trial to Investigate the Effect of Continued Adefovir Versus Combination Regimens of Telbivudine Plus Adefovir, and Telbivudine Plus Tenofovir in Patients With Chronic Hepatitis B and Suboptimal Viral Suppression (PROACTIV Study [NCT00409019] | Phase 4 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to Study cancelled: Withdrawn before enrollment of any participants) |
Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study [NCT04585737] | Phase 4 | 222 participants (Actual) | Interventional | 2020-09-22 | Completed |
Efficacy, Safety, and Tolerability of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults With HIV-HBV Coinfection [NCT03797014] | Phase 4 | 28 participants (Actual) | Interventional | 2019-04-30 | Completed |
Tenofovir Versus Lamivudine for Patients of Chronic Hepatitis B With Severe Acute Exacerbation [NCT01848743] | Phase 3 | 120 participants (Anticipated) | Interventional | 2013-04-30 | Recruiting |
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study. [NCT00192634] | Phase 4 | 357 participants (Actual) | Interventional | 2005-12-31 | Completed |
Pegylated Interferon Alfa-2a Versus Emtricitabine / Tenofovir +/- Pegylated Interferon Alfa-2a for the Treatment of Chronic HBe-Ag Positive Hepatitis B Infection in HIV-Coinfected Patients - the PEGPLUS Trial [NCT00221286] | Phase 3 | 2 participants (Actual) | Interventional | 2004-09-30 | Terminated(stopped due to Lack of accrual) |
Tenofovir Disoproxil Fumarate Improves Outcomes Following Palliative Transarterial Chemoembolization for Hepatitis B Virus Related Hepatocellular Carcinoma [NCT01872988] | Phase 3 | 320 participants (Anticipated) | Interventional | 2012-09-30 | Terminated(stopped due to Difficult in patient enrollment) |
Optimizing the Delivery of HIV Post-exposure Prophylaxis: A Randomized Controlled Trial of Text Messaging Support and Physician to Nurse Task-shifting [NCT03259698] | Phase 2 | 434 participants (Anticipated) | Interventional | 2021-11-04 | Recruiting |
Reverse Transcriptase Inhibitors in Aicardi Goutières Syndrome [NCT03304717] | Phase 1/Phase 2 | 34 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study) [NCT04405271] | Phase 3 | 1,378 participants (Anticipated) | Interventional | 2020-07-31 | Not yet recruiting |
An Open-label, Randomized Study to Evaluate the Acute Immunologic Responses in Asian Subjects With E Antigen Positive Chronic Hepatitis B Following Initiation of Therapy for Hepatitis B With Pegasys, Nucleoside Analogues, or Both. [NCT00962871] | Phase 1 | 30 participants (Actual) | Interventional | 2009-08-31 | Completed |
ENLIGHTEN: Establishing Novel Antiretroviral (ARV) Imaging for Hair to Elucidate Non-Adherence [NCT03218592] | Phase 4 | 36 participants (Actual) | Interventional | 2017-06-28 | Completed |
Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers [NCT01488526] | Phase 4 | 200 participants (Actual) | Interventional | 2012-03-01 | Completed |
Body Compartment Pharmacokinetics of Anti-retroviral Agents That May be Considered for Future On-demand Peri-exposure HIV Prophylaxis Regimens [NCT03976752] | Phase 1 | 41 participants (Actual) | Interventional | 2019-03-13 | Completed |
Open Label Randomized Controlled Trial to Assess the Impact of Prophylactic Exposure to Tenofovir Gel on the Efficacy of Subsequent Tenofovir-containing Antiretroviral Therapy on Viral Suppression [NCT01387022] | | 59 participants (Actual) | Interventional | 2011-06-30 | Completed |
Phase 2 Expanded Safety Study of Tenofovir Gel in Pregnancy [NCT01490671] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn |
Randomized Trial of Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Who Have Undergone Lamivudine/Adefovir Add-on Treatment [NCT01491295] | Phase 4 | 160 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting |
The Pharmacokinetics of Co-formulated Emtricitabine/Tenofovir/Efavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region, Tanzania [NCT00474435] | Phase 2 | 30 participants (Anticipated) | Interventional | 2008-11-30 | Recruiting |
Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects [NCT03279146] | Phase 1 | 29 participants (Actual) | Interventional | 2017-09-06 | Completed |
Phase I, 90-Day Safety, Pharmacokinetic, And Pharmacodynamic Study Of Intravaginal Rings Releasing Tenofovir And Levonorgestrel [NCT03279120] | Phase 1 | 66 participants (Actual) | Interventional | 2017-09-28 | Completed |
The ADAPT Study: A Phase II, Randomized, Open-Label, Pharmacokinetic and Behavioral Study of the Use of Intermittent Oral Emtricitabine/Tenofovir Disoproxil Fumarate Pre-Exposure Prophylaxis (PrEP) Pre-Exposure Prophylaxis (PrEP) [NCT01327651] | Phase 2 | 622 participants (Actual) | Interventional | 2011-08-31 | Completed |
A Randomized, Multicenter, Prospective Study to Compare Antiviral Efficacy and Safety of Switching to ETV Plus TDF Versus Maintaining LAM/LDT Plus ADF Combination in CHC With PVR to LAM/LDF Plus ADF Combination Rescue Therapy for YMDD Mutation [NCT01597934] | Phase 4 | 104 participants (Anticipated) | Interventional | 2012-08-31 | Active, not recruiting |
Pilot Study to Measure Exposure to Atazanavir, as a Component of Pharmacokinetic Parameters and Adherence Measured With MEMS in Naive HIV-infected Patients Treated Once Daily With Atazanavir Combined to Ritonavir and to Tenofovir/Emtricitabine. ANRS 134 C [NCT00528060] | Phase 2 | 35 participants (Actual) | Interventional | 2008-01-31 | Completed |
Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz [NCT04022967] | Phase 3 | 480 participants (Actual) | Interventional | 2020-09-21 | Active, not recruiting |
Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission [NCT02937779] | Phase 4 | 933 participants (Anticipated) | Interventional | 2017-10-04 | Active, not recruiting |
Pharmacokinetics of Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Pre-exposure Prophylaxis in Transgender Women Receiving Feminizing Hormone Therapy [NCT03270969] | Phase 1 | 15 participants (Actual) | Interventional | 2018-01-05 | Completed |
Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions in Women at Low Risk for HIV-1 Infection [NCT00594373] | Phase 1 | 30 participants (Actual) | Interventional | | Completed |
Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study [NCT00537966] | | 2,017 participants (Anticipated) | Interventional | 2002-01-31 | Recruiting |
A Randomized, Open Label, Multicenter Study Comparing the Safety and Efficacy of Once Daily Regimen Containing Epzicom or Truvada Combined With Ritonavir Boosted Atazanavir as Initial Therapy for HIV-1 Infection (ET Study) [NCT00544128] | Phase 4 | 109 participants (Actual) | Interventional | 2007-10-31 | Completed |
A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B [NCT02908191] | Phase 1 | 86 participants (Actual) | Interventional | 2016-11-30 | Completed |
A Multicentre, Randomized Controlled Trial in HBsAg Seroclearance After Receiving Combined Therapy of Peginterferon and Tenofovir in Nucleos(t)Ide Analogue-treated Patients With HBV Related Liver Fibrosis. [NCT04640129] | Phase 4 | 272 participants (Anticipated) | Interventional | 2020-11-30 | Not yet recruiting |
Exploratory Pharmacokinetic and Pharmacodynamic Study of Oral F/TAF for the Prevention of HIV Acquisition [NCT02904369] | Phase 1 | 73 participants (Actual) | Interventional | 2016-10-06 | Completed |
The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury [NCT04674423] | Phase 4 | 40 participants (Anticipated) | Interventional | 2020-05-14 | Recruiting |
A Pilot Study of Rapid HIV Treatment Initiation, Access and Engagement in Care (RHAE) [NCT03512964] | | 32 participants (Actual) | Interventional | 2016-11-29 | Completed |
Treating HIV-infected Elite Controllers as a Model of HIV Remission [NCT01025427] | Phase 4 | 16 participants (Actual) | Interventional | 2009-12-31 | Completed |
Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT01448616] | Phase 4 | 73 participants (Actual) | Interventional | 2012-02-29 | Completed |
An Open-Label, Pilot, Randomized, Multi-Center Study to Compare Efficacy and Safety of Tenofovir Monotherapy Alone With Tenofovir Monotherapy Followed by Concurrent Combination of Pegylated Interferon-Alpha-2b and Tenofovir or Tenofovir Monotherapy Follow [NCT01727271] | Phase 4 | 0 participants (Actual) | Interventional | 2013-08-31 | Withdrawn |
The Efficacy of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Patients Receiving Biological DMARDs (bDMARDs) [NCT05001672] | Phase 4 | 108 participants (Anticipated) | Interventional | 2021-08-15 | Not yet recruiting |
Switching to Tenofovir Disoproxil Fumarate vs. Continuing Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response During Entecavir Therapy: STEEP Study [NCT01711567] | Phase 4 | 60 participants (Actual) | Interventional | 2013-04-30 | Completed |
A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients [NCT03013556] | Phase 4 | 180 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
A Phase 4, Open-Label Study to Investigate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (Viread(R)) in Preventing Hepatocellular Carcinoma Recurrence in Chronic Hepatitis B Virus Infected Patients With Low Viral Load at Baseline Treated With R [NCT02308319] | Phase 4 | 124 participants (Anticipated) | Interventional | 2015-01-31 | Not yet recruiting |
Open-Label, Single-Centre, Randomised Pilot Study to Evaluate Immunovirological and Clinical Evolution of a Combination With Nucleoside Analogues/Nucleotides (Trizivir +Tenofovir) in Multiresistant Patients With Virological Failure [NCT00356616] | Phase 4 | 24 participants (Actual) | Interventional | 2005-09-30 | Terminated(stopped due to terminated) |
Prospective Study on the Incidence of Hepatitis B Virus Reactivation in Untreated Patients With Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide [NCT03804372] | Phase 2 | 180 participants (Anticipated) | Interventional | 2020-07-07 | Recruiting |
Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone [NCT00552240] | Phase 4 | 154 participants (Actual) | Interventional | 2007-09-30 | Completed |
An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal [NCT02180438] | Phase 4 | 30 participants (Actual) | Interventional | 2014-09-30 | Completed |
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects [NCT02403674] | Phase 3 | 734 participants (Actual) | Interventional | 2015-06-05 | Completed |
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 III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-H [NCT00234910] | Phase 3 | 152 participants (Actual) | Interventional | 2005-01-31 | 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 |
An Open-Label, Randomized Study to Determine the Impact of Antiretroviral Treatment in HCV/HIV-Coinfected Subjects With High CD4+ Cell Count on the Efficacy of Hepatitis C Treatment With Pegylated Interferon Alfa-2A and Ribavirin [NCT00100581] | | 2 participants (Actual) | Interventional | | Completed |
A Multicenter Randomized Controlled Open-label Trial of Tenofovir Plus Entecavir Combination vs. Tenofovir Monotherapy in Chronic Hepatitis B Patients With Genotypic Resistance to Adefovir and Partial Virologic Response to Ongoing Treatment [NCT01639066] | Phase 4 | 102 participants (Actual) | Interventional | 2012-09-25 | Completed |
Phase II, Open-Label,Randomised, Comparator Study of Substitution w/Tenofovir or Abacavir in HIV-1 Infected Individuals, w/Viral Load Less 50 Copies/mL, Receiving a Thymidine Analogue (Zidovudine or Stavudine) as Part of HAART. [NCT00270556] | Phase 2 | 100 participants | Interventional | 2003-01-31 | Completed |
Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy [NCT03563742] | Phase 3 | 58 participants (Actual) | Interventional | 2018-09-24 | Terminated(stopped due to High SF rate (less treatment-naïve subjects & subjects with viral load <100000). Reevaluation in scientific position in India after internal discussion.) |
Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana [NCT00111150] | Phase 2/Phase 3 | 1,200 participants | Interventional | 2005-09-30 | Terminated(stopped due to Consenting participants entered tenofovir/emtricitabine oral prophylaxis trial) |
Study of Daily Oral Tenofovir (Tenofovir Disoproxil Fumarate) to Prevent HIV-1 Infection Among Sex Workers in Cambodia [NCT00078182] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | | Withdrawn |
A Phase I Clinical Trial Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Disintegration Time of Vaginal Tablets Containing Tenofovir and/or Emtricitabine [NCT01694407] | Phase 1 | 48 participants (Actual) | Interventional | 2013-02-28 | Completed |
A Phase I Open Label Trial of the Safety and Pharmacokinetics of Tenofovir Disoproxil Fumarate in HIV-1 Infected Pregnant Women and Their Infants [NCT00120471] | Phase 1 | 122 participants (Actual) | Interventional | 2006-11-30 | 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 |
Randomized Open Label Study Assessing the Antiviral Activity, Toxicity and Pharmacologic Interaction of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir as Part of a Salvage Regimen in HIV Infected Patients With Multiple Treatment Failures (ANR [NCT00122577] | Phase 2 | 50 participants | Interventional | 2002-03-31 | Terminated |
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department [NCT03711253] | Phase 4 | 40 participants (Anticipated) | Interventional | 2019-10-14 | Active, not recruiting |
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 |
"Analysis of Proximal Renal Tubular Function of Real World Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF" [NCT02957994] | Phase 4 | 82 participants (Actual) | Interventional | 2016-12-22 | Active, not recruiting |
A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virol [NCT00102206] | Phase 2 | 6 participants (Actual) | Interventional | | 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 |
Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa [NCT00441298] | Phase 2 | 889 participants (Actual) | Interventional | 2007-05-31 | 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 |
A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofov [NCT05979311] | Phase 3 | 412 participants (Anticipated) | Interventional | 2023-12-29 | Not yet recruiting |
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 |
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) |
An Open Label Study to Investigate the Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age [NCT01335620] | Phase 4 | 19 participants (Actual) | Interventional | 2011-04-30 | Completed |
Interferon Alfa Sensitivity in HIV/HCV Coinfected Persons Before and After Antiretroviral Therapy [NCT01285050] | Phase 4 | 20 participants (Actual) | Interventional | 2011-01-31 | Completed |
An Open-Label Study to Assess the Anti-HIV-1 Activity of Tenofovir Disoproxil Fumarate (TDF) in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1 [NCT00016588] | | 0 participants | Interventional | 2001-05-31 | Completed |
Contribution of the Integrase Inhibitor Dolutegravir to Obesity and Cardiovascular Disease in Persons Living With HIV [NCT04340388] | Phase 4 | 10 participants (Actual) | Interventional | 2020-09-17 | Completed |
Open-label Multicenter Study to Assess the Efficacy, the Tolerability and the Adherence of a Once Daily (QD) Taken Antiretroviral Therapy (ART) Containing the NtRTI Tenofovir DF 300 mg in Combination With the Best Suitable Once a Day Regimen Being 1 NRTI [NCT00324688] | Phase 4 | 60 participants | Interventional | 2003-03-31 | Completed |
Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo [NCT03255915] | Early Phase 1 | 15 participants (Actual) | Interventional | 2018-09-20 | Active, not recruiting |
A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine [NCT00931801] | Phase 4 | 43 participants (Actual) | Interventional | 2009-12-31 | Completed |
Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia [NCT00334256] | Phase 2 | 72 participants (Actual) | Interventional | 2006-10-31 | Completed |
A Study to Probe The Safety And Durability of Tenofovir And a Cell Cycle Agent to Maintain Viral Suppression [NCT00344981] | | 9 participants (Actual) | Interventional | 2003-06-30 | Completed |
A Multi-centre, Double Blind, Double Dummy, Randomised, Controlled Study to Evaluate the Efficacy and Safety of TDF 300mg Once Daily (QD) Versus Adefovir Dipivoxil (ADV) 10mg QD in Chinese Subjects With CHB [NCT01300234] | Phase 3 | 512 participants (Actual) | Interventional | 2011-03-30 | 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) |
Efficacy of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients With High Viral Load But Slight Aminotransferase Elevation [NCT01522625] | Phase 4 | 160 participants (Actual) | Interventional | 2012-01-31 | Completed |
A Phase I/II Study of Safety and Efficacy of Lamivudine (EPIVIR®) and Tenofovir Disoproxil Fumarate (VIREAD®) Used to Lower the Plasma Level of Viral RNA of HERV-K(HML2) in Patients With Lymphoma [NCT01528865] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(stopped due to Funding was removed.) |
A Pilot Study to Determine the Impact on Dyslipidemia of the Addition of Tenofovir to Stable Background Antiretroviral Therapy in HIV-Infected Subjects [NCT00109603] | | 17 participants (Actual) | Interventional | 2005-05-31 | Completed |
Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel [NCT00111943] | Phase 2 | 200 participants (Actual) | Interventional | | Completed |
A Phase 3, Open-Label, Multicenter Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00007436] | Phase 3 | 0 participants | Interventional | | Active, not recruiting |
Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR [NCT00115609] | Phase 3 | 70 participants (Actual) | Interventional | 2006-01-31 | Completed |
Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men [NCT00131677] | Phase 2 | 400 participants (Actual) | Interventional | 2005-02-28 | Completed |
Early Intensification of Combination Antiretroviral Therapy Including FUZEON® in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 Trial [NCT00120367] | Phase 2 | 30 participants | Interventional | 2005-04-30 | Completed |
Phase I Safety and Acceptability Study of the Vaginal Microbicide Agent PMPA Gel [NCT00028132] | Phase 1 | 120 participants | Interventional | | Completed |
A Randomized, Comparative Study of Lopinavir/Ritonavir Versus GW433908 and Ritonavir Versus Lopinavir/Ritonavir and GW433908 (In Combination With Tenofovir Disoproxil Fumarate and One or Two Nucleoside Reverse Transcriptase Inhibitors) in HIV-1-Infected S [NCT00028366] | | 56 participants | Interventional | | Completed |
Safety and Efficacy of Finite Versus Continuous Nucleos(t)Ide Analogues Therapy in Patients With Chronic Hepatitis B: A Multicenter Randomized Controlled Trial [NCT05793268] | | 360 participants (Anticipated) | Interventional | 2022-12-20 | Active, not recruiting |
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 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1 [NCT00036634] | Phase 1/Phase 2 | 30 participants (Actual) | Interventional | 2002-03-31 | Completed |
A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects [NCT00043966] | Phase 3 | 200 participants | Interventional | 2002-07-31 | Completed |
A Phase II, Randomized, Open-Label Study Comparing Fixed-Dose Versus Concentration-Adjusted Lopinavir/Ritonavir Therapy in HIV-Infected Subjects on Salvage Therapy [NCT00046033] | Phase 2 | 118 participants | Interventional | | Completed |
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC [NCT01533272] | Phase 4 | 240 participants (Actual) | Interventional | 2012-02-29 | Completed |
A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV [NCT00053638] | Phase 3 | 345 participants | Interventional | 2003-02-28 | 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 |
A Phase II Study of the Predictive Value of Pharmacokinetic-Adjusted Phenotypic Susceptibility (C12h/IC50) on Antiretroviral Response to Ritonavir-Enhanced Protease Inhibitors in Subjects With Failure of Previous Protease Inhibitor-Based Regimens [NCT00027339] | Phase 2 | 53 participants (Actual) | Interventional | | Completed |
A Multicenter Clinical Trial to Evaluate the Feasibility and Outcome of Same-day Antiretroviral Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests [NCT04712058] | | 200 participants (Anticipated) | Interventional | 2021-01-20 | Recruiting |
Immunologic Consequences of Antiretroviral Therapy Intensification in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315/375 [NCT00034086] | | 22 participants | Interventional | | Completed |
A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1 [NCT00038220] | Phase 2 | 40 participants | Interventional | 2000-07-31 | Completed |
Efficacy and Safety of TAF for 48 Weeks in HBeAg Positive CHB Patients [NCT04864366] | | 150 participants (Actual) | Observational | 2021-04-30 | Active, not recruiting |
A Multicenter, Open-label, Prospective Study to Evaluate Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Combination in Subjects With Multi-drug Resistant Chronic Hepatitis B Virus Infection [NCT01594905] | Phase 4 | 90 participants (Anticipated) | Interventional | 2012-08-31 | Active, not recruiting |
A Single-dose, Open-label, Randomized, Crossover Study to Assess the Relative Bioavailability of the Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Administered Orally as a Whole Tablet, as a Split Table [NCT02984852] | Phase 1 | 30 participants (Actual) | Interventional | 2016-12-31 | Completed |
A Phase III, Randomized, Open-Label Comparison of Lopinavir/Ritonavir Plus Efavirenz Versus Lopinavir/Ritonavir Plus 2 NRTIs Versus Efavirenz Plus 2 NRTIs as Initial Therapy for HIV-1 Infection [NCT00050895] | Phase 3 | 775 participants | Interventional | | Completed |
A Pilot Study to Measure the Clearance of Replication-Competent HIV-1 in Resting Memory CD4+ Cells in HIV-1-Infected Subjects Who Receive Enfuvirtide Plus Oral Combination Antiretroviral Therapy [NCT00051831] | | 19 participants (Actual) | Interventional | 2003-10-31 | Completed |
A Phase I Study of Tenofovir Disoproxil Fumarate (PMPA Prodrug), A Novel Nucleotide Analog Reverse Transcriptase Inhibitor in Children With HIV Infection [NCT00024986] | Phase 1 | 30 participants | Interventional | 2001-10-31 | Completed |
Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients [NCT02967939] | Phase 3 | 123 participants (Actual) | Interventional | 2017-03-28 | Completed |
A Multi-centre, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate(TDF) Treatment in Chinese Chronic Hepatitis B (CHB) Subjects Following Failure of Multiple Nucleos(t)Ide Analogues(NAs) [NCT02195518] | Phase 4 | 213 participants (Actual) | Interventional | 2015-03-18 | Completed |
A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavir [NCT00158821] | Phase 3 | 180 participants (Anticipated) | Interventional | 2000-03-31 | Completed |
See Detailed Description [NCT00044577] | Phase 3 | 166 participants | Interventional | 2002-07-16 | Completed |
Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection [NCT00192595] | Phase 4 | 36 participants (Actual) | Interventional | 2004-01-31 | Completed |
Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection [NCT02650271] | Phase 3 | 240 participants (Anticipated) | Interventional | 2021-02-02 | Recruiting |
Optimizing Pediatric HIV-1 Treatment in Infants With Prophylactic Exposure to Nevirapine, Nairobi, Kenya (6-12 Month RCT) [NCT00427297] | Phase 3 | 34 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to There is no longer equipoise. DSMB recommended termination.) |
Phase I/II Study of the Pharmacokinetics, Safety and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents [NCT03332095] | Phase 1/Phase 2 | 55 participants (Actual) | Interventional | 2018-07-02 | Completed |
Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth [NCT05403047] | Phase 4 | 150 participants (Anticipated) | Interventional | 2022-07-31 | Not yet recruiting |
IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya [NCT03988387] | | 200 participants (Actual) | Interventional | 2019-10-31 | 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 |
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 [NCT03593655] | Phase 2 | 247 participants (Actual) | Interventional | 2019-01-14 | Completed |
A Phase 4, Single-Arm Study of the Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Patients With Active Illicit Substance Use [NCT03998176] | Phase 4 | 43 participants (Actual) | Interventional | 2019-10-09 | Completed |
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study [NCT01450189] | | 46 participants (Actual) | Interventional | 2011-10-31 | Completed |
Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum [NCT04518228] | | 325 participants (Anticipated) | Observational | 2021-06-08 | Recruiting |
Compassionate Use Access to REP 2139-Mg for the Treatment of Chronic HBV Infection or Chronic HBV / HDV Co-infection [NCT05683548] | | 0 participants | Expanded Access | | Available |
An Open Label Study to Examine the Characteristics of HIV Decay Following Introduction of Combination Antiretroviral Therapy Including Raltegravir During Primary and Chronic HIV Infection [NCT00641641] | | 16 participants (Actual) | Interventional | 2008-03-31 | Completed |
A Multicenter Controlled Open-label Trial of Evaluating Tenofovir Alafenamide, Tenofovir Disoproxil Fumarate and Entecavir in Acute-on-chronic Liver Failure of Chronic Hepatitis B Patients [NCT03640728] | | 200 participants (Anticipated) | Observational | 2019-01-25 | Recruiting |
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 |
Higher Risk of Kidney Function Decline With Entecavir Than Tenofovir Alafenamide in Patients With HBV Related Acute-on-chronic Liver Failure: Real-World Study [NCT05453448] | | 272 participants (Actual) | Interventional | 2022-05-01 | Completed |
Advanced Neuroimaging Evaluation of the Central Nervous System Biological Changes Associated With Efavirenz Therapy and Switch to an Elvitegravir-based Regimen [NCT01929759] | | 10 participants (Actual) | Interventional | 2014-01-31 | Completed |
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa: a Phase 3b, Open-label, Hybrid Type 2 Implementation and Effectiveness Trial [NCT06133686] | Phase 3 | 400 participants (Anticipated) | Interventional | 2024-04-01 | Not yet recruiting |
A Phase III Randomized Trial of Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus (HBV) Infection Receiving Anti-Cancer Therapy for Solid Tumors [NCT03887702] | Phase 3 | 444 participants (Anticipated) | Interventional | 2020-01-17 | Active, not recruiting |
Molecular, Biochemical and Clinical Differences Between Stavudine and Tenofovir, Each Combined With Lamivudine and Efavirenz in South African HIV-infected Patients [NCT01601899] | Phase 4 | 60 participants (Actual) | Interventional | 2008-10-31 | Terminated(stopped due to DSMB decision to begin closeout process in view of April 2010 SA HAART guideline) |
A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine Once Daily Compared to Atazanavir and Ritonavir Plus Tenofovir/Emtricitabine Once Daily in HIV-1 Infected Antiretroviral Therapy Naïve Women [NCT01910402] | Phase 3 | 499 participants (Actual) | Interventional | 2013-08-22 | Completed |
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 |
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) [NCT03471624] | Phase 4 | 270 participants (Actual) | Interventional | 2018-05-01 | Completed |
A Phase 3, Open Label, Randomised, Parallel Group Study to Compare the Effect on Prevention and Resolution of Treatment Related Adverse Events of a Simplified, Once Daily Regimen of a Fixed Dose Combination Tablet of Emtricitabine and Tenofovir DF Versus [NCT00323544] | Phase 3 | 220 participants | Interventional | 2004-10-31 | Completed |
Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO [NCT00302822] | Phase 3 | 195 participants (Actual) | Interventional | 2006-04-30 | Completed |
Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV [NCT00344760] | Phase 4 | 2 participants (Anticipated) | Interventional | 2005-01-31 | Completed |
Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women [NCT03902418] | | 1,200 participants (Actual) | Observational | 2019-08-01 | Active, not recruiting |
A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC [NCT01620944] | Phase 3 | 3 participants (Actual) | Interventional | 2012-07-31 | Terminated(stopped due to Business objectives have changed) |
Maraviroc Switch Central Nervous System (CNS) Substudy: a Substudy of MARCH, a Randomised, Open-label Study to Evaluate the Efficacy and Safety of Maraviroc (MVC) as a Switch for Either Nucleoside or Nucleotide Analogue Reverse Transcriptase Inhibitors (N [NCT01637233] | | 28 participants (Actual) | Observational | 2012-06-30 | Completed |
Maraviroc Switch Collaborative Study Renal Substudy [NCT01637259] | Phase 4 | 76 participants (Actual) | Interventional | 2012-06-30 | Completed |
A Multicenter Randomized Controlled Open-label Trial of Tenofovir vs. Tenofovir Plus Entecavir in Chronic Hepatitis B Patients With Genotypic Resistance to Entecavir and Partial Virologic Response to Ongoing Treatment [NCT01639092] | Phase 4 | 88 participants (Actual) | Interventional | 2012-09-28 | Completed |
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Tenofovir Disoproxil Fumarate in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00002450] | Phase 3 | 600 participants | Interventional | | Completed |
Changes in Weight After Switch to Dolutegravir/Lamivudine or Doravirine/Tenofovir/Lamivudine Compared to Continued Treatment With Dolutegravir/Tenofovir/Lamivudine for Virologically Suppressed HIV Infection. AVERTAS-2 [NCT04903847] | Phase 4 | 126 participants (Anticipated) | Interventional | 2021-02-02 | Recruiting |
A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Viro [NCT04129554] | Phase 2 | 130 participants (Actual) | Interventional | 2019-11-06 | Completed |
Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study [NCT01694017] | Phase 4 | 68 participants (Actual) | Interventional | 2012-11-30 | Completed |
Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir [NCT00592124] | Phase 2 | 168 participants (Actual) | Interventional | 2008-06-30 | Completed |
The Pharmacokinetic Parameters of Tenofovir (TFV) in Maternal Blood and Breast Milk in Women Treated With Daily Tenofovir Disoproxil Fumarate (TDF; 300mg) for Prevention of Mother to Child Transmission (PMTCT) of Hepatitis B Virus (HBV) Mono-infection [NCT04114890] | Phase 2 | 27 participants (Actual) | Interventional | 2021-01-08 | Active, not recruiting |
What is the Impact of Current HIV Medication Regimens on Endothelial Dysfunction? [NCT03782142] | | 22 participants (Actual) | Observational | 2018-11-01 | Completed |
A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine [NCT01701882] | Phase 3 | 40 participants (Actual) | Interventional | 2012-09-30 | Completed |
A Prospective and Open-Label Study of the Effect on Proximal Tubular Function in Asian-American Patients Receiving Tenofovir Disoproxil Fumarate (TDF) or Entecavir (ETV) for HBV Treatment [NCT01715987] | | 48 participants (Actual) | Observational | 2012-10-31 | Terminated |
A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B. [NCT01732224] | | 69 participants (Actual) | Interventional | 2012-11-30 | Completed |
Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA. [NCT01732367] | Phase 4 | 171 participants (Actual) | Interventional | 2012-11-30 | Completed |
A Phase IIa, Randomized, Double-blind, Active-controlled, 12-week Study of Amdoxovir (Two Doses) Versus Tenofovir DF, in Combination With Zidovudine in HIV-1 Treatment-experienced Subjects With M184I/V Mutation in Addition to 0-2 Confirmed Thymidine Analo [NCT01737359] | Phase 2 | 2 participants (Actual) | Interventional | 2012-12-31 | Terminated |
Long-term Study to Observe Safety and Efficacy of TAF in Patients With Chronic Hepatitis B [NCT03489239] | Phase 3 | 27 participants (Actual) | Interventional | 2017-11-16 | Active, not recruiting |
Nevirapine vs Ritonavir-boosted Lopinavir in ART HIV-infected Adults in a Resource-limited Setting; a Randomized, Multicenter, Parallel Group Study [NCT01772940] | Phase 4 | 425 participants (Actual) | Interventional | 2008-12-31 | Completed |
Virological and Immunological Safety of a Dose Reduction Strategy Antiretroviral Regimen With Efavirenz / Tenofovir / Emtricitabine [NCT01778413] | Phase 4 | 60 participants (Actual) | Interventional | 2013-05-31 | Completed |
In Vivo Drug Interaction Pharmacokinetic Study of Tenofovir 1% Gel and Three Commonly Used Vaginal Products [NCT01813162] | Phase 1 | 101 participants (Actual) | Interventional | 2013-12-31 | Completed |
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine With the Omission of Immune Globulin to Prevent Hepatitis B Transmission in Mother With High Viral Load: A Multi-Center, Prospective, Randomized and Open-Label Study [NCT03476083] | Phase 4 | 280 participants (Anticipated) | Interventional | 2018-06-10 | Recruiting |
Efficacy and Safety Evaluation of TDF-based Regimen in Thai HIV-infected Children [NCT01815255] | | 36 participants (Actual) | Observational | 2010-12-31 | Completed |
A Pilot Demonstration Project to Operationalize Pre-exposure Prophylaxis as Part of Combination HIV Prevention Among Men Who Have Sex With Men (MSM) and Transgender Women in Los Angeles County [NCT01781806] | Phase 4 | 328 participants (Actual) | Interventional | 2013-05-31 | Completed |
A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) [NCT02397096] | Phase 3 | 673 participants (Actual) | Interventional | 2015-06-09 | 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 |
Phase 3, Randomized Clinical Trial to Assess the Efficacy and Safety of Tenofovir in Hepatitis B Virus Infected, s and e Antigen Positive, Pregnant Women to Prevent Perinatal Transmission Despite Infant Passive-active HBV Immunization. [NCT01745822] | Phase 3 | 654 participants (Actual) | Interventional | 2013-01-31 | Completed |
Effects of Biectegravir-Emtricitabine-Tenofovir Alafenamide on Coronary Flow Reserve in Stable HIV Patients (B/F/TAF-CFR) - Pilot Study [NCT03656783] | Phase 3 | 25 participants (Actual) | Interventional | 2018-09-14 | Completed |
The Efficacy and Safety of Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection [NCT04296695] | Phase 4 | 250 participants (Anticipated) | Interventional | 2021-07-14 | Active, not recruiting |
Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects [NCT01803074] | Phase 2 | 107 participants (Actual) | Interventional | 2013-04-04 | Completed |
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Antiviral Activity of the Addition of PMPA Prodrug to Combination Antiretroviral Regimens in Treatment-Experienced HIV-Infected Patients [NCT00002415] | Phase 2 | 175 participants | Interventional | | Completed |
A Phase 2b, Double-Blind, Placebo-Controlled, Exploratory Randomized Trial to Determine the Bone, Immunologic, Virologic, and Neurocognitive Effects of a Novel Maraviroc-Containing Antiretroviral Regimen in Treatment-Naïve Patients Infected With R5-Tropic [NCT01400412] | Phase 2 | 262 participants (Actual) | Interventional | 2012-01-17 | Completed |
Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b [NCT04195074] | | 300 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
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 |
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection [NCT05410496] | Phase 4 | 50 participants (Anticipated) | Interventional | 2021-06-22 | Recruiting |
Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial [NCT04359095] | Phase 2/Phase 3 | 650 participants (Actual) | Interventional | 2020-08-18 | Completed |
Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV. [NCT03126370] | Phase 4 | 10 participants (Actual) | Interventional | 2018-01-08 | Completed |
Investigation on Antiviral Therapy of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B Patients Based on Detection of Interferon Gene Mutation and Interferon Receptor [NCT02973646] | Phase 4 | 100 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients [NCT03018821] | | 250 participants (Anticipated) | Interventional | 2017-01-31 | 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 |
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 |
A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads [NCT01044771] | | 20 participants (Actual) | Interventional | 2010-01-31 | 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 |
Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (ECF/TAF) Switch Followed by Ledipasvir-Sofosbuvir HCV Therapy in HIV-HCV Co-Infection: A CIHR Canadian HIV Trials Network-Gilead Pilot Trial Proposal [NCT02660905] | Phase 3 | 25 participants (Actual) | Interventional | 2016-04-30 | Completed |
Clinical Efficacy and Safety of Tenofovir Disoproxil Fumarate and Entcavir in Treatment of Chronic Hepatitis B Patients in Upper Egypt [NCT05874440] | | 100 participants (Anticipated) | Observational | 2023-04-15 | Recruiting |
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 |
Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV [NCT03043326] | | 1,000 participants (Anticipated) | Observational | 2017-01-23 | 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 |
TEN Switch - An Observational Phase IV Study to Evaluate the Safety and Efficacy of Substituting Tenofovir for Didanosine in Virologically Controlled HIV-infected Patients Co-infected With Hepatitis C Virus. [NCT00358696] | Phase 4 | 30 participants (Anticipated) | Interventional | 2006-07-31 | Completed |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Positive, [NCT02452528] | Phase 2 | 4 participants (Actual) | Interventional | 2015-08-31 | Terminated(stopped due to Company decision to discontinue trial) |
The Efficacy and Safety of Tenofovir Alafenamide Fumarate Compared With Other Nucleoside Analogues (Acid) to Treat Patients With Low-level Viremia of HBV [NCT04501224] | | 200 participants (Anticipated) | Interventional | 2020-08-03 | Recruiting |
A Phase 2b Study to Evaluate the Efficacy, Safety and PK of a Combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for Treatment of HIV-1 Infection in Patients With Drug-susceptible Tuberculosis on a Rifampicin-based Regimen [NCT04734652] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-02-18 | Recruiting |
A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH) [NCT02577029] | Phase 2 | 79 participants (Actual) | Interventional | 2015-12-31 | Terminated(stopped due to Company decision to discontinue trial) |
A Phase 1, Drug-Drug Interaction Study to Evaluate the Safety, Tolerability, and the Induction Potential of TBAJ-876 on CYP3A4 and P-glycoprotein and the Inhibition Potential of TBAJ-876 on P-glycoprotein in Healthy Adult Subjects [NCT05526911] | Phase 1 | 28 participants (Actual) | Interventional | 2022-07-20 | Completed |
A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With HBeAg Negative, [NCT02604199] | Phase 2 | 58 participants (Actual) | Interventional | 2015-09-30 | Terminated(stopped due to Company decision to discontinue trial) |
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 |
A Randomized, Double Blind Phase 1 Safety, Acceptability, and Pharmacokinetic Study Comparing Three Formulations of Tenofovir 1% Gel Administered Rectally to HIV-1 Seronegative Adults [NCT01575405] | Phase 1 | 13 participants (Actual) | Interventional | 2013-03-31 | Completed |
An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations [NCT01575418] | Phase 1 | 9 participants (Actual) | Interventional | 2013-03-31 | Completed |
Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir [NCT01576731] | Phase 4 | 240 participants (Actual) | Interventional | 2012-07-31 | Completed |
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection [NCT04507607] | Early Phase 1 | 50 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
A Study to Evaluate the Potential Drug-Drug Interaction Between Danoprevir When Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir in Healthy Adult Volunteers [NCT01592305] | Phase 1 | 40 participants (Actual) | Interventional | 2012-05-31 | Completed |
Randomized Study Comparing Nucleoside Analogues Plus Tenofovir and Nucleoside Analogues Plus Adefovir in Chronic Hepatitis B Patients With Suboptimal Response to Adefovir-based Combination Therapy Due to Nucleoside Analogues Resistance [NCT01595633] | Phase 4 | 124 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
Bone Health in Aging HIV Infected Women: Improvement or Prevention of Changes in Bone Mineral Density by Switching Antiretroviral Agents. Is There an Optimal Time to Intervene? [NCT02815566] | Phase 4 | 34 participants (Actual) | Interventional | 2017-09-12 | 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 |
A Phase 1 Open Label Study Evaluating the Distribution of a Tenofovir Douche in Combination With Tap Water Douching and Simulated Receptive Anal Intercourse (DREAM-02) [NCT04195776] | Phase 1 | 6 participants (Actual) | Interventional | 2021-06-01 | Completed |
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women [NCT03220152] | Phase 4 | 120 participants (Anticipated) | Interventional | 2017-07-10 | Recruiting |
CCTG584: Viral Dynamics and Pharmacokinetics of Tenofovir and Abacavir Monotherapy Versus the Combination Therapy of TDF-ABC in HIV-Infected Treatment Naive Patients [NCT00214890] | Phase 2 | 21 participants (Actual) | Interventional | 2004-12-07 | Completed |
Serologic and Virologic Outcomes of Tenofovir in Asian Chronic Hepatitis B Patients With Prior Nucleoside Analogue Exposure [NCT01728935] | | 141 participants (Actual) | Interventional | 2008-04-30 | Completed |
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, and Pharmacokinetics, and Antiviral Activity of 9-[(R)-2-(Phosphonomethoxy)Propyl] Adenine (PMPA) in HIV-Infected Patients [NCT00002180] | Phase 1 | 0 participants | Interventional | | Completed |
PrEP Adherence Monitoring Using Dried Blood Spots [NCT02022657] | Phase 1/Phase 2 | 52 participants (Actual) | Interventional | 2014-04-30 | Completed |
A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicis [NCT02431247] | Phase 3 | 725 participants (Actual) | Interventional | 2015-07-06 | Completed |
SWITCH OR ADD PEGYLATED-INTERFERON IN CHRONIC HEPATITIS B PATIENTS ON LONG TERM NUCLEOS(T)IDE THERAPY (SWAP TRIAL) [NCT01928511] | Phase 4 | 254 participants (Actual) | Interventional | 2014-01-31 | 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 |
A Switch Clinical Trial of Antiretrovirals to Compare the Impact of Doravirine Versus Integrase Inhibitors With Backbone of Emtricitabine and Tenofovir Alafenamide on Instigators of Atherosclerosis in Persons With Chronic Treated HIV. [NCT04820933] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2024-02-01 | Not yet recruiting |
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 |
A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1 [NCT03499483] | Phase 4 | 52 participants (Actual) | Interventional | 2019-01-24 | Completed |
Express Testing and Same-day Initiation of PrEP [NCT05690815] | | 816 participants (Anticipated) | Observational | 2023-01-24 | Recruiting |
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 |
Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects [NCT00365339] | Phase 1 | 40 participants | Interventional | 2006-04-30 | Completed |
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir [NCT05423834] | | 1,800 participants (Anticipated) | Observational [Patient Registry] | 2022-09-01 | Active, not recruiting |
Pharmacokinetic Study of an Optimized Dose Ratio of Dolutegravir/Emtricitabine/Tenofovir Alafenamide Fumarate: Expediting a UNIVERSAL First Line Regimen for All Children Living With HIV in Africa [NCT05993767] | Phase 2 | 50 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting |
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women [NCT03060785] | Phase 1 | 16 participants (Actual) | Interventional | 2016-03-08 | Completed |
Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy and Tolerability of Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir DF Compared to Unmodified HAART in HIV-1 Infected Subjects Who Have Achieved Virological Suppression on [NCT00365612] | Phase 4 | 300 participants (Anticipated) | Interventional | 2006-07-31 | Completed |
Feasibility of Short-Term PrEP Uptake for MSM With Episodic High-Risk for HIV [NCT02495779] | | 54 participants (Actual) | Interventional | 2015-07-31 | Completed |
Gender-Specific Combination HIV Prevention for Youth in High Burden Settings (MP3-Youth) [NCT01571128] | | 1,215 participants (Actual) | Interventional | 2014-11-30 | Completed |
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs [NCT03537404] | Phase 1 | 36 participants (Actual) | Interventional | 2017-04-24 | Completed |
A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. Switching [NCT01709084] | Phase 3 | 426 participants (Actual) | Interventional | 2013-10-02 | Completed |
HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) [NCT02437110] | Phase 1 | 122 participants (Actual) | Interventional | 2019-04-01 | Active, not recruiting |
Combination Therapy of Tenofovir and Telbivudine in Immune-tolerant Patients With Chronic Hepatitis B Awaiting Assisted Reproduction [NCT02338674] | Phase 1/Phase 2 | 121 participants (Actual) | Interventional | 2014-10-31 | Completed |
Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision Through Family Planning Services in KwaZulu-Natal, South Africa [NCT01691768] | Phase 2/Phase 3 | 372 participants (Actual) | Interventional | 2012-10-31 | Completed |
Western Australian Pre-exposure Prophylaxis for HIV Implementation Trial [NCT03327155] | Phase 3 | 900 participants (Actual) | Interventional | 2017-11-16 | Completed |
Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis [NCT04880577] | Phase 2 | 0 participants (Actual) | Interventional | 2022-09-15 | Withdrawn(stopped due to Funding) |
Investigating Influence of Pregnancy-induced Changes in Antiretroviral Pharmacokinetics, Together With Polymorphisms in Drug Disposition Genes, on Viral Decay Dynamics in HIV Positive Women Starting Therapy Late in Pregnancy and Postpartum [NCT03284645] | | 194 participants (Actual) | Observational | 2017-12-22 | Completed |
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance, Pharmacokinetics, and Antiviral Activity of 9-[2-(R)-[[Bis[[(Isopropoxycarbonyl)- Oxy]Methoxy]Phosphinoyl]Methoxy]Propyl]Adenine Fumarate (PMPA Prodrug) in HIV-Infe [NCT00002396] | Phase 1 | 60 participants | Interventional | | Active, not recruiting |
Study of the Feasibility and Acceptability of an Adherence Promotion Package for Postpartum Women on Pre-exposure Prophylaxis (PrEP) [NCT04897737] | | 106 participants (Actual) | Interventional | 2020-11-05 | Completed |
Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor for Determining Adherence Using Different Dosing Regimens of Disoproxil Fumarate/Emtricitabine (TDF/FTC) [NCT04870671] | Early Phase 1 | 14 participants (Actual) | Interventional | 2021-03-08 | Completed |
Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK- [NCT02116660] | Phase 2 | 11 participants (Actual) | Interventional | 2014-09-03 | Terminated(stopped due to This study was terminated early due to poor recruitment.) |
Pharmacokinetics Study of Tenofovir in HIV-infected Thai Children Using Tenofovir-based Regimen [NCT02404259] | | 32 participants (Actual) | Interventional | 2010-06-30 | Completed |
Comprehensive HIV Prevention Package for MSM in Port Elizabeth [NCT02449733] | | 101 participants (Actual) | Interventional | 2015-05-31 | Completed |
An Open-Label, Multicenter, Compassionate Access Study of the Safety of Tenofovir Disoproxil Fumarate Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Patients [NCT00002453] | | 300 participants | Interventional | 1999-12-31 | Completed |
A Prospective Cohort Study of Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B Patients Who Are Unsatisfied to Entecavir Therapy [NCT05583006] | | 60 participants (Anticipated) | Observational | 2023-11-06 | Recruiting |
A Multiple-Center, Randomized, Partially Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Effects of 12-Week Treatment With RO6864018 in Virologically Suppressed Patients Wit [NCT02391805] | Phase 2 | 31 participants (Actual) | Interventional | 2015-05-17 | Completed |
Baseline Characteristics and Long Term Clinical Outcomes of Patients Using Malawi's New First Line Antiretroviral Regimen at Lighthouse: The Lighthouse Tenofovir Cohort [NCT02381275] | | 1,500 participants (Actual) | Observational | 2014-08-14 | Active, not recruiting |
Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy [NCT02369965] | Phase 3 | 418 participants (Actual) | Interventional | 2014-02-19 | Completed |
Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial [NCT04231565] | | 100 participants (Anticipated) | Interventional | 2021-01-31 | Recruiting |
A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir [NCT02039323] | Phase 1 | 6 participants (Actual) | Interventional | 2014-02-28 | Completed |
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females - A Sub-study of HPTN 084 [NCT04824131] | Phase 2 | 50 participants (Actual) | Interventional | 2020-11-04 | Completed |
A Pilot Study to Assess Virologic Suppression and Immune Recovery With Raltegravir and Lopinavir/Ritonavir and Raltegravir and Emtricitabine/Tenofovir in HIV-1 Infected Treatment-naïve Subjects [NCT00654147] | Phase 2 | 44 participants (Actual) | Interventional | 2008-04-30 | Completed |
A Multi-centre, Open Label, Parallel Group Trial to Evaluate the Pharmacokinetic Interactions Between BI 207127 (600 mg t.i.d. or 600 mg b.i.d.) and BI 201335 (120 mg q.d.) Given in Combination With Ribavirin for 24 Weeks, and Their Combined Effect on the [NCT01525628] | Phase 1 | 72 participants (Actual) | Interventional | 2012-04-30 | Completed |
A Single-center, Randomized, Open-label, Active-controlled Phase Ic/IIb Study to Evaluate the Efficacy,Safety and Pharmacokinetics of Hepenofovir Fumarate Tablets in Patients With CHB [NCT06122454] | Phase 1/Phase 2 | 48 participants (Anticipated) | Interventional | 2022-11-10 | Recruiting |
A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects [NCT00244712] | Phase 4 | 688 participants (Actual) | Interventional | 2005-07-31 | Completed |
Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir [NCT01283555] | | 25 participants (Actual) | Interventional | 2011-01-31 | Completed |
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study [NCT02245022] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2017-03-14 | Completed |
Artery Elasticity After Switch From Epzicom to Truvada [NCT00998582] | Phase 4 | 27 participants (Actual) | Interventional | 2009-10-31 | Terminated(stopped due to Low enrollment) |
A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults [NCT02386098] | Phase 2 | 86 participants (Actual) | Interventional | 2015-07-08 | Terminated(stopped due to GI Intolerability) |
Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis [NCT04196998] | | 150 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
Parrying the Pitfalls of PrEP: Preventing Premature PrEP Discontinuation and STIs Among MSM [NCT05072093] | Phase 4 | 200 participants (Anticipated) | Interventional | 2021-11-20 | Recruiting |
A Prospective, Randomized, Open-label Study of the Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCC [NCT03084250] | Phase 4 | 150 participants (Anticipated) | Interventional | 2017-03-10 | Active, not recruiting |
Pharmacoepidemiology Study to Define the Long-term Safety Profile of Tenofovir Disoproxil Fumarate (Tenofovir DF, Viread®) and Describe the Management of Tenofovir DF-associated Renal and Bone Toxicity in Chronic Hepatitis B (CHB)-Infected Adolescents Age [NCT02479880] | Phase 4 | 30 participants (Actual) | Interventional | 2015-07-03 | Terminated |
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 |
Hellenic Multicenter Real-life Clinical Study for Bulevirtide Therapy in Chronic Hepatitis D: HERACLIS-BLV [NCT05928000] | | 80 participants (Anticipated) | Observational [Patient Registry] | 2023-05-01 | Recruiting |
A Prospective Randomized Controlled Trial of Tenofovir and Entecavir in the Treatment of Long-term Prognosis in Patients With Hepatitis B-related Hepatocellular Carcinoma After Curative Resection [NCT04392700] | Phase 3 | 706 participants (Anticipated) | Interventional | 2019-07-25 | Recruiting |
Dose-Proportionality and Intra-Individual Variability of Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate In Healthy Volunteers [NCT01276600] | Phase 1 | 32 participants (Actual) | Interventional | 2011-01-31 | Completed |
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere) [NCT01066858] | | 1,765 participants (Actual) | Observational | 2011-03-22 | 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 |
A Multicenter, Open-label, Single Arm Trial for the Effectiveness of Antiviral Treatment in Cirrhotic Patients With Low-level Hepatitis B Virus DNA Levels With a Comparison to Matched Historical Controls (ATTACH) [NCT04780204] | Phase 4 | 200 participants (Anticipated) | Interventional | 2021-08-23 | Recruiting |
A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients [NCT03780543] | Phase 2 | 92 participants (Actual) | Interventional | 2018-12-20 | Terminated(stopped due to Sponsor decision) |
Delivery of Pre-exposure Prophylaxis to Individuals With High Sexual Risk of HIV Infection in Hong Kong - an Implementation Study [NCT04367688] | | 400 participants (Anticipated) | Observational | 2020-03-01 | Recruiting |
A Randomized, Blinded, 12-week Comparison of Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected Treatment-naive Participants. There is a 36 Week, Open-label, Extension Phase for Eligible Participants. [NCT00350272] | Phase 2 | 76 participants (Actual) | Interventional | 2006-05-31 | Completed |
A Multi-Center, Randomized, Open-label, Parallel, Active-controlled, Non-inferiority, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of Switching to Tenolid Tab (Tenofovir Disoproxil) From Viread Tab (Tenofovir Disoproxil Fumarate) in Chronic [NCT05286346] | Phase 4 | 113 participants (Actual) | Interventional | 2018-10-12 | Completed |
A Phase 2A Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose Ranging Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepat [NCT04847440] | Phase 2 | 40 participants (Actual) | Interventional | 2021-03-30 | Terminated(stopped due to Terminated by the Sponsor) |
Pilot Study of Raltegravir/Tenofovir/Emtricitabine Versus Efavirenz/Tenofovir/Emtricitabine for Adults With Acute HIV-1 Infection: Exploring the Role of Integrase Inhibition in Early HIV Pathogenesis [NCT00734344] | | 18 participants (Actual) | Interventional | 2008-09-30 | Completed |
A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppres [NCT01641809] | Phase 2 | 244 participants (Actual) | Interventional | 2012-08-06 | Completed |
Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and Antiretroviral Therapy (ART) [NCT01903031] | Phase 2 | 84 participants (Actual) | Interventional | 2014-12-30 | Completed |
A Randomized, Open-label, Multi-part Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers [NCT03032536] | Phase 1 | 54 participants (Actual) | Interventional | 2017-01-31 | Terminated(stopped due to Sponsor decision.) |
A Pilot Project to Operationalize the Prevention Strategy of Post Exposure Prophylaxis Following Sexual Exposure to HIV in Combination With Educational Programming and Behavioral Risk Reduction Strategies in Los Angeles County [NCT00949234] | Phase 2 | 267 participants (Actual) | Interventional | 2010-03-31 | 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 |
PrEP Point-of-Care Brief-Intervention for Adherence Among Young Men Who Have Sex With Men [NCT05353283] | | 60 participants (Anticipated) | Interventional | 2023-09-01 | Recruiting |
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 |
DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV: an Open-label Randomized Clinical Trial [NCT04884139] | Phase 4 | 555 participants (Anticipated) | Interventional | 2021-07-14 | Active, not recruiting |
Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence [NCT02447016] | Phase 4 | 25 participants (Actual) | Interventional | 2015-05-31 | Terminated(stopped due to no more participants taking atripla) |
Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease [NCT05063071] | Phase 4 | 150 participants (Anticipated) | Interventional | 2021-07-29 | Active, not recruiting |
An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects [NCT03070405] | Phase 1 | 20 participants (Anticipated) | Interventional | 2016-10-31 | Active, not recruiting |
A Phase 1, Blinded, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-64457744 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Ascending Doses [NCT05423106] | Phase 1 | 60 participants (Actual) | Interventional | 2022-07-04 | Terminated(stopped due to Strategic business decision, not due to safety concerns) |
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States [NCT00414518] | | 16 participants (Actual) | Interventional | 2007-01-31 | Completed |
A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Versus Adefovir Added to Continuing Lamivudine in Adults With Lamivudine- Resistant Chronic Hepatitis B Virus Infection [NCT00605384] | Phase 3 | 4 participants (Actual) | Interventional | 2008-08-31 | Terminated(stopped due to Business Objectives Have Changed) |
A Randomized Controlled Pilot Trial Comparing Continued Antiretroviral Therapy With Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) With Switch to Tenofovir/Emtricitabine/Raltegravir (TDF/FTC/RAL) on Changes in Endothelial Function and Markers of Bone Met [NCT01270802] | Phase 4 | 30 participants (Actual) | Interventional | 2011-04-30 | 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 Real-World Study of Sequential Combination Therapy With Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B [NCT03357822] | Phase 4 | 2,000 participants (Anticipated) | Interventional | 2018-01-25 | Recruiting |
The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community [NCT03120936] | Phase 4 | 158 participants (Actual) | Interventional | 2017-08-08 | 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 |
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks [NCT02470650] | Phase 4 | 150 participants (Anticipated) | Interventional | 2015-06-30 | Recruiting |
A Prospective, Single-Arm, Open-Label Study to Evaluate the Effect of Fixed-Dose Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate on T-Cell Activation, Absolute CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir in Treatment-Naïve HIV-1 [NCT01777997] | Phase 4 | 38 participants (Actual) | Interventional | 2013-04-25 | Completed |
Treatment of Hepatitis B in Resource-limited Settings - a Pilot Program in East Africa [NCT02344498] | | 1,350 participants (Actual) | Observational | 2015-01-31 | 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 |
Comparison of Pharmacokinetics of Tenofovir Alafenamide (TAF) With Tenofovir Disoproxil (TDF) in Pregnant and Postpartum Women and Their Infants in PrEP-PP Study [NCT04937881] | Phase 3 | 50 participants (Actual) | Interventional | 2022-06-13 | Completed |
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety, Efficacy and Dose-Response of BMS-663068 in Treatment-experienced HIV-1 Subjects, Followed by an Open-Label Period on the Recommended Dose [NCT01384734] | Phase 2 | 254 participants (Actual) | Interventional | 2011-07-26 | Completed |
Combined HIV Adolescent PrEP and Prevention: On Demand Pre-exposure Prophylaxis to Provide Protection From HIV in Men - Using Foreskin Tissue to Estimate Protection (Phase II) [NCT03986970] | Phase 2 | 72 participants (Actual) | Interventional | 2019-11-11 | Completed |
Community-based Venues for Delivery of Healthcare Services in Umlazi, South Africa: Proof of Concept Pilot Conducted in Hair Salons [NCT04222504] | | 500 participants (Anticipated) | Interventional | 2021-02-08 | Recruiting |
A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects [NCT04551261] | Phase 1 | 28 participants (Actual) | Interventional | 2021-01-10 | Completed |
Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for W [NCT02302547] | Phase 3 | 224 participants (Actual) | Interventional | 2014-12-31 | Completed |
A Multi-centre, Prospective, Randomised Trial of Short Course Alendronate Therapy or Placebo Combined With Vitamin D and Calcium to Prevent Loss of Bone Mineral Density in Antiretroviral-naïve, HIV-1 Infected Subjects Initiating Antiretroviral Therapy [NCT02322099] | Phase 4 | 53 participants (Actual) | Interventional | 2016-05-31 | Terminated(stopped due to Due to the COVID-19 pandemic the study was terminated prematurely) |
The Safety of Anti-viral Therapy in Preventing Mother-to-child Transmission of Hepatitis B Virus in Pregnant Women After Discontinuation [NCT03468907] | Phase 4 | 111 participants (Actual) | Interventional | 2015-06-01 | Completed |
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment [NCT05398393] | | 150 participants (Anticipated) | Interventional | 2022-01-01 | Enrolling by invitation |
A Phase 1b Randomized, Open Label, Active-Controlled Study to Assess the Safety, Viral Kinetics, and Anti-HBV Activity of GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B (CHB) Infection [NCT01671787] | Phase 1 | 51 participants (Actual) | Interventional | 2012-03-31 | Completed |
A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Expo [NCT01505114] | Phase 2 | 594 participants (Actual) | Interventional | 2012-06-30 | Completed |
Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE) [NCT04249037] | Phase 4 | 10 participants (Actual) | Interventional | 2020-12-15 | Terminated(stopped due to Insufficient enrollment) |
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 |
Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project [NCT04331704] | Phase 4 | 88 participants (Anticipated) | Interventional | 2021-01-12 | Recruiting |
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 |
An Open-label Rollover Study in Chinese Patients After Finishing a 3-year Randomize Trial for Chronic Hepatitis B With High Serum Viral Load But Mild Elevated Aminotransferase [NCT02463019] | Phase 4 | 160 participants (Anticipated) | Interventional | 2015-01-31 | Enrolling by invitation |
Simplifying Hepatitis B Care in Pregnancy by Combining Birth-dose Vaccine and Tenofovir: The COMBAT HBV Feasibility Trial [NCT05705427] | Phase 4 | 560 participants (Anticipated) | Interventional | 2023-08-17 | Recruiting |
Utilization of Hepatitis B Virus Nucleic Acid Test Positive Donors for Hepatitis B Vaccinated Lung Transplant Candidates [NCT05404919] | Phase 2 | 10 participants (Anticipated) | Interventional | 2022-09-06 | Recruiting |
Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Entecavir Plus Tenofovir Combination Therapy-Multicenter Randomized [NCT03236610] | Phase 3 | 112 participants (Anticipated) | Interventional | 2016-01-01 | Recruiting |
"Phase IV, Single-center, Open Study to Evaluate the Benefits of the Start of Immediate Treatment Without Immunovirological Data (Same Day Treatment) Compared to Conventional Treatment With BIC / FTC / TAF (Bictegravir/Emtricitabina/Tenofovir) in Naive Pa [NCT05606055] | Phase 4 | 100 participants (Actual) | Interventional | 2020-12-01 | Completed |
The Incidence of Postpartum Hepatitis in Pregnant Women With High HBVDNA Loads [NCT03214302] | | 560 participants (Anticipated) | Interventional | 2017-01-01 | Recruiting |
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial [NCT03933384] | Phase 4 | 420 participants (Anticipated) | Interventional | 2019-08-19 | Recruiting |
Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection [NCT04483674] | Phase 2 | 66 participants (Anticipated) | Interventional | 2020-12-04 | Recruiting |
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment [NCT02174276] | Phase 2 | 195 participants (Actual) | Interventional | 2014-07-24 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24 |
NCT00035932 (38) [back to overview] | Mean Change From Baseline in HIV RNA at Week 96 |
NCT00035932 (38) [back to overview] | Mean Change From Baseline in HIV RNA at Week 48 |
NCT00035932 (38) [back to overview] | Mean Change From Baseline in HIV RNA at Week 2 |
NCT00035932 (38) [back to overview] | Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24 |
NCT00035932 (38) [back to overview] | Fasting Glucose Mean Change From Baseline at Week 48 |
NCT00035932 (38) [back to overview] | HIV IC50 at Week 24 |
NCT00035932 (38) [back to overview] | PR Interval and Change From Baseline by Analysis Time Point |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) |
NCT00035932 (38) [back to overview] | Most Common AEs and AEs of Interest Through Week 48 |
NCT00035932 (38) [back to overview] | Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) |
NCT00035932 (38) [back to overview] | Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) |
NCT00035932 (38) [back to overview] | Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values |
NCT00035932 (38) [back to overview] | Lipid Mean Percent Change From Baseline at Week 96, Observed Values |
NCT00035932 (38) [back to overview] | Lipid Mean Percent Change From Baseline at Week 48 |
NCT00035932 (38) [back to overview] | Lipid Mean Percent Change From Baseline at Week 24 |
NCT00035932 (38) [back to overview] | HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 |
NCT00035932 (38) [back to overview] | Grade 3/4 Laboratory Abnormalities Through Week 48 |
NCT00035932 (38) [back to overview] | Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point |
NCT00035932 (38) [back to overview] | Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 |
NCT00035932 (38) [back to overview] | Inhibitory Quotient at Week 24 |
NCT00035932 (38) [back to overview] | Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 |
NCT00035932 (38) [back to overview] | Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96 |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48 |
NCT00035932 (38) [back to overview] | Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96 |
NCT00035932 (38) [back to overview] | Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48 |
NCT00035932 (38) [back to overview] | Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 |
NCT00035932 (38) [back to overview] | Change From Baseline in CD4 Cell Count at Week 24 |
NCT00035932 (38) [back to overview] | Change From Baseline in CD4 Cell Count at Week 48 |
NCT00035932 (38) [back to overview] | Change From Baseline in CD4 Cell Count at Week 96 |
NCT00035932 (38) [back to overview] | Fasting Glucose Mean Change From Baseline at Week 24 |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs |
NCT00042289 (26) [back to overview] | Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs |
NCT00042289 (26) [back to overview] | Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms |
NCT00042289 (26) [back to overview] | Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms |
NCT00042289 (26) [back to overview] | Plasma Concentration for Contraceptives |
NCT00042289 (26) [back to overview] | PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs |
NCT00074581 (2) [back to overview] | Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
NCT00074581 (2) [back to overview] | All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Treatment Failure (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Treatment Failure (PI Comparison) |
NCT00084136 (18) [back to overview] | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) |
NCT00084136 (18) [back to overview] | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) |
NCT00084136 (18) [back to overview] | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Immunologic Failure (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Immunologic Failure (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) |
NCT00089505 (9) [back to overview] | Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month |
NCT00089505 (9) [back to overview] | Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry |
NCT00089505 (9) [back to overview] | Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen. |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced Virologic Failure or Died. |
NCT00089505 (9) [back to overview] | Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality |
NCT00089505 (9) [back to overview] | CD4 Count Change From Randomization |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced HIV-related Disease Progression or Death |
NCT00089505 (9) [back to overview] | Percent of Participants Who Experienced Virologic Failure or Died |
NCT00090779 (9) [back to overview] | Number of Participants in IT Arm Off Treatment Before 36 Weeks |
NCT00090779 (9) [back to overview] | Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00090779 (9) [back to overview] | Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00090779 (9) [back to overview] | Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm |
NCT00090779 (9) [back to overview] | Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm |
NCT00090779 (9) [back to overview] | Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%. |
NCT00090779 (9) [back to overview] | Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm |
NCT00090779 (9) [back to overview] | Time to Treatment Initiation or Death |
NCT00090779 (9) [back to overview] | Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00099632 (5) [back to overview] | Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping |
NCT00099632 (5) [back to overview] | Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. |
NCT00099632 (5) [back to overview] | Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. |
NCT00099632 (5) [back to overview] | Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12 |
NCT00099632 (5) [back to overview] | Number of Participants Who Discontinued Study Treatment Prematurely |
NCT00100048 (26) [back to overview] | Change From Baseline in CD4 Cell Count at Week 96 |
NCT00100048 (26) [back to overview] | Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II) |
NCT00100048 (26) [back to overview] | Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II) |
NCT00100048 (26) [back to overview] | Change From Baseline in Plasma HIV RNA at Week 240 |
NCT00100048 (26) [back to overview] | Change From Baseline in Plasma HIV RNA at Week 96 |
NCT00100048 (26) [back to overview] | Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I) |
NCT00100048 (26) [back to overview] | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II) |
NCT00100048 (26) [back to overview] | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240 |
NCT00100048 (26) [back to overview] | Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48 |
NCT00100048 (26) [back to overview] | Number of Patients With Laboratory Adverse Experiences (LAEs) |
NCT00100048 (26) [back to overview] | Number of Patients With Serious CAEs and Non-serious CAEs at Week 144 |
NCT00100048 (26) [back to overview] | Change From Baseline in CD4 (T-helper) Cell Count at Week 240 |
NCT00100048 (26) [back to overview] | Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96 |
NCT00100048 (26) [back to overview] | Number of Patients With Drug-related LAEs |
NCT00100048 (26) [back to overview] | Number of Patients With Drug-related CAEs |
NCT00100048 (26) [back to overview] | Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I) |
NCT00100048 (26) [back to overview] | Number of Patients With Clinical Adverse Experiences (CAEs) |
NCT00100048 (26) [back to overview] | Number of Patients That Discontinued With LAEs |
NCT00100048 (26) [back to overview] | Number of Patients That Discontinued With CAEs |
NCT00100048 (26) [back to overview] | Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs) |
NCT00100048 (26) [back to overview] | Number of Patients With Serious LAEs |
NCT00100048 (26) [back to overview] | Number of Patients With Serious Drug-related LAEs |
NCT00100048 (26) [back to overview] | Number of Patients With Serious Drug-related CAEs |
NCT00100048 (26) [back to overview] | Number of Patients With Serious CAEs (Cohort I and II Combined) |
NCT00100048 (26) [back to overview] | Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240 |
NCT00100048 (26) [back to overview] | Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II) |
NCT00105079 (6) [back to overview] | Number of Participants Assessed for Adverse Events (AEs) |
NCT00105079 (6) [back to overview] | Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count |
NCT00105079 (6) [back to overview] | Change From Baseline in HIV-1 RNA Viral Load |
NCT00105079 (6) [back to overview] | Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL |
NCT00105079 (6) [back to overview] | Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL |
NCT00105079 (6) [back to overview] | Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) |
NCT00118898 (22) [back to overview] | Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL |
NCT00118898 (22) [back to overview] | Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Treatment Modification |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Regimen Failure |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Change in Fasting Total Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Change in CD4 Count (Cells/mm3) From Baseline |
NCT00118898 (22) [back to overview] | Number of Participants With Virologic Failure and Emergence of Major Resistance |
NCT00118898 (22) [back to overview] | Number of Participants With Virologic Failure |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Virologic Failure |
NCT00118898 (22) [back to overview] | Change in Fasting Triglyceride Level From Baseline |
NCT00118898 (22) [back to overview] | The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL |
NCT00118898 (22) [back to overview] | Time From Randomization to Virologic Failure |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to Treatment Modification |
NCT00118898 (22) [back to overview] | Number of Participants With a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Number of Participants With Regimen Failure |
NCT00118898 (22) [back to overview] | Number of Participants With Treatment Modification |
NCT00118898 (22) [back to overview] | Amount of Study Follow-up |
NCT00119106 (8) [back to overview] | Adverse Events |
NCT00119106 (8) [back to overview] | HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group |
NCT00119106 (8) [back to overview] | Number of Participants Reporting Injecting and Sharing Needles |
NCT00119106 (8) [back to overview] | Number of Participants With Tenofovir-associated Resistance Mutations. |
NCT00119106 (8) [back to overview] | Number Participants Who Reported More Than One Sexual Partner at Baseline |
NCT00119106 (8) [back to overview] | Rates of HIV Seroconversion |
NCT00119106 (8) [back to overview] | Adherence to Study Drug/Placebo |
NCT00119106 (8) [back to overview] | Renal Toxicity |
NCT00119379 (6) [back to overview] | Change in Fat mtDNA Content |
NCT00119379 (6) [back to overview] | Change in Lumbar Spine Bone Mineral Density (BMD) |
NCT00119379 (6) [back to overview] | Change in Trunk Fat |
NCT00119379 (6) [back to overview] | Change in PBMC mtDNA |
NCT00119379 (6) [back to overview] | Change in Limb Fat |
NCT00119379 (6) [back to overview] | Change in Hip Bone Mineral Density (BMD) |
NCT00131677 (6) [back to overview] | >5% Bone Mineral Density Decline at Femoral Neck |
NCT00131677 (6) [back to overview] | Adherence to Study Drug |
NCT00131677 (6) [back to overview] | Number of Breakthrough HIV Infections |
NCT00131677 (6) [back to overview] | Clinical Safety--Hypophosphatemia |
NCT00131677 (6) [back to overview] | Clinical Safety--Creatinine Elevations |
NCT00131677 (6) [back to overview] | Behavioral Safety--Unprotected Anal Sex (UAS) |
NCT00214890 (6) [back to overview] | Evaluate Change in Cellular Regulatory Enzymes Involved With Nucleoside Analogue Transport Across Cell Membranes as Assessed by RT-PCR of Specific mRNA Transcripts |
NCT00214890 (6) [back to overview] | Compare the Plasma Data of the Two Monotherapy Regimens to the Dual NRTI Regimen |
NCT00214890 (6) [back to overview] | Compare the Intracellular Pharmacokinetic (PK) Data of the Two Monotherapy Regimens to the Dual NRTI Regimen |
NCT00214890 (6) [back to overview] | Change in Short-term Virologic Response |
NCT00214890 (6) [back to overview] | Determine Total Number of NRTI-associated Mutations After 7 Days of ABC or TDF Monotherapy or After 7 Days of Dual NRTI Therapy With ABC + TDF |
NCT00214890 (6) [back to overview] | Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy |
NCT00244712 (14) [back to overview] | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 |
NCT00244712 (14) [back to overview] | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 |
NCT00244712 (14) [back to overview] | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility |
NCT00244712 (14) [back to overview] | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks |
NCT00244712 (14) [back to overview] | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 96 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 168 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 144 |
NCT00298363 (38) [back to overview] | In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144 |
NCT00298363 (38) [back to overview] | Percent Probability of Tolerability Failure |
NCT00298363 (38) [back to overview] | Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL |
NCT00298363 (38) [back to overview] | Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normal ALT at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normalized ALT at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normalized ALT at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168 |
NCT00307489 (19) [back to overview] | Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48 |
NCT00307489 (19) [back to overview] | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168 |
NCT00307489 (19) [back to overview] | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48 |
NCT00307489 (19) [back to overview] | Change From Baseline in log10 Plasma HBV DNA Levels at Week 168 |
NCT00307489 (19) [back to overview] | Change From Baseline in log10 Plasma HBV DNA Levels at Week 48 |
NCT00307489 (19) [back to overview] | HBeAg Seroconversion at Week 48 |
NCT00307489 (19) [back to overview] | HBsAg Loss at Week 168 |
NCT00307489 (19) [back to overview] | HBsAg Loss at Week 48 |
NCT00307489 (19) [back to overview] | Hepatitis B Early Antigen (HBeAg) Loss at Week 168 |
NCT00307489 (19) [back to overview] | Hepatitis B Early Antigen (HBeAg) Loss at Week 48 |
NCT00307489 (19) [back to overview] | Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normal ALT at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48 |
NCT00335322 (2) [back to overview] | Time Weighted Mean Change From Baseline Plasma HIV-RNA |
NCT00335322 (2) [back to overview] | Time-weighted Mean Change From Baseline Plasma HIV-RNA. |
NCT00344461 (6) [back to overview] | Patients With Plasma HIV RNA < 50 Copies/mL |
NCT00344461 (6) [back to overview] | Number of Participants With Sustained Virologic Response |
NCT00344461 (6) [back to overview] | Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities |
NCT00344461 (6) [back to overview] | Patients With Plasma HIV RNA < 400 Copies/mL |
NCT00344461 (6) [back to overview] | Change in Plasma HIV RNA From Baseline to Week 96 |
NCT00344461 (6) [back to overview] | Changes in CD4 Cell Count From Baseline and Week 96 |
NCT00350272 (2) [back to overview] | The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day |
NCT00350272 (2) [back to overview] | The Safety Profile Of Elvucitabine. |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 288 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 288 in CD4 Count |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 240 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 240 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 240 in CD4 Count |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 24 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 192 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 192 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 192 in CD4 Count |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 144 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 144 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 144 in CD4 Count |
NCT00352053 (45) [back to overview] | Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA |
NCT00352053 (45) [back to overview] | Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA |
NCT00352053 (45) [back to overview] | Percentage of Participants With Virologic Failure Through Week 48 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 24 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192 |
NCT00352053 (45) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288 |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96 |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48 |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 48 in CD4 Count |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24 |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192 |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144 |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 96 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 96 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 96 in CD4 Count |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 48 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 48 in CD4 Percentage |
NCT00352053 (45) [back to overview] | Change From Baseline to Week 288 in HIV-1 RNA |
NCT00352053 (45) [back to overview] | Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240 |
NCT00357552 (11) [back to overview] | Change in CD4+ Cell Counts From Study Entry to Week 104 |
NCT00357552 (11) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 |
NCT00357552 (11) [back to overview] | Percentage of Subjects Reporting Not Skipping Medications in the Last Month. |
NCT00357552 (11) [back to overview] | Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening. |
NCT00357552 (11) [back to overview] | Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma |
NCT00357552 (11) [back to overview] | Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure. |
NCT00357552 (11) [back to overview] | Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification |
NCT00357552 (11) [back to overview] | Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study. |
NCT00357552 (11) [back to overview] | Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy |
NCT00357552 (11) [back to overview] | Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure. |
NCT00357552 (11) [back to overview] | Number of Participants With Study-targeted Diagnoses and Clinical Events |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 240 |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 96 |
NCT00369941 (73) [back to overview] | Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 240 |
NCT00410072 (16) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants Who Achieved HBV DNA Levels |
NCT00410072 (16) [back to overview] | Percentage of Participants Who Achieved HBV DNA Levels |
NCT00410072 (16) [back to overview] | Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status |
NCT00410072 (16) [back to overview] | Number of Participants With Virologic Breakthrough at Week 96 |
NCT00410072 (16) [back to overview] | Number of Participants With HBV Resistance Through Week 48 |
NCT00410072 (16) [back to overview] | Number of Participants With HBV Resistance at Week 96 |
NCT00410072 (16) [back to overview] | Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities |
NCT00410072 (16) [back to overview] | Mean Log 10 HBV DNA at Weeks 48 and 96 |
NCT00410072 (16) [back to overview] | Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 |
NCT00410072 (16) [back to overview] | Number of Participants With Virologic Breakthrough at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBV DNA by PCR Category at Week 48 |
NCT00410202 (25) [back to overview] | Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment |
NCT00410202 (25) [back to overview] | Number of Participants With Laboratory Abnormalities: Serum Chemistry |
NCT00410202 (25) [back to overview] | Number of Participants With Laboratory Abnormalities: Hematology |
NCT00410202 (25) [back to overview] | Cumulative Probability of Emergent Genotypic Resistance at Year 2 |
NCT00410202 (25) [back to overview] | Cumulative Probability of Emergent Genotypic Resistance at Year 1 |
NCT00410202 (25) [back to overview] | Change in Mean log10 From Baseline in HBV DNA at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only) |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only) |
NCT00410202 (25) [back to overview] | Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only) |
NCT00410202 (25) [back to overview] | Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only) |
NCT00410202 (25) [back to overview] | Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants With HBV DNA by PCR Category at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48 |
NCT00410202 (25) [back to overview] | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48 |
NCT00410202 (25) [back to overview] | Change in Mean log10 From Baseline in HBV DNA at Week 96 |
NCT00410202 (25) [back to overview] | Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96 |
NCT00414518 (3) [back to overview] | Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome |
NCT00414518 (3) [back to overview] | Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms |
NCT00414518 (3) [back to overview] | Viral Set Point |
NCT00427297 (4) [back to overview] | Immunologic Failure |
NCT00427297 (4) [back to overview] | Incidence of Severe Adverse Events (Excluding Mortality) |
NCT00427297 (4) [back to overview] | Viral Failure |
NCT00427297 (4) [back to overview] | Incidence of Mortality |
NCT00442962 (11) [back to overview] | Time to First Dose Modification |
NCT00442962 (11) [back to overview] | Percentage of Participants With Early Virologic Suppression |
NCT00442962 (11) [back to overview] | Percentage of Participants With Early Virologic Response |
NCT00442962 (11) [back to overview] | Percentage of Participants With Late Virologic Suppression |
NCT00442962 (11) [back to overview] | Early Changes in CD4 Count From Baseline |
NCT00442962 (11) [back to overview] | Time to First Safety Event |
NCT00442962 (11) [back to overview] | Time to Initial Virologic Response |
NCT00442962 (11) [back to overview] | Time to Initial Virological Failure |
NCT00442962 (11) [back to overview] | Late Change in CD4 Count From Baseline |
NCT00442962 (11) [back to overview] | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) |
NCT00442962 (11) [back to overview] | Percentage of Participants With Late Virologic Response |
NCT00448669 (6) [back to overview] | Rates of Adherence to Study Medication |
NCT00448669 (6) [back to overview] | Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts |
NCT00448669 (6) [back to overview] | Antiretroviral (ARV) Resistance Patterns in Seroconverters |
NCT00448669 (6) [back to overview] | CD4 Evaluation After HIV Seroconversion |
NCT00448669 (6) [back to overview] | HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms |
NCT00448669 (6) [back to overview] | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms |
NCT00507507 (13) [back to overview] | Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Occurrence of HBV Resistance Mutations |
NCT00507507 (13) [back to overview] | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 |
NCT00507507 (13) [back to overview] | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 |
NCT00507507 (13) [back to overview] | Change From Baseline in HBV DNA at Week 192 |
NCT00507507 (13) [back to overview] | Change From Baseline in HBV DNA at Week 144 |
NCT00507507 (13) [back to overview] | Change From Baseline in HBV DNA at Week 48 |
NCT00507507 (13) [back to overview] | Change From Baseline in HBV DNA at Week 96 |
NCT00507507 (13) [back to overview] | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192 |
NCT00524173 (4) [back to overview] | Number of Participants With HBV DNA <1000 IU/ml at Week 192 |
NCT00524173 (4) [back to overview] | Number of Participants With Loss of HBsAg |
NCT00524173 (4) [back to overview] | Number of Participants With Normalized Alanine Aminotransferase (ALT) |
NCT00524173 (4) [back to overview] | Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48 |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 144 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 192 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 240 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 288 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 336 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 384 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 432 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 48 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 480 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 528 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Percentage at 96 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144 |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48 |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96 |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks |
NCT00528957 (46) [back to overview] | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot) |
NCT00528957 (46) [back to overview] | Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot) |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks |
NCT00528957 (46) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks |
NCT00528957 (46) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 |
NCT00549198 (58) [back to overview] | "Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized" |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting CNS Side Effects of Any Severity |
NCT00552240 (46) [back to overview] | Change in Framingham Score |
NCT00552240 (46) [back to overview] | Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio |
NCT00552240 (46) [back to overview] | Change in Fasting Plasma Triglycerides Level |
NCT00552240 (46) [back to overview] | Change in Fasting Plasma Total Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 8. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 6. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 4. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 36. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 24. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 2. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 12. |
NCT00552240 (46) [back to overview] | AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death |
NCT00552240 (46) [back to overview] | Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Response (VR) |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Success (FDA Definition) |
NCT00552240 (46) [back to overview] | Number of Patients With Virologic Rebound to >400 Copies/ml |
NCT00552240 (46) [back to overview] | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities |
NCT00552240 (46) [back to overview] | Percentage Adherence by Pill Count |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment |
NCT00552240 (46) [back to overview] | Incidence of Patients With AIDS Progression at Each Visit |
NCT00552240 (46) [back to overview] | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml |
NCT00552240 (46) [back to overview] | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting Rash of Any Severity |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting Hepatic Events of Any Severity |
NCT00557245 (11) [back to overview] | Head Circumference Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants |
NCT00557245 (11) [back to overview] | Length Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up |
NCT00557245 (11) [back to overview] | Study Drug Adherence: Self-reported Missed Doses of Study Drug |
NCT00557245 (11) [back to overview] | Weight Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Prevalence of Unprotected Sex During Follow-up |
NCT00557245 (11) [back to overview] | Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug. |
NCT00557245 (11) [back to overview] | Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC |
NCT00557245 (11) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
NCT00557245 (11) [back to overview] | Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. |
NCT00592124 (9) [back to overview] | Length of Time Vaginal Sexual Intercourse Took Place After Using Gel. |
NCT00592124 (9) [back to overview] | Number of Days Product Missed |
NCT00592124 (9) [back to overview] | Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol |
NCT00592124 (9) [back to overview] | Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use) |
NCT00592124 (9) [back to overview] | Self-reported Adherence to Each Regimen |
NCT00592124 (9) [back to overview] | Reported Sharing of Product |
NCT00592124 (9) [back to overview] | Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet. |
NCT00592124 (9) [back to overview] | Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel. |
NCT00592124 (9) [back to overview] | Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet. |
NCT00594646 (2) [back to overview] | Number of HIV-1 Infected Participants |
NCT00594646 (2) [back to overview] | Medication Regimen Completion Rates |
NCT00605384 (1) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Lab Event |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Lab or Sign/Symptom Event |
NCT00608569 (8) [back to overview] | Adherence to Second Line HAART Regimen |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Sign or Symptom |
NCT00608569 (8) [back to overview] | CD4 Count at Follow-up Visits |
NCT00608569 (8) [back to overview] | CD8 Count at Follow-up Visits |
NCT00608569 (8) [back to overview] | Confirmed Virologic Failure at or Prior to Week 24 |
NCT00608569 (8) [back to overview] | Confirmed Virologic Failure at or Prior to Week 48 |
NCT00625404 (12) [back to overview] | Participant Report of Change in Number of Sexual Partners |
NCT00625404 (12) [back to overview] | HIV Infection |
NCT00625404 (12) [back to overview] | FTC and/or Tenofovir Resistance |
NCT00625404 (12) [back to overview] | Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher AST Elevation |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher ALT Elevation |
NCT00625404 (12) [back to overview] | CD4+ T-cell Count |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher Reduction in Phosphorus |
NCT00625404 (12) [back to overview] | Confirmed Grade 2 or Higher Serum Creatinine Toxicity |
NCT00625404 (12) [back to overview] | Pregnancy Complications |
NCT00625404 (12) [back to overview] | Pill Counts and Participant Report of Adherence to Once-daily Pill Taking |
NCT00625404 (12) [back to overview] | Plasma HIV RNA Level (HIV-1 Viral Load) |
NCT00632970 (1) [back to overview] | Absolute Change in CD4 Cell Counts |
NCT00641641 (1) [back to overview] | Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) |
NCT00654147 (6) [back to overview] | Time to Virologic Failure |
NCT00654147 (6) [back to overview] | Time to Confirmed Virologic Failure |
NCT00654147 (6) [back to overview] | Study Medication Toxicity-related Discontinuation . |
NCT00654147 (6) [back to overview] | Study Medication Tolerability |
NCT00654147 (6) [back to overview] | Weeks to HIV-1 RNA <200 Copies/ml |
NCT00654147 (6) [back to overview] | Change From Baseline CD4+ and CD8+ Cell Counts |
NCT00662545 (5) [back to overview] | HIV RNA < 75 Copies/ml |
NCT00662545 (5) [back to overview] | Hepatitis B Virus (HBV) DNA |
NCT00662545 (5) [back to overview] | Incidence of Permanent Discontinuation Due to Toxicity |
NCT00662545 (5) [back to overview] | Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy) |
NCT00662545 (5) [back to overview] | Incidence of ALT Flares |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Oral TDF and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product |
NCT00705679 (11) [back to overview] | Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Eosinophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Fasting Glucose (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hematocrit (Fraction) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hips Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter) |
NCT00711009 (82) [back to overview] | Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Basophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Bicarbonate (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Calcium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Chest Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Chloride (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Cholesterol (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Creatine Phosphokinase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Creatinine (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Adiponectin (Micrograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Alanine Aminotransferase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Albumin (Grams/Liter) |
NCT00711009 (82) [back to overview] | Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values |
NCT00711009 (82) [back to overview] | Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events |
NCT00711009 (82) [back to overview] | Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Alkaline Phosphatase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hemoglobin (Grams/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams) |
NCT00711009 (82) [back to overview] | Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. |
NCT00711009 (82) [back to overview] | Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit |
NCT00711009 (82) [back to overview] | Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672 |
NCT00711009 (82) [back to overview] | Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication |
NCT00711009 (82) [back to overview] | Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication |
NCT00711009 (82) [back to overview] | Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM) |
NCT00711009 (82) [back to overview] | Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00711009 (82) [back to overview] | Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Weight (kg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Waist Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Urine Specific Gravity |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Urine pH |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Uric Acid (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Triglycerides (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Total Protein (Grams/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Total Bilirubin (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Temperature (°F) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sodium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Potassium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Platelet Count (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Neutrophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Monocytes (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Mid-Thigh Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Mid-Arm Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Magnesium (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lymphocytes (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lipase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Leptin (Nanograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lactate (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Interleukin-6 (Nanograms/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Insulin (Picomoles/Liter) |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Fasting Lipid Parameters at Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00724711 (14) [back to overview] | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Fasting Glucose at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline C-Reactive Protein at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Fibrinogen at Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Whole Body BMD at Week 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72 |
NCT00734162 (37) [back to overview] | Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Whole Body BMD at Week 96 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Whole Body BMD at Week 72 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Whole Body BMD at Week 48 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Whole Body BMD at Week 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Whole Body BMD at Week 144 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Spine BMD at Week 96 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Spine BMD at Week 72 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Spine BMD at Week 192 |
NCT00734162 (37) [back to overview] | Percent Change From Baseline in Spine BMD at Week 144 |
NCT00734162 (37) [back to overview] | Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Whole Body BMD at Week 96 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Whole Body BMD at Week 72 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Whole Body BMD at Week 48 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Whole Body BMD at Week 144 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Spine BMD at Week 96 |
NCT00734162 (37) [back to overview] | Number of Participants With Changes in Drug-Resistant Mutations During the Study |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Spine BMD at Week 72 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Spine BMD at Week 48 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Spine BMD at Week 192 |
NCT00734162 (37) [back to overview] | Change From Baseline in Z-score for Spine BMD at Week 144 |
NCT00734162 (37) [back to overview] | Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192 |
NCT00734162 (37) [back to overview] | Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192 |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 2 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 4 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 5 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 4 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 6 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 7 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 6 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 8 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 6 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 8 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 4 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 2 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 14 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 9 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 10 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 11 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 10 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 1 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 10 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 12 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 14 Months |
NCT00734344 (32) [back to overview] | Mean CD4 Count Between Treatment Groups at 3 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 2 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 8 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 4 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 6 Months |
NCT00734344 (32) [back to overview] | Mean Platelet Count Between Treatment Groups at 8 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 10 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 12 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 12 Months |
NCT00734344 (32) [back to overview] | Mean Hematocrit Between Treatment Groups at 14 Months |
NCT00734344 (32) [back to overview] | Mean White Blood Cell Count Between Treatment Groups at 2 Months |
NCT00736190 (10) [back to overview] | Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48 |
NCT00736190 (10) [back to overview] | Summary of Resistance Surveillance for Participants Without Virologic Breakthrough |
NCT00736190 (10) [back to overview] | Summary of Resistance Surveillance for Participants With Virologic Breakthrough |
NCT00736190 (10) [back to overview] | Summary of Resistance Surveillance for Participants Who Discontinued the Study Early |
NCT00736190 (10) [back to overview] | Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion |
NCT00736190 (10) [back to overview] | Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) |
NCT00736190 (10) [back to overview] | Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48 |
NCT00736190 (10) [back to overview] | Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48 |
NCT00736190 (10) [back to overview] | Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48 |
NCT00736190 (10) [back to overview] | Change From Baseline in FibroTest Value |
NCT00752856 (4) [back to overview] | To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations. |
NCT00752856 (4) [back to overview] | Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48 |
NCT00752856 (4) [back to overview] | Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4. |
NCT00752856 (4) [back to overview] | Viral Suppression Efficacy at 48 Weeks |
NCT00757783 (16) [back to overview] | Change From Baseline in Glucose at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48 |
NCT00757783 (16) [back to overview] | Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Insulin at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF). |
NCT00757783 (16) [back to overview] | Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12 |
NCT00757783 (16) [back to overview] | Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values. |
NCT00757783 (16) [back to overview] | Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA. |
NCT00757783 (16) [back to overview] | Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F) |
NCT00757783 (16) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF). |
NCT00757783 (16) [back to overview] | Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48. |
NCT00762892 (5) [back to overview] | Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in Homocysteine at 6 Months |
NCT00762892 (5) [back to overview] | Change From Baseline in CD4 Count at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in Lipids at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in Log HIV Viral Load at 48 Weeks |
NCT00768989 (28) [back to overview] | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) |
NCT00768989 (28) [back to overview] | Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 |
NCT00768989 (28) [back to overview] | Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 |
NCT00768989 (28) [back to overview] | Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose |
NCT00768989 (28) [back to overview] | Atazanavir Time of Maximum Observed Plasma Concentration (Tmax) |
NCT00768989 (28) [back to overview] | Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 |
NCT00768989 (28) [back to overview] | Atazanavir Terminal Elimination Half Life |
NCT00768989 (28) [back to overview] | Atazanavir Individual Inhibitory Quotient (IQ) |
NCT00768989 (28) [back to overview] | Raltegravir Cmin 12 Hours Postdose |
NCT00768989 (28) [back to overview] | Raltegravir Cmax in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Raltegravir AUC (0-12h) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96 |
NCT00768989 (28) [back to overview] | Atazanavir Cmin Prior to the Morning Dose |
NCT00768989 (28) [back to overview] | Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Raltegravir Cmin Prior to the Morning Dose |
NCT00768989 (28) [back to overview] | Raltegravir Terminal Elimination Half Life |
NCT00768989 (28) [back to overview] | Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Raltegravir Tmax |
NCT00768989 (28) [back to overview] | Baseline and Mean Change From Baseline in Total Cholesterol Levels |
NCT00768989 (28) [back to overview] | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Electrocardiogram Findings |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Total Bilirubin Level |
NCT00768989 (28) [back to overview] | Number of Nonresponders at Week 8 |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48 |
NCT00768989 (28) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count |
NCT00805675 (9) [back to overview] | Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12 |
NCT00805675 (9) [back to overview] | Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8. |
NCT00805675 (9) [back to overview] | Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production. |
NCT00805675 (9) [back to overview] | "Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12" |
NCT00805675 (9) [back to overview] | Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12. |
NCT00805675 (9) [back to overview] | Characterization of Very Early Viral Kinetics Through Estimated Viral Load |
NCT00805675 (9) [back to overview] | Characterization of Very Early Viral Kinetics Through Half-live of Free Virus |
NCT00805675 (9) [back to overview] | Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss |
NCT00805675 (9) [back to overview] | Characterization of Very Early Viral Kinetics Through Viral Clearance |
NCT00811954 (19) [back to overview] | Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Incidence of First Adverse Event by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Probability of First Virologic Failure by Week 96 |
NCT00811954 (19) [back to overview] | Incidence of Death or AIDS Defining Events (CDC Category C) |
NCT00811954 (19) [back to overview] | Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD) |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With INI Resistance |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With NRTI Resistance |
NCT00811954 (19) [back to overview] | Change in Waist Circumference From Baseline |
NCT00811954 (19) [back to overview] | Change in Framingham 10-year Risk of MI or Coronary Death From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting Triglycerides Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting Total Cholesterol Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting Plasma Glucose Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting HDL Cholesterol Level From Baseline |
NCT00811954 (19) [back to overview] | CD4+ T-cell Count Changes From Baseline |
NCT00811954 (19) [back to overview] | CD4+ T-cell Count |
NCT00811954 (19) [back to overview] | Change in Waist:Height Ratio From Baseline |
NCT00811954 (19) [back to overview] | Self-reported Adherence |
NCT00827112 (16) [back to overview] | Number of Participants With Phenotypic Resistance |
NCT00827112 (16) [back to overview] | Time-Averaged Difference (TAD) in log10 Viral Load |
NCT00827112 (16) [back to overview] | Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA |
NCT00827112 (16) [back to overview] | Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 |
NCT00827112 (16) [back to overview] | Number of Participants With Genotypic Resistance |
NCT00827112 (16) [back to overview] | Average Observed Plasma Concentration (Cavg) of Maraviroc |
NCT00827112 (16) [back to overview] | HIV-1 RNA Levels at Baseline |
NCT00827112 (16) [back to overview] | Minimum Observed Plasma Concentration (Cmin) of Maraviroc |
NCT00827112 (16) [back to overview] | Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA |
NCT00827112 (16) [back to overview] | Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay |
NCT00827112 (16) [back to overview] | Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 |
NCT00827112 (16) [back to overview] | Time to Loss of Virological Response (TLOVR) |
NCT00827112 (16) [back to overview] | Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 |
NCT00827112 (16) [back to overview] | Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) |
NCT00827112 (16) [back to overview] | Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 |
NCT00827112 (16) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Maraviroc |
NCT00851799 (27) [back to overview] | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 |
NCT00851799 (27) [back to overview] | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 |
NCT00851799 (27) [back to overview] | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 |
NCT00851799 (27) [back to overview] | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 |
NCT00851799 (27) [back to overview] | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Lean Mass From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 |
NCT00851799 (27) [back to overview] | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Percent Change in Total Limb Fat From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Percent Change in Trunk Fat From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 |
NCT00856323 (4) [back to overview] | Self-reported Methamphetamine Use in Previous 30 Days. |
NCT00856323 (4) [back to overview] | Post-Exposure Prophylaxis Medication Adherence |
NCT00856323 (4) [back to overview] | HIV-related Sexual Risk Behaviors in Previous 30 Days. |
NCT00856323 (4) [back to overview] | Description of Incident STI Infections. |
NCT00862823 (2) [back to overview] | Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz |
NCT00862823 (2) [back to overview] | Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz |
NCT00869960 (8) [back to overview] | Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00885664 (11) [back to overview] | IL-10 |
NCT00885664 (11) [back to overview] | IL-4 |
NCT00885664 (11) [back to overview] | IL-6 |
NCT00885664 (11) [back to overview] | IL-7 |
NCT00885664 (11) [back to overview] | IL-8 |
NCT00885664 (11) [back to overview] | INF Gamma |
NCT00885664 (11) [back to overview] | TNF Alpha |
NCT00885664 (11) [back to overview] | Symptom Score |
NCT00885664 (11) [back to overview] | SF-12 Physical Capacity Score |
NCT00885664 (11) [back to overview] | SF-12 Mental Capacity Score |
NCT00885664 (11) [back to overview] | IL-1 Beta |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr) |
NCT00896051 (18) [back to overview] | Change From Pre-Baseline in Log10 Viral Load Over Time |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax) |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax) |
NCT00896051 (18) [back to overview] | The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method |
NCT00896051 (18) [back to overview] | The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method |
NCT00896051 (18) [back to overview] | The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method |
NCT00896051 (18) [back to overview] | Time to Confirmed Virologic Response |
NCT00896051 (18) [back to overview] | Time to Virologic Failure |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax) |
NCT00896051 (18) [back to overview] | Change From Prebaseline in CD4+ Cell Count Over Time |
NCT00896051 (18) [back to overview] | Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr) |
NCT00896051 (18) [back to overview] | Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48 |
NCT00924898 (6) [back to overview] | Number of Participants Without Virologic Failure at Week 48 |
NCT00924898 (6) [back to overview] | Number of Participants Without Virologic Failure at Week 24 |
NCT00924898 (6) [back to overview] | Number of Participants With HIV RNA Suppression at Week 96 |
NCT00924898 (6) [back to overview] | Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment |
NCT00924898 (6) [back to overview] | Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications |
NCT00924898 (6) [back to overview] | Time to HIV RNA Suppression <50 Copies/mL |
NCT00928187 (13) [back to overview] | Patients With Plasma HIV RNA < 200 Copies/ml |
NCT00928187 (13) [back to overview] | Number of Patients With WHO Stage 3 and 4 HIV Related Events |
NCT00928187 (13) [back to overview] | Number of Patients With Resistance Mutations |
NCT00928187 (13) [back to overview] | Number of Patients With Plasma HIV RNA < 50 Copies/mL |
NCT00928187 (13) [back to overview] | Number of Patients With HIV Plasma Viral Load < 50 Copies/ml |
NCT00928187 (13) [back to overview] | Number of Patients With HIV Plasma Viral Load < 200 Copies/ml |
NCT00928187 (13) [back to overview] | Tolerance: Neuropathies (Grade 1 to 4) |
NCT00928187 (13) [back to overview] | Adherence |
NCT00928187 (13) [back to overview] | Development of Metabolic Syndrome |
NCT00928187 (13) [back to overview] | Gain in CD4 Cells Between Baseline and W48 |
NCT00928187 (13) [back to overview] | Number of Patients Discontinuing Study Treatment |
NCT00928187 (13) [back to overview] | Tolerance: Gastrointestinal Complains |
NCT00928187 (13) [back to overview] | Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate) |
NCT00931801 (4) [back to overview] | Change in Quality of Life From Baseline to 48 Weeks of Study Treatment |
NCT00931801 (4) [back to overview] | The Change in Adherence to Study Treatment Arm From Baseline to Week 48 |
NCT00931801 (4) [back to overview] | The Difference in CD4 From Baseline to Week 48 |
NCT00931801 (4) [back to overview] | Maintenance of Virologic Suppression |
NCT00959894 (25) [back to overview] | Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks |
NCT00959894 (25) [back to overview] | Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults |
NCT00959894 (25) [back to overview] | Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results |
NCT00959894 (25) [back to overview] | Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State |
NCT00959894 (25) [back to overview] | Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy |
NCT00959894 (25) [back to overview] | Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24 |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00960622 (1) [back to overview] | Change in Peak Oxygen Uptake. |
NCT00962871 (2) [back to overview] | Mean Change From Baseline in HBV-DNA log10 |
NCT00962871 (2) [back to overview] | Mean Change From Baseline in Viral Quantitative e Antibody |
NCT00998582 (2) [back to overview] | Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 |
NCT00998582 (2) [back to overview] | Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24 |
NCT01003990 (1) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death |
NCT01025427 (1) [back to overview] | Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24 |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Actual Number of Study Visits Completed by 24 Weeks |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Overall |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 12 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 16 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 20 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 4 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 8 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 12 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 16 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 20 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 24 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 4 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 8 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Over Time Based on Self-Report Calendar Data |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 |
NCT01033942 (96) [back to overview] | Acceptability of Being Contacted by the Research Team in Between Visits |
NCT01033942 (96) [back to overview] | Acceptability of Being Randomly Assigned to a Group |
NCT01033942 (96) [back to overview] | Acceptability of Having an HIV Test at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Health Clinic for Study Visits |
NCT01033942 (96) [back to overview] | Acceptability of Participating in Group Sessions |
NCT01033942 (96) [back to overview] | Acceptability of Physical Examination by a Doctor |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Felt Sick or Ill |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Simply Forgot |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Was Away From Home |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Acceptability of Questions About Sexual Behavior at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Risk Reduction Counseling at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Size of Pill |
NCT01033942 (96) [back to overview] | Acceptability of Taking Part in the Study |
NCT01033942 (96) [back to overview] | Acceptability of Taking the Pill Everyday |
NCT01033942 (96) [back to overview] | Acceptability of the Color of the Pill |
NCT01033942 (96) [back to overview] | Acceptability of the Taste of the Pill |
NCT01033942 (96) [back to overview] | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 12 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 16 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 20 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 24 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 4 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 8 |
NCT01044771 (2) [back to overview] | Patients Without HIV Re-bound |
NCT01044771 (2) [back to overview] | Patients With Reduced or Resolved Proteinuria |
NCT01061151 (28) [back to overview] | Maternal Health Component: Other Targeted Medical Conditions |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Tuberculosis |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death |
NCT01061151 (28) [back to overview] | Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events |
NCT01061151 (28) [back to overview] | Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Death |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of AIDS-defining Illness |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Infant HIV Infections |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Confirmed Infant HIV Infections |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Obstetrical Complications |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Obstetrical Complications |
NCT01061151 (28) [back to overview] | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Event or Death |
NCT01061151 (28) [back to overview] | Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures |
NCT01061151 (28) [back to overview] | Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery |
NCT01061151 (28) [back to overview] | Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery |
NCT01061151 (28) [back to overview] | Postpartum Component: Incidence of Confirmed Infant HIV Infection |
NCT01061151 (28) [back to overview] | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) |
NCT01061151 (28) [back to overview] | Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01063036 (11) [back to overview] | Percentage of Participants With a Virologic Response at Week 48 - Treated Population |
NCT01063036 (11) [back to overview] | Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population |
NCT01063036 (11) [back to overview] | Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population |
NCT01063036 (11) [back to overview] | Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population |
NCT01063036 (11) [back to overview] | Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population |
NCT01063036 (11) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline |
NCT01063036 (11) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline |
NCT01063036 (11) [back to overview] | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline |
NCT01063036 (11) [back to overview] | Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population |
NCT01063036 (11) [back to overview] | Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline |
NCT01063036 (11) [back to overview] | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population |
NCT01140880 (4) [back to overview] | Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) |
NCT01140880 (4) [back to overview] | Course Completion |
NCT01140880 (4) [back to overview] | Medication Adherence |
NCT01140880 (4) [back to overview] | Time From Exposure to Truvada Initiation |
NCT01154673 (1) [back to overview] | Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART. |
NCT01195467 (2) [back to overview] | The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment |
NCT01195467 (2) [back to overview] | The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment |
NCT01214759 (2) [back to overview] | Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study |
NCT01214759 (2) [back to overview] | Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months |
NCT01232127 (7) [back to overview] | Number of Participants With Abnormalities in Laboratory Test Results |
NCT01232127 (7) [back to overview] | Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir |
NCT01232127 (7) [back to overview] | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest |
NCT01232127 (7) [back to overview] | Number of Participants With Abnormalities in Vital Signs |
NCT01232127 (7) [back to overview] | Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings |
NCT01232127 (7) [back to overview] | Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir |
NCT01232127 (7) [back to overview] | Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir |
NCT01270802 (2) [back to overview] | Change in Flow-mediated Dilation (FMD) of the Brachial Artery |
NCT01270802 (2) [back to overview] | Change in Serum Levels of Vitamin D |
NCT01283555 (23) [back to overview] | Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort |
NCT01283555 (23) [back to overview] | Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors |
NCT01283555 (23) [back to overview] | Number of Participants Reporting Applicator Easy to Insert |
NCT01283555 (23) [back to overview] | Number of Participants Reporting Applicator Easy to Fill |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention |
NCT01283555 (23) [back to overview] | Number of Colposcopic Findings (Baseline and After One Week of Product Use) |
NCT01283555 (23) [back to overview] | Number of Respondents Reporting Confidence With Filling the User-filled Applicator |
NCT01283555 (23) [back to overview] | Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That Both Applicators Were Acceptable |
NCT01283555 (23) [back to overview] | Filling Precision (5% Range) |
NCT01283555 (23) [back to overview] | Filling Precision (10% Range) |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That the Instructions for Use Were Helpful |
NCT01283555 (23) [back to overview] | Filled Volume |
NCT01283555 (23) [back to overview] | Dosing Volume (Expressed Volume) |
NCT01283555 (23) [back to overview] | Dosing Precision, 5% (Expressed Volume) |
NCT01283555 (23) [back to overview] | Dosing Precision, 10% (Expressed Volume) |
NCT01283555 (23) [back to overview] | Filling Accuracy (% of Target Dose) |
NCT01283555 (23) [back to overview] | Dosing Accuracy (% of Target Dose Delivered) |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That the Gel Was Easy to Dispense |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator |
NCT01283555 (23) [back to overview] | Number of Participants Reporting That Applicator Was Comfortable to Use |
NCT01285050 (1) [back to overview] | HCV RNA |
NCT01300234 (15) [back to overview] | Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240 |
NCT01300234 (15) [back to overview] | Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2. |
NCT01300234 (15) [back to overview] | Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48 |
NCT01300234 (15) [back to overview] | Number of Participants in the Indicated Category for Renal Laboratory Abnormalities |
NCT01300234 (15) [back to overview] | Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs) |
NCT01300234 (15) [back to overview] | Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240 |
NCT01300234 (15) [back to overview] | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE) |
NCT01300234 (15) [back to overview] | Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus |
NCT01300234 (15) [back to overview] | Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240 |
NCT01300234 (15) [back to overview] | Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 |
NCT01300234 (15) [back to overview] | Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline |
NCT01300234 (15) [back to overview] | Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240 |
NCT01300234 (15) [back to overview] | Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48 |
NCT01300234 (15) [back to overview] | Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240 |
NCT01300234 (15) [back to overview] | Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240. |
NCT01327651 (28) [back to overview] | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm |
NCT01327651 (28) [back to overview] | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) |
NCT01327651 (28) [back to overview] | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing |
NCT01327651 (28) [back to overview] | Self-reported Side Effect or Symptom Scores |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | The Total Pills Actually Used Over the Follow-up Period |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data |
NCT01327651 (28) [back to overview] | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01332227 (7) [back to overview] | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 |
NCT01332227 (7) [back to overview] | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 |
NCT01332227 (7) [back to overview] | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 |
NCT01332227 (7) [back to overview] | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 |
NCT01332227 (7) [back to overview] | Number of Participants With Virologic Rebound at Weeks 24 and 48 |
NCT01332227 (7) [back to overview] | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 |
NCT01332227 (7) [back to overview] | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs |
NCT01335620 (2) [back to overview] | Cerebral Function; Changes in Global Cognitive Z-score |
NCT01335620 (2) [back to overview] | Drug Levels in Blood |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22 |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15 |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22 |
NCT01340196 (8) [back to overview] | Number of Patients With Drug Related Adverse Events During the Trial |
NCT01340196 (8) [back to overview] | Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22 |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15 |
NCT01340196 (8) [back to overview] | Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15 |
NCT01345630 (25) [back to overview] | The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA). |
NCT01345630 (25) [back to overview] | Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria. |
NCT01345630 (25) [back to overview] | Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin |
NCT01345630 (25) [back to overview] | Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF). |
NCT01345630 (25) [back to overview] | Tropism Change Between Screening or Baseline and PDTF |
NCT01345630 (25) [back to overview] | Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1) |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD |
NCT01345630 (25) [back to overview] | Severity of Abnormal Laboratory Values |
NCT01345630 (25) [back to overview] | Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%) |
NCT01345630 (25) [back to overview] | Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%) |
NCT01345630 (25) [back to overview] | Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria |
NCT01345630 (25) [back to overview] | Number of Participants With Abnormal Laboratory Values |
NCT01345630 (25) [back to overview] | Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48. |
NCT01345630 (25) [back to overview] | Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48 |
NCT01345630 (25) [back to overview] | Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3) |
NCT01345630 (25) [back to overview] | Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3) |
NCT01345630 (25) [back to overview] | Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48 |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD |
NCT01345630 (25) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL. |
NCT01345630 (25) [back to overview] | Number of Treatment-related AEs |
NCT01345630 (25) [back to overview] | Number of Participants With Treatment-emergent Serious Adverse Events |
NCT01345630 (25) [back to overview] | Number of Participants With Grade 3 or 4 AEs |
NCT01345630 (25) [back to overview] | Number of Participants Who Discontinued Due to AEs |
NCT01345630 (25) [back to overview] | Frequency of Adverse Events (AE). |
NCT01352117 (12) [back to overview] | Percentage of Participants With Etoposide Dose Modification |
NCT01352117 (12) [back to overview] | Percentage of Participants With ARV Dose Modification |
NCT01352117 (12) [back to overview] | Change in Peripheral Blood CD4+ Lymphocyte Cell Count |
NCT01352117 (12) [back to overview] | Change in Peripheral Blood CD4+ Lymphocyte Cell Count |
NCT01352117 (12) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Events |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS-IRIS |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A |
NCT01352117 (12) [back to overview] | Cumulative Incidence of Initial KS Progressive Disease by Week 96 |
NCT01352117 (12) [back to overview] | Cumulative Incidence of Initial KS Partial or Complete Response by Week 96 |
NCT01352117 (12) [back to overview] | Percentage of Participants With HIV-1 RNA Suppression |
NCT01352117 (12) [back to overview] | Percentage of Participants With HIV-1 RNA Suppression |
NCT01352715 (9) [back to overview] | Number of Participants With a New AIDS-defining Events or Death |
NCT01352715 (9) [back to overview] | Number of Participants Discontinuing Randomized Treatment for Toxicity |
NCT01352715 (9) [back to overview] | Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure |
NCT01352715 (9) [back to overview] | Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline |
NCT01352715 (9) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline |
NCT01352715 (9) [back to overview] | Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death |
NCT01352715 (9) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48 |
NCT01352715 (9) [back to overview] | Cumulative Probability of Virologic Failure by Week 48 |
NCT01352715 (9) [back to overview] | Percentage of Time Spent in Hospital |
NCT01369212 (18) [back to overview] | Number of Participants With HBV DNA<1000 IU/mL at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With HBsAg Seroconversion at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With HBsAg Seroconversion at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With HBeAg Seroconversion at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With HBeAg Seroconversion at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With HBeAg Loss at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192 |
NCT01369212 (18) [back to overview] | Cumulative Percent of Participants With HBsAg Loss at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With Adverse Events |
NCT01369212 (18) [back to overview] | Cumulative Percent of Participants With HBsAg Loss at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With Serious Adverse Events |
NCT01369212 (18) [back to overview] | Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With HBV DNA<20 IU/mL at Week 240 |
NCT01369212 (18) [back to overview] | Number of Participants With HBV DNA<20 IU/mL at Week 192 |
NCT01369212 (18) [back to overview] | Number of Participants With HBV DNA<1000 IU/mL at Week 240 |
NCT01379508 (4) [back to overview] | eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study |
NCT01379508 (4) [back to overview] | Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) - |
NCT01379508 (4) [back to overview] | Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT) |
NCT01379508 (4) [back to overview] | Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT) |
NCT01384734 (17) [back to overview] | Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy |
NCT01384734 (17) [back to overview] | Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period |
NCT01384734 (17) [back to overview] | Number of Participants With Newly-emergent Genotypic Substitutions at Week 24 |
NCT01384734 (17) [back to overview] | Number of Participants With Newly-emergent Genotypic Substitutions at Week 96 |
NCT01384734 (17) [back to overview] | Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period |
NCT01384734 (17) [back to overview] | Number of Participants With SAE and Discontinuation Due to AEs During Primary Study |
NCT01384734 (17) [back to overview] | Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24 |
NCT01384734 (17) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study |
NCT01384734 (17) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period |
NCT01384734 (17) [back to overview] | Number of Participants With Newly-emergent Genotypic Substitutions at Week 48 |
NCT01384734 (17) [back to overview] | Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48 |
NCT01384734 (17) [back to overview] | Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96 |
NCT01384734 (17) [back to overview] | Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24 |
NCT01384734 (17) [back to overview] | Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA |
NCT01384734 (17) [back to overview] | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24 |
NCT01384734 (17) [back to overview] | Change From Baseline in CD4+ T-cell Count |
NCT01384734 (17) [back to overview] | Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy |
NCT01387022 (4) [back to overview] | Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation |
NCT01387022 (4) [back to overview] | Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables |
NCT01387022 (4) [back to overview] | Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations |
NCT01387022 (4) [back to overview] | The Antiretroviral Treatment Failure Rate at 12 Months. |
NCT01400412 (20) [back to overview] | Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Lumbar Spine Bone Mineral Density (BMD) |
NCT01400412 (20) [back to overview] | Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) |
NCT01400412 (20) [back to overview] | Number of Participants Who Died During the Study |
NCT01400412 (20) [back to overview] | Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events |
NCT01400412 (20) [back to overview] | Change in CD4 Count From Baseline to Week 24 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | CD8+ T-cell Change From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Level of IP-10 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Levels of D-dimer From Baseline |
NCT01400412 (20) [back to overview] | Change in Levels of IL-6 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Levels of sCD14 From Baseline |
NCT01400412 (20) [back to overview] | Number of Participants Who Experienced Bone Fractures |
NCT01400412 (20) [back to overview] | Change in Levels of sCD163 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Cumulative Probability of Virologic Failure by Week 48 |
NCT01400412 (20) [back to overview] | Change in CD4 Count From Baseline to Week 48 |
NCT01435018 (37) [back to overview] | Self-reported Adherence to ART Therapy |
NCT01435018 (37) [back to overview] | Number of Participants With Treatment-related Toxicities and Adverse Events (AEs) |
NCT01435018 (37) [back to overview] | Number of Participants With Symptomatic Peripheral Neuropathy (SPN) |
NCT01435018 (37) [back to overview] | Number of Participants With Peripheral Neuropathy (PN) |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4 |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3 |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2 |
NCT01435018 (37) [back to overview] | Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Objective Response for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Objective Response for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Duration of Objective Response for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Duration of Objective Response for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death for BV+ART vs PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART |
NCT01448616 (4) [back to overview] | HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo |
NCT01448616 (4) [back to overview] | Within-person Changes in Log-copy Numbers of HSV |
NCT01448616 (4) [back to overview] | Genital Lesion Rate |
NCT01448616 (4) [back to overview] | Asymptomatic Shedding (Shedding on Days Without Genital Lesions) |
NCT01450189 (30) [back to overview] | Cumulative Incidence Herpes Simplex Virus Type 2 |
NCT01450189 (30) [back to overview] | Number of Adverse Events |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 52 Weeks |
NCT01450189 (30) [back to overview] | Number of Partners Reporting for HIV Testing |
NCT01450189 (30) [back to overview] | Proportion of Participants Completing Full Course of ARVs in Arm BIA |
NCT01450189 (30) [back to overview] | Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment. |
NCT01450189 (30) [back to overview] | Proportion of Partners Reporting for HIV Testing |
NCT01450189 (30) [back to overview] | Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening |
NCT01450189 (30) [back to overview] | Proportion of Persons Completing All Scheduled Visits in Each Study Arm |
NCT01450189 (30) [back to overview] | Prevalence of AHI Among Persons Screened |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 26, Women |
NCT01450189 (30) [back to overview] | Proportion of Persons With AHI Successfully Recruited Into the Study |
NCT01450189 (30) [back to overview] | Suppression of HIV RNA to <1000c/ml at 12 Weeks |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 52, Women |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 52, Men |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 26, Men |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 12, Women |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 12, Men |
NCT01450189 (30) [back to overview] | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
NCT01450189 (30) [back to overview] | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 52 Weeks |
NCT01450189 (30) [back to overview] | Cumulative Incidence Herpes Simplex Virus Type 2 |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 52 |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 26 |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 12 |
NCT01450189 (30) [back to overview] | Time to HIV RNA Suppression <1000 c/ml |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 12 Weeks |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 26 Weeks |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 12 Weeks |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 26 Weeks |
NCT01505114 (1) [back to overview] | Occurrence of Grade 3 or Higher Adverse Events (AEs) |
NCT01525628 (24) [back to overview] | AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333) |
NCT01525628 (24) [back to overview] | AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168 |
NCT01525628 (24) [back to overview] | Cmax of Deleobuvir (BI 207127) |
NCT01525628 (24) [back to overview] | Cmax of 1-OH-Midazolam (1-hydroxy-midazolam) |
NCT01525628 (24) [back to overview] | AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide) |
NCT01525628 (24) [back to overview] | Cmax of Tolbutamide |
NCT01525628 (24) [back to overview] | Cmax of Midazolam |
NCT01525628 (24) [back to overview] | Cmax of Faldaprevir (BI 201335) |
NCT01525628 (24) [back to overview] | Cmax of Deleobuvir Reduction Metabolite CD 6168 |
NCT01525628 (24) [back to overview] | Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide) |
NCT01525628 (24) [back to overview] | Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333) |
NCT01525628 (24) [back to overview] | C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333) |
NCT01525628 (24) [back to overview] | C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide) |
NCT01525628 (24) [back to overview] | C6hr of Deleobuvir Reduction Metabolite CD 6168 |
NCT01525628 (24) [back to overview] | Cmax of Caffeine |
NCT01525628 (24) [back to overview] | C6hr of Deleobuvir (BI 207127) |
NCT01525628 (24) [back to overview] | C24hr of Faldaprevir (BI 201335) |
NCT01525628 (24) [back to overview] | AUC 0-infinity of Tolbutamide |
NCT01525628 (24) [back to overview] | AUC 0-infinity of Midazolam |
NCT01525628 (24) [back to overview] | AUC 0-infinity of Caffeine |
NCT01525628 (24) [back to overview] | AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam) |
NCT01525628 (24) [back to overview] | AUC 0-6hr of Deleobuvir (BI 207127) |
NCT01525628 (24) [back to overview] | Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours |
NCT01525628 (24) [back to overview] | Number of Participants With Sustained Virological Response (SVR12) |
NCT01605890 (12) [back to overview] | Number of Participants With Treatment Switch or Discontinuation |
NCT01605890 (12) [back to overview] | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48 |
NCT01605890 (12) [back to overview] | Median Change of CD4 Lymphocytes at Week 48 |
NCT01605890 (12) [back to overview] | Percentage of Participants in Therapeutic Success |
NCT01605890 (12) [back to overview] | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24 |
NCT01605890 (12) [back to overview] | Number of Clinical and Biological Events |
NCT01605890 (12) [back to overview] | Median Change in CD4 Lymphocytes Count at Week 12 |
NCT01605890 (12) [back to overview] | Number of Participants With Clinical Progression |
NCT01605890 (12) [back to overview] | Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL |
NCT01605890 (12) [back to overview] | Number of Virological Failure Participants With Resistance Mutations |
NCT01605890 (12) [back to overview] | Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire |
NCT01605890 (12) [back to overview] | Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence |
NCT01632891 (7) [back to overview] | Change in log10(Pf Gametocyte Density) From Entry to Day 30 |
NCT01632891 (7) [back to overview] | Number of Participants With Detectable Pf Gametocyte Density |
NCT01632891 (7) [back to overview] | Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance |
NCT01632891 (7) [back to overview] | Change in log10(Pf Parasite Density) From Entry to Day 30 |
NCT01632891 (7) [back to overview] | Number of Participants With Uncomplicated Clinical Malaria |
NCT01632891 (7) [back to overview] | Time to First Pf SCP Clearance |
NCT01632891 (7) [back to overview] | Log10(Pf Parasite Density) |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Total Cholesterol |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Glucose |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol |
NCT01641367 (60) [back to overview] | Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in CD4+ T-cell Count |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks |
NCT01641367 (60) [back to overview] | Time to First Dose Modification Due to Grade 3 or 4 Toxicity |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation. |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death or Hospitalization. |
NCT01641367 (60) [back to overview] | Number of Weeks of Follow-up [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Number of Weeks of Follow-up |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Death or Hospitalization by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Triglycerides |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Death |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Death [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death by Week 48 |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events |
NCT01641809 (57) [back to overview] | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase |
NCT01641809 (57) [back to overview] | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 |
NCT01641809 (57) [back to overview] | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 |
NCT01641809 (57) [back to overview] | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Number of Participants With AEs and SAEs Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With AEs and SAEs-Induction Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in CD4+ Cell Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in CD4+ Cell Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in ALT, AST and CK Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in ALT, AST and CK Over Time by Visit |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase |
NCT01641809 (57) [back to overview] | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease |
NCT01641809 (57) [back to overview] | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance |
NCT01641809 (57) [back to overview] | Number of Participants With Treatment Emergent Phenotypic Resistance |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Hemoglobin Level Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Hemoglobin Level Over Time by Visit |
NCT01641809 (57) [back to overview] | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 |
NCT01651403 (29) [back to overview] | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48 |
NCT01651403 (29) [back to overview] | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96 |
NCT01651403 (29) [back to overview] | Percent Change From Baseline in BMD of Spine at Week 192 |
NCT01651403 (29) [back to overview] | Percent Change From Baseline in BMD of Spine at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192 |
NCT01651403 (29) [back to overview] | Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBsAg Loss at Week 192 |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBsAg Loss at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Week 192 |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBsAg Seroconversion at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range |
NCT01651403 (29) [back to overview] | Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach) |
NCT01651403 (29) [back to overview] | Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach) |
NCT01651403 (29) [back to overview] | Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192 |
NCT01651403 (29) [back to overview] | Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192 |
NCT01651403 (29) [back to overview] | Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48 |
NCT01651403 (29) [back to overview] | Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192 |
NCT01651403 (29) [back to overview] | Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48 |
NCT01651403 (29) [back to overview] | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144 |
NCT01651403 (29) [back to overview] | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192 |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Safety: Grade 2 or Higher Adverse Events |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product? |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it? |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently? |
NCT01687218 (12) [back to overview] | Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma |
NCT01691768 (8) [back to overview] | Human Papillomavirus Incidence Rates |
NCT01691768 (8) [back to overview] | Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up |
NCT01691768 (8) [back to overview] | Mean Number of Returned Used Applicators Per Month (i.e in 30 Days) |
NCT01691768 (8) [back to overview] | Pregnancy Incidence Rates |
NCT01691768 (8) [back to overview] | Percentage of Participants Achieving Adherence >80%. |
NCT01691768 (8) [back to overview] | Product Acceptability |
NCT01691768 (8) [back to overview] | HIV Viral Load Among HIV Seroconverters |
NCT01691768 (8) [back to overview] | HIV Incidence Rates |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48 |
NCT01709084 (6) [back to overview] | Percentage of Participant With Treatment Adherence Based on Tablet Count |
NCT01709084 (6) [back to overview] | Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48 |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. |
NCT01745822 (5) [back to overview] | Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age |
NCT01745822 (5) [back to overview] | Percentage of Participants With Flares After Study Treatment Interruption |
NCT01745822 (5) [back to overview] | Percentage of Participants With Adverse Events |
NCT01745822 (5) [back to overview] | Weight, Height and Head Circumference for Age |
NCT01745822 (5) [back to overview] | Percentage of Infants With Hepatitis B Infection at 6 Months of Age |
NCT01769456 (12) [back to overview] | Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Number of Participants Using Text Messaging Reminders |
NCT01769456 (12) [back to overview] | Number of Participants With Decrease in Bone Mineral Density |
NCT01769456 (12) [back to overview] | Acceptability of PrEP Regimen and Study Visits |
NCT01769456 (12) [back to overview] | Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex |
NCT01769456 (12) [back to overview] | Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Estimation of Medication Adherence by Dried Blood Spot (DBS) Results |
NCT01769456 (12) [back to overview] | Rating of the Reasons for Missing Medications on a 4-point Likert Scale. |
NCT01769456 (12) [back to overview] | Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study |
NCT01769456 (12) [back to overview] | Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners |
NCT01769456 (12) [back to overview] | Total Body Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01772823 (15) [back to overview] | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) |
NCT01772823 (15) [back to overview] | Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders |
NCT01772823 (15) [back to overview] | Lumbar Spine Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) |
NCT01772823 (15) [back to overview] | Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders |
NCT01772823 (15) [back to overview] | Femoral Neck Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 |
NCT01772823 (15) [back to overview] | Number of Participants With Unprotected Sex Acts |
NCT01772823 (15) [back to overview] | Number of Sex Partners |
NCT01772823 (15) [back to overview] | Total Body Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) |
NCT01772823 (15) [back to overview] | Total Hip Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Number of Participants With Serum Creatinine Event of Grade 1 or Higher |
NCT01772823 (15) [back to overview] | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure |
NCT01772823 (15) [back to overview] | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) |
NCT01777997 (9) [back to overview] | Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay |
NCT01777997 (9) [back to overview] | Change in Quality of Life (QoL) Index |
NCT01777997 (9) [back to overview] | Change in Levels of D-dimer |
NCT01777997 (9) [back to overview] | Change in Levels of CD8+ T-cell Activation |
NCT01777997 (9) [back to overview] | Change in CD4+ T-cell Count |
NCT01777997 (9) [back to overview] | Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) |
NCT01777997 (9) [back to overview] | Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs) |
NCT01777997 (9) [back to overview] | Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART |
NCT01777997 (9) [back to overview] | Change in Levels of Interleukin (IL)-6 |
NCT01781806 (3) [back to overview] | Number of Participants With a Grade 2 or Higher Adverse Event by Cohort |
NCT01781806 (3) [back to overview] | Number of HIV Seroconversions by Cohort. |
NCT01781806 (3) [back to overview] | Cohort H PrEP Engagement by Study Visit |
NCT01803074 (28) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B |
NCT01803074 (28) [back to overview] | Maximum Observed Plasma Concentrations (Cmax) - Part B |
NCT01803074 (28) [back to overview] | Maximum Observed Plasma Concentrations (Cmax) - Part A and C |
NCT01803074 (28) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C |
NCT01803074 (28) [back to overview] | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B |
NCT01803074 (28) [back to overview] | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C |
NCT01803074 (28) [back to overview] | Accumulation Index (AI): Part A and C |
NCT01803074 (28) [back to overview] | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B |
NCT01803074 (28) [back to overview] | Plasma Half-life: Part A and C |
NCT01803074 (28) [back to overview] | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 |
NCT01803074 (28) [back to overview] | Apparent Total Body Clearance: Part A and C |
NCT01803074 (28) [back to overview] | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C |
NCT01803074 (28) [back to overview] | Degree of Fluctuation (DF): Part A and C |
NCT01803074 (28) [back to overview] | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C |
NCT01803074 (28) [back to overview] | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Heart Rate |
NCT01803074 (28) [back to overview] | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C |
NCT01803074 (28) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) - Part B |
NCT01803074 (28) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C |
NCT01803074 (28) [back to overview] | Plasma Concentration 24 Hours Post-Dose (C24) - Part B |
NCT01803074 (28) [back to overview] | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C |
NCT01803074 (28) [back to overview] | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B |
NCT01803074 (28) [back to overview] | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C |
NCT01803074 (28) [back to overview] | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) |
NCT01803074 (28) [back to overview] | Number of Participants With Abnormal Changes in Physical Examination |
NCT01855867 (3) [back to overview] | Number of Participants With Self-Reported Missed Doses |
NCT01855867 (3) [back to overview] | nPEP Failure (HIV Infection During Study Participation) |
NCT01855867 (3) [back to overview] | Number of Adverse Event Occurrences |
NCT01903031 (21) [back to overview] | ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL. |
NCT01903031 (21) [back to overview] | Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | Ethinyl Estradiol Concentrations at Study Day 21 |
NCT01903031 (21) [back to overview] | Etonogestrel Concentrations at Study Day 21 |
NCT01903031 (21) [back to overview] | Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment |
NCT01903031 (21) [back to overview] | ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C |
NCT01903031 (21) [back to overview] | EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B |
NCT01903031 (21) [back to overview] | EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B |
NCT01903031 (21) [back to overview] | EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B |
NCT01903031 (21) [back to overview] | EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B |
NCT01903031 (21) [back to overview] | Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14. |
NCT01903031 (21) [back to overview] | Etonogestrel Concentrations Obtained on Study Days 7 and 14 |
NCT01903031 (21) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups |
NCT01910402 (48) [back to overview] | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Albumin at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase |
NCT01910402 (48) [back to overview] | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase |
NCT01910402 (48) [back to overview] | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase |
NCT01910402 (48) [back to overview] | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline |
NCT01910402 (48) [back to overview] | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS |
NCT01910402 (48) [back to overview] | Change From Baseline in TC/HDL Ratio at Week 48 |
NCT01910402 (48) [back to overview] | Change From Baseline in Triglycerides at Week 48 |
NCT01910402 (48) [back to overview] | Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 |
NCT01910402 (48) [back to overview] | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With AEs by Maximum Toxicity-Continuation Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Creatinine Clearance at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Erythrocytes at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Hematocrit Count at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Lipase at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 |
NCT01910402 (48) [back to overview] | HIVTSQs Total Score at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Number of Participants With AEs by Maximum Toxicity-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Any AEs, and SAEs in Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase |
NCT01929759 (8) [back to overview] | Neurocognitive Changes |
NCT01929759 (8) [back to overview] | Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) |
NCT01929759 (8) [back to overview] | Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8 |
NCT01929759 (8) [back to overview] | Effect of EFV and Its Metabolites |
NCT01929759 (8) [back to overview] | Fasting Lipid Profile |
NCT01929759 (8) [back to overview] | Markers of Immune Activation |
NCT01929759 (8) [back to overview] | Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI) |
NCT01929759 (8) [back to overview] | Sleep Quality |
NCT02022657 (1) [back to overview] | Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada |
NCT02116660 (1) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) |
NCT02174276 (19) [back to overview] | Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48 |
NCT02174276 (19) [back to overview] | Mean Change in Serum HBsAg From Baseline to Week 24 |
NCT02174276 (19) [back to overview] | Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available |
NCT02174276 (19) [back to overview] | Percentage of Participants Experiencing Virologic Breakthrough at Week 24 |
NCT02174276 (19) [back to overview] | Percentage of Participants Experiencing Virologic Breakthrough at Week 48 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBeAg Loss at Week 24 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBeAg Loss at Week 48 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBsAg Loss at Week 24 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBsAg Loss at Week 48 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBV DNA < LLOQ at Week 48 |
NCT02174276 (19) [back to overview] | Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24 |
NCT02174276 (19) [back to overview] | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12 |
NCT02174276 (19) [back to overview] | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48 |
NCT02174276 (19) [back to overview] | Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24 |
NCT02174276 (19) [back to overview] | Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24 |
NCT02174276 (19) [back to overview] | Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24 |
NCT02174276 (19) [back to overview] | Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48 |
NCT02174276 (19) [back to overview] | Mean Change in HBsAg From Baseline to Week 12 |
NCT02174276 (19) [back to overview] | Mean Change in HBsAg From Baseline to Week 48 |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events |
NCT02180438 (12) [back to overview] | Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml) |
NCT02180438 (12) [back to overview] | Interim 24 Weeks Analysis of Death |
NCT02180438 (12) [back to overview] | Grade 3 or 4 Adverse Events |
NCT02180438 (12) [back to overview] | Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF |
NCT02180438 (12) [back to overview] | < 50 CD4 T-cell Increase at 48 Weeks From Baseline |
NCT02180438 (12) [back to overview] | CD4 T-cell Count at 48 Weeks < Baseline |
NCT02180438 (12) [back to overview] | Death |
NCT02180438 (12) [back to overview] | Switching Off Stribild Prior to 48 Weeks |
NCT02180438 (12) [back to overview] | New WHO Stage 3 or 4 Event |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of HIV-2 Virologic Failure |
NCT02195518 (18) [back to overview] | Change From Baseline in Hemoglobin (Hb) |
NCT02195518 (18) [back to overview] | Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96 |
NCT02195518 (18) [back to overview] | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline |
NCT02195518 (18) [back to overview] | Percentage of Participants Who Experienced Viral Breakthrough up to Week 144 |
NCT02195518 (18) [back to overview] | Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 |
NCT02195518 (18) [back to overview] | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 |
NCT02195518 (18) [back to overview] | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144 |
NCT02195518 (18) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs |
NCT02195518 (18) [back to overview] | Change From Baseline in Red Blood Cells (RBC) |
NCT02195518 (18) [back to overview] | Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144 |
NCT02195518 (18) [back to overview] | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameters: Albumin, Total Protein |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate |
NCT02195518 (18) [back to overview] | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose. |
NCT02195518 (18) [back to overview] | Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144 |
NCT02213328 (11) [back to overview] | Number of Participants With Acceptability as Per Questionnaire Administered at Week 48 |
NCT02213328 (11) [back to overview] | 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 |
NCT02213328 (11) [back to overview] | Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit |
NCT02213328 (11) [back to overview] | Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP |
NCT02213328 (11) [back to overview] | Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events |
NCT02213328 (11) [back to overview] | Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period |
NCT02213328 (11) [back to overview] | Number of Adolescents Enrolled and Retained in the Study |
NCT02213328 (11) [back to overview] | Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit |
NCT02213328 (11) [back to overview] | Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52 |
NCT02213328 (11) [back to overview] | Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment |
NCT02213328 (11) [back to overview] | Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36 |
NCT02224456 (24) [back to overview] | Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 |
NCT02224456 (24) [back to overview] | Change From Baseline in Red Blood Cells (RBC) |
NCT02224456 (24) [back to overview] | Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA |
NCT02224456 (24) [back to overview] | Change From Baseline in Hemoglobin (Hb) |
NCT02224456 (24) [back to overview] | Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR) |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameters: Albumin and Total Protein |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH) |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose |
NCT02224456 (24) [back to overview] | Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240 |
NCT02224456 (24) [back to overview] | Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192 |
NCT02224456 (24) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs |
NCT02224456 (24) [back to overview] | Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240 |
NCT02224456 (24) [back to overview] | Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240. |
NCT02224456 (24) [back to overview] | Percentage of Participants Who Experienced Viral Breakthrough |
NCT02224456 (24) [back to overview] | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline |
NCT02224456 (24) [back to overview] | Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240 |
NCT02224456 (24) [back to overview] | Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240 |
NCT02224456 (24) [back to overview] | Percentage of Participants With Histological Improvement at Week 216 |
NCT02224456 (24) [back to overview] | Percentage of Participants With Disease Progression at Week 240 |
NCT02224456 (24) [back to overview] | Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240 |
NCT02224456 (24) [back to overview] | Percentage of Participants With Cirrhosis Reversal at Week 216 |
NCT02224456 (24) [back to overview] | Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate |
NCT02251236 (4) [back to overview] | Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline |
NCT02251236 (4) [back to overview] | Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24 |
NCT02251236 (4) [back to overview] | Concentration of Tenofovir in Cerebrospinal Fluid at Week 24 |
NCT02251236 (4) [back to overview] | Concentration of Tenofovir in Cerebrospinal Fluid at Baseline |
NCT02386098 (8) [back to overview] | Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 |
NCT02386098 (8) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1 |
NCT02386098 (8) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 |
NCT02386098 (8) [back to overview] | Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 |
NCT02386098 (8) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 |
NCT02386098 (8) [back to overview] | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 |
NCT02386098 (8) [back to overview] | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 |
NCT02386098 (8) [back to overview] | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 |
NCT02397096 (12) [back to overview] | Percentage of Participants Discontinuing From Study Medication Due to an AE(s) |
NCT02397096 (12) [back to overview] | Percentage of Participants Experiencing ≥1 Adverse Event (AE) |
NCT02397096 (12) [back to overview] | Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE) |
NCT02397096 (12) [back to overview] | Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL |
NCT02397096 (12) [back to overview] | Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL |
NCT02397096 (12) [back to overview] | Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL |
NCT02397096 (12) [back to overview] | Percentage of Participants With HIV-1 RNA >=50 Copies/mL |
NCT02397096 (12) [back to overview] | Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts |
NCT02397096 (12) [back to overview] | Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) |
NCT02397096 (12) [back to overview] | Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
NCT02397096 (12) [back to overview] | Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts |
NCT02397096 (12) [back to overview] | Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration |
NCT02401230 (13) [back to overview] | Median Cumulative Amount of p24 |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Secretion Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Secretion Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Plasma Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Plasma Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration |
NCT02401230 (13) [back to overview] | Median Percentage of CD4 Positive T-Cells |
NCT02403674 (14) [back to overview] | Change From Baseline in Fasting Non-HDL-C at Week 48 |
NCT02403674 (14) [back to overview] | Change From Baseline in Fasting Triglycerides at Week 48 |
NCT02403674 (14) [back to overview] | Percentage of Participants Discontinuing From Study Medication Due to an AE(s) |
NCT02403674 (14) [back to overview] | Percentage of Participants Experiencing ≥1 AE |
NCT02403674 (14) [back to overview] | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
NCT02403674 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 |
NCT02403674 (14) [back to overview] | Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48 |
NCT02403674 (14) [back to overview] | Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs) |
NCT02403674 (14) [back to overview] | Percentage of Participants With Tier-2 Neuropsychiatric AEs |
NCT02403674 (14) [back to overview] | Plasma Concentration of Doravirine at Week 48 |
NCT02403674 (14) [back to overview] | Change From Baseline in CD4 Cell Counts at Week 48 |
NCT02403674 (14) [back to overview] | Change From Baseline in Fasting Cholesterol at Week 48 |
NCT02403674 (14) [back to overview] | Change From Baseline in Fasting HDL-C at Week 48 |
NCT02403674 (14) [back to overview] | Change From Baseline in Fasting LDL-C at Week 48 |
NCT02431247 (64) [back to overview] | Change From Reference in log10 HIV-1 RNA Levels at Week 96 |
NCT02431247 (64) [back to overview] | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula |
NCT02431247 (64) [back to overview] | Change From Reference in Serum Creatinine |
NCT02431247 (64) [back to overview] | Change From Reference in UACR |
NCT02431247 (64) [back to overview] | Change From Reference in UB2MGCR |
NCT02431247 (64) [back to overview] | Change From Reference in UPCR |
NCT02431247 (64) [back to overview] | Change From Reference in URBPCR |
NCT02431247 (64) [back to overview] | Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48 |
NCT02431247 (64) [back to overview] | Percent Change From Reference in Urine FEPO4 |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach |
NCT02431247 (64) [back to overview] | Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide |
NCT02431247 (64) [back to overview] | Predose (Trough) Plasma Concentration (C0h) of Darunavir |
NCT02431247 (64) [back to overview] | CD4+ Cell Count Post-Week From 96 to End of Extension |
NCT02431247 (64) [back to overview] | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in BMD T-score of Hip and Spine |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Reference in BMD T-score of Hip and Spine at Week 96 |
NCT02431247 (64) [back to overview] | Number of Participants With ARV Resistance |
NCT02431247 (64) [back to overview] | Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) |
NCT02431247 (64) [back to overview] | Percent Change From Reference in Hip and Spine BMD |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48 |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96 |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula |
NCT02431247 (64) [back to overview] | Change From Reference in eGFRcr by CKD-EPI Formula |
NCT02431247 (64) [back to overview] | Change From Reference in CD4+ Cell Count at Week 96 |
NCT02431247 (64) [back to overview] | Change From Reference in ALP Levels |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Serum Creatinine at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in log10 HIV-1 RNA Levels at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48 |
NCT02431247 (64) [back to overview] | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir |
NCT02431247 (64) [back to overview] | Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Percentage of Participants With PDVF Post-week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of Serum CTX |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of PTH |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of 25-OH Vitamin D |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of Serum P1NP |
NCT02452528 (1) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs) |
NCT02479880 (1) [back to overview] | Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96 |
NCT02495779 (1) [back to overview] | Number of Participants With PrEP Adherence |
NCT02556333 (1) [back to overview] | HIV RNA Change From Baseline to Day 10 |
NCT02577029 (1) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment |
NCT02603120 (7) [back to overview] | Spine Bone Mineral Density (BMD) at Baseline |
NCT02603120 (7) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm |
NCT02603120 (7) [back to overview] | Percentage Change From Baseline in Spine BMD at Week 48 |
NCT02603120 (7) [back to overview] | Percentage Change From Baseline in Hip BMD at Week 48 |
NCT02603120 (7) [back to overview] | Hip Bone Mineral Density at Baseline |
NCT02603120 (7) [back to overview] | Change From Baseline in CD4+ Cell Count at Week 48 |
NCT02603120 (7) [back to overview] | Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm |
NCT02604199 (3) [back to overview] | Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 |
NCT02604199 (3) [back to overview] | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs |
NCT02604199 (3) [back to overview] | Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) Over Time |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 29 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 15 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 15 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 15 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 113 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 113 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 85 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113 |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 113 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs |
NCT02604212 (26) [back to overview] | Change From Baseline in Log qHBsAg Over Time |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 99 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 99 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 99 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 85 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 85 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 71 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 71 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 71 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 57 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 57 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 57 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 43 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 43 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 43 in Log qHBsAg, by Category |
NCT02604212 (26) [back to overview] | Change From Baseline at Day 29 in Log qHBsAg, by Category |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96 |
NCT02629822 (14) [back to overview] | Change From Baseline in CD4 Cell Count at Week 48 |
NCT02629822 (14) [back to overview] | Change From Baseline in CD4 Cell Count at Week 192 |
NCT02629822 (14) [back to overview] | Time to Loss of Virologic Response |
NCT02629822 (14) [back to overview] | Change From Baseline in CD4 Cell Count at Week 96 |
NCT02629822 (14) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96 |
NCT02629822 (14) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48. |
NCT02629822 (14) [back to overview] | Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96 |
NCT02629822 (14) [back to overview] | Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48 |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96 |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48 |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192 |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192 |
NCT02629822 (14) [back to overview] | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48 |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Drug-related SAEs Through Study Week 12 |
NCT02652260 (20) [back to overview] | Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups |
NCT02652260 (20) [back to overview] | CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups |
NCT02652260 (20) [back to overview] | Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups |
NCT02652260 (20) [back to overview] | Change From Baseline in Fasting Lipids at Week 12 |
NCT02652260 (20) [back to overview] | Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4 |
NCT02652260 (20) [back to overview] | Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups |
NCT02652260 (20) [back to overview] | Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12 |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12 |
NCT02652260 (20) [back to overview] | Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Drug-related AEs Through Study Week 12 |
NCT02652260 (20) [back to overview] | Change From Baseline in CNS Toxicity Score at Week 12 |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch |
NCT02652260 (20) [back to overview] | Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch |
NCT02652260 (20) [back to overview] | Number of Participants With One or More Adverse Events (AEs) Through Study Week 12 |
NCT02652260 (20) [back to overview] | Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12 |
NCT02652260 (20) [back to overview] | Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch |
NCT02652260 (20) [back to overview] | Change From Baseline in CNS Toxicity Score at Week 4 |
NCT02652260 (20) [back to overview] | Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups |
NCT02738008 (1) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
NCT02797522 (2) [back to overview] | Number of Participants With TEAEs: CHB Participants |
NCT02797522 (2) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers |
NCT02815566 (2) [back to overview] | % Change in Bone Mineral Density From Baseline at the Femoral Neck |
NCT02815566 (2) [back to overview] | Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831673 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Weeks 24 and 48 |
NCT02831673 (64) [back to overview] | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 144 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Week 96 |
NCT02831673 (64) [back to overview] | Number of Participants With AEs by Maximum Severity Grades up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Any AE and SAE up to Week 148 |
NCT02831673 (64) [back to overview] | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With HIV-1 Disease Progression up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Week 96 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 96 |
NCT02831764 (64) [back to overview] | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831764 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With HIV-1 Disease Progression up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 |
NCT02831764 (64) [back to overview] | Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 |
NCT02831764 (64) [back to overview] | Number of Participants With AEs by Maximum Severity Grades up to Week 148 |
NCT02831764 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Weeks 24 and 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 |
NCT02859558 (4) [back to overview] | Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation |
NCT02859558 (4) [back to overview] | Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) |
NCT02859558 (4) [back to overview] | HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry |
NCT02859558 (4) [back to overview] | HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry |
NCT02888106 (13) [back to overview] | Percentage of Patients With HBsAg Negativation |
NCT02888106 (13) [back to overview] | Percentage of Patients With HВsAg Response |
NCT02888106 (13) [back to overview] | Percentage of Patients With Negative HBV DNA by PCR |
NCT02888106 (13) [back to overview] | Percentage of Patients With Normalized ALT |
NCT02888106 (13) [back to overview] | The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72. |
NCT02888106 (13) [back to overview] | Percentage of Patients With Negative HDV RNA by PCR |
NCT02888106 (13) [back to overview] | Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment |
NCT02888106 (13) [back to overview] | Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region). |
NCT02888106 (13) [back to overview] | Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment. |
NCT02888106 (13) [back to overview] | Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment |
NCT02888106 (13) [back to overview] | Change in the Gene Expression Analyses From Baseline to Post-treatment |
NCT02888106 (13) [back to overview] | Percentage of Patients With Combined Response |
NCT02888106 (13) [back to overview] | Percentage of Patients With Negative HDV RNA by PCR |
NCT02962739 (1) [back to overview] | Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy |
NCT02968576 (2) [back to overview] | Area Under the Concentration-time Curve (AUC) |
NCT02968576 (2) [back to overview] | Peak Plasma Concentration (Cmax) |
NCT03048422 (23) [back to overview] | Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event |
NCT03048422 (23) [back to overview] | Maternal Change in Creatinine Clearance |
NCT03048422 (23) [back to overview] | Percentage of Infants Born Small for Gestational Age |
NCT03048422 (23) [back to overview] | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome |
NCT03048422 (23) [back to overview] | Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome |
NCT03048422 (23) [back to overview] | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory |
NCT03048422 (23) [back to overview] | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm |
NCT03048422 (23) [back to overview] | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm |
NCT03048422 (23) [back to overview] | Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Antepartum |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Overall |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Postpartum |
NCT03048422 (23) [back to overview] | Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis |
NCT03048422 (23) [back to overview] | Infant Creatinine Clearance |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery |
NCT03048422 (23) [back to overview] | Percentage of Mother-Infant Pairs With Preterm Deliveries |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infant Deaths |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infant HIV-infection |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event |
NCT03126370 (6) [back to overview] | Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks |
NCT03126370 (6) [back to overview] | Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) |
NCT03126370 (6) [back to overview] | Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio |
NCT03164564 (2) [back to overview] | Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 |
NCT03164564 (2) [back to overview] | Number of Pariicipants With Documented Incident HIV Infections |
NCT03202511 (2) [back to overview] | PBMC TFV-DP AUC GMR |
NCT03202511 (2) [back to overview] | Plasma TFV AUC0-INF GMR |
NCT03218592 (4) [back to overview] | Whole Blood Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Plasma Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Hair Antiretroviral Imaging |
NCT03258710 (36) [back to overview] | Percentage of Eosinophils at Indicated Time Points |
NCT03258710 (36) [back to overview] | Percentage of Basophils at Indicated Time Points |
NCT03258710 (36) [back to overview] | Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values |
NCT03258710 (36) [back to overview] | Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96 |
NCT03258710 (36) [back to overview] | Absolute Values for Hematology Parameter: Hemoglobin |
NCT03258710 (36) [back to overview] | Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
NCT03258710 (36) [back to overview] | Absolute Values for Hematology Parameter: Prothrombin Time |
NCT03258710 (36) [back to overview] | Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count |
NCT03258710 (36) [back to overview] | Absolute Values for Hematology Parameter: Hematocrit |
NCT03258710 (36) [back to overview] | Absolute Values for Heart Rate |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN) |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR) |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance |
NCT03258710 (36) [back to overview] | Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP) |
NCT03258710 (36) [back to overview] | Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96 |
NCT03258710 (36) [back to overview] | Absolute Values for Temperature |
NCT03258710 (36) [back to overview] | Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Change From Baseline Values for Beta-2-microglobulin |
NCT03258710 (36) [back to overview] | Change From Baseline Values for Bone Density |
NCT03258710 (36) [back to overview] | Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate |
NCT03258710 (36) [back to overview] | Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) |
NCT03258710 (36) [back to overview] | Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48 |
NCT03258710 (36) [back to overview] | Percentage of Total Neutrophils at Indicated Time Points |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96 |
NCT03258710 (36) [back to overview] | Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48 |
NCT03258710 (36) [back to overview] | Percentage of Monocytes at Indicated Time Points |
NCT03258710 (36) [back to overview] | Percentage of Lymphocytes at Indicated Time Points |
NCT03272347 (18) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 |
NCT03272347 (18) [back to overview] | Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24 |
NCT03272347 (18) [back to overview] | Change From Baseline in CD4+ T-cell Count at Week 96 |
NCT03272347 (18) [back to overview] | Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4) |
NCT03272347 (18) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4) |
NCT03272347 (18) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
NCT03272347 (18) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
NCT03272347 (18) [back to overview] | Number of Participants Discontinuing Study Drug Due to AEs up to Week 144 |
NCT03272347 (18) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 |
NCT03272347 (18) [back to overview] | Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
NCT03272347 (18) [back to overview] | Number of Participants Experiencing AEs From Week 96 Through Study Duration |
NCT03272347 (18) [back to overview] | Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4) |
NCT03272347 (18) [back to overview] | Change From Baseline in CD4+ T-cell Count at Week 144 |
NCT03272347 (18) [back to overview] | Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4) |
NCT03272347 (18) [back to overview] | Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration |
NCT03272347 (18) [back to overview] | Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen |
NCT03272347 (18) [back to overview] | Number of Participants Experiencing Adverse Events (AEs) up to Week 144 |
NCT03272347 (18) [back to overview] | Change From Baseline in CD4+ T-cell Count at Week 48 |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1) |
NCT03332095 (38) [back to overview] | PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1) |
NCT03332095 (38) [back to overview] | PK Parameter: Cmax of Tenofovir (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: Cmax of DOR (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: Cmax of 3TC (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: C24hr of DOR (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: C24hr of 3TC (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug |
NCT03332095 (38) [back to overview] | Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study |
NCT03332095 (38) [back to overview] | Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Serious Adverse Events (SAEs) Assessed as Related to Study Drug |
NCT03332095 (38) [back to overview] | Percentage of Participants With Serious Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study |
NCT03332095 (38) [back to overview] | Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1) |
NCT03332095 (38) [back to overview] | PK Parameter: AUC0-24hr of 3TC (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: AUC0-24hr of DOR (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: AUC0-24hr of Tenofovir (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Grade 3 or Higher Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study |
NCT03332095 (38) [back to overview] | Percentage of Participants With Grade 3 or Higher Adverse Events (AEs) Assessed as Related to Study Drug |
NCT03332095 (38) [back to overview] | Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2) |
NCT03332095 (38) [back to overview] | PK Parameter: C24hr of Tenofovir (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2) |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2) |
NCT03332095 (38) [back to overview] | Percentage of Participants With Permanent Discontinuation of Study Drug Due to Adverse Events Assessed as Related to Study Drug (Cohort 2) Through End of Study |
NCT03332095 (38) [back to overview] | Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2) |
NCT03387462 (4) [back to overview] | DOT Diary Mobile App Ease of Use |
NCT03387462 (4) [back to overview] | Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP |
NCT03387462 (4) [back to overview] | Assessment of Situations and Reasons for Sub-optimal Use of the App |
NCT03387462 (4) [back to overview] | DOT Diary Mobile App Acceptability |
NCT03471624 (4) [back to overview] | The Mean Bone Mass Density (T-score) Change |
NCT03471624 (4) [back to overview] | Number of Participants With Normal Alanine Aminotransferase (ALT). |
NCT03471624 (4) [back to overview] | Calculated eGFR |
NCT03471624 (4) [back to overview] | Number of Participants With HBV DNA <20 IU Per mL |
NCT03510468 (1) [back to overview] | Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr) |
NCT03512964 (4) [back to overview] | Number of Patients Who Accepted Rapid HIV Treatment Initiation |
NCT03512964 (4) [back to overview] | Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day |
NCT03512964 (4) [back to overview] | Number of Patients Who Receive Rapid HIV Treatment Initiation |
NCT03512964 (4) [back to overview] | Number of Patients Offered Rapid HIV Treatment Initiation |
NCT03537404 (10) [back to overview] | AUCtau of Raltegravir |
NCT03537404 (10) [back to overview] | AUCtau of Narlaprevir |
NCT03537404 (10) [back to overview] | AUCtau of Tenofovir |
NCT03537404 (10) [back to overview] | Number of Patients With Abnormal ECG Changes |
NCT03537404 (10) [back to overview] | Number of Patients With Changes in Vital Signs |
NCT03537404 (10) [back to overview] | Number of Patients With Adverse Events |
NCT03537404 (10) [back to overview] | Cmax of Tenofovir |
NCT03537404 (10) [back to overview] | Cmax of Raltegravir |
NCT03537404 (10) [back to overview] | Cmax of Narlaprevir |
NCT03537404 (10) [back to overview] | Number of Patients With Abnormal Laboratory Values |
NCT03546621 (8) [back to overview] | Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results |
NCT03546621 (8) [back to overview] | Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24 |
NCT03546621 (8) [back to overview] | Durability of HDV RNA Response |
NCT03546621 (8) [back to overview] | Changes in ALT Values |
NCT03546621 (8) [back to overview] | Change in Hepatitis B Surface Antigen |
NCT03546621 (8) [back to overview] | Change (Absence of Increase) in Fibrosis Marker |
NCT03546621 (8) [back to overview] | Absence of a Fibrosis Progression According to the Findings of Transient Elastometry |
NCT03546621 (8) [back to overview] | Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline |
NCT03567382 (5) [back to overview] | Number of Infants Receiving Timely Birth Dose Vaccination |
NCT03567382 (5) [back to overview] | Number of Participants With Lab Testing Acceptability Survey Scores >80% |
NCT03567382 (5) [back to overview] | Number of Mothers With Infant Vaccination Acceptability Survey Scores >80% |
NCT03567382 (5) [back to overview] | Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy |
NCT03567382 (5) [back to overview] | Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV |
NCT03576066 (12) [back to overview] | Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
NCT03576066 (12) [back to overview] | Number of Participants With a Clinically-significant Change in Vital Signs |
NCT03576066 (12) [back to overview] | Number of Participants With a Clinically-significant Electrocardiogram Abnormality |
NCT03576066 (12) [back to overview] | Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy |
NCT03576066 (12) [back to overview] | Number of Participants With One or More Abnormal Safety Laboratory Result |
NCT03576066 (12) [back to overview] | Number of Participants With One or More Adverse Events |
NCT03576066 (12) [back to overview] | Number of Participants With Premature Study Discontinuation |
NCT03576066 (12) [back to overview] | Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC |
NCT03576066 (12) [back to overview] | Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC |
NCT03576066 (12) [back to overview] | Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy |
NCT03576066 (12) [back to overview] | Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
NCT03576066 (12) [back to overview] | Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy |
NCT03593655 (4) [back to overview] | Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets |
NCT03593655 (4) [back to overview] | Number of Participant-Visits Reporting Acceptability of Study Product |
NCT03593655 (4) [back to overview] | Number of Participants With Grade 2 or Higher Adverse Events (AEs) |
NCT03593655 (4) [back to overview] | Number of Participant-Visits With No Product Use |
NCT03656783 (5) [back to overview] | Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L)) |
NCT03656783 (5) [back to overview] | Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) |
NCT03656783 (5) [back to overview] | Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) |
NCT03656783 (5) [back to overview] | Change in Peak Stress Global MBF |
NCT03656783 (5) [back to overview] | Change in Global CFR |
NCT03717129 (9) [back to overview] | EVG Cmax |
NCT03717129 (9) [back to overview] | AUC0-∞ for FTC |
NCT03717129 (9) [back to overview] | Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG |
NCT03717129 (9) [back to overview] | TFV Half-life |
NCT03717129 (9) [back to overview] | TFV Cmax |
NCT03717129 (9) [back to overview] | FTC Half-life |
NCT03717129 (9) [back to overview] | EVG Half-life |
NCT03717129 (9) [back to overview] | FTC Cmax |
NCT03717129 (9) [back to overview] | AUC0-∞ for Tenofovir (TFV) |
NCT03780543 (5) [back to overview] | Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy |
NCT03780543 (5) [back to overview] | Sustained Viral Response (SVR) at 24 Weeks Off Treatment |
NCT03780543 (5) [back to overview] | Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS) |
NCT03780543 (5) [back to overview] | Number of Subjects With Adverse Events |
NCT03780543 (5) [back to overview] | Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy |
NCT03797014 (10) [back to overview] | ALT Normalization at Week 24 |
NCT03797014 (10) [back to overview] | HBeAg Loss at Week 48 |
NCT03797014 (10) [back to overview] | CD4 Cell Count Change at Week 24 |
NCT03797014 (10) [back to overview] | CD4 Cell Count Change at Week 48 |
NCT03797014 (10) [back to overview] | HBsAg Loss at Week 48 |
NCT03797014 (10) [back to overview] | HBV DNA at Week 24 |
NCT03797014 (10) [back to overview] | HBV DNA at Week 48 |
NCT03797014 (10) [back to overview] | HIV-1 RNA at Week 24 |
NCT03797014 (10) [back to overview] | HIV-1 RNA at Week 48 |
NCT03797014 (10) [back to overview] | ALT Normalization at Week 48 |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of MCV |
NCT03836729 (107) [back to overview] | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Tmax of FTC |
NCT03836729 (107) [back to overview] | Period 2: Tmax of TAF |
NCT03836729 (107) [back to overview] | Period 2: Tmax of TFV |
NCT03836729 (107) [back to overview] | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Blood Pressure |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Pulse Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Pulse Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Heart Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF |
NCT03836729 (107) [back to overview] | Period 1: AUC (0-tau) of FTC |
NCT03836729 (107) [back to overview] | Period 1: AUC (0-tau) of Tenofovir (TFV) |
NCT03836729 (107) [back to overview] | Period 1: Cmax of TFV |
NCT03836729 (107) [back to overview] | Period 1: Ctau of TFV |
NCT03836729 (107) [back to overview] | Period 1: Maximum Observed Concentration (Cmax) of TAF |
NCT03836729 (107) [back to overview] | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC |
NCT03836729 (107) [back to overview] | Period 1: Tmax of FTC |
NCT03836729 (107) [back to overview] | Period 1: Tmax of TAF |
NCT03836729 (107) [back to overview] | Period 1: Tmax of TFV |
NCT03836729 (107) [back to overview] | Period 1:Cmax of FTC |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of FTC |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of TAF |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of TFV |
NCT03836729 (107) [back to overview] | Period 2: Cmax of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Cmax of TAF |
NCT03836729 (107) [back to overview] | Period 2: Cmax of TFV |
NCT03836729 (107) [back to overview] | Period 2: Ctau of FTC |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Blood Pressure |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK) |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Heart Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Erythrocytes |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Hematocrit |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Hemoglobin |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Pulse Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Temperature |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Blood Pressure |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Heart Rate |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Temperature |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Hematocrit |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: MCH |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: MCV |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Blood Pressure |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Heart Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Hematocrit |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of MCH |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Pulse Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Temperature |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: MCV |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: MCH |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Hematocrit |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Temperature |
NCT03836729 (107) [back to overview] | Period 2: Ctau of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Ctau of TFV |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 2:Cmax of FTC |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) |
NCT03917420 (11) [back to overview] | Average Tenofovir Concentrations in Plasma. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Concentrations in Plasma. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Progesterone Concentrations in Serum. |
NCT03917420 (11) [back to overview] | Average Estradiol Concentrations in Serum. |
NCT03917420 (11) [back to overview] | Average Testosterone Concentrations in Serum. |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03998176 (4) [back to overview] | Percentage of Participants With Grade 3 or Greater Adverse Events |
NCT03998176 (4) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
NCT03998176 (4) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
NCT03998176 (4) [back to overview] | Percentage of Participants With Grade 3 or Greater Adverse Events |
NCT04050371 (3) [back to overview] | Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS) |
NCT04050371 (3) [back to overview] | Estradiol Concentration |
NCT04050371 (3) [back to overview] | Total Testosterone |
NCT04140266 (26) [back to overview] | Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms |
NCT04140266 (26) [back to overview] | Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N) |
NCT04140266 (26) [back to overview] | Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant DPV Concentrations From Plasma by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant FTC-TP Concentration by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal TFV-DP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal FTC-TP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal DPV Concentrations From Plasma by Visit |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant TFV-DP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable TFV-DP Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable Plasma DPV Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable FTC-TP Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations |
NCT04140266 (26) [back to overview] | The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product |
NCT04140266 (26) [back to overview] | Residual Drug Levels in Returned VRs |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations |
NCT04140266 (26) [back to overview] | Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms |
NCT04140266 (26) [back to overview] | Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms |
NCT04233879 (8) [back to overview] | Change From Baseline in Body Weight at Week 48 |
NCT04233879 (8) [back to overview] | Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48 |
NCT04233879 (8) [back to overview] | Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48 |
NCT04318210 (7) [back to overview] | Number of Sex Acts by Condom Usage |
NCT04318210 (7) [back to overview] | Self-reported Drug Adherence Over the Past 3 Days |
NCT04318210 (7) [back to overview] | Serious Adverse Events |
NCT04318210 (7) [back to overview] | Number of Sex Partners |
NCT04318210 (7) [back to overview] | HIV Seroconversion |
NCT04318210 (7) [back to overview] | Extracellular Tenofovir (TFV) for Recent Drug Exposure |
NCT04318210 (7) [back to overview] | Intracellular Tenofovir-diphosphate (TFV-DP) |
NCT04465916 (2) [back to overview] | HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment |
NCT04465916 (2) [back to overview] | Virologic Failure Rate |
NCT04686279 (3) [back to overview] | Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire |
NCT04686279 (3) [back to overview] | Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events |
NCT04686279 (3) [back to overview] | Tenofovir Diphosphate (TFV-DP) Concentration |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA Off-Treatment |
NCT04820686 (20) [back to overview] | Number of Participants With One or More Adverse Events (AEs) |
NCT04820686 (20) [back to overview] | Number of Participants With One or More Abnormal Laboratory Result |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) On-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA On-Treatment |
NCT04820686 (20) [back to overview] | Number of Participants With Premature Treatment Discontinuation Due to AEs |
NCT04820686 (20) [back to overview] | Number of Participants With Premature Treatment Discontinuation Due to AEs |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Hepatitis B Core-related Antigen (HBcrAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA On-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA Off-Treatment |
NCT04820686 (20) [back to overview] | Number of Participants With Premature Treatment Discontinuation Due to AEs |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 HBV RNA Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment |
NCT04820686 (20) [back to overview] | Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment |
NCT04897737 (2) [back to overview] | Participant Partners Who Tested for HIV |
NCT04897737 (2) [back to overview] | Recent PrEP Adherence |
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
(NCT00035932)
Timeframe: Week 24
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 95 |
ATV 400 mg / SQV | 74 |
LPV / RTV | 93 |
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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 24
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 46 |
ATV 400 mg / SQV | 25 |
LPV / RTV | 50 |
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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 96
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 52 |
LPV / RTV | 53 |
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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 48
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 64 |
ATV 400 mg / SQV | 42 |
LPV / RTV | 67 |
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Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 24
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 76 |
ATV 400 mg / SQV | 50 |
LPV / RTV | 74 |
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Mean Change From Baseline in HIV RNA at Week 96
(NCT00035932)
Timeframe: Baseline, Week 96
Intervention | log10 c/mL (Mean) |
---|
ATV 300 mg / RTV | -2.29 |
LPV / RTV | -2.08 |
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Mean Change From Baseline in HIV RNA at Week 48
(NCT00035932)
Timeframe: Baseline, Week 48
Intervention | log10 c/mL (Mean) |
---|
ATV 300 mg / RTV | -1.93 |
ATV 400 mg / SQV | -1.55 |
LPV / RTV | -1.87 |
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Mean Change From Baseline in HIV RNA at Week 2
(NCT00035932)
Timeframe: Baseline, Week 2
Intervention | log10 c/mL (Mean) |
---|
ATV 300 mg / RTV | -1.18 |
ATV 400 mg / SQV | -1.14 |
LPV / RTV | -1.30 |
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Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
(NCT00035932)
Timeframe: Baseline, Week 24
Intervention | log10 c/mL (Mean) |
---|
ATV 300 mg / RTV | -1.86 |
ATV 400 mg / SQV | -1.52 |
LPV / RTV | -1.89 |
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Fasting Glucose Mean Change From Baseline at Week 48
(NCT00035932)
Timeframe: Week 48
Intervention | mg/dL (Mean) |
---|
ATV 300 mg / RTV | 4 |
ATV 400 mg / SQV | -1 |
LPV / RTV | 1 |
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HIV IC50 at Week 24
IC50: inhibitory concentration of drug required to reduce viral replication by 50%. (NCT00035932)
Timeframe: Week 24
Intervention | ng/mL (Mean) |
---|
ATV 300 mg / RTV | 17.83 |
ATV 400 mg / SQV | 22.84 |
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PR Interval and Change From Baseline by Analysis Time Point
The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function. (NCT00035932)
Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
Intervention | msec (Mean) |
---|
| Baseline Mean (n=119, 110, 118) | Mean Change at Week 4 predose (n=117, 104, 110) | Mean Change Wk 4 2-3 hrs postdose (n=113,102,106) | Mean Change Wk 4 6-12 hrs postdose (n=112,101,105) | Mean Change at Week 12 (n=110, 97, 107) | Mean Change at Week 24 (n=108, 92, 109) | Mean Change at Week 48 (n=89, 75, 97) |
---|
ATV 300 mg / RTV | 153 | 4 | 1 | 2 | 5 | 2 | 0 |
,ATV 400 mg / SQV | 155 | 9 | 6 | 6 | 7 | 7 | 2 |
,LPV / RTV | 154 | 3 | 1 | 2 | 8 | 5 | 4 |
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Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI. (NCT00035932)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Overall (n=120, 115, 123) | PI Sensitive (n=88, 84, 88) | PI Resistant (n=32, 30, 33) |
---|
ATV 300 mg / RTV | 77 | 65 | 12 |
,ATV 400 mg / SQV | 60 | 52 | 7 |
,LPV / RTV | 84 | 67 | 16 |
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Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Overall (n=120, 115, 123) | PI Sensitive (n=88, 83, 88) | PI Resistant (n=32, 30, 33) |
---|
ATV 300 mg / RTV | 95 | 79 | 16 |
,ATV 400 mg / SQV | 74 | 58 | 15 |
,LPV / RTV | 93 | 72 | 19 |
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Most Common AEs and AEs of Interest Through Week 48
Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia. (NCT00035932)
Timeframe: From Enrollment to Week 48
Intervention | participants (Number) |
---|
| Diarrhea (Most Common) | Headache (Most Common) | Nausea (Most Common) | Jaundice (AE of Interest) | Ocular Icterus (AE of Interest) | Hyperbilirubinemia (AE of Interest) |
---|
ATV 300 mg / RTV | 25 | 21 | 19 | 19 | 13 | 24 |
,ATV 400 mg / SQV | 29 | 24 | 24 | 6 | 3 | 8 |
,LPV / RTV | 54 | 18 | 15 | 0 | 0 | 1 |
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Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)
The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48
Intervention | units on a scale (Mean) |
---|
| Baseline (n=98, 85, 101) | Mid-Study (n=102, 83, 97) | Final (n=95, 81, 96) |
---|
ATV 300 mg / RTV | 81.33 | 84.89 | 82.77 |
,ATV 400 mg / SQV | 81.72 | 83.34 | 85.80 |
,LPV / RTV | 81.52 | 85.09 | 86.16 |
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Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)
The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48
Intervention | units on a scale (Mean) |
---|
| Baseline (n=99, 86, 100) | Mid-Study (n=103, 83, 95) | Final (n=93, 84, 96) |
---|
ATV 300 mg / RTV | 0.83 | 0.87 | 0.84 |
,ATV 400 mg / SQV | 0.85 | 0.86 | 0.85 |
,LPV / RTV | 0.86 | 0.89 | 0.88 |
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Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values
"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose." (NCT00035932)
Timeframe: collected at the pre-dose time point after receiving atazanavir for at least four weeks
Intervention | ng/mL (Mean) |
---|
| ATV (n=40,23) | RTV (n=40,0) | SQV (n=0,19) |
---|
ATV 300 mg / RTV | 719.53 | 154.83 | NA |
,ATV 400 mg / SQV | 312.01 | NA | 52.15 |
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Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Week 96
Intervention | percent change in lipid values (Number) |
---|
| Total Cholesterol (n=60, 46, 54) | HDL Cholesterol (n=60, 46, 54) | Fasting LDL Cholesterol (n=52, 39, 43) | Fasting Triglycerides (n=52, 40, 43) |
---|
ATV 300 mg / RTV | -7 | -5 | -11 | -2 |
,ATV 400 mg / SQV | -1 | 3 | -7 | 4 |
,LPV / RTV | 9 | 7 | 1 | 30 |
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Lipid Mean Percent Change From Baseline at Week 48
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Week 48
Intervention | percent change in lipid values (Number) |
---|
| Total Cholesterol | HDL Cholesterol | Fasting LDL Cholesterol | Fasting Triglycerides |
---|
ATV 300 mg / RTV | -8 | -7 | -10 | -4 |
,ATV 400 mg / SQV | -4 | 4 | -3 | -14 |
,LPV / RTV | 6 | 2 | 1 | 30 |
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Lipid Mean Percent Change From Baseline at Week 24
Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | percent change (Number) |
---|
| Total Cholesterol | High Density Lipoprotein (HDL) Cholesterol | Fasting Low Density Lipoprotein (LDL) Cholesterol | Fasting Triglycerides |
---|
ATV 300 mg / RTV | -8 | -7 | -10 | -2 |
,ATV 400 mg / SQV | -9 | -1 | -11 | -14 |
,LPV / RTV | 3 | 0 | -4 | 31 |
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HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24
Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | log10 c/mL (Mean) |
---|
| Baseline Values | Week 24 Values | Change from Baseline at Week 24 |
---|
ATV 300 mg / RTV | 4.53 | 2.62 | -1.91 |
,ATV 400 mg / SQV | 4.41 | 2.83 | -1.57 |
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Grade 3/4 Laboratory Abnormalities Through Week 48
Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4). (NCT00035932)
Timeframe: From Enrollment to Week 48
Intervention | participants (Number) |
---|
| Neutrophil Reduction | Platelet Reduction | ALT Elevation | AST Elevation | Total Bilirubin Elevation |
---|
ATV 300 mg / RTV | 8 | 2 | 5 | 4 | 58 |
,ATV 400 mg / SQV | 8 | 4 | 4 | 2 | 22 |
,LPV / RTV | 10 | 3 | 4 | 4 | 1 |
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Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula. (NCT00035932)
Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48
Intervention | msec (Mean) |
---|
| Baseline Mean (n=119, 110, 118) | Mean Change at Week 4 predose (n=117, 104, 110) | Mean Change Wk 4 2-3 hrs postdose (n=113,102,106) | Mean Change Wk 4 6-12 hrs postdose (n=112,101,105) | Mean Change at Week 12 (n=110, 97, 107) | Mean Change at Week 24 (n=108, 92, 109) | Mean Change at Week 48 (n=89, 75, 97) |
---|
ATV 300 mg / RTV | 390 | -3 | -2 | -4 | 2 | 1 | -1 |
,ATV 400 mg / SQV | 387 | 1 | -3 | -1 | 3 | 3 | -1 |
,LPV / RTV | 390 | -2 | -7 | -8 | 2 | 2 | 0 |
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Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48
AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. (NCT00035932)
Timeframe: From Enrollment through Week 48
Intervention | participants (Number) |
---|
| Deaths (n = 120, 115, 123) | AEs leading to discontinuation (n = 119, 110, 118) | SAEs (n = 120, 115, 123) | AEs, grades 1-4 (n = 119, 110, 118) | AEs, grades 3-4 (n = 119, 110, 118) |
---|
ATV 300 mg / RTV | 0 | 6 | 12 | 97 | 11 |
,ATV 400 mg / SQV | 1 | 8 | 14 | 93 | 18 |
,LPV / RTV | 1 | 5 | 11 | 103 | 12 |
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Inhibitory Quotient at Week 24
Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | ratio (Mean) |
---|
ATV 300 mg / RTV | 136.94 |
ATV 400 mg / SQV | 25.04 |
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Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | Pearson Correlation Coefficient (Number) |
---|
| ATV Cmin | IQ (<10; >=10) | # of PI Mutations at baseline (<4; >=4) |
---|
ATV 300 mg / RTV | 0.37 | 0.376 | -0.395 |
,ATV 400 mg / SQV | -0.21 | 0.105 | -0.227 |
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Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire
The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance. (NCT00035932)
Timeframe: Baseline, Week 24, Week 48
Intervention | participants (Number) |
---|
| Adherent at Baseline (n=27, 25, 33) | Adherent at Week 24 (n=18, 11, 25) | Adherent at Week 48 (n=11, 4, 20) |
---|
ATV 300 mg / RTV | 12 | 10 | 8 |
,ATV 400 mg / SQV | 10 | 5 | 2 |
,LPV / RTV | 18 | 23 | 13 |
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Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
(NCT00035932)
Timeframe: Week 96
Intervention | Participants (Number) |
---|
ATV 300 mg / RTV | 61 |
LPV / RTV | 57 |
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Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
(NCT00035932)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
ATV 300 mg / RTV | 76 |
ATV 400 mg / SQV | 60 |
LPV / RTV | 84 |
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Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96. (NCT00035932)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 61 |
LPV / RTV | 58 |
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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 96
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 38 |
LPV / RTV | 41 |
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Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound. (NCT00035932)
Timeframe: Week 48
Intervention | participants (Number) |
---|
ATV 300 mg / RTV | 43 |
ATV 400 mg / SQV | 28 |
LPV / RTV | 52 |
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Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored. (NCT00035932)
Timeframe: Baseline, Week 24
Intervention | Pearson Correlation Coefficient (Number) |
---|
| ATV Cmin | IQ (<10; >=10) | # of PI Mutations at baseline (<4; >=4) |
---|
ATV 300 mg / RTV | -0.056 | -0.391 | 0.306 |
,ATV 400 mg / SQV | 0.254 | -0.081 | 0.437 |
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Change From Baseline in CD4 Cell Count at Week 24
(NCT00035932)
Timeframe: Baseline, Week 24
Intervention | cells/mm3 (Mean) |
---|
ATV 300 mg / RTV | 83 |
ATV 400 mg / SQV | 59 |
LPV / RTV | 90 |
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Change From Baseline in CD4 Cell Count at Week 48
(NCT00035932)
Timeframe: Baseline, Week 48
Intervention | cells/mm3 (Mean) |
---|
ATV 300 mg / RTV | 110 |
ATV 400 mg / SQV | 72 |
LPV / RTV | 121 |
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Change From Baseline in CD4 Cell Count at Week 96
(NCT00035932)
Timeframe: Baseline, Week 96
Intervention | cells/mm3 (Mean) |
---|
ATV 300 mg / RTV | 122 |
LPV / RTV | 154 |
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Fasting Glucose Mean Change From Baseline at Week 24
(NCT00035932)
Timeframe: Baseline, Week 24
Intervention | mg/dL (Mean) |
---|
ATV 300 mg / RTV | 0 |
ATV 400 mg / SQV | -3 |
LPV / RTV | 0 |
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PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
Intervention | ng/mL (Geometric Mean) |
---|
| 3rd Trimester | Postpartum |
---|
MVC 150 or 300mg b.i.d. | 108 | 128 |
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PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Intervention | ng*hour/mL (Geometric Mean) |
---|
| 2nd Trimester | 3rd Trimester | Postpartum |
---|
MVC 150 or 300mg b.i.d. | NA | 2717 | 3645 |
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Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
Intervention | mcg/mL (Median) |
---|
| 2-10 hours after birth | 18-28 hours after birth | 36-72 hours after birth | 5-9 days after birth |
---|
DRV/COBI 800/150 mg q.d. | 0.35 | 1.43 | 1.87 | 1.72 |
,DTG 50mg q.d. | 1.73 | 1.53 | 1.00 | 0.06 |
,EFV 600 mg q.d. (Outside THA) | 1.1 | 1.0 | 0.9 | 0.4 |
,EVG/COBI 150/150mg q.d. | 0.132 | 0.032 | 0.005 | 0.005 |
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Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
Intervention | Participants (Count of Participants) |
---|
| 2nd Trimester | 3rd Trimester | Postpartum |
---|
ATV/RTV Arm 1: 300/100mg q.d. | 1 | 12 | 12 |
,DRV/COBI 800/150 mg q.d. | 3 | 4 | 14 |
,DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 7 | 16 | 22 |
,DRV/RTV 600/100mg b.i.d. | 7 | 19 | 22 |
,DRV/RTV 800/100mg q.d. | 9 | 19 | 22 |
,DTG 50mg q.d. | 9 | 20 | 23 |
,EFV 600 mg q.d. (Outside THA) | 12 | 33 | 34 |
,ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 8 | 29 | 27 |
,ETR 200mg b.i.d. | 5 | 13 | 7 |
,EVG/COBI 150/150mg q.d. | 8 | 10 | 18 |
,FPV/RTV 700/100mg b.i.d. | 8 | 26 | 22 |
,IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 10 | 19 | 26 |
,LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 9 | 30 | 27 |
,ATV/COBI 300/150 mg q.d. | 1 | 2 | 5 |
,NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 15 | 14 |
,RAL 400mg b.i.d. | 11 | 33 | 30 |
,RPV 25mg q.d. | 14 | 26 | 25 |
,TAF 10mg q.d. w/COBI | 15 | 23 | 22 |
,TAF 25mg q.d. | 13 | 23 | 24 |
,TAF 25mg q.d. w/COBI or RTV Boosting | 10 | 24 | 18 |
,TFV 300mg q.d. | 2 | 27 | 27 |
,TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 1 | 11 | 12 |
,TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 7 | 23 | 32 |
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Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
Intervention | Participants (Count of Participants) |
---|
| 3rd Trimester | Postpartum |
---|
EFV 600mg q.d. | 20 | 21 |
,MVC 150 or 300mg b.i.d. | 8 | 7 |
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Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.
Intervention | mcg*hr/mL (Median) |
---|
| Before contraceptive initiation | After contraceptive initiation |
---|
ATV/RTV/TFV 300/100/300mg q.d. With ENG | 53.96 | 55.25 |
,EFV 600mg q.d. With ENG | 53.64 | 56.65 |
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Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.
Intervention | mcg*hr/mL (Median) |
---|
| Before contraceptive initiation | After contraceptive initiation |
---|
LPV/RTV 400/100 b.i.d. With ENG | 115.97 | 100.20 |
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Plasma Concentration for Contraceptives
Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum
Intervention | pg/mL (Median) |
---|
ATV/RTV/TFV 300/100/300mg q.d. With ENG | 604 |
LPV/RTV 400/100 b.i.d. With ENG | 428 |
EFV 600mg q.d. With ENG | 125 |
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Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
Intervention | hour (Median) |
---|
DTG 50mg q.d. | 32.8 |
EVG/COBI 150/150mg q.d. | 7.6 |
DRV/COBI 800/150 mg q.d. | NA |
EFV 600 mg q.d. (Outside THA) | 65.6 |
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Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner. (NCT00074581)
Timeframe: Throughout study
Intervention | event rate per 100 person-yr (Number) |
---|
Early-ART | 0.07 |
Delayed-ART | 1.03 |
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All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. (NCT00074581)
Timeframe: Throughout study
Intervention | event rate per 100 person-yr (Number) |
---|
Early-ART | 0.44 |
Delayed-ART | 1.41 |
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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 24 | NA |
,ZDV/3TC+EFV | 0 | 16 | NA |
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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 using follow-up through study closure on May 31,2010
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 0 | NA |
,ZDV/3TC+EFV | 0 | 0 | 32 |
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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 0 | 0 | 48 |
,ZDV/3TC+EFV | 0 | 16 | NA |
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Time to Treatment Failure (NRTI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 16 | 40 | NA |
,ZDV/3TC+EFV | 16 | 40 | NA |
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Time to Treatment Failure (PI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 16 | 24 | 120 |
,ZDV/3TC+EFV | 16 | 40 | NA |
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Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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 |
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Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
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 |
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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 7 | 18 | 76 |
,ZDV/3TC+EFV | 16 | 34 | NA |
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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
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 |
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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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 |
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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until study closed (May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 18 | 36 | 201 |
,ZDV/3TC+EFV | 16 | 34 | 163 |
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Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until study closure (May 31, 2010)
Intervention | weeks (Number) |
---|
| 10th percentile | 25th percentile | 50th percentile |
---|
TDF/FTC+EFV | 4 | 32 | 224 |
,ZDV/3TC+EFV | 4 | 12 | 112 |
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Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
Intervention | weeks (Number) |
---|
| 10th percentile | 25th percentile | 50th percentile |
---|
ddI+FTC+ATV | 4 | 32 | 144 |
,ZDV/3TC+EFV | 4 | 12 | 96 |
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Time to Immunologic Failure (NRTI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile |
---|
TDF/FTC+EFV | 48 | 104 | NA |
,ZDV/3TC+EFV | 48 | 128 | NA |
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Time to Immunologic Failure (PI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
ddI+FTC+ATV | 48 | NA |
,ZDV/3TC+EFV | 48 | 112 |
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up through study closure on May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile |
---|
TDF/FTC+EFV | 0 | 24 |
,ZDV/3TC+EFV | 0 | 16 |
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 using follow-up through study closure on May 31,2010
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 0 | NA |
,ZDV/3TC+EFV | 0 | 0 | 32 |
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 0 | 0 | 48 |
,ZDV/3TC+EFV | 0 | 0 | 32 |
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Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month
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 |
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Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry
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 |
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Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry
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 |
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Number of Participants Who Experienced Virologic Failure or Died.
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 |
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Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality
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 |
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CD4 Count Change From Randomization
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 |
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Percent of Participants Who Experienced Virologic Failure or Died
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 |
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Number of Participants in IT Arm Off Treatment Before 36 Weeks
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 |
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Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
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 |
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Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
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 |
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Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm
"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 |
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Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm
"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 |
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Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.
(NCT00090779)
Timeframe: 96 weeks since randomization
Intervention | participants (Number) |
---|
IT Arm | 2 |
DT Arm | 8 |
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Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
(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 |
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Time to Treatment Initiation or Death
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 |
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Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
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 |
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Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
"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 |
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Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
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 |
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Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
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 |
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Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
"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 |
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Number of Participants Who Discontinued Study Treatment Prematurely
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 |
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Change From Baseline in CD4 Cell Count at Week 96
(NCT00100048)
Timeframe: Baseline and Week 96
Intervention | cells/mm3 (Mean) |
---|
MK0518 b.i.d. | 221.2 |
EFV Combo Therapy | 232.4 |
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Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3) (NCT00100048)
Timeframe: Baseline and Week 24
Intervention | cells/mm3 (Mean) |
---|
MK0518 100 mg b.i.d. | 184 |
MK0518 200 mg b.i.d | 122 |
MK0518 400 mg b.i.d. | 147 |
MK0518 600 mg b.i.d. | 134 |
EFV Combo Therapy | 101 |
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Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)
Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL) (NCT00100048)
Timeframe: Baseline and Week 24
Intervention | copies/mL (Mean) |
---|
MK0518 100 mg b.i.d. | -2.39 |
MK0518 200 mg b.i.d | -2.20 |
MK0518 400 mg b.i.d. | -2.33 |
MK0518 600 mg b.i.d. | -2.49 |
EFV Combo Therapy | -2.44 |
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Change From Baseline in Plasma HIV RNA at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Baseline and Week 240
Intervention | Log10Copies/mL (Mean) |
---|
MK-0518 b.i.d. | -2.29 |
EVF Combo Therapy | -2.07 |
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Change From Baseline in Plasma HIV RNA at Week 96
(NCT00100048)
Timeframe: Baseline and Week 96
Intervention | copies/mL (Mean) |
---|
MK0518 b.i.d. | -2.30 |
EFV Combo Therapy | -2.28 |
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Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)
Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL) (NCT00100048)
Timeframe: Baseline and Day 10
Intervention | copies/mL (Mean) |
---|
MK0518 100 mg b.i.d. | -1.93 |
MK0518 200 mg b.i.d | -1.98 |
MK0518 400 mg b.i.d. | -1.66 |
MK0518 600 mg b.i.d. | -2.16 |
Placebo | -0.17 |
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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)
(NCT00100048)
Timeframe: Week 24
Intervention | participants (Number) |
---|
MK0518 100 mg b.i.d. | 31 |
MK0518 200 mg b.i.d | 27 |
MK0518 400 mg b.i.d. | 35 |
MK0518 600 mg b.i.d. | 32 |
EFV Combo Therapy | 32 |
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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay. (NCT00100048)
Timeframe: Week 240
Intervention | Participants (Number) |
---|
MK-0518 b.i.d. | 115 |
EVF Combo Therapy | 25 |
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Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48
(NCT00100048)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
MK0518 100 mg b.i.d. | 38 |
MK0518 200 mg b.i.d | 34 |
MK0518 400 mg b.i.d. | 40 |
MK0518 600 mg b.i.d. | 36 |
EFV Combo Therapy | 33 |
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Number of Patients With Laboratory Adverse Experiences (LAEs)
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product (NCT00100048)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
| With LAEs | Without LAEs |
---|
EFV Combo Therapy | 8 | 30 |
,MK0518 100 mg b.i.d. | 8 | 31 |
,MK0518 200 mg b.i.d. | 7 | 33 |
,MK0518 400 mg b.i.d. | 11 | 30 |
,MK0518 600 mg b.i.d. | 5 | 35 |
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Number of Patients With Serious CAEs and Non-serious CAEs at Week 144
"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product" (NCT00100048)
Timeframe: 144 Weeks
Intervention | participants (Number) |
---|
| With CAEs | Without CAEs | With serious CAEs | Without serious CAEs |
---|
EFV Combo Therapy | 35 | 3 | 4 | 34 |
,MK0518 b.i.d. | 153 | 7 | 18 | 142 |
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Change From Baseline in CD4 (T-helper) Cell Count at Week 240
Change in number of CD4 cells/mm^3 from baseline to Week 240. (NCT00100048)
Timeframe: Baseline and Week 240
Intervention | cells/mm^3 (Mean) |
---|
MK-0518 b.i.d. | 301.7 |
EVF Combo Therapy | 275.6 |
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Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96
(NCT00100048)
Timeframe: 96 Weeks
Intervention | participants (Number) |
---|
| HIV RNA <50 copies/mL | HIV RNA <400 copies/mL |
---|
EFV Combo Therapy | 32 | 32 |
,MK0518 b.i.d. | 133 | 135 |
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Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)
"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose." (NCT00100048)
Timeframe: 10 days
Intervention | participants (Number) |
---|
| With CAEs | Without CAEs | With Serious CAEs | Without Serious CAEs |
---|
MK0518 100 mg b.i.d. | 4 | 3 | 0 | 7 |
,MK0518 200 mg b.i.d. | 2 | 5 | 0 | 7 |
,MK0518 400 mg b.i.d. | 3 | 3 | 0 | 6 |
,MK0518 600 mg b.i.d. | 5 | 3 | 0 | 8 |
,Placebo | 5 | 2 | 0 | 7 |
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Number of Patients With Clinical Adverse Experiences (CAEs)
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. (NCT00100048)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
| With CAEs | Without CAEs |
---|
EFV Combo Therapy | 34 | 4 |
,MK0518 100 mg b.i.d. | 31 | 8 |
,MK0518 200 mg b.i.d. | 35 | 5 |
,MK0518 400 mg b.i.d. | 36 | 5 |
,MK0518 600 mg b.i.d. | 35 | 5 |
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Number of Patients That Discontinued With LAEs
(NCT00100048)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
| Discontinued With LAEs | Did Not Discontinue With LAEs |
---|
EFV Combo Therapy | 0 | 38 |
,MK0518 100 mg b.i.d. | 0 | 39 |
,MK0518 200 mg b.i.d | 0 | 40 |
,MK0518 400 mg b.i.d. | 0 | 41 |
,MK0518 600 mg b.i.d. | 1 | 39 |
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Number of Patients That Discontinued With CAEs
(NCT00100048)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
| Discontinued with CAEs | Did Not Discontinue with CAEs |
---|
EFV Combo Therapy | 0 | 38 |
,MK0518 100 mg b.i.d. | 0 | 39 |
,MK0518 200 mg b.i.d | 0 | 40 |
,MK0518 400 mg b.i.d. | 0 | 41 |
,MK0518 600 mg b.i.d. | 0 | 40 |
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Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)
"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose." (NCT00100048)
Timeframe: Week 240
Intervention | Participants (Number) |
---|
| Adverse experiences | Serious adverse experiences |
---|
EVF Combo Therapy | 35 | 4 |
,MK-0518 b.i.d. | 154 | 25 |
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Number of Patients With Serious LAEs
Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
| With serious LAEs | Without serious LAEs |
---|
EFV Combo Therapy | 0 | 38 |
,MK0518 100 mg b.i.d. | 0 | 39 |
,MK0518 200 mg b.i.d. | 0 | 40 |
,MK0518 400 mg b.i.d. | 0 | 41 |
,MK0518 600 mg b.i.d. | 0 | 40 |
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Number of Patients With Serious CAEs (Cohort I and II Combined)
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose (NCT00100048)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
| With Serious CAEs | Without Serious CAEs |
---|
EFV Combo Therapy | 2 | 36 |
,MK0518 100 mg b.i.d. | 2 | 37 |
,MK0518 200 mg b.i.d. | 5 | 35 |
,MK0518 400 mg b.i.d. | 0 | 41 |
,MK0518 600 mg b.i.d. | 2 | 38 |
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Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240
HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay. (NCT00100048)
Timeframe: Week 240
Intervention | Participants (Number) |
---|
MK-0518 b.i.d. | 110 |
EFV Combo Therapy | 24 |
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Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)
(NCT00100048)
Timeframe: Week 24
Intervention | participants (Number) |
---|
MK0518 100 mg b.i.d. | 28 |
MK0518 200 mg b.i.d | 27 |
MK0518 400 mg b.i.d. | 33 |
MK0518 600 mg b.i.d. | 32 |
EFV Combo Therapy | 31 |
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Number of Participants Assessed for Adverse Events (AEs)
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 |
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Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
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 |
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Change From Baseline in HIV-1 RNA Viral Load
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 |
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Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
"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 |
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Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
"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 |
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Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
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 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 85 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 79.5 |
CBV+EFV | 70.4 |
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Change in Limb Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. (NCT00112047)
Timeframe: Week 48 to Week 96
Intervention | limb fat (kg) (Mean) |
---|
EFV+FTC+TDF | 0.74 |
CBV+EFV | -0.77 |
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Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 74.5 |
CBV+EFV | 66.9 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 28 |
CBV+EFV | 41 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 19 |
CBV+EFV | 30 |
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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 20 |
CBV+EFV | 23 |
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Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | total body fat (kg) (Mean) |
---|
All Atripla | 0.37 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 25 |
CBV+EFV | 37 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 13 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 34 |
CBV+EFV | 43 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 23 |
CBV+EFV | 32 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 15 |
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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 63.1 |
CBV+EFV | 51.6 |
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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 87 |
All Atripla (From Atripla Baseline) | 85 |
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Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 80.4 |
CBV+EFV | 69.3 |
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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 60.8 |
CBV+EFV | 50.4 |
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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 84 |
All Atripla (From Atripla Baseline) | 82 |
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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 9 |
CBV+EFV | 16 |
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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 9 |
CBV+EFV | 17 |
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Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 16 |
CBV+EFV | 24 |
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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 11 |
CBV+EFV | 17 |
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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 11 |
All Atripla (From Atripla Baseline) | 2 |
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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 21 |
CBV+EFV | 25 |
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Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 22 |
All Atripla (From Atripla Baseline) | 4 |
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Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Composite Score (Mean) |
---|
All Atripla | 0.9 |
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Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Composite Score (Mean) |
---|
All Atripla | 0.0 |
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Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Bothers me (W 144 and W 240) | Does not bother me (W 144 and W 240) | Bothers me (W 144); does not bother me (W 240) | Does not bother me (W 144); bothers me (W 240) |
---|
All Atripla | 41 | 126 | 31 | 28 |
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Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 180 | 10 | 9 | 23 |
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Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 182 | 6 | 8 | 29 |
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Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 32 |
CBV+EFV | 38 |
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Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 192 | 8 | 9 | 17 |
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Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 166 | 21 | 13 | 26 |
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Change in Limb Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | limb fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.13 |
CBV+EFV | -1.09 |
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Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | limb fat (kg) (Mean) |
---|
All Atripla | 0.12 |
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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 96
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.30 |
CBV+EFV | -3.25 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 67.2 |
CBV+EFV | 60.9 |
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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 48
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.31 |
CBV+EFV | -3.26 |
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Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 144
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.32 |
CBV+EFV | -3.30 |
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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 96
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 270 |
CBV+EFV | 237 |
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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Study baseline to Week 48
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 190 |
CBV+EFV | 158 |
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Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 144
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 312 |
CBV+EFV | 271 |
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Change in Total Body Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | total body fat (kg) (Mean) |
---|
EFV+FTC+TDF | 2.47 |
CBV+EFV | -1.18 |
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Change in Total Body Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: 48 weeks to 96 weeks
Intervention | total body fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.69 |
CBV+EFV | -0.82 |
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Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | trunk fat (kg) (Mean) |
---|
All Atripla | 0.27 |
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Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value (NCT00112047)
Timeframe: Study/Atripla baseline to Week 240 (Atripla Week 96)
Intervention | CD4 Cell count (Cells/mm^3) (Mean) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 346 |
All Atripla (From Atripla Baseline) | 42 |
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Change in Trunk Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | trunk fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.30 |
CBV+EFV | -0.10 |
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Change in Trunk Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 96
Intervention | trunk fat (kg) (Mean) |
---|
EFV+FTC+TDF | 0.94 |
CBV+EFV | -0.04 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: 144 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 70.9 |
CBV+EFV | 58.1 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 87 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: 48 weeks
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 84.4 |
CBV+EFV | 72.8 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: 96 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 74.6 |
CBV+EFV | 61.9 |
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Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 64.3 |
CBV+EFV | 56.3 |
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Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
(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 |
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Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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Cumulative Probability of Not Experiencing Treatment Modification
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
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 |
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Cumulative Probability of Not Experiencing Regimen Failure
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
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 |
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Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96
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 |
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Change in Fasting Total Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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Change in CD4 Count (Cells/mm3) From Baseline
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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Number of Participants With Virologic Failure and Emergence of Major Resistance
Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Number of Participants With Virologic Failure
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Cumulative Probability of Not Experiencing Virologic Failure
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96
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 |
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Change in Fasting Triglyceride Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
(NCT00118898)
Timeframe: At Weeks 48 and 96
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 |
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Time From Randomization to Virologic Failure
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Time From Treatment Dispensation to a Grade 3/4 Safety Event
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.
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 |
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Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Time From Treatment Dispensation to Treatment Modification
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Number of Participants With a Grade 3/4 Safety Event
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks
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 |
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Number of Participants With Regimen Failure
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Number of Participants With Treatment Modification
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
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 |
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Amount of Study Follow-up
Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks
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 |
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Adverse Events
Number of Participants with adverse clinical events in tenofovir and placebo arms (NCT00119106)
Timeframe: Up to 6.9 years
Intervention | participants (Number) |
---|
Tenofovir | 1098 |
Placebo | 1083 |
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HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group
Plasma HIV RNA concentrations. (NCT00119106)
Timeframe: Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion
Intervention | Copies/mL (Mean) |
---|
Tenofovir | 929829 |
Placebo | 120061 |
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Number of Participants Reporting Injecting and Sharing Needles
"Number of Participants reporting injecting and sharing needles:~Assessed injecting and sharing at baseline and every 3 months during follow-up. We used GEE to determine if there was a significant decline in injecting and sharing." (NCT00119106)
Timeframe: Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years
Intervention | participants (Number) |
---|
Tenofovir | 58 |
Placebo | 59 |
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Number of Participants With Tenofovir-associated Resistance Mutations.
Measure tenofovir associated resistance mutations (ie, K65R and K70E) in amplified viral RNA specimens from HIV-positive participants in the placebo and tenofovir groups. (NCT00119106)
Timeframe: Specimens collected at the time of HIV seroconversion
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 0 |
Placebo | 0 |
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Number Participants Who Reported More Than One Sexual Partner at Baseline
Number of participants (NCT00119106)
Timeframe: At enrolment
Intervention | Participants (Count of Participants) |
---|
Tenofovir Group | 251 |
Placebo Group | 271 |
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Rates of HIV Seroconversion
Kaplan Meier survival curve. (NCT00119106)
Timeframe: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years
Intervention | Infections/ 100 person-years (Number) |
---|
Tenofovir | 17 |
Placebo | 33 |
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Adherence to Study Drug/Placebo
Mean number of days that participants took study drug based on study drug diaries by study group. (NCT00119106)
Timeframe: Participants were asked about adherence at 3 month visits, up to 6.9 years.
Intervention | days (Mean) |
---|
Tenofovir | 84 |
Placebo | 84 |
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Renal Toxicity
Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities (NCT00119106)
Timeframe: Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years
Intervention | participants (Number) |
---|
Tenofovir | 3 |
Placebo | 3 |
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Change in Fat mtDNA Content
Subcutaneous abdominal fat mitochondrial DNA (mtDNA) (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | copies/cell (Median) |
---|
Uridine Supplementation | -169 |
Switch to TDF | 321 |
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Change in Lumbar Spine Bone Mineral Density (BMD)
Change in lumbar spine bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | lumbar spine BMD, g/cm^2 (Median) |
---|
Uridine Supplementation | 0.39 |
Switch to TDF | 0.0 |
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Change in Trunk Fat
Change in trunk fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | trunk fat (kg) (Median) |
---|
Uridine Supplementation | 0.2 |
Switch to TDF | 0.7 |
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Change in PBMC mtDNA
Peripheral blood mononuclear cell (PBMC) mitochondrial DNA (mtDNA), measured in copies/cell (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | copies/cell (Median) |
---|
Uridine Supplementation | -24 |
Switch to TDF | -52 |
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Change in Limb Fat
Change in limb fat as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | limb fat (kg) (Median) |
---|
Uridine Supplementation | 0.1 |
Switch to TDF | 0.4 |
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Change in Hip Bone Mineral Density (BMD)
Change in hip bone mineral density (BMD) as measured by dual-energy x-ray absorbtiometry (DEXA) scan (NCT00119379)
Timeframe: Baseline to Week 48
Intervention | hip BMD, g/cm^2 (Median) |
---|
Uridine Supplementation | 0.45 |
Switch to TDF | -3.3 |
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>5% Bone Mineral Density Decline at Femoral Neck
Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck. (NCT00131677)
Timeframe: 24 months (immediate arm), 15 months (delayed arm)
Intervention | percentage of participants (Number) |
---|
Tenofovir Disoproxil Fumarate | 13 |
Placebo | 6 |
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Adherence to Study Drug
Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps. (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)
Intervention | percentage of doses (Number) |
---|
Treatment Emergent Cohort | 77 |
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Number of Breakthrough HIV Infections
Number of participants with HIV seroconversions occuring while on study drug (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)
Intervention | participants (Number) |
---|
Tenofovir Disoproxil Fumarate | 0 |
Placebo | 4 |
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Clinical Safety--Hypophosphatemia
Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale) (NCT00131677)
Timeframe: 24 months (immediate arm), 15 months (delayed arm)
Intervention | participants (Number) |
---|
Tenofovir Disoproxil Fumarate | 1 |
Placebo | 5 |
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Clinical Safety--Creatinine Elevations
Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale) (NCT00131677)
Timeframe: 24 months (immediate arm) and 15 months (delayed arm)
Intervention | Participants (Number) |
---|
Tenofovir Disoproxil Fumarate | 0 |
Placebo | 0 |
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Behavioral Safety--Unprotected Anal Sex (UAS)
Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study. (NCT00131677)
Timeframe: Nine months
Intervention | percentage of ppts reporting UAS (Number) |
---|
All Enrolled Participants | -9 |
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Evaluate Change in Cellular Regulatory Enzymes Involved With Nucleoside Analogue Transport Across Cell Membranes as Assessed by RT-PCR of Specific mRNA Transcripts
"At day 1 and day 63 a PBMC sample for RT-PCR of nucleoside analogue transport enzymes (enzymes for efflux, influx) will be collected. The day 1 specimen should be stored and sent with day 8 PK specimens to USC. Day 63 specimen should be sent to USC after collection and processing.~Blood volume: 20 mL Blood volume: 20 mL" (NCT00214890)
Timeframe: Day 1 and Day 63
Intervention | fmol/10^6 cells (Median) |
---|
| dGTP concentrations | dATP concentrations |
---|
Abacavir | 2464 | 3314 |
,Tenofovir | 4026 | 3238 |
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Compare the Plasma Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
"At day 49 of Sequence 2 a 24-hour post dose plasma sample should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL plasma samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK:~Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days~Plasma NRTI and intracellular ddNTP concentrations were measured 7 days after treatment with ABC or TDF alone and were compared to levels obtained after 7 days of treatment with both drugs" (NCT00214890)
Timeframe: 49 days
Intervention | (mcg/mL)*hr (Median) |
---|
| monotherapy | dual therapy |
---|
Abacavir | 12.54 | 13.62 |
,Tenofovir | 3.82 | 4.09 |
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Compare the Intracellular Pharmacokinetic (PK) Data of the Two Monotherapy Regimens to the Dual NRTI Regimen
"At day 49 of Sequence 2 a 24-hour post dose intracellular (PBMC) should be collected and processed. All 7 samples from the sparse PK (time 0, 30-min, 1-hr, 2-hr, 3-hr, 6-hr and 24-hr post dose) should be sent overnight to appropriate off-site lab for analysis. Since the patient is on dual therapy and the each drug is measured in separate labs each PBMC samples should be split at each time-point with half of the samples shipped to Gilead and half shipped to USC (two separate shipments). ALL intracellular (PBMC) samples should be sent to USC. Since samples have to be split we will need to collect double the blood for the intracellular (PBMC) PK:~Blood volume (PBMC-plasma): 40 mL - each draw Blood volume (plasma only): 3 mL - each draw Blood volume: 169 mL- over 2 days~Intracellular ddNTP concentrations were measured after 7 days on monotherapy and after 7 days on dual therapy" (NCT00214890)
Timeframe: 49 days
Intervention | fmol/10^6 cells (Median) |
---|
| monotherapy | dual therapy |
---|
Abacavir | 72.2 | 80.9 |
,Tenofovir | 49.3 | 108.1 |
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Change in Short-term Virologic Response
Relative potencies of two monotherapy regimens (TDF alone vs. ABC alone) compared to the dual NRTI regimen of TDF+ABC as assessed by the short-term virologic response. (Change in HIV RNA copies/mL at baseline and day 7 for monotherapy, baseline and day 49 for dual therapy.) (NCT00214890)
Timeframe: 49 days
Intervention | log(10) copies/mL per day (Median) |
---|
| monotherapy | dual therapy (combined TDF+ABC) |
---|
Abacavir | -.15 | -.16 |
,Tenofovir | -.11 | -.16 |
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Determine Total Number of NRTI-associated Mutations After 7 Days of ABC or TDF Monotherapy or After 7 Days of Dual NRTI Therapy With ABC + TDF
Subjects will be randomized to either TDF or ABC PO route for 7 days, which involves a fixed number of subjects. A sample size of 20 subjects (10 ABC and 10 TDF monotherapy and 20 ABC+TDF dual-therapy in HIV-positive patients). We determined the count of NRTI-associated mutations that emerged after 7 days of ABC or TDF monotherapy or after 7 days of dual NRTI therapy with ABC + TDF. (NCT00214890)
Timeframe: 7 days
Intervention | mutations (Number) |
---|
Tenofovir | 0 |
Abacavir | 0 |
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Compare the Relative Viral Potency of TDF Monotherapy Versus ABC Monotherapy
Eligible patients will be randomized into two monotherapy arms (TDF and ABC) for a short (one week) viral dynamics and pharmacokinetics evaluation to determine their potency. After a one-month washout period, all patients will start a dual-therapy of ABC+TDF. Viral dynamics and pharmacokinetics of the dual-therapy will be evaluated during the first week of the treatment. EFV will be added to the regimen after one week of the dual-therapy administered. Relative potencies of two monotherapy regimens (TDF alone vs. ABC alone) assessed by the short-term virologic response. (Change in HIV RNA copies/mL at baseline and day 7 for monotherapy) (NCT00214890)
Timeframe: Baseline and day 7
Intervention | log(10) copies/mL per day (Median) |
---|
Tenofovir | -0.11 |
Abacavir | -0.15 |
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Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated. (NCT00244712)
Timeframe: Baseline through 96 weeks
Intervention | participants (Number) |
---|
| Participants (Par.) with suspected ABC HSR | Mild or Grade 1 | Moderate or Grade 2 | Severe or Grade 3 | Not Applicable | Par. with proximal renal tubule dysfunction |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 14 | 1 | 8 | 4 | 1 | 0 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 3 | 0 | 2 | 1 | 0 | 5 |
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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 75.2 | 70.9 | 93.8 | 71.4 | 63.9 | 58.4 | 92.8 | 60.1 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71.3 | 66.4 | 92.2 | 66.2 | 61.2 | 56.3 | 96.3 | 56.9 |
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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 76 | 72 | 94 | 72 | 65 | 60 | 92 | 61 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71 | 66 | 91 | 65 | 60 | 55 | 97 | 56 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
| TLOVR | Obs | M/D=F |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 62.6 | 84.3 | 64.3 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 61.1 | 86.8 | 62.3 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included | TLOVR | Obs | M/D=F |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 59.9 | 52.1 | 86.9 | 56.4 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 58.0 | 51.0 | 91.3 | 54.5 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | MD=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | MD=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 71 | 67 | 89 | 68 | 63 | 57 | 89 | 59 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 69 | 62 | 88 | 62 | 58 | 52 | 94 | 54 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 63 | 57 | 78 | 59 | 56 | 46 | 84 | 54 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 65 | 60 | 86 | 62 | 58 | 51 | 88 | 55 |
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Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)
Intervention | participants (Number) |
---|
| Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V) | Reduced pheno susceptibility to lamivudine/M184V | Reduced phen susceptibility to lamivudine/M184M/V | Reduced pheno susceptibility to lamivudine/M184M/I | Reduced pheno susceptibility to lamivudine/M184A/V | Reduced pheno susceptibility to lamivudine/M184I | Reduced pheno suscept. to lamivudine/M184M/I/V | Reduced pheno suscept. to emtricitabine/M184V | Reduced pheno suscept. to emtricitabine/M184M/V | Reduced pheno suscept. to emtricitabine/M184M/I | Reduced pheno suscept. to emtricitabine/M184A/V | Reduced pheno suscept. to emtricitabine/M184I | Reduced pheno suscept. to emtricitabine/M184M/I/V |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 11 | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 | 0 | 0 | 0 | 0 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 17 | 9 | 0 | 1 | 1 | 1 | 1 | 9 | 0 | 1 | 1 | 1 | 1 |
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Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)
Intervention | participants (Number) |
---|
| No. with paired genotypes at baseline and wk 96 | Participants with treatment-emergent mutations | NRTI-associated mutations | NNRTI-associated mutations | PI-associated mutations |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 45 | 18 | 11 | 4 | 11 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 41 | 22 | 17 | 3 | 7 |
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Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions. (NCT00244712)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Protocol-defined virologic failure | Fail to confirm HIV-1 RNA <200 copies/mL by wk 24 | Confirmed HIV-1 RNA rebound to >= 200 copies/mL | Suspected HIV-1 RNA rebound to >= 200 copies/mL |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 49 | 21 | 28 | 12 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 48 | 24 | 24 | 11 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 67.5 |
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 67.2 |
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Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 75 | 70 | 94 | 71 | 63 | 56 | 93 | 59 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71 | 67 | 94 | 68 | 63 | 58 | 96 | 58 |
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In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
(NCT00298363)
Timeframe: Baseline to Week 168
Intervention | Days (Number) |
---|
Tenofovir DF | NA |
FTC/TDF | NA |
Entecavir | NA |
Overall | NA |
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
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 |
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
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 |
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Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
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 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
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 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
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 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
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 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
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 |
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Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
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 |
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Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
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 |
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
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 |
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
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 |
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Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
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 |
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Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
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 |
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Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
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 |
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
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 |
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
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 |
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Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
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 |
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Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
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 |
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
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 |
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
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 |
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
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 |
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Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
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 |
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Percent Probability of Tolerability Failure
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 |
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Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
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 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
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 |
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Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
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 |
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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
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 |
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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
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 |
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Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
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 |
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Percentage of Participants With Normal ALT at Week 48
ULN for males = 43 U/L; 34 U/L for females (NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 66.7 |
Emtricitibine/Tenofovir DF | 73.1 |
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Percentage of Participants With Normalized ALT at Week 168
Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 68.0 |
Emtricitibine/Tenofovir DF | 70.8 |
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Percentage of Participants With Normalized ALT at Week 48
Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 40.7 |
Emtricitibine/Tenofovir DF | 61.5 |
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Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168
P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 80.4 |
Emtricitibine/Tenofovir DF | 78.0 |
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Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
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Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48
(NCT00307489)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 75.5 |
Emtricitibine/Tenofovir DF | 69.2 |
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Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | U/mL (Mean) |
---|
Tenofovir DF | -26.8 |
Emtricitibine/Tenofovir DF | -54.5 |
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Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | U/mL (Mean) |
---|
Tenofovir DF | -21.6 |
Emtricitibine/Tenofovir DF | -41.4 |
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Change From Baseline in log10 Plasma HBV DNA Levels at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | log10 copies/mL (Mean) |
---|
Tenofovir DF | -3.79 |
Emtricitibine/Tenofovir DF | -3.48 |
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Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | log10 copies/mL (Mean) |
---|
Tenofovir DF | -3.58 |
Emtricitibine/Tenofovir DF | -3.34 |
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HBeAg Seroconversion at Week 48
Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 2 |
Emtricitibine/Tenofovir DF | 3 |
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HBsAg Loss at Week 168
Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
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HBsAg Loss at Week 48
Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
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Hepatitis B Early Antigen (HBeAg) Loss at Week 168
Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 21.6 |
Emtricitibine/Tenofovir DF | 24.3 |
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Hepatitis B Early Antigen (HBeAg) Loss at Week 48
Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 3 |
Emtricitibine/Tenofovir DF | 3 |
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Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
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Percentage of Participants With Normal ALT at Week 168
ULN for males = 43 U/L; ULN for females = 34 U/L (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 74.0 |
Emtricitibine/Tenofovir DF | 74.0 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 82.4 |
Emtricitibine/Tenofovir DF | 84.0 |
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Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 81.1 |
Emtricitibine/Tenofovir DF | 80.8 |
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Time Weighted Mean Change From Baseline Plasma HIV-RNA
(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 |
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Time-weighted Mean Change From Baseline Plasma HIV-RNA.
(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 |
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Patients With Plasma HIV RNA < 50 Copies/mL
The number of participants with plasma HIV RNA < 50 copies/mL (NCT00344461)
Timeframe: 96 weeks.
Intervention | Participants (Count of Participants) |
---|
Single Group (TDF/FTC & NVP) | 32 |
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Number of Participants With Sustained Virologic Response
The primary outcome is sustained Virologic response, defined as HIV-1 RNA <500 copies/mL until trial completion at 96 weeks. (NCT00344461)
Timeframe: 96 Weeks
Intervention | Participants (Count of Participants) |
---|
Single Group (TDF/FTC & NVP) | 33 |
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Patients With Grade 2, 3 and 4 Adverse Events and Laboratory Toxicities
The number of participants with grades 2,3 and 4 adverse events and laboratory toxicities. (NCT00344461)
Timeframe: Protocol length is 96 weeks
Intervention | Participants (Count of Participants) |
---|
Nevirapine, FTC, Tenofovir | 13 |
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Patients With Plasma HIV RNA < 400 Copies/mL
The number of participants with plasma HIV RNA < 400 copies/mL (NCT00344461)
Timeframe: 96 weeks
Intervention | Participants (Count of Participants) |
---|
Nevirapine, FTC, Tenofovir | 32 |
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Change in Plasma HIV RNA From Baseline to Week 96
Percent Change From Baseline in Plasma HIV RNA at 96 weeks (NCT00344461)
Timeframe: Baseline to week 96
Intervention | percentage of change (Mean) |
---|
Nevirapine, FTC, Tenofovir | 3.32 |
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Changes in CD4 Cell Count From Baseline and Week 96
To determine the mean change from Baseline in CD4 cell count to week 96. (NCT00344461)
Timeframe: Baseline to week 96
Intervention | percentage of CD4 Increase (Mean) |
---|
Nevirapine, FTC, Tenofovir | 252 |
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The Proportion Of Participants With Virologic Response For 10 mg/Day Elvucitabine In HIV-1-Infected Participants By 12 Weeks Compared With The Proportion Of Participants With Lamivudine 300 mg/Day
The proportion of participants having achieved a virologic response for elvucitabine 10 mg/day in combination with efavirenz and tenofovir in HIV-1-infected participants over 12 weeks compared with the proportion of participants having achieved a virologic response for lamivudine 300 mg/day in combination with efavirenz and tenofovir. Virologic response was defined as having achieved undetectable (<50 copies/mL) HIV-1 RNA levels from baseline assessment. (NCT00350272)
Timeframe: 12 weeks
Intervention | percentage of participants (Number) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 |
---|
Elvucitabine | 13.5 | 16.2 | 27.0 | 35.1 | 54.1 | 56.8 |
,Lamivudine | 8.1 | 10.8 | 35.1 | 54.1 | 56.8 | 70.3 |
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The Safety Profile Of Elvucitabine.
Determination of the safety profile of elvucitabine as defined by the frequency, type and severity of treatment-emergent adverse events (AEs) and the frequency of Grade 3 and Grade 4 laboratory abnormalities. (NCT00350272)
Timeframe: 12 weeks
Intervention | participants (Number) |
---|
| Treatment emergent adverse events | Treatment emergent severe adverse events | Treatment related serious adverse events | Discontinuations due to adverse events | Treatment emergent Grade 3/4 lab abnormalities |
---|
Elvucitabine, Efavirenz,Tenofovir | 36 | 3 | 0 | 2 | 6 |
,Lamivudine,Efavirenz,Tenofovir | 35 | 2 | 0 | 0 | 5 |
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Change From Baseline to Week 288 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 288 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 7.4 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 4.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 11.9 |
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Change From Baseline to Week 288 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 288 weeks
Intervention | cells/mm^3 (Median) |
---|
Tenofovir DF | 310 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 100 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 309 |
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Change From Baseline to Week 240 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 240 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -2.5 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -0.4 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -1.4 |
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Change From Baseline to Week 240 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 240 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 10.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 8.9 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 18.9 |
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Change From Baseline to Week 240 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 240 weeks
Intervention | cells/mm^3 (Median) |
---|
Tenofovir DF | 221 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 571 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 258 |
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Change From Baseline to Week 24 in Cluster Determinant 4 (CD4) Count
(NCT00352053)
Timeframe: Baseline to 24 weeks
Intervention | cells/mm3 (Median) |
---|
Tenofovir DF | 69 |
Placebo | 49 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -43 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -12 |
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Change From Baseline to Week 24 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 24 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 3.0 |
Placebo | 2.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -1.0 |
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Change From Baseline to Week 192 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 192 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -2.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -0.1 |
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Change From Baseline to Week 192 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 192 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 5.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 1.9 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 4.8 |
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Change From Baseline to Week 192 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 192 weeks
Intervention | cells/mm^3 (Median) |
---|
Tenofovir DF | 166 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -70 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -23 |
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Change From Baseline to Week 144 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 144 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -2.5 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.2 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0.7 |
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Change From Baseline to Week 144 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 144 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 6.5 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 5.5 |
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Change From Baseline to Week 144 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 144 weeks
Intervention | cells/mm^3 (Median) |
---|
Tenofovir DF | 188 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -88 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 33 |
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Time-weighted Average Change From Baseline Through Week 48 (DAVG48) in Plasma HIV-1 RNA
"DAVG48 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 48 minus the baseline value. DAVG48 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the double-blind phase of the study early were included up until the point of discontinuation from the study (ie, missing data were not imputed)." (NCT00352053)
Timeframe: Baseline to 48 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -1.423 |
Placebo | -1.352 |
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Time-weighted Average Change From Baseline Through Week 24 (DAVG24) in Plasma HIV-1 RNA
"DAVG24 was defined as the time-weighted average between the first postbaseline value through the last value up to Week 24 minus the baseline value. DAVG24 was calculated using the trapezoidal rule with all available postbaseline data minus the baseline value.~Data for participants who discontinued the randomized (double-blind) phase of the study early were included up until the point of study discontinuation (missing data not imputed)." (NCT00352053)
Timeframe: Baseline to 24 Weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -1.580 |
Placebo | -1.549 |
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Percentage of Participants With Virologic Failure Through Week 48
"Virologic failure was defined as either nonresponse or viral rebound.~Nonresponse (failure to achieve response). Response was defined as either~A ≥ 0.5 log10 copies/mL decrease in HIV-1 RNA from baseline at 2 consecutive visits, or~HIV-1 RNA < 400 copies/mL at 2 consecutive visits.~Viral rebound was defined as either~Participants who achieved a ≥ 0.5 log10 copies/mL decrease from baseline in plasma HIV-1 RNA at 2 consecutive visits, who then subsequently achieved plasma HIV-1 RNA values ≥ 1.0 log10 copies/mL above their on-study nadir (lowest value) and/or plasma HIV-1 RNA values ≥ the baseline value at 2 consecutive visits, or~Participants who achieved plasma HIV-1 RNA levels of < 400 copies/mL at 2 consecutive visits, and then subsequently had plasma HIV-1 RNA levels > 1000 copies/mL at 2 consecutive visits.~The virologic failure rate was estimated from Kaplan-Meier product limit method by including all HIV-1 RNA data collected during the double-blind phase." (NCT00352053)
Timeframe: Up to 48 weeks
Intervention | Kaplan-Meier percentage (Number) |
---|
Tenofovir DF | 51 |
Placebo | 39 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
(NCT00352053)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 47.4 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 58.8 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 33.3 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
(NCT00352053)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 27.3 |
Placebo | 36.6 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 61.1 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 288
(NCT00352053)
Timeframe: Week 288
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 100.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 240
(NCT00352053)
Timeframe: Week 240
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 75.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 100.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 100.0 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
(NCT00352053)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 20.5 |
Placebo | 34.1 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 77.8 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192
(NCT00352053)
Timeframe: Week 192
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 42.9 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 60.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 50.0 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144
(NCT00352053)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 70.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 45.5 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
(NCT00352053)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 63.2 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 70.6 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 33.3 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
(NCT00352053)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 34.1 |
Placebo | 43.9 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 77.8 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Change From Baseline to Week 24 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 24 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -1.23 |
Placebo | -1.27 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -0.1 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 288
(NCT00352053)
Timeframe: Week 288
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 100.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 240
(NCT00352053)
Timeframe: Week 240
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 75.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 100.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 100.0 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 24
(NCT00352053)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 40.9 |
Placebo | 41.5 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 83.3 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 6.3 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 192
(NCT00352053)
Timeframe: Week 192
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 57.1 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 80.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 50.0 |
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Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
(NCT00352053)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 70.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 72.7 |
Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL | 0 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0log 10 Copies/mL From Baseline to Week 288
(NCT00352053)
Timeframe: Baseline to 288 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 96
(NCT00352053)
Timeframe: Baseline to 96 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 73.7 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 5.9 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 33.3 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 48
(NCT00352053)
Timeframe: Baseline to 48 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 47.7 |
Placebo | 53.7 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Change From Baseline to Week 48 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 48 weeks
Intervention | cells/mm3 (Median) |
---|
Tenofovir DF | 152 |
Placebo | 148 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 15 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -47 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 24
(NCT00352053)
Timeframe: Baseline to 24 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 56.8 |
Placebo | 51.2 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 12.5 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 192
(NCT00352053)
Timeframe: Baseline to 192 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 71.4 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 50.0 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 144
(NCT00352053)
Timeframe: Baseline to 144 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 90.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0 |
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Change From Baseline to Week 96 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 96 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -2.1 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0.1 |
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Change From Baseline to Week 96 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 96 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 5.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 2.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 9.0 |
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Change From Baseline to Week 96 in CD4 Count
(NCT00352053)
Timeframe: Baseline to 96 weeks
Intervention | cells/mm3 (Median) |
---|
Tenofovir DF | 152 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -6 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -69 |
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Change From Baseline to Week 48 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 48 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -0.97 |
Placebo | -1.53 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0.2 |
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Change From Baseline to Week 48 in CD4 Percentage
CD4 percentage is the percentage of total lymphocytes that are CD4 cells. (NCT00352053)
Timeframe: Baseline to 48 weeks
Intervention | Percentage of CD4 lymphocytes (Median) |
---|
Tenofovir DF | 6.0 |
Placebo | 5.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 2.0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | -1.0 |
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Change From Baseline to Week 288 in HIV-1 RNA
(NCT00352053)
Timeframe: Baseline to 288 weeks
Intervention | log10 copies/mL (Median) |
---|
Tenofovir DF | -1.1 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | -0.8 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 0.6 |
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Percentage of Participants With an HIV-1 RNA Decrease of ≥ 1.0 log10 Copies/mL From Baseline to Week 240
(NCT00352053)
Timeframe: Baseline to 240 weeks
Intervention | Percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
Placebo/TDF, HIV-1 RNA < 1000 Copies/mL | 0 |
Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL | 100.0 |
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Change in CD4+ Cell Counts From Study Entry to Week 104
(NCT00357552)
Timeframe: Study entry and week 104
Intervention | cells/mm^3 (Median) |
---|
LPV/r Monotherapy | 213 |
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Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104
(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 |
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Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
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 |
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Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.
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 |
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Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
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 |
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Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
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 |
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Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
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 |
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Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
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 |
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Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
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 |
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Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.
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 |
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Number of Participants With Study-targeted Diagnoses and Clinical Events
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 |
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Change From Baseline in CD4 Cell Count at Week 240
Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 240
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 373.7 |
Efavirenz 600 mg q.h.s. | 311.6 |
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Change From Baseline in CD4 Cell Count at Week 96
Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 96
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 239.6 |
Efavirenz 600 mg q.h.s. | 224.8 |
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Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 48
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 189.1 |
Efavirenz 600 mg q.h.s. | 163.3 |
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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 224 |
Efavirenz 600 mg q.h.s. | 203 |
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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 206 |
Efavirenz 600 mg q.h.s. | 181 |
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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 252 |
Efavirenz 600 mg q.h.s. | 241 |
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Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 240 |
Efavirenz 600 mg q.h.s. | 229 |
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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 212 |
Efavirenz 600 mg q.h.s. | 192 |
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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 198 |
Efavirenz 600 mg q.h.s. | 171 |
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Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 228 |
Efavirenz 600 mg q.h.s. | 222 |
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Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 241 |
Efavirenz 600 mg q.h.s. | 230 |
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Number of Participants Discontinued With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
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 |
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Number of Participants Discontinued With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
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 |
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Number of Participants Discontinued With LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
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 |
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Number of Participants Discontinued With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
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 |
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Number of Participants That Died by Week 156
All participant deaths in the span of 156 weeks on study were recorded. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 1 | 281 |
,MK-0518 400 mg b.i.d. | 4 | 277 |
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Number of Participants That Died by Week 240
All participant deaths in the span of 240 weeks on study were recorded. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 5 | 277 |
,MK-0518 400 mg b.i.d. | 5 | 276 |
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Number of Participants That Died by Week 48
All participant deaths in the span of 48 weeks on study were recorded. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 0 | 282 |
,MK-0518 400 mg b.i.d. | 2 | 279 |
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Number of Participants That Died by Week 96
All participant deaths in the span of 96 weeks on study were recorded. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 0 | 282 |
,MK-0518 400 mg b.i.d. | 3 | 278 |
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Number of Participants That Discontinued With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
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 |
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Number of Participants That Discontinued With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
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 |
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Number of Participants That Discontinued With CAEs at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
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 |
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Number of Participants That Discontinued With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
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 |
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Number of Participants That Discontinued With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
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 |
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Number of Participants That Discontinued With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
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 |
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Number of Participants That Discontinued With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
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 |
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Number of Participants That Discontinued With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
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 |
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Number of Participants With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 276 | 6 |
,MK-0518 400 mg b.i.d. | 267 | 14 |
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Number of Participants With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 276 | 6 |
,MK-0518 400 mg b.i.d. | 271 | 10 |
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Number of Participants With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 274 | 8 |
,MK-0518 400 mg b.i.d. | 265 | 16 |
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Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 272 | 10 |
,MK-0518 400 mg b.i.d. | 253 | 28 |
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Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 41 | 241 |
,MK-0518 400 mg b.i.d. | 27 | 254 |
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Number of Participants With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 63 | 219 |
,MK-0518 400 mg b.i.d. | 41 | 240 |
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Number of Participants With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 53 | 229 |
,MK-0518 400 mg b.i.d. | 33 | 248 |
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Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression (NCT00369941)
Timeframe: 8 Weeks
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 |
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Number of Participants With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
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 |
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Number of Participants With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
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 |
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Number of Participants With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
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 |
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Number of Participants With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
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 |
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Number of Participants With Serious LAEs at Week 156
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 156 Weeks
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 |
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Number of Participants With Serious LAEs at Week 240
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 240 Weeks
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 |
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Number of Participants With Serious LAEs at Week 48
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 48 Weeks
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 |
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Number of Participants With Serious LAEs at Week 96
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 96 Weeks
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 |
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Change From Baseline in CD4 Cell Count at Week 156
Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 156
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 331.7 |
Efavirenz 600 mg q.h.s. | 295.2 |
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Number of Participants With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 77 | 205 |
,MK-0518 400 mg b.i.d. | 56 | 225 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96
HBsAg = A part of the hepatitis B virus. When found in the blood, HBsAg is an early marker of infection. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percent of participants (Number) |
---|
| Week 48 | Week 96 |
---|
ETV 0.5 mg | 3.2 | 4.0 |
,ETV 0.5 mg +TDF 300 mg | 1.4 | 5.1 |
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96
HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
ETV 0.5 mg | 25.4 | 3.97 |
,ETV 0.5 mg +TDF 300 mg | 19.6 | 29.7 |
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Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
ETV 0.5 mg | 0.8 | 1.6 |
,ETV 0.5 mg +TDF 300 mg | 0.7 | 2.9 |
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Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96
HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
ETV 0.5 mg | 22.2 | 32.5 |
,ETV 0.5 mg +TDF 300 mg | 18.1 | 21.7 |
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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96
ALT normalization= ≤1*upper limit of normal (ULN). Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Overall at Week 48 | Overall at Week 96 |
---|
ETV 0.5 mg | 83.0 | 81.9 |
,ETV 0.5 mg +TDF 300 mg | 72.6 | 68.0 |
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Percentage of Participants Who Achieved HBV DNA Levels LOQ=lower limit of quantitation. LOQ=29 IU/mL, or approximately 169 copies/mL. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Overall at Week 48 | Overall at Week 96 |
---|
ETV 0.5 mg | 67.6 | 74.7 |
,ETV 0.5 mg +TDF 300 mg | 74.6 | 81.7 |
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Percentage of Participants Who Achieved HBV DNA Levels LOD=Lower limit of detection. LOD) LOD=10 IU/mL, or approximately 58 copies/mL. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific.Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Overall at Week 48 | Overall at Week 96 |
---|
ETV 0.5 mg | 58.2 | 68.1 |
,ETV 0.5 mg +TDF 300 mg | 66.0 | 76.6 |
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Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| HBeAg+ at Week 48 (n=126, n=138) | HBeAg- at Week 48 (n=56, n=59) | HBeAg+ at Week 96 (n=126, n=138) | HBeAg- at Week 96 (n=56, n=59) |
---|
ETV 0.5 mg | 61.1 | 91.1 | 69.8 | 91.1 |
,ETV 0.5 mg +TDF 300 mg | 74.6 | 93.2 | 80.4 | 89.8 |
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Number of Participants With Virologic Breakthrough at Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough=confirmed >=1 log10 increase in HBV DNA from moving nadir (NCT00410072)
Timeframe: Week 96
Intervention | Participants (Number) |
---|
| ETVr | TDFr |
---|
ETV 0.5 mg | 0 | 0 |
,ETV 0.5 mg +TDF 300 mg | 0 | 0 |
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Number of Participants With HBV Resistance Through Week 48
ETVr=entecavir resistance; TDFr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. (NCT00410072)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| ETVr | TDFr |
---|
ETV 0.5 mg | 0 | 0 |
,ETV 0.5 mg +TDF 300 mg | 0 | 0 |
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Number of Participants With HBV Resistance at Week 96
ETVr=entecavir resistance; TFDr=tenofovir resistance. HBV polymerase using the Trugene® HBV Genotyping Kit. HBV resistance: genotyping of HBV polymerase will be performed on stored viral samples at any timepoint when considered appropriate based on virologic response, including any specimen with detectable HBV DNA. When appropriate, phenotyping will also be used. (NCT00410072)
Timeframe: Week 96
Intervention | Participants (Number) |
---|
| ETVr | TDFr |
---|
ETV 0.5 mg | 0 | 0 |
,ETV 0.5 mg +TDF 300 mg | 0 | 0 |
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Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96
Using the Roche COBAS TaqMan - HPS assay. Lower limit of Quantitation (LOQ) is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix-, method-, and analyte-specific. (NCT00410072)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| < LOQ (29 IU/mL) at Week 48 | LOQ - <50 IU/mL at Week 48 | 50 - <172 IU/mL at Week 48 | 172 - <1720 IU/mL at Week 48 | 1720 - <17,200 IU/mL at Week 48 | 17,200 - <172,000 IU/mL at Week 48 | ≥172,000 IU/mL at Week 48 | Missing at Week 48 | < LOQ (29 IU/mL) at Week 96 | LOQ - <50 IU/mL at Week 96 | 50 - <172 IU/mL at Week 96 | 172 - <1720 IU/mL at Week 96 | 1720 - <17,200 IU/mL at Week 96 | 17,200 - <172,000 IU/mL at Week 96 | ≥172,000 IU/mL at Week 96 | Missing at Week 96 |
---|
ETV 0.5 mg | 67.6 | 2.7 | 7.1 | 7.7 | 9.3 | 1.6 | 0.5 | 3.3 | 74.7 | 1.6 | 3.3 | 5.5 | 4.9 | 0.5 | 0 | 9.3 |
,ETV 0.5 mg +TDF 300 mg | 74.6 | 5.6 | 6.6 | 4.1 | 0.5 | 0 | 0 | 8.6 | 81.7 | 1.5 | 1.0 | 1.5 | 0 | 0 | 0.5 | 13.7 |
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Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. (NCT00410072)
Timeframe: From enrollment through Week 100 + 24-week follow-up
Intervention | Participants (Number) |
---|
| Deaths | SAEs | Adverse events | Discontinuations due to AEs | Related AEs |
---|
ETV 0.5 mg | 0 | 12 | 132 | 2 | 39 |
,ETV 0.5 mg +TDF 300 mg | 3 | 14 | 131 | 5 | 49 |
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Mean Log 10 HBV DNA at Weeks 48 and 96
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan - HPS assay. Reduction in Log 10 HBV count=reduced viral load. (NCT00410072)
Timeframe: Baseline, Weeks 48 and 96
Intervention | log10 copies/mL (Mean) |
---|
| Baseline (n=182, 197) | Overall at Week 48 (n=176, 180) | Overall at Week 96 (n=165, 170) |
---|
ETV 0.5 mg | 7.48 | 1.88 | 1.68 |
,ETV 0.5 mg +TDF 300 mg | 7.53 | 1.56 | 1.51 |
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Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96
HBV DNA levels <50 IU/mL=approximately 300 copies/mL. Analyses of binary efficacy endpoint during on-treatment period focused on participants who received treatment and used the analysis of noncompleter=failure (NC=F). All participants who received treatment were included in the denominator, and participants with missing measurements were counted as nonresponders for the specific endpoints. (NCT00410072)
Timeframe: At Week 96
Intervention | Percentage of participants (Number) |
---|
ETV 0.5 mg | 76.4 |
ETV 0.5 mg +TDF 300 mg | 83.2 |
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Number of Participants With Virologic Breakthrough at Week 48
ETVr=entecavir resistance; TFDr=tenofovir resistance. Virologic breakthrough= confirmed >= 1 log10 increase in HBV DNA from the on-treatment nadir (NCT00410072)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| ETVr | TDFr |
---|
ETV 0.5 mg | 0 | 0 |
,ETV 0.5 mg +TDF 300 mg | 0 | 0 |
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Percentage of Participants With HBV DNA by PCR Category at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
| < LOQ (29 IU/mL) | LOQ to < 50 | 50 to < 172 | 172 to < 1,720 | 1,720 to < 17,200 | 17,200 to < 172,000 | >= 172,000 | Missing |
---|
ADV+LVD Combination Therapy | 16.8 | 2.9 | 5.8 | 12.4 | 31.4 | 24.8 | 4.4 | 1.5 |
,ETV Monotherapy | 13.6 | 2.9 | 2.9 | 7.9 | 22.1 | 25.7 | 23.6 | 1.4 |
,ETV+ADV Combination Therapy | 25.4 | 0 | 8.0 | 26.1 | 28.3 | 8.0 | 0.7 | 3.6 |
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Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations Due to Adverse Events or Laboratory Abnormalities During Treatment
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Grade 1 = mild, Grade 2= moderate, Grade 3 = severe, Grade 4 = life threatening/disabling, Grade 5 = death. (NCT00410202)
Timeframe: From start of study therapy through Week 100 + 5 days
Intervention | participants (Number) |
---|
| Deaths | SAEs | Discontinuations due to AEs | AEs | Grade 2-4 Related AEs | Grade 3-4 Related AEs |
---|
ADV+LVD Combination Therapy | 1 | 12 | 2 | 92 | 1 | 9 |
,ETV Monotherapy | 0 | 17 | 2 | 109 | 12 | 7 |
,ETV+ADV Combination Therapy | 0 | 11 | 1 | 101 | 2 | 5 |
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Number of Participants With Laboratory Abnormalities: Serum Chemistry
ULN=upper limit of normal (Normal ranges are Central lab data and vary according to the site). ALT:>1.25*ULN, AST:>1.25*ULN, ALP:>1.25*ULN, Total Bilirubin:>1.1*ULN, Serum Lipase:>1.10*ULN, Creatinine:>1.1*ULN, Blood Urea Nitrogen:1.25*ULN, Hyperglycemia:>116 mg/dL, Hypoglycemia:<64 mg/dL, Hyponatremia:<132meq/L, Hypokalemia:<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, <3 g/dL; Hypernatremia:>148 meq/L, Hyperkalemia:>5.6 meq/L, Hypokalemia:<3.4 meq/L, Hyperchloremia:>113 meq/L, Hypochloremia:<93 meq/L; ALT flare: on treatment (OT), >2*Baseline and >10*ULN; off treatment (OF), 2*end of dosing value and >10*ULN (NCT00410202)
Timeframe: On treatment : Day 1 through Week 100 + 5 days; Offtreatment = End of OT period through 24 weeks
Intervention | participants (Number) |
---|
| Alanine aminotransferase (ALT) | Aspartate aminotransferase (AST) | Alkaline Phosphatase (ALP) | Albumin | Serum Lipase | Creatinine | Blood Urea Nitrogen | Hyperglycemia | Hypoglycemia | Hypernatremia | Hyponatremia | Hyperkalemia | Hypokalemia | Hyperchloremia | Hypochloremia | ALT flare - Ontreatment | ALT flare - Offtreatment |
---|
ADV+LVD Combination Therapy | 74 | 53 | 6 | 1 | 24 | 4 | 2 | 37 | 9 | 10 | 0 | 5 | 2 | 1 | 0 | 2 | 0 |
,ETV Monotherapy | 83 | 62 | 4 | 1 | 33 | 2 | 1 | 46 | 5 | 10 | 0 | 4 | 2 | 1 | 0 | 2 | 0 |
,ETV+ADV Combination Therapy | 76 | 60 | 8 | 1 | 24 | 2 | 0 | 39 | 9 | 10 | 0 | 3 | 4 | 1 | 1 | 3 | 0 |
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Number of Participants With Laboratory Abnormalities: Hematology
Criteria for hematology abnormalities were: Hemoglobin: <=11.0 g/dL; White Blood Cells: <4000/mm^3; Absolute Neutrophils (includes absolute bands): <1500/mm^3; Platelets: <=99,000/mm^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline. (NCT00410202)
Timeframe: From start of study through Week 100 + 5 days
Intervention | participants (Number) |
---|
| Hemoglobin | White Blood Cells | Neutrophils | Platelets | International Normalized Ratio |
---|
ADV+LVD Combination Therapy | 11 | 38 | 15 | 12 | 9 |
,ETV Monotherapy | 9 | 48 | 17 | 14 | 7 |
,ETV+ADV Combination Therapy | 8 | 53 | 14 | 13 | 8 |
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Cumulative Probability of Emergent Genotypic Resistance at Year 2
"Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 2
Intervention | percentage of participants (Number) |
---|
| ETVr : n=130, 128, 131 | ADVr/TDFr : n=132, 134, 131 | ETVr or ADVr/TDFr : n=128, 125, 127 | ETVr and ADVr/TDFr : n=134, 137, 135 | ETVr with VBT: n=130, 128, 131 | ADVr/TDFr with VBT: n=132, 134, 131 | ETVr or ADVr/TDFr with VBT: n=128, 125, 127 | ETVr and ADVr/TDFr with VBT: n=134, 137, 135 |
---|
ADV+LVD Combination Therapy | 1.5 | 2.2 | 3.8 | 0 | 0 | 0 | 0 | 0 |
,ETV Monotherapy | 9.8 | 1.5 | 10.7 | 0.7 | 6.2 | 0.7 | 6.3 | 0.7 |
,ETV+ADV Combination Therapy | 0.8 | 0.7 | 1.5 | 0 | 0 | 0 | 0 | 0 |
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Cumulative Probability of Emergent Genotypic Resistance at Year 1
"yr=year. Cumulative probability (CP): Ptotal=1-(1-Pyr1)*(1-Pyr2) where Pyear(i)= number of participants with events at Year i divided by number of participants at risk at Year i for i = 1,2. An event is defined as resistance or resistance with virologic breakthrough in a yearly interval. Participants 'at risk' are those who were treated during Year i and did not develop that resistance or resistance with virologic breakthrough prior to Year i. CP were calculated separately for ETV, ADV and TDF resistance. Participants who discontinue from study drug in Year i were assumed to be in follow up for the entire year. (VBT; a ≥ 1 log10 increase in HBV DNA from the on-treatment nadir, confirmed by 2 sequential HBV DNA results or observed at the last on-treatment HBV DNA). ETVr = ETV resistance (rtM204V/I/S plus any substitution at rtT184, rtS202, or rtM250); ADVr/TDFr = ADV/TDF resistance (rtA181T/V or rtN236T = ADVr and TDFr, rtA194T = TDFr only)." (NCT00410202)
Timeframe: Year 1
Intervention | percentage of participants (Number) |
---|
| ETVr : n=134, 134, 134 | ADVr /TDFr : n=137, 137, 135 | ETVr or TDFr/ADVr : n=133, 132, 132 | ETVr and TDFr/ADVr : n=138, 139, 137 | ETVr with VBT: n=134, 134, 134 | ADVr /TDFr with VBT: n=137, 137, 135 | ETVr or ADVr/TDFr with VBT: n=133, 132, 132 | ETVr and ADVr/TDFr with VBT: n=138, 139, 137 |
---|
ADV+LVD Combination Therapy | 0.7 | 1.5 | 2.3 | 0 | 0 | 0 | 0 | 0 |
,ETV Monotherapy | 3 | 0.7 | 3.8 | 0 | 0.7 | 0 | 0.8 | 0 |
,ETV+ADV Combination Therapy | 0 | 0.7 | 0.8 | 0 | 0 | 0 | 0 | 0 |
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Change in Mean log10 From Baseline in HBV DNA at Week 48
HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load, negative values means reduction. (NCT00410202)
Timeframe: Baseline, Week 48
Intervention | log10 (IU/mL (Mean) |
---|
| HBV DNA at Week 48 | Change from baseline |
---|
ADV+LVD Combination Therapy | 3.36 | -4.11 |
,ETV Monotherapy | 4.01 | -3.35 |
,ETV+ADV Combination Therapy | 2.79 | -4.65 |
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Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 50 IU/mL (Approximately 300 Copies/mL) by Polymerase Chain Reaction (PCR) at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan High Pure System (HPS) assay. HBV DNA less than (<)50 International units per milliliter (IU/mL) = approximately 300 copies/mL. Percentage of participants calculated n/N; n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 25.4 |
ETV Monotherapy | 16.4 |
ADV+LVD Combination Therapy | 19.7 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 96
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 0 |
ETV Monotherapy | 0 |
ADV+LVD Combination Therapy | 0 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 0.7 |
ETV Monotherapy | 0 |
ADV+LVD Combination Therapy | 0.7 |
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Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at Week 96
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. HBV DNA < 50 IU/mL = approximately 300 copies/mL. Percentage n/N: n= number of participants with HBV DNA <50 IU/mL; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 43.5 |
ETV Monotherapy | 39.3 |
ADV+LVD Combination Therapy | 28.5 |
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Percentage of Participants With HBsAg Seroconversion at Week 96
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 0 |
ETV Monotherapy | 0 |
ADV+LVD Combination Therapy | 0 |
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Percentage of Participants With HBsAg Seroconversion at Week 48
HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 0.7 |
ETV Monotherapy | 0 |
ADV+LVD Combination Therapy | 0 |
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Percentage of Participants With HBeAg Seroconversion at Week 96 (Treated HBeAg-positive Participants Only)
HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 7.2 |
ETV Monotherapy | 3.6 |
ADV+LVD Combination Therapy | 5.1 |
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Percentage of Participants With HBeAg Seroconversion at Week 48 (Treated HBeAg-positive Participants Only)
HBeAg is a hepatitis B viral protein. It is an indicator of active viral replication. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb). (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 5.1 |
ETV Monotherapy | 2.9 |
ADV+LVD Combination Therapy | 3.7 |
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Percentage of Participants With Confirmed HBeAg Loss at Week 96 (Treated HBeAg Positive Participants Only)
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 12.3 |
ETV Monotherapy | 10.7 |
ADV+LVD Combination Therapy | 13.9 |
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Percentage of Participants With Confirmed HBeAg Loss at Week 48 (Treated HBeAg Positive Participants Only)
HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 7.2 |
ETV Monotherapy | 6.5 |
ADV+LVD Combination Therapy | 5.9 |
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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 96
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L. (NCT00410202)
Timeframe: Baseline, Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 76.9 |
ETV Monotherapy | 74.4 |
ADV+LVD Combination Therapy | 79.7 |
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Percentage of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieve ALT Normalization at Week 48
ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 or 48 U/L. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 75.6 |
ETV Monotherapy | 78.0 |
ADV+LVD Combination Therapy | 76.8 |
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Percentage of Participants With HBV DNA by PCR Category at Week 96
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
| < LOQ (29 IU/mL) | LOQ to < 50 | 50 to < 172 | 172 to < 1,720 | 1,720 to < 17,200 | 17,200 to < 172,000 | >= 172,000 | Missing |
---|
ADV+LVD Combination Therapy | 25.5 | 2.9 | 5.8 | 18.2 | 24.8 | 13.9 | 2.9 | 5.8 |
,ETV Monotherapy | 36.4 | 2.9 | 3.6 | 6.4 | 10.0 | 15.7 | 16.4 | 8.6 |
,ETV+ADV Combination Therapy | 38.4 | 5.1 | 10.1 | 15.2 | 20.3 | 5.8 | 0 | 5.1 |
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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 25.4 |
ETV Monotherapy | 13.6 |
ADV+LVD Combination Therapy | 16.8 |
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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 96
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest amount or concentration of analyte in a sample, which can be reliably detected, but not necessarily quantified. (NCT00410202)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 33.3 |
ETV Monotherapy | 27.1 |
ADV+LVD Combination Therapy | 20.4 |
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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Detection (LOD = 10 IU/mL [Approximately 58 Copies/mL]) at Week 48
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOD is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix-, method-, and analyte-specific. (NCT00410202)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 20.3 |
ETV Monotherapy | 11.4 |
ADV+LVD Combination Therapy | 11.7 |
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Change in Mean log10 From Baseline in HBV DNA at Week 96
HBV DNA was analyzed by PCR, using the Roche COBAS® TaqMan HPS assay. Reduction in log10 HBV count=reduced viral load. (NCT00410202)
Timeframe: Baseline, Week 96
Intervention | participants (Mean) |
---|
ETV+ADV Combination Therapy | -5.06 |
ETV Monotherapy | -4.17 |
ADV+LVD Combination Therapy | -4.49 |
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Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 96
HBV DNA assessments were performed using the Roche COBAS® TaqMan HPS assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Percentage n/N: n= number of participants with outcome result; N = number of participants analyzed. (NCT00410202)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
ETV+ADV Combination Therapy | 38.4 |
ETV Monotherapy | 36.4 |
ADV+LVD Combination Therapy | 25.5 |
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Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
(NCT00414518)
Timeframe: At Week 24
Intervention | participants (Number) |
---|
Arm A | 1 |
Arm B | 1 |
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Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
(NCT00414518)
Timeframe: At Week 24
Intervention | Log 10 copies of virus/ml (Mean) |
---|
12 Week Treatment Arm Followed by Treatment Interruption | 4.8627 |
CD4 T Cell Guided Therapyh | 4.2620 |
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Viral Set Point
set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus (NCT00414518)
Timeframe: Throughout study
Intervention | Log 10 copies virus/ml (Mean) |
---|
12 Week Treatment Folllowed by Treatment Interruption | 4.8627 |
CD4 T Cell Guided Therapy | 4.2434 |
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Immunologic Failure
Immunologic treatment failure was defined as CD4% dropping below 15%, after a previous result greater than or equal to 15% (following along WHO Guidelines). (NCT00427297)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
NVP-containing | 2 |
NVP-sparing | 1 |
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Incidence of Severe Adverse Events (Excluding Mortality)
(NCT00427297)
Timeframe: 2 years
Intervention | event (Number) |
---|
NVP-containing | 21 |
NVP-sparing | 6 |
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Viral Failure
Virologic treatment failure was defined as follow-up (at least 24 weeks after enrollment date) viral load > 400 copies. (NCT00427297)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
NVP-containing | 2 |
NVP-sparing | 2 |
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Incidence of Mortality
Death during follow-up (NCT00427297)
Timeframe: 2 years
Intervention | Participants (Count of Participants) |
---|
NVP-containing | 4 |
NVP-sparing | 5 |
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Time to First Dose Modification
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 |
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Percentage of Participants With Early Virologic Suppression
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 |
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Percentage of Participants With Early Virologic Response
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 |
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Percentage of Participants With Late Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Week 48
Intervention | percentage (Number) |
---|
EFV + FTC/TDF | 70.5 |
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Early Changes in CD4 Count From Baseline
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 |
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Time to First Safety Event
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 |
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Time to Initial Virologic Response
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 |
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Time to Initial Virological Failure
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 |
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Late Change in CD4 Count From Baseline
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 |
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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
(NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 10th percentile | 15th percentile | 20th percentile |
---|
EFV + FTC/TDF | 16 | 24 | 24 |
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Percentage of Participants With Late Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 48
Intervention | percentage (Number) |
---|
EFV + FTC/TDF | 80.43 |
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Rates of Adherence to Study Medication
The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. (NCT00448669)
Timeframe: 36 months
Intervention | Percentage of pills taken (Mean) |
---|
TDF-FTC, Condoms, Risk Counseling | 93.5 |
Placebo, Condoms, Risk Counseling | 93.6 |
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Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts
We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. (NCT00448669)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
| Baseline | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 7 | Month 8 | Month 9 | Month 10 | Month 11 | Month 12 |
---|
Placebo, Condoms, Risk Counseling | 113 | 86 | 90 | 83 | 66 | 61 | 67 | 45 | 49 | 45 | 36 | 33 | 30 |
,TDF-FTC, Condoms, Risk Counseling | 124 | 94 | 97 | 92 | 73 | 67 | 70 | 55 | 57 | 55 | 51 | 36 | 54 |
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Antiretroviral (ARV) Resistance Patterns in Seroconverters
Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. (NCT00448669)
Timeframe: At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis
Intervention | Participants (Count of Participants) |
---|
TDF-FTC, Condoms, Risk Counseling | 1 |
Placebo, Condoms, Risk Counseling | 1 |
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CD4 Evaluation After HIV Seroconversion
Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. (NCT00448669)
Timeframe: 1-year post seroconversion
Intervention | cells/microliter (Geometric Mean) |
---|
TDF-FTC Seroconvertor Group | 500 |
Placebo Seroconvertor Group | 466 |
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HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms
Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). (NCT00448669)
Timeframe: Monthly, for up to 3 years
Intervention | infections/100 person-years (Number) |
---|
TDF-FTC, Condoms, Risk Counseling | 1.2 |
Placebo, Condoms, Risk Counseling | 3.1 |
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Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms
Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. (NCT00448669)
Timeframe: Monthly, for up to 3 years
Intervention | percentage of participants with AE (Number) |
---|
TDF-FTC, Condoms, Risk Counseling | 91.2 |
Placebo, Condoms, Risk Counseling | 88.2 |
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Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192
"The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point." (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 0 | 0 | 0 | 1 |
,Tenofovir DF | 0 | 2 | 4 | 4 |
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Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192
The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 0 | 0 | 0 | 0 |
,Tenofovir DF | 0 | 0 | 0 | 0 |
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Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192
Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 54 | 50 | 46 | 44 |
,Tenofovir DF | 52 | 52 | 51 | 41 |
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Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192
"The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive.~No statistical analysis is presented for Week 48 because no participants met the criteria at that time point." (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 0 | 0 | 0 | 0 |
,Tenofovir DF | 0 | 2 | 4 | 3 |
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Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192
The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 0 | 0 | 0 | 0 |
,Tenofovir DF | 0 | 0 | 0 | 0 |
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Occurrence of HBV Resistance Mutations
The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192). (NCT00507507)
Timeframe: Baseline to Week 192
Intervention | participants (Number) |
---|
| Conserved (with/without polymorphic) site changes | Polymorphic site changes only |
---|
FTC+Tenofovir DF | 5 | 9 |
,Tenofovir DF | 6 | 16 |
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Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192
The percentage of participants with HBV DNA < 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
FTC+Tenofovir DF | 33.9 | 64.5 | 72.6 | 69.4 |
,Tenofovir DF | 29.7 | 45.3 | 50.0 | 45.3 |
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Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144
The percentage of participants with HBV DNA < 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Weeks 48, 96, and 144
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 |
---|
FTC+Tenofovir DF | 59.7 | 75.8 | 80.6 |
,Tenofovir DF | 40.6 | 53.1 | 62.5 |
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Change From Baseline in HBV DNA at Week 192
The change from baseline in HBV DNA at Week 192 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 192
Intervention | log_10 copies/mL (Mean) |
---|
Tenofovir DF | -6.32 |
FTC+Tenofovir DF | -6.70 |
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Change From Baseline in HBV DNA at Week 144
The change from baseline in HBV DNA at Week 144 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 144
Intervention | log_10 copies/mL (Mean) |
---|
Tenofovir DF | -6.66 |
FTC+Tenofovir DF | -6.62 |
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Change From Baseline in HBV DNA at Week 48
The change from baseline in HBV DNA at Week 48 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 48
Intervention | log_10 copies/mL (Mean) |
---|
Tenofovir DF | -6.22 |
FTC+Tenofovir DF | -6.49 |
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Change From Baseline in HBV DNA at Week 96
The change from baseline in HBV DNA at Week 96 was analyzed. (NCT00507507)
Timeframe: Baseline to Week 96
Intervention | log_10 copies/mL (Mean) |
---|
Tenofovir DF | -6.46 |
FTC+Tenofovir DF | -6.55 |
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Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192
The percentage of participants with HBV DNA < 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation. (NCT00507507)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 54.7 |
FTC+Tenofovir DF | 75.8 |
[back to top]
Number of Participants With HBV DNA <1000 IU/ml at Week 192
Number of participants whose serum HBV DNA level was <1000 IU/ml at Week 192 (NCT00524173)
Timeframe: At Week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 12 |
Tenofovir & Emtricitabine | 12 |
[back to top]
Number of Participants With Loss of HBsAg
The number of participants whose serum hepatitis B surface antigen was no longer detectable. (NCT00524173)
Timeframe: 192 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 1 |
Tenofovir & Emtricitabine | 0 |
[back to top]
Number of Participants With Normalized Alanine Aminotransferase (ALT)
Number of participants whose serum ALT levels were measured within normal limits. (NCT00524173)
Timeframe: 192 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 8 |
Tenofovir & Emtricitabine | 13 |
[back to top]
Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48
Number of subjects whose serum HBV DNA level was <1000 IU/ml at Week 48 (NCT00524173)
Timeframe: At Week 48
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 11 |
Tenofovir & Emtricitabine | 13 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks
This is the change from baseline in CD4 cell count after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -620 |
(Stavudine or Zidovudine)/TDF | -305 |
All TDF | -512 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks
This is the change from baseline in CD4 cell count after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -795 |
(Stavudine or Zidovudine)/TDF | -302 |
All TDF | -631 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks
This is the change from baseline in CD4 cell count after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -97 |
Stavudine or Zidovudine | -11 |
All TDF | 2 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks
This is the change from baseline in CD4 cell count after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -923 |
(Stavudine or Zidovudine)/TDF | -448 |
All TDF | -813 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks
This is the change from baseline in CD4 cell count after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -710 |
All TDF | -710 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks
This is the change from baseline in CD4 cell count after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -77 |
(Stavudine or Zidovudine)/TDF | -56 |
All TDF | -67 |
[back to top]
Change From Baseline in CD4 Percentage at 144 Weeks
This is the change from baseline in CD4 percentage after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 0.8 |
(Stavudine or Zidovudine)/TDF | -0.1 |
All TDF | 0.3 |
[back to top]
Change From Baseline in CD4 Percentage at 192 Weeks
This is the change from baseline in CD4 percentage after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 1.1 |
(Stavudine or Zidovudine)/TDF | 0.6 |
All TDF | 0.8 |
[back to top]
Change From Baseline in CD4 Percentage at 240 Weeks
This is the change from baseline in CD4 percentage after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 1.3 |
(Stavudine or Zidovudine)/TDF | -0.9 |
All TDF | 0.1 |
[back to top]
Change From Baseline in CD4 Percentage at 288 Weeks
This is the change from baseline in CD4 percentage after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 2.0 |
(Stavudine or Zidovudine)/TDF | 0.5 |
All TDF | 1.3 |
[back to top]
Change From Baseline in CD4 Percentage at 336 Weeks
This is the change from baseline in CD4 percentage after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 2.0 |
(Stavudine or Zidovudine)/TDF | 0.8 |
All TDF | 1.4 |
[back to top]
Change From Baseline in CD4 Percentage at 384 Weeks
This is the change from baseline in CD4 percentage after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 384 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 0.5 |
(Stavudine or Zidovudine)/TDF | 1.6 |
All TDF | 0.9 |
[back to top]
Change From Baseline in CD4 Percentage at 432 Weeks
This is the change from baseline in CD4 percentage after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 432 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 0.3 |
(Stavudine or Zidovudine)/TDF | 2.9 |
All TDF | 1.1 |
[back to top]
Change From Baseline in CD4 Percentage at 48 Weeks
This is the change from baseline in CD4 percentage after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: Baseline and 48 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 0.3 |
Stavudine or Zidovudine | 1.1 |
All TDF | 0.6 |
[back to top]
Change From Baseline in CD4 Percentage at 480 Weeks
This is the change from baseline in CD4 percentage after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 480 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 2.3 |
(Stavudine or Zidovudine)/TDF | 5.0 |
All TDF | 2.9 |
[back to top]
Change From Baseline in CD4 Percentage at 528 Weeks
This is the change from baseline in CD4 percentage after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 528 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 4.5 |
All TDF | 4.5 |
[back to top]
Change From Baseline in CD4 Percentage at 96 Weeks
This is the change from baseline in CD4 percentage after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 96 weeks
Intervention | percentage (Mean) |
---|
Tenofovir DF | 1.3 |
(Stavudine or Zidovudine)/TDF | -0.1 |
All TDF | 0.6 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 70.6 |
(Stavudine or Zidovudine)/TDF | 82.5 |
All TDF | 77.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 70.6 |
(Stavudine or Zidovudine)/TDF | 75.7 |
All TDF | 73.2 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 81.5 |
(Stavudine or Zidovudine)/TDF | 67.6 |
All TDF | 73.4 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 90.9 |
(Stavudine or Zidovudine)/TDF | 100.0 |
All TDF | 95.3 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
(Stavudine or Zidovudine)/TDF | 100.0 |
All TDF | 100.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
(Stavudine or Zidovudine)/TDF | 85.7 |
All TDF | 95.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 88.9 |
(Stavudine or Zidovudine)/TDF | 100.0 |
All TDF | 90.9 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
All TDF | 100.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 73.7 |
(Stavudine or Zidovudine)/TDF | 87.5 |
All TDF | 80.8 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 83.3 |
Stavudine or Zidovudine | 91.8 |
All TDF | 85.4 |
[back to top]
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96
This is the percentage of participants with HIV-1 RNA < 400 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 81.6 |
(Stavudine or Zidovudine)/TDF | 85.4 |
All TDF | 83.5 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: 144 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 63.2 |
(Stavudine or Zidovudine)/TDF | 75.0 |
All TDF | 69.2 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: 192 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 67.6 |
(Stavudine or Zidovudine)/TDF | 75.0 |
All TDF | 71.6 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: 240 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 70.6 |
(Stavudine or Zidovudine)/TDF | 73.0 |
All TDF | 71.8 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: 288 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 81.5 |
(Stavudine or Zidovudine)/TDF | 62.2 |
All TDF | 70.3 |
[back to top]
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)
This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 75.0 |
Stavudine or Zidovudine | 81.3 |
[back to top]
Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)
This is the percentage of participants with virologic success after 48 weeks of exposure to randomized study drug. The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT00528957)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 88.6 |
Stavudine or Zidovudine | 89.6 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 96 weeks of exposure to TDF. (NCT00528957)
Timeframe: 96 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 76.3 |
(Stavudine or Zidovudine)/TDF | 68.3 |
All TDF | 72.2 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 528 weeks of exposure to TDF. (NCT00528957)
Timeframe: 528 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
All TDF | 100.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 480 weeks of exposure to TDF. (NCT00528957)
Timeframe: 480 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 77.8 |
(Stavudine or Zidovudine)/TDF | 50.0 |
All TDF | 72.7 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 48 weeks of exposure to randomized study drug. (NCT00528957)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 70.8 |
Stavudine or Zidovudine | 85.7 |
All TDF | 68.5 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 432 weeks of exposure to TDF. (NCT00528957)
Timeframe: 432 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100.0 |
(Stavudine or Zidovudine)/TDF | 71.4 |
All TDF | 90.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 384 weeks of exposure to TDF. (NCT00528957)
Timeframe: 384 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 88.2 |
(Stavudine or Zidovudine)/TDF | 100.0 |
All TDF | 92.3 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks
This is the percentage of participants with HIV-1 RNA < 50 copies/mL after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: 336 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 86.4 |
(Stavudine or Zidovudine)/TDF | 90.5 |
All TDF | 88.4 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks
This is the change from baseline in CD4 cell count after 144 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 144 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -139 |
(Stavudine or Zidovudine)/TDF | -146 |
All TDF | -142 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks
This is the change from baseline in CD4 cell count after 192 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 192 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -304 |
(Stavudine or Zidovudine)/TDF | -177 |
All TDF | -233 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks
This is the change from baseline in CD4 cell count after 240 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 240 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -369 |
(Stavudine or Zidovudine)/TDF | -296 |
All TDF | -329 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks
This is the change from baseline in CD4 cell count after 288 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 288 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -346 |
(Stavudine or Zidovudine)/TDF | -256 |
All TDF | -302 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks
This is the change from baseline in CD4 cell count after 336 weeks of exposure to TDF. (NCT00528957)
Timeframe: Baseline and 336 weeks
Intervention | cells/mm^3 (Mean) |
---|
Tenofovir DF | -415 |
(Stavudine or Zidovudine)/TDF | -283 |
All TDF | -350 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 15 | 11 | 4 | 4 | 15 | 12 | 3 | 3 |
,TDF/FTC FDC | 38 | 19 | 7 | 5 | 27 | 16 | 6 | 4 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 23 | 15 | 4 | 4 | 21 | 11 | 4 | 3 |
,TDF/FTC FDC | 21 | 14 | 3 | 2 | 21 | 9 | 2 | 0 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 16 | 16 | 4 | 3 | 15 | 10 | 2 | 2 |
,TDF/FTC FDC | 26 | 20 | 6 | 4 | 24 | 17 | 3 | 3 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| >=2%, spine, n=59, 79 | >=6%, spine, n=59, 79 | >=2%, hip, n=58, 76 | >=6%, hip, n=58, 76 |
---|
ABC/3TC FDC | 21 | 3 | 33 | 1 |
,TDF/FTC FDC | 39 | 8 | 52 | 13 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| >=2%, spine, n=125, 141 | >=6%, spine, n=125, 141 | >=2%, hip, n=119, 140 | >=6%, hip, n=119, 140 |
---|
ABC/3TC FDC | 51 | 5 | 54 | 3 |
,TDF/FTC FDC | 84 | 13 | 111 | 17 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| >=2%, spine, n=142, 165 | >=6%, spine, n=142, 165 | >=2%, hip, n=137, 160 | >=6%, hip, n=137, 160 |
---|
ABC/3TC FDC | 73 | 10 | 38 | 1 |
,TDF/FTC FDC | 115 | 17 | 93 | 6 |
[back to top]
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=64, 82 | Osteporosis, spine, n=64, 82 | Osteopenia, hip, n=65, 80 | Osteoporosis, hip, n=65, 80 |
---|
ABC/3TC FDC | 21 | 5 | 20 | 0 |
,TDF/FTC FDC | 34 | 3 | 31 | 0 |
[back to top]
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ug/L (Geometric Mean) |
---|
ABC/3TC FDC | 3.01 |
TDF/FTC FDC | 5.79 |
[back to top]
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.868 |
TDF/FTC FDC | 0.939 |
[back to top]
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ug/L (Geometric Mean) |
---|
ABC/3TC FDC | 1.111 |
TDF/FTC FDC | 2.542 |
[back to top]
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.542 |
TDF/FTC FDC | 0.984 |
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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | cells/mm^3 (Median) |
---|
ABC/3TC FDC | 150.0 |
TDF/FTC FDC | 150.0 |
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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 4.37 |
TDF/FTC FDC | 2.68 |
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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | cells/millimeters cubed (mm^3) (Median) |
---|
ABC/3TC FDC | 110.0 |
TDF/FTC FDC | 100.0 |
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Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | micrograms per Liter (ug/L) (Geometric Mean) |
---|
ABC/3TC FDC | 1.2 |
TDF/FTC FDC | 1.4 |
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Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.872 |
TDF/FTC FDC | 0.973 |
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Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | cells/mm^3 (Median) |
---|
ABC/3TC FDC | 235.0 |
TDF/FTC FDC | 220.0 |
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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=132, 147 | Osteporosis, spine, n=132, 147 | Osteopenia, hip, n=130, 147 | Osteoporosis, hip, n=130, 147 |
---|
ABC/3TC FDC | 41 | 15 | 37 | 4 |
,TDF/FTC FDC | 57 | 5 | 50 | 0 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 46 | 52 | 36 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 96 | 37 | 9 | 1 | 9 | 8 | 0 | 0 | 2 |
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Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=147, 173 | Osteporosis, spine, n=147, 173 | Osteopenia, hip, n=149, 170 | Osteoporosis, hip, n=149, 170 |
---|
ABC/3TC FDC | 41 | 16 | 38 | 4 |
,TDF/FTC FDC | 68 | 9 | 54 | 1 |
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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Bone density decreased | Rash | Dizziness | Hypersensitivity | Abnormal dreams | Drug eruption | Depression |
---|
ABC/3TC FDC | 33 | 11 | 0 | 2 | 1 | 3 | 3 | 1 | 0 |
,TDF/FTC FDC | 28 | 1 | 8 | 3 | 3 | 0 | 0 | 1 | 2 |
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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 48
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Bone density decreased | Rash | Dizziness | Hypersensitivity | Drug eruption |
---|
ABC/3TC FDC | 29 | 11 | 0 | 2 | 1 | 3 | 1 |
,TDF/FTC FDC | 21 | 1 | 2 | 3 | 3 | 0 | 1 |
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Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Rash | Dizziness | Hypersensitivity | Drug eruption |
---|
ABC/3TC FDC | 26 | 11 | 2 | 0 | 3 | 1 |
,TDF/FTC FDC | 14 | 1 | 3 | 2 | 0 | 1 |
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Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Any treatment-emergent mutation | NRTI | NNRTI |
---|
ABC/3TC FDC | 4 | 4 | 2 |
,TDF/FTC FDC | 0 | 0 | 0 |
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"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"
Participants were asked at each visit whether or not they utilized unplanned healthcare resources. (NCT00549198)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Week 4, Yes, n=178, 183 | Week 4, No, n=178, 183 | Week 12, Yes, n=162, 177 | Week 12, No, n=162, 177 | Week 24, Yes, n=156, 173 | Week 24, No, n=156, 173 | Week 36, Yes, n=148, 169 | Week 36, No, n=148, 169 | Week 48, Yes, n=137, 161 | Week 48, No, n=137, 161 | Week 60, Yes, n=129, 148 | Week 60, No, n=129, 148 | Week 72, Yes, n=126, 139 | Week 72, No, n=126, 139 | Week 84, Yes, n=121, 136 | Week 84, No, n=121, 136 | Week 96, Yes, n=113, 135 | Week 96, No, n=113, 135 |
---|
ABC/3TC FDC | 60 | 118 | 56 | 106 | 70 | 86 | 48 | 100 | 44 | 93 | 47 | 82 | 48 | 78 | 34 | 87 | 30 | 83 |
,TDF/FTC FDC | 49 | 134 | 47 | 130 | 59 | 114 | 50 | 119 | 36 | 125 | 44 | 104 | 40 | 99 | 24 | 108 | 17 | 118 |
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -0.87 |
TDF/FTC FDC | -1.70 |
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.59 |
TDF/FTC FDC | -2.41 |
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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -2.12 |
TDF/FTC FDC | -3.30 |
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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -2.17 |
TDF/FTC FDC | -3.55 |
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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.90 |
TDF/FTC FDC | -3.56 |
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Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.19 |
TDF/FTC FDC | -2.73 |
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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | mL/min/1.73m^2 (Mean) |
---|
ABC/3TC FDC | 1.48 |
TDF/FTC FDC | -1.15 |
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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | milliliters per minute (mL/min)/1.73 m^2 (Mean) |
---|
ABC/3TC FDC | 0.22 |
TDF/FTC FDC | 1.18 |
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Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | mL/min/1.73m^2 (Mean) |
---|
ABC/3TC FDC | 2.78 |
TDF/FTC FDC | 0.43 |
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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 2.66 |
TDF/FTC FDC | 3.80 |
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Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 4.27 |
TDF/FTC FDC | 2.54 |
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Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 1.099 |
TDF/FTC FDC | 1.550 |
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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 126 | 147 |
,TDF/FTC FDC | 144 | 168 |
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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 121 | 130 |
,TDF/FTC FDC | 145 | 151 |
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Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 98 | 110 |
,TDF/FTC FDC | 113 | 126 |
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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 97 | 11 | 5 | 1 | 0 | 0 |
,TDF/FTC FDC | 114 | 15 | 5 | 1 | 0 | 0 |
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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Missing | Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 12 | 90 | 7 | 3 | 0 | 0 | 0 |
,TDF/FTC FDC | 19 | 106 | 5 | 3 | 0 | 0 | 0 |
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Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Missing | Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 11 | 75 | 3 | 4 | 0 | 0 | 0 |
,TDF/FTC FDC | 18 | 83 | 4 | 4 | 0 | 0 | 0 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 19 | 72 | 10 | 0 | 12 | 26 | 0 | 0 | 10 |
,TDF/FTC FDC | 36 | 66 | 9 | 1 | 30 | 12 | 0 | 3 | 5 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 17 | 67 | 18 | 0 | 11 | 27 | 0 | 0 | 10 |
,TDF/FTC FDC | 28 | 73 | 10 | 0 | 23 | 20 | 0 | 3 | 5 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 11 | 66 | 25 | 0 | 8 | 30 | 0 | 0 | 10 |
,TDF/FTC FDC | 23 | 75 | 13 | 0 | 17 | 27 | 0 | 1 | 7 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 54 | 47 | 32 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 104 | 29 | 9 | 3 | 9 | 6 | 0 | 0 | 2 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 39 | 49 | 46 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 86 | 47 | 10 | 1 | 9 | 8 | 0 | 0 | 2 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 63 | 21 | 23 | 0 | 5 | 5 | 9 | 0 | 2 | 5 | 12 | 3 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 78 | 19 | 9 | 0 | 7 | 10 | 15 | 0 | 6 | 3 | 15 | 0 | 0 | 0 | 1 | 0 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 55 | 22 | 30 | 0 | 4 | 5 | 11 | 0 | 2 | 4 | 12 | 4 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 70 | 23 | 12 | 1 | 6 | 7 | 19 | 0 | 5 | 3 | 15 | 0 | 0 | 0 | 1 | 0 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 47 | 25 | 34 | 1 | 4 | 4 | 11 | 1 | 2 | 4 | 11 | 5 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 55 | 31 | 20 | 1 | 5 | 8 | 19 | 0 | 5 | 2 | 16 | 0 | 0 | 0 | 1 | 0 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 22 | 41 | 22 | 6 | 1 | 0 | 6 | 17 | 12 | 4 | 0 | 1 | 2 | 4 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 46 | 43 | 11 | 1 | 0 | 5 | 22 | 11 | 5 | 1 | 0 | 6 | 3 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 20 | 38 | 27 | 8 | 1 | 0 | 4 | 19 | 12 | 4 | 0 | 1 | 2 | 3 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 42 | 46 | 12 | 1 | 0 | 3 | 21 | 13 | 6 | 1 | 0 | 3 | 5 | 4 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 18 | 35 | 29 | 9 | 3 | 0 | 4 | 17 | 12 | 6 | 0 | 1 | 2 | 3 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 37 | 46 | 17 | 1 | 0 | 1 | 19 | 16 | 7 | 2 | 0 | 3 | 5 | 3 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 3 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 6 | 0 | 8 | 0 | 19 | 0 | 2 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 3 | 2 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 3 | 0 | 5 | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 |
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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Total bilirubin Grade 3 | Total bilirubin, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 7 | 0 | 9 | 0 | 20 | 0 | 3 | 0 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 0 | 5 | 2 | 0 | 2 | 1 | 0 | 2 | 3 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 3 | 0 | 6 | 0 | 0 | 0 | 4 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 0 |
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Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Total bilirubin, Grade 3 | Total bilirubin, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 3 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 9 | 0 | 13 | 0 | 22 | 0 | 2 | 1 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 4 | 0 | 6 | 4 | 0 | 2 | 1 | 0 | 3 | 5 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 5 | 0 | 5 | 0 | 0 | 0 | 4 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 2 | 2 | 3 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 1 | 3 | 0 | 0 |
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Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | nanograms per Liter (ng/L) (Geometric Mean) |
---|
ABC/3TC FDC | 89.9 |
TDF/FTC FDC | 203.6 |
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Proportion of Patients Reporting CNS Side Effects of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 25 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 23 |
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Change in Framingham Score
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%. (NCT00552240)
Timeframe: baseline to week 48
Intervention | percent 10-year risk (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.09 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 0.14 |
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Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
(NCT00552240)
Timeframe: baseline to week 48
Intervention | ratio (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.38 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | -0.02 |
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Change in Fasting Plasma Triglycerides Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -4.7 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 8.4 |
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Change in Fasting Plasma Total Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 18.2 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 13.8 |
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Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 8.7 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 6.9 |
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Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 9.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 3.5 |
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Change in CD4+ Cell Count From Baseline to Week 8.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 8
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 111.9 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 90.5 |
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Change in CD4+ Cell Count From Baseline to Week 6.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 6
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 87.2 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 78.4 |
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Change in CD4+ Cell Count From Baseline to Week 48.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 48
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 155.1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 160.4 |
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Change in CD4+ Cell Count From Baseline to Week 4.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 4
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 76.4 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63.0 |
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Change in CD4+ Cell Count From Baseline to Week 36.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 36
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 147.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 120.5 |
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Change in CD4+ Cell Count From Baseline to Week 24.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 24
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 131.8 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 132.5 |
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Change in CD4+ Cell Count From Baseline to Week 2.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 2
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 62.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 61.0 |
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Change in CD4+ Cell Count From Baseline to Week 12.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 12
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 123.1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 102.2 |
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AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)." (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 3 |
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Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
using 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT00552240)
Timeframe: baseline to week 48
Intervention | ml/min/1.73m^2 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.06 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | -12.81 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 10 | 62 | 5 |
,Nevirapine (NVP) Plus Truvada | 12 | 53 | 10 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 31 | 41 | 5 |
,Nevirapine (NVP) Plus Truvada | 38 | 27 | 10 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 54 | 2 | 21 |
,Nevirapine (NVP) Plus Truvada | 43 | 1 | 31 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 44 | 23 | 10 |
,Nevirapine (NVP) Plus Truvada | 40 | 21 | 14 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 58 | 15 | 4 |
,Nevirapine (NVP) Plus Truvada | 48 | 11 | 16 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 43 | 27 | 7 |
,Nevirapine (NVP) Plus Truvada | 42 | 20 | 13 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 5 | 63 | 9 |
,Nevirapine (NVP) Plus Truvada | 6 | 62 | 7 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment. (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 8 |
,Nevirapine (NVP) Plus Truvada | 42 | 2 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 8 | 21 |
,Nevirapine (NVP) Plus Truvada | 42 | 2 | 31 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 14 | 53 | 10 |
,Nevirapine (NVP) Plus Truvada | 23 | 38 | 14 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 23 | 50 | 4 |
,Nevirapine (NVP) Plus Truvada | 34 | 25 | 16 |
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Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 24 and week 48
Intervention | Participants (Number) |
---|
| At week 24 | At week 48 |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 4 | 9 |
,Nevirapine (NVP) Plus Truvada | 1 | 2 |
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Number of Participants With Virologic Response (VR)
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. (NCT00552240)
Timeframe: baseline to week 48
Intervention | participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 50 | 27 |
,Nevirapine (NVP) Plus Truvada | 46 | 29 |
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Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48. (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 51 | 26 |
,Nevirapine (NVP) Plus Truvada | 48 | 27 |
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Number of Participants With Virologic Success (FDA Definition)
HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS). (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 29 |
,Nevirapine (NVP) Plus Truvada | 42 | 33 |
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Number of Patients With Virologic Rebound to >400 Copies/ml
HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Rebound following response | No rebound following response |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 6 | 63 |
,Nevirapine (NVP) Plus Truvada | 2 | 55 |
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Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
| Grade 2 moderate | Grade 3 severe | Grade 4 potential lifethreatening |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 31 | 7 | 3 |
,Nevirapine (NVP) Plus Truvada | 25 | 8 | 7 |
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Percentage Adherence by Pill Count
Number of pills not returned / number of treatment days in percent (%) (NCT00552240)
Timeframe: baseline to week 48
Intervention | percentage adherence (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 94.3 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 97.0 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63 | 3 | 11 |
,Nevirapine (NVP) Plus Truvada | 51 | 6 | 18 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 59 | 1 | 17 |
,Nevirapine (NVP) Plus Truvada | 54 | 3 | 18 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 55 | 5 | 17 |
,Nevirapine (NVP) Plus Truvada | 53 | 4 | 18 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 17 | 51 | 9 |
,Nevirapine (NVP) Plus Truvada | 24 | 44 | 7 |
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Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63 | 7 | 7 |
,Nevirapine (NVP) Plus Truvada | 56 | 6 | 13 |
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Incidence of Patients With AIDS Progression at Each Visit
Cumulative incidence of patients with AIDS progression are shown (NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
| week 0 | week 2 | week 4 | week 6 | week 8 | week 12 | week 24 | week 36 | week 48 | week 50 | End of Study Visit |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 3 | 3 | 3 | 3 |
,Nevirapine (NVP) Plus Truvada | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 |
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Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
(NCT00552240)
Timeframe: baseline to week 48
Intervention | days (Median) |
---|
Nevirapine (NVP) Plus Truvada | 55 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 84 |
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Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time to response whereby patients withdrawing early were censored after their withdrawal (NCT00552240)
Timeframe: baseline to week 48
Intervention | days (Median) |
---|
Nevirapine (NVP) Plus Truvada | 57 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 84 |
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Proportion of Patients Reporting Rash of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 21 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 19 |
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Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 61 | 5 | 11 |
,Nevirapine (NVP) Plus Truvada | 48 | 9 | 18 |
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Proportion of Patients Reporting Hepatic Events of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 5 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 24 |
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Head Circumference Among Infants Born to Female Participants Taking Study Drug
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 |
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Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
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 |
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Length Among Infants Born to Female Participants Taking Study Drug
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 |
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Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
"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 |
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Study Drug Adherence: Self-reported Missed Doses of Study Drug
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 |
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Weight Among Infants Born to Female Participants Taking Study Drug
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 |
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Prevalence of Unprotected Sex During Follow-up
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 |
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Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
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 |
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Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
"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 |
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Number of Participants With Serious Adverse Events (SAEs)
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 |
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Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
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 |
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Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter). (NCT00592124)
Timeframe: Measured through Week 21
Intervention | minutes (Median) |
---|
Vaginal and Oral Tenofovir | 60.0 |
Vaginal Tenofovir | 60.0 |
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Number of Days Product Missed
This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product. (NCT00592124)
Timeframe: Measured through Week 21
Intervention | days (Mean) |
---|
Vaginal and Oral Tenofovir | 0.9 |
Oral Tenofovir | 0.9 |
Vaginal Tenofovir | 0.9 |
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Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
(NCT00592124)
Timeframe: Measured through Week 21
Intervention | Participants (Count of Participants) |
---|
Vaginal and Oral Tenofovir | 5 |
Oral Tenofovir | 5 |
Vaginal Tenofovir | 3 |
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Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage. (NCT00592124)
Timeframe: Measured through Week 21
Intervention | ng/mL, ng/mg, ng/mL (Median) |
---|
| Serum TFV Cmax | Tissue TFV | Cervicovaginal lavage |
---|
Oral Tenofovir | 332 | 0.15 | 5380 |
,Vaginal and Oral Tenofovir | 337 | 104 | 1600000 |
,Vaginal Tenofovir | 3.9 | 113 | 3100000 |
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Self-reported Adherence to Each Regimen
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent. (NCT00592124)
Timeframe: Measured through Week 21
Intervention | percentage of expected doses (Mean) |
---|
Vaginal and Oral Tenofovir | 94 |
Oral Tenofovir | 93.8 |
Vaginal Tenofovir | 93.9 |
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Reported Sharing of Product
Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant. (NCT00592124)
Timeframe: Measured through Week 21
Intervention | Participants (Count of Participants) |
---|
Vaginal and Oral Tenofovir | 2 |
Oral Tenofovir | 0 |
Vaginal Tenofovir | 3 |
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Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter). (NCT00592124)
Timeframe: Measured through Week 21
Intervention | minutes (Median) |
---|
Vaginal and Oral Tenofovir | 90.0 |
Oral Tenofovir | 120.0 |
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Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter). (NCT00592124)
Timeframe: Measured through Week 21
Intervention | minutes (Median) |
---|
Vaginal and Oral Tenofovir | 75.0 |
Vaginal Tenofovir | 120.0 |
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Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter). (NCT00592124)
Timeframe: Measured through Week 21
Intervention | minutes (Median) |
---|
Vaginal and Oral Tenofovir | 60.0 |
Oral Tenofovir | 90.0 |
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Number of HIV-1 Infected Participants
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected (NCT00594646)
Timeframe: 90 days
Intervention | participants (Number) |
---|
Group 1 | 0 |
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Medication Regimen Completion Rates
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 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event. (NCT00605384)
Timeframe: Day 1 through end of treatment (Week 100 +/- 5 days)
Intervention | participants (Number) |
---|
| AEs | SAEs | Deaths | Discontinuations due to AEs | Discontinuations due to Laboratory Abnormalities |
---|
Adefovir + Continuing Lamivudine | 1 | 0 | 0 | 0 | 0 |
,Entecavir + Tenofovir | 1 | 0 | 0 | 0 | 0 |
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Time to First Grade 3 or 4 Lab Event
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 |
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Time to First Grade 3 or 4 Lab or Sign/Symptom Event
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 |
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Adherence to Second Line HAART Regimen
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 |
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Time to First Grade 3 or 4 Sign or Symptom
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 |
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CD4 Count at Follow-up Visits
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 |
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CD8 Count at Follow-up Visits
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 |
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Confirmed Virologic Failure at or Prior to Week 24
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 |
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Confirmed Virologic Failure at or Prior to Week 48
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 |
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Participant Report of Change in Number of Sexual Partners
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 |
[back to top]
HIV Infection
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 |
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FTC and/or Tenofovir Resistance
"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 |
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Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
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 |
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Confirmed Grade 3 or Higher AST Elevation
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 |
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Confirmed Grade 3 or Higher ALT Elevation
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 |
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CD4+ T-cell Count
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 |
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Confirmed Grade 3 or Higher Reduction in Phosphorus
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 |
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Confirmed Grade 2 or Higher Serum Creatinine Toxicity
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 |
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Pregnancy Complications
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 |
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Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
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 |
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Plasma HIV RNA Level (HIV-1 Viral Load)
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 |
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Absolute Change in CD4 Cell Counts
(NCT00632970)
Timeframe: 24 and 48 weeks
Intervention | cells/mm^3 (Mean) |
---|
Raltegravir | 50 |
Lopinavir/Ritonavir | 50 |
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Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
change was calculated as the mean of 12 assessments minus the baseline value (NCT00641641)
Timeframe: 12 times within 48 weeks.
Intervention | log copies/mL plasma (Mean) |
---|
Drug Intervention | 5.4 |
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Time to Virologic Failure
time to virologic failure at week 24 (up to 48 weeks) (NCT00654147)
Timeframe: week 24 (up to 48 weeks)
Intervention | weeks (Median) |
---|
Raltegravir & Lopinavir/Ritonavir | 3.2296 |
Raltegravir & Emtricitabine/Tenofovir | 2.9952 |
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Time to Confirmed Virologic Failure
time to confirmed viologic failure at 24 weeks (up to 48 weeks) (NCT00654147)
Timeframe: weeks
Intervention | weeks (Median) |
---|
Raltegravir & Lopinavir/Ritonavir | 28 |
Raltegravir & Emtricitabine/Tenofovir | 29 |
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Study Medication Tolerability
study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment (NCT00654147)
Timeframe: date started study treatment to first week documented change study treatment up to week 48
Intervention | participants (Number) |
---|
Raltegravir & Lopinavir/Ritonavir | 1 |
Raltegravir & Emtricitabine/Tenofovir | 0 |
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Weeks to HIV-1 RNA <200 Copies/ml
time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml (NCT00654147)
Timeframe: from date of treatment start to first week documented viral suppression
Intervention | week to viral supresssion (Median) |
---|
| week to <200 Copies/ml | week to <50 Copies/ml |
---|
Raltegravir & Emtricitabine/Tenofovir | 28 | 56 |
,Raltegravir & Lopinavir/Ritonavir | 28 | 56 |
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Change From Baseline CD4+ and CD8+ Cell Counts
mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms (NCT00654147)
Timeframe: Baseline, Weeks 16 and 24
Intervention | cells/mm3 (Mean) |
---|
| week 16 CD4 cells | week 24 CD4 cells |
---|
Raltegravir & Emtricitabine/Tenofovir | 452.11 | 482.36 |
,Raltegravir & Lopinavir/Ritonavir | 516.34 | 521.31 |
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HIV RNA < 75 Copies/ml
(NCT00662545)
Timeframe: entry, week 12, and week 24
Intervention | participants (Number) |
---|
Entecavir Intensification | 5 |
Standard of Care | 5 |
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Hepatitis B Virus (HBV) DNA
"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 |
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Incidence of Permanent Discontinuation Due to Toxicity
(NCT00662545)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Entecavir Intensification | 0 |
Standard of Care | 0 |
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Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
(NCT00662545)
Timeframe: every 4 weeks for 24 weeks
Intervention | participants (Number) |
---|
Entecavir Intensification | 0 |
Standard of Care | 0 |
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Incidence of ALT Flares
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 |
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Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
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 |
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Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
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 |
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Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms
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 |
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Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
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 |
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Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
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 |
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Person-years of Follow-up of Oral TDF and Oral Placebo Arms
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 |
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Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
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 |
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Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
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 |
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Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
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 |
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Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events
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 |
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Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
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 |
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Mean Change From Baseline in Eosinophils (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | millimoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.011 |
LPV/r + RAL | 0.109 |
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Mean Change From Baseline in Hematocrit (Fraction)
Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | % by volume of packed RBCs in blood (Mean) |
---|
LPV/r + FTC/TDF | 0.038 |
LPV/r + RAL | 0.036 |
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Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.046 |
LPV/r + RAL | -0.028 |
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Mean Change From Baseline in Hips Measurement (cm)
Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 2.45 |
LPV/r + RAL | 4.70 |
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Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.257 |
LPV/r + RAL | 0.346 |
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Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.8 |
LPV/r + RAL | -9.6 |
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Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | -1.0 |
LPV/r + RAL | -1.1 |
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Mean Change From Baseline in Basophils (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.5 |
LPV/r + RAL | -0.8 |
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Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.00 |
LPV/r + RAL | 0.37 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 13.75 |
LPV/r + RAL | 27.01 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.67 |
LPV/r + RAL | 2.56 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 3.48 |
LPV/r + RAL | 6.34 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 7.28 |
LPV/r + RAL | 21.53 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -1.49 |
LPV/r + RAL | -1.25 |
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Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 1.3 |
LPV/r + RAL | 1.3 |
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Mean Change From Baseline in Calcium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.040 |
LPV/r + RAL | -0.016 |
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Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | milliliters/second (Mean) |
---|
LPV/r + FTC/TDF | -0.122 |
LPV/r + RAL | -0.024 |
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Mean Change From Baseline in Chest Measurement (cm)
Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.13 |
LPV/r + RAL | 4.06 |
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Mean Change From Baseline in Chloride (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.4 |
LPV/r + RAL | 0.2 |
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Mean Change From Baseline in Cholesterol (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.808 |
LPV/r + RAL | 1.113 |
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Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | 398.9 |
LPV/r + RAL | 157.2 |
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Mean Change From Baseline in Creatinine (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 5.7 |
LPV/r + RAL | 1.6 |
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Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
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 |
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Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -6.1 |
LPV/r + RAL | -13.4 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -0.33 |
LPV/r + RAL | 1.52 |
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Mean Change From Baseline in Albumin (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | 1.4 |
LPV/r + RAL | 1.3 |
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Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Baseline to Week 96
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 |
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Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 96
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 |
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Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | 14.5 |
LPV/r + RAL | 1.7 |
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Mean Change From Baseline in Hemoglobin (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | 5.4 |
LPV/r + RAL | 5.1 |
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Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.97 |
LPV/r + RAL | 2.27 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -3.69 |
LPV/r + RAL | 0.52 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/cm^2 (Mean) |
---|
LPV/r + FTC/TDF | -2.48 |
LPV/r + RAL | 0.68 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 15.32 |
LPV/r + RAL | 28.82 |
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Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred. (NCT00711009)
Timeframe: Baseline to Week 96
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 |
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Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
(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 |
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Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Percentage of Participants (Number) |
---|
LPV/r + FTC/TDF | 79.1 |
LPV/r + RAL | 77.8 |
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Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 84.6 |
LPV/r + RAL | 86.2 |
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Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 82.5 |
LPV/r + RAL | 85.5 |
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Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 75.5 |
LPV/r + RAL | 76.0 |
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Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 48
Intervention | Percentage of Participants (Number) |
---|
LPV/r + FTC/TDF | 84.8 |
LPV/r + RAL | 83.2 |
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Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Participants (Number) |
---|
LPV/r + FTC/TDF | 0 |
LPV/r + RAL | 1 |
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Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Weight (kg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | kg (Mean) |
---|
LPV/r + FTC/TDF | 1.83 |
LPV/r + RAL | 3.77 |
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Mean Change From Baseline in Waist Measurement (cm)
Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.88 |
LPV/r + RAL | 4.93 |
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Mean Change From Baseline in Urine Specific Gravity
Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | ratio of urine density to water density (Mean) |
---|
LPV/r + FTC/TDF | 0.0042 |
LPV/r + RAL | 0.0052 |
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Mean Change From Baseline in Urine pH
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | pH (Mean) |
---|
LPV/r + FTC/TDF | 0.00 |
LPV/r + RAL | 0.03 |
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Mean Change From Baseline in Uric Acid (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -29.0 |
LPV/r + RAL | -6.1 |
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Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.846 |
LPV/r + RAL | 1.103 |
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Mean Change From Baseline in Total Protein (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | -6.3 |
LPV/r + RAL | -7.2 |
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Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.9 |
LPV/r + RAL | 1.9 |
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Mean Change From Baseline in Temperature (°F)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | °F (Mean) |
---|
LPV/r + FTC/TDF | -0.152 |
LPV/r + RAL | -0.183 |
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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | picograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | -1257.9 |
LPV/r + RAL | -1594.7 |
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Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | picograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | -138.602 |
LPV/r + RAL | -166.403 |
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Mean Change From Baseline in Sodium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.1 |
LPV/r + RAL | 0.7 |
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Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | mm Hg (Mean) |
---|
LPV/r + FTC/TDF | -0.7 |
LPV/r + RAL | -2.4 |
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Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | beats per minute (Mean) |
---|
LPV/r + FTC/TDF | -4.6 |
LPV/r + RAL | -6.3 |
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Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | mm Hg (Mean) |
---|
LPV/r + FTC/TDF | -2.4 |
LPV/r + RAL | -1.8 |
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Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^12/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.12 |
LPV/r + RAL | 0.16 |
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Mean Change From Baseline in Potassium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.13 |
LPV/r + RAL | 0.03 |
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Mean Change From Baseline in Platelet Count (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 4.32 |
LPV/r + RAL | 6.96 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 12.71 |
LPV/r + RAL | 25.31 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.08 |
LPV/r + RAL | 1.56 |
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Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 2.9 |
LPV/r + RAL | 5.4 |
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Mean Change From Baseline in Neutrophils (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Monocytes (x 10^9/Liter)
(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 |
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Mean Change From Baseline in Mid-Thigh Measurement (cm)
Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 2.09 |
LPV/r + RAL | 5.13 |
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Mean Change From Baseline in Mid-Arm Measurement (cm)
Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.76 |
LPV/r + RAL | 4.71 |
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Mean Change From Baseline in Magnesium (Millimoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | millimoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.019 |
LPV/r + RAL | -0.009 |
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Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.332 |
LPV/r + RAL | 0.368 |
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Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | ratio (Mean) |
---|
LPV/r + FTC/TDF | -0.056 |
LPV/r + RAL | -0.040 |
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Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.535 |
LPV/r + RAL | 0.715 |
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Mean Change From Baseline in Lipase (Units/Liter)
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 |
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Mean Change From Baseline in Leptin (Nanograms/Milliliter)
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 |
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Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -21.157 |
LPV/r + RAL | -28.926 |
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Mean Change From Baseline in Lactate (Millimoles/Liter)
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 |
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Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | nanograms/liter (Mean) |
---|
LPV/r + FTC/TDF | -1.584 |
LPV/r + RAL | -53.286 |
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Mean Change From Baseline in Insulin (Picomoles/Liter)
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 |
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Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
| On-Treatment Response Analysis (Missing = Failure) | Snapshot Responder Analysis (Virologic Success) |
---|
ABC/3TC + PI/r | 82.1 | 82.1 |
,TVD + PI/r | 84.4 | 84.4 |
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Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | pg/mL (Mean) |
---|
| IL-10 | IL-6 | TNF-alpha |
---|
ABC/3TC + PI/r | -0.2 | -0.6 | 4.7 |
,TVD + PI/r | 0.0 | -0.2 | 0.0 |
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Change From Baseline Fasting Lipid Parameters at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
| Total Cholesterol | LDL (low-density lipoprotein) | HDL (high-density lipoprotein) | Triglycerides |
---|
ABC/3TC + PI/r | -4 | 2 | 0 | -23 |
,TVD + PI/r | -21 | -6 | -2 | -51 |
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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 93.0 |
ABC/3TC + PI/r | 91.1 |
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Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 99.2 |
ABC/3TC + PI/r | 97.2 |
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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 86.4 |
ABC/3TC + PI/r | 83.3 |
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Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | cells/microliter (Mean) |
---|
TVD + PI/r | 8 |
ABC/3TC + PI/r | 34 |
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Change From Baseline Fasting Glucose at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | 1 |
ABC/3TC + PI/r | 1 |
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Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mL/min/1.73m^2 (Mean) |
---|
TVD + PI/r | -9.0 |
ABC/3TC + PI/r | -3.7 |
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Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | Ratio (Mean) |
---|
TVD + PI/r | -0.1 |
ABC/3TC + PI/r | -0.1 |
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Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mL/min (Mean) |
---|
TVD + PI/r | -8.4 |
ABC/3TC + PI/r | -4.1 |
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Change From Baseline C-Reactive Protein at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | -0.026 |
ABC/3TC + PI/r | 0.225 |
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Change From Baseline Fibrinogen at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | -4 |
ABC/3TC + PI/r | 14 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
| TLOVR Responder Analysis | On-Treatment Response Analysis (Missing = Failure) | Snapshot Responder Analysis (Virologic Success) |
---|
ABC/3TC + PI/r | 76.3 | 77.6 | 77.6 |
,TVD + PI/r | 77.9 | 79.9 | 79.9 |
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Change From Baseline in Z-score for Whole Body BMD at Week 192
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.34 |
TDF 15-17 Years | -0.11 |
Placebo 12-14 Years | -0.21 |
Placebo 15-17 Years | -0.19 |
Total TDF 12-17 Years | -0.16 |
Total Placebo 12-17 Years | -0.19 |
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Percentage of Participants With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL and Normalized ALT at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 55.6 | 66.7 | 77.8 |
,Placebo 15-17 Years | 0 | 0 | 54.5 | 69.7 | 57.6 |
,TDF 12-14 Years | 85.7 | 85.7 | 85.7 | 57.1 | 85.7 |
,TDF 15-17 Years | 71.4 | 71.4 | 78.6 | 71.4 | 67.9 |
,Total Placebo 12-17 Years | 0 | 0 | 54.8 | 69.0 | 61.9 |
,Total TDF 12-17 Years | 74.3 | 74.3 | 80.0 | 68.6 | 71.4 |
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Percentage of Participants With Abnormal ALT at Baseline Who Had Normalized ALT at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 11.1 | 22.2 | 66.7 | 66.7 | 77.8 |
,Placebo 15-17 Years | 21.2 | 33.3 | 63.6 | 72.7 | 69.7 |
,TDF 12-14 Years | 85.7 | 85.7 | 85.7 | 57.1 | 85.7 |
,TDF 15-17 Years | 71.4 | 71.4 | 78.6 | 71.4 | 75.0 |
,Total Placebo 12-17 Years | 19.0 | 31.0 | 64.3 | 71.4 | 71.4 |
,Total TDF 12-17 Years | 74.3 | 74.3 | 80.0 | 68.6 | 77.1 |
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Percentage of Participants With at Least a 6% Decrease From Baseline in Spine BMD at Weeks 48, 96, 144, and 192
The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Weeks 48, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 0 | 0 |
,Placebo 15-17 Years | 0 | 0 | 0 | 4.9 |
,TDF 12-14 Years | 0 | 0 | 0 | 0 |
,TDF 15-17 Years | 0 | 2.4 | 2.4 | 4.8 |
,Total Placebo 12-17 Years | 0 | 0 | 0 | 3.7 |
,Total TDF 12-17 Years | 0 | 1.9 | 1.9 | 3.8 |
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Percentage of Participants With HBsAg Seroconversion at Weeks 48, 72, 96, 144, and 192
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,Placebo 15-17 Years | 0 | 0 | 0 | 0 | 0 |
,TDF 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,TDF 15-17 Years | 0 | 2.4 | 2.4 | 2.4 | 0 |
,Total Placebo 12-17 Years | 0 | 0 | 0 | 0 | 0 |
,Total TDF 12-17 Years | 0 | 1.9 | 1.9 | 1.9 | 0 |
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Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 53.8 | 69.2 | 76.9 |
,Placebo 15-17 Years | 0 | 0 | 63.4 | 82.9 | 73.2 |
,TDF 12-14 Years | 80.0 | 90.0 | 90.0 | 90.0 | 90.0 |
,TDF 15-17 Years | 81.0 | 83.3 | 88.1 | 88.1 | 83.3 |
,Total Placebo 12-17 Years | 0 | 0 | 61.1 | 79.6 | 74.1 |
,Total TDF 12-17 Years | 80.8 | 84.6 | 88.5 | 88.5 | 84.6 |
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Percentage of Participants With HBV DNA < 400 Copies/mL at Week 72
"The percentage of participants with HBV DNA < 400 copies/mL at Week 72 was summarized by treatment and age group (grouped by baseline age for analysis), using the missing = failure (M = F) analysis with the double-blind efficacy evaluation (DBEE) algorithm.~In the M = F analysis method, all missing data were considered as failure to meet the outcome measure threshold. This method was combined with the DBEE algorithm, which included all available data for the double-blind period, and any data for the open-label period were not included; data generated during treatment-free follow-up from subjects who achieved HBsAg loss and entered treatment-free follow-up during double-blind treatment period were included." (NCT00734162)
Timeframe: Week 72
Intervention | percentage of participants (Number) |
---|
TDF 12-14 Years | 90.0 |
TDF 15-17 Years | 88.1 |
Placebo 12-14 Years | 0 |
Placebo 15-17 Years | 0 |
Total TDF 12-17 Years | 88.5 |
Total Placebo 12-17 Years | 0 |
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Percentage of Participants With at Least a 6% Decrease From Baseline in Bone Mineral Density (BMD) of the Spine at Week 72
"Data were summarized by treatment and age group (grouped by baseline age for analysis).~In contrast with what was previously reported in the interim results posting, 1 participant met the primary safety endpoint of at least a 6% decrease from baseline in spine BMD at Week 72, based on the final BMD data analysis. The apparent discrepancy was due to the correction factor applied to the subject-specific BMD calculations performed at the time of the Interim Week 72 clinical study report that could not take into account the actual Week 72 phantom data (ie, calibration test used in longitudinal clinical trials to monitor and adjust for shifts in the dual-energy x-ray absorptiometry (DXA) scanner calibration over time), which were not provided by the site at that time. The correction factor applied to the final analysis has been properly based on all phantom data through the end of Week 72, as well as through the end of Week 192." (NCT00734162)
Timeframe: Baseline to Week 72
Intervention | percentage of participants (Number) |
---|
TDF 12-14 Years | 0 |
TDF 15-17 Years | 2.4 |
Placebo 12-14 Years | 0 |
Placebo 15-17 Years | 0 |
Total TDF 12-17 Years | 1.9 |
Total Placebo 12-17 Years | 0 |
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Percent Change From Baseline in Whole Body BMD at Week 96
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 8.034 |
TDF 15-17 Years | 3.023 |
Placebo 12-14 Years | 10.056 |
Placebo 15-17 Years | 4.291 |
Total TDF 12-17 Years | 3.943 |
Total Placebo 12-17 Years | 5.675 |
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Percent Change From Baseline in Whole Body BMD at Week 72
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 7.282 |
TDF 15-17 Years | 2.141 |
Placebo 12-14 Years | 8.480 |
Placebo 15-17 Years | 4.335 |
Total TDF 12-17 Years | 3.067 |
Total Placebo 12-17 Years | 5.391 |
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Percent Change From Baseline in Whole Body BMD at Week 48
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 5.123 |
TDF 15-17 Years | 1.339 |
Placebo 12-14 Years | 5.470 |
Placebo 15-17 Years | 3.236 |
Total TDF 12-17 Years | 2.048 |
Total Placebo 12-17 Years | 3.817 |
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Percent Change From Baseline in Whole Body BMD at Week 192
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 13.923 |
TDF 15-17 Years | 4.295 |
Placebo 12-14 Years | 14.797 |
Placebo 15-17 Years | 4.549 |
Total TDF 12-17 Years | 6.086 |
Total Placebo 12-17 Years | 7.223 |
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Percentage of Participants With HBV DNA < 400 Copies/mL and Normal ALT at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 46.2 | 53.8 | 69.2 |
,Placebo 15-17 Years | 0 | 0 | 51.2 | 68.3 | 63.4 |
,TDF 12-14 Years | 70.0 | 80.0 | 80.0 | 60.0 | 80.0 |
,TDF 15-17 Years | 69.0 | 69.0 | 73.8 | 69.0 | 64.3 |
,Total Placebo 12-17 Years | 0 | 0 | 50.0 | 64.8 | 64.8 |
,Total TDF 12-17 Years | 69.2 | 71.2 | 75.0 | 67.3 | 67.3 |
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Percent Change From Baseline in Whole Body BMD at Week 144
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 10.940 |
TDF 15-17 Years | 3.529 |
Placebo 12-14 Years | 12.638 |
Placebo 15-17 Years | 4.730 |
Total TDF 12-17 Years | 4.949 |
Total Placebo 12-17 Years | 6.505 |
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Percent Change From Baseline in Spine Bone Mineral Density (BMD) at Week 48
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 9.234 |
TDF 15-17 Years | 2.114 |
Placebo 12-14 Years | 9.038 |
Placebo 15-17 Years | 4.435 |
Total TDF 12-17 Years | 3.510 |
Total Placebo 12-17 Years | 5.562 |
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Percent Change From Baseline in Spine BMD at Week 96
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 13.811 |
TDF 15-17 Years | 4.196 |
Placebo 12-14 Years | 16.687 |
Placebo 15-17 Years | 4.272 |
Total TDF 12-17 Years | 6.119 |
Total Placebo 12-17 Years | 7.003 |
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Percent Change From Baseline in Spine BMD at Week 72
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 11.516 |
TDF 15-17 Years | 3.589 |
Placebo 12-14 Years | 14.131 |
Placebo 15-17 Years | 6.117 |
Total TDF 12-17 Years | 5.144 |
Total Placebo 12-17 Years | 8.080 |
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Percent Change From Baseline in Spine BMD at Week 192
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 23.933 |
TDF 15-17 Years | 6.673 |
Placebo 12-14 Years | 25.036 |
Placebo 15-17 Years | 6.867 |
Total TDF 12-17 Years | 10.050 |
Total Placebo 12-17 Years | 11.212 |
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Percent Change From Baseline in Spine BMD at Week 144
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144
Intervention | percentage change (Mean) |
---|
TDF 12-14 Years | 19.224 |
TDF 15-17 Years | 5.289 |
Placebo 12-14 Years | 21.346 |
Placebo 15-17 Years | 6.144 |
Total TDF 12-17 Years | 8.133 |
Total Placebo 12-17 Years | 9.311 |
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Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 53.8 | 69.2 | 76.9 |
,Placebo 15-17 Years | 0 | 68.3 | 85.4 | 73.2 |
,TDF 12-14 Years | 90.0 | 90.0 | 100.0 | 90.0 |
,TDF 15-17 Years | 85.7 | 88.1 | 90.5 | 85.7 |
,Total Placebo 12-17 Years | 0 | 64.8 | 81.5 | 74.1 |
,Total TDF 12-17 Years | 86.5 | 88.5 | 92.3 | 86.5 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis), using the M = F. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,Placebo 15-17 Years | 0 | 0 | 0 | 0 | 0 |
,TDF 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,TDF 15-17 Years | 0 | 2.4 | 2.4 | 2.4 | 2.4 |
,Total Placebo 12-17 Years | 0 | 0 | 0 | 0 | 0 |
,Total TDF 12-17 Years | 0 | 1.9 | 1.9 | 1.9 | 1.9 |
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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 30.8 | 30.8 | 69.2 | 69.2 | 84.6 |
,Placebo 15-17 Years | 26.8 | 41.5 | 65.9 | 75.6 | 75.6 |
,TDF 12-14 Years | 70.0 | 80.0 | 80.0 | 60.0 | 80.0 |
,TDF 15-17 Years | 76.2 | 76.2 | 76.2 | 71.4 | 71.4 |
,Total Placebo 12-17 Years | 27.8 | 38.9 | 66.7 | 74.1 | 77.8 |
,Total TDF 12-17 Years | 75.0 | 76.9 | 76.9 | 69.2 | 73.1 |
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Change From Baseline in Z-score for Whole Body BMD at Week 96
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.12 |
TDF 15-17 Years | -0.19 |
Placebo 12-14 Years | 0.09 |
Placebo 15-17 Years | -0.06 |
Total TDF 12-17 Years | -0.18 |
Total Placebo 12-17 Years | -0.03 |
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Change From Baseline in Z-score for Whole Body BMD at Week 72
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | 0.02 |
TDF 15-17 Years | -0.19 |
Placebo 12-14 Years | 0.20 |
Placebo 15-17 Years | 0.06 |
Total TDF 12-17 Years | -0.16 |
Total Placebo 12-17 Years | 0.09 |
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Change From Baseline in Z-score for Whole Body BMD at Week 48
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | 0.02 |
TDF 15-17 Years | -0.15 |
Placebo 12-14 Years | 0.10 |
Placebo 15-17 Years | 0.04 |
Total TDF 12-17 Years | -0.12 |
Total Placebo 12-17 Years | 0.05 |
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Change From Baseline in Z-score for Whole Body BMD at Week 144
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.27 |
TDF 15-17 Years | -0.21 |
Placebo 12-14 Years | -0.06 |
Placebo 15-17 Years | -0.16 |
Total TDF 12-17 Years | -0.22 |
Total Placebo 12-17 Years | -0.14 |
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Change From Baseline in Z-score for Spine BMD at Week 96
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 96
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.19 |
TDF 15-17 Years | -0.07 |
Placebo 12-14 Years | -0.02 |
Placebo 15-17 Years | -0.13 |
Total TDF 12-17 Years | -0.10 |
Total Placebo 12-17 Years | -0.11 |
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Number of Participants With Changes in Drug-Resistant Mutations During the Study
The number of participants with changes in drug-resistant mutations during the study was summarized. (NCT00734162)
Timeframe: Baseline through Week 192
Intervention | participants (Number) |
---|
| New TDF Drug-Resistant Mutations | Enrichment of TDF Drug-Resistant Mutations |
---|
Total Placebo 12-17 Years | 0 | 0 |
,Total TDF 12-17 Years | 0 | 0 |
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Change From Baseline in Z-score for Spine BMD at Week 72
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 72
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.10 |
TDF 15-17 Years | -0.05 |
Placebo 12-14 Years | 0.09 |
Placebo 15-17 Years | 0.10 |
Total TDF 12-17 Years | -0.06 |
Total Placebo 12-17 Years | 0.10 |
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Change From Baseline in Z-score for Spine BMD at Week 48
To assess any effect of treatment on growth, Z-scores were used to express the deviation from a reference population for lumbar spine BMD. A Z-score of 0 indicated that a subject was typical of the population for their age, ethnicity, and gender. A negative Z-score indicated that the subject's recorded value was lower than typical for their age, ethnicity, and gender. A positive Z-score indicates that the subject's recorded value was higher than typical for their age, ethnicity, and gender. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 48
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | 0.02 |
TDF 15-17 Years | -0.10 |
Placebo 12-14 Years | 0.04 |
Placebo 15-17 Years | 0.05 |
Total TDF 12-17 Years | -0.08 |
Total Placebo 12-17 Years | 0.05 |
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Change From Baseline in Z-score for Spine BMD at Week 192
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 192
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.24 |
TDF 15-17 Years | 0.08 |
Placebo 12-14 Years | -0.26 |
Placebo 15-17 Years | -0.05 |
Total TDF 12-17 Years | 0.02 |
Total Placebo 12-17 Years | -0.10 |
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Change From Baseline in Z-score for Spine BMD at Week 144
Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Week 144
Intervention | z-score (Mean) |
---|
TDF 12-14 Years | -0.20 |
TDF 15-17 Years | -0.05 |
Placebo 12-14 Years | -0.16 |
Placebo 15-17 Years | -0.04 |
Total TDF 12-17 Years | -0.08 |
Total Placebo 12-17 Years | -0.06 |
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Percentage of Participants With at Least a 6% Decrease From Baseline in Whole Body BMD at Weeks 48, 72, 96, 144, and 192
The percentage of participants reported is the cumulative incidence from baseline to the respective time point. Data were summarized by treatment and age group (grouped by baseline age for analysis). (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,Placebo 15-17 Years | 0 | 0 | 0 | 2.4 | 2.4 |
,TDF 12-14 Years | 0 | 0 | 0 | 0 | 0 |
,TDF 15-17 Years | 0 | 0 | 0 | 0 | 0 |
,Total Placebo 12-17 Years | 0 | 0 | 0 | 1.9 | 1.9 |
,Total TDF 12-17 Years | 0 | 0 | 0 | 0 | 0 |
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Percentage of Participants Who Were HBeAg-Positive With Abnormal ALT at Baseline Who Had HBV DNA < 400 Copies/mL, Normalized ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 33.3 | 55.6 | 55.6 |
,Placebo 15-17 Years | 0 | 0 | 24.2 | 27.3 | 27.3 |
,TDF 12-14 Years | 16.7 | 16.7 | 50.0 | 33.3 | 50.0 |
,TDF 15-17 Years | 18.5 | 22.2 | 33.3 | 29.6 | 29.6 |
,Total Placebo 12-17 Years | 0 | 0 | 26.2 | 33.3 | 33.3 |
,Total TDF 12-17 Years | 18.2 | 21.2 | 36.4 | 30.3 | 33.3 |
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Percentage of Participants Who Were HBeAg-Positive at Baseline Who Had HBV DNA < 400 Copies/mL, Normal ALT, and HBeAg Loss/Seroconversion at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 0 | 0 | 30.8 | 46.2 | 46.2 |
,Placebo 15-17 Years | 0 | 0 | 22.9 | 25.7 | 25.7 |
,TDF 12-14 Years | 11.1 | 11.1 | 44.4 | 22.2 | 33.3 |
,TDF 15-17 Years | 12.8 | 15.4 | 28.2 | 30.8 | 28.2 |
,Total Placebo 12-17 Years | 0 | 0 | 25.0 | 31.3 | 31.3 |
,Total TDF 12-17 Years | 12.5 | 14.6 | 31.3 | 29.2 | 29.2 |
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Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Seroconversion at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 7.7 | 23.1 | 38.5 | 53.8 | 53.8 |
,Placebo 15-17 Years | 8.6 | 11.4 | 25.7 | 34.3 | 37.1 |
,TDF 12-14 Years | 11.1 | 11.1 | 44.4 | 33.3 | 33.3 |
,TDF 15-17 Years | 15.4 | 23.1 | 30.8 | 38.5 | 38.5 |
,Total Placebo 12-17 Years | 8.3 | 14.6 | 29.2 | 39.6 | 41.7 |
,Total TDF 12-17 Years | 14.6 | 20.8 | 33.3 | 37.5 | 37.5 |
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Percentage of Participants Who Were HBeAg-Positive at Baseline and Who Had HBeAg Loss at Weeks 48, 72, 96, 144, and 192
Data were summarized by treatment and age group (grouped by baseline age for analysis) using the missing = failure method. (NCT00734162)
Timeframe: Baseline; Weeks 48, 72, 96, 144, and 192
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 72 | Week 96 | Week 144 | Week 192 |
---|
Placebo 12-14 Years | 7.7 | 23.1 | 38.5 | 53.8 | 53.8 |
,Placebo 15-17 Years | 8.6 | 11.4 | 28.6 | 34.3 | 37.1 |
,TDF 12-14 Years | 11.1 | 11.1 | 44.4 | 44.4 | 33.3 |
,TDF 15-17 Years | 17.9 | 23.1 | 30.8 | 38.5 | 43.6 |
,Total Placebo 12-17 Years | 8.3 | 14.6 | 31.3 | 39.6 | 41.7 |
,Total TDF 12-17 Years | 16.7 | 20.8 | 33.3 | 39.6 | 41.7 |
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Mean Hematocrit Between Treatment Groups at 2 Months
Mean hematocrit of all subjects at 2 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 2 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 41.5 |
Efavirenz Plus Truvada | 41.8 |
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Mean CD4 Count Between Treatment Groups at 4 Months
Mean CD4 count between groups 4 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 4 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 617.2 |
Efavirenz Plus Truvada | 646.5 |
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Mean CD4 Count Between Treatment Groups at 5 Months
Mean CD4 count between groups 5 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 5 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 805.7 |
Efavirenz Plus Truvada | 539.6 |
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Mean Hematocrit Between Treatment Groups at 4 Months
Mean hematocrit of all subjects at 4 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 4 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 41.4 |
Efavirenz Plus Truvada | 43 |
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Mean CD4 Count Between Treatment Groups at 6 Months
Mean CD4 count between groups 6 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 6 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 652.2 |
Efavirenz Plus Truvada | 673.5 |
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Mean CD4 Count Between Treatment Groups at 7 Months
Mean CD4 count between groups 7 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 7 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 504 |
Efavirenz Plus Truvada | 552.5 |
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Mean Hematocrit Between Treatment Groups at 6 Months
Mean hematocrit of all subjects at 6 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 6 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 42.1 |
Efavirenz Plus Truvada | 39.8 |
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Mean White Blood Cell Count Between Treatment Groups at 8 Months
Mean WBC count of all subjects as determined by standard lab procedures at 8 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 8 months after baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 6240 |
Efavirenz Plus Truvada | 4607 |
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Mean White Blood Cell Count Between Treatment Groups at 6 Months
Mean WBC count of all subjects as determined by standard lab procedures at 6 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 6 months after baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 5219 |
Efavirenz Plus Truvada | 4522 |
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Mean CD4 Count Between Treatment Groups at 8 Months
Mean CD4 count between groups 8 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 8 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 464.5 |
Efavirenz Plus Truvada | 586.5 |
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Mean White Blood Cell Count Between Treatment Groups at 4 Months
Mean WBC count of all subjects as determined by standard lab procedures at 4 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 4 months post baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 5850 |
Efavirenz Plus Truvada | 4948 |
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Mean CD4 Count Between Treatment Groups at 2 Months
Mean CD4 count between groups 2 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 2 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 703.1 |
Efavirenz Plus Truvada | 527.2 |
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Mean White Blood Cell Count Between Treatment Groups at 14 Months
Mean WBC count of all subjects as determined by standard lab procedures at 14 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 14 months after baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 3180 |
Efavirenz Plus Truvada | 4903 |
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Mean CD4 Count Between Treatment Groups at 9 Months
Mean CD4 count between groups 9 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 9 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 306 |
Efavirenz Plus Truvada | 571 |
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Mean Hematocrit Between Treatment Groups at 10 Months
Mean hematocrit of all subjects at 10 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 10 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 45 |
Efavirenz Plus Truvada | 38 |
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Mean CD4 Count Between Treatment Groups at 11 Months
Mean CD4 count between groups 11 months after of starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 11 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 495 |
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Mean CD4 Count Between Treatment Groups at 10 Months
Mean CD4 count between groups 10 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 10 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 469 |
Efavirenz Plus Truvada | 571.5 |
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Mean CD4 Count Between Treatment Groups at 1 Months
Mean CD4 count between groups 1 month after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 1 month after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 629.1 |
Efavirenz Plus Truvada | 535 |
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Mean Platelet Count Between Treatment Groups at 10 Months
The mean platelet count between treatment groups at 10 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 10 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 193500 |
Efavirenz Plus Truvada | 243300 |
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Mean Platelet Count Between Treatment Groups at 12 Months
The mean platelet count between treatment groups at 12 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 12 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 255600 |
Efavirenz Plus Truvada | 185500 |
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Mean Platelet Count Between Treatment Groups at 14 Months
The mean platelet count between treatment groups at 14 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 217400 |
Efavirenz Plus Truvada | 216800 |
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Mean CD4 Count Between Treatment Groups at 3 Months
Mean CD4 count between groups 3 months after starting study drug. CD4 cells are types of white blood cells called T lymphocytes or T cells that fight infection. CD4 counts are most often used to evaluate the immune system of a person diagnosed with a human immunodeficiency virus (HIV) infection to help stage and monitor progression of the disease and monitor effectiveness of antiretroviral treatment. A CD4 count is typically reported as an absolute level or count of cells (expressed as cells per cubic millimeter of blood). A normal CD4 count ranges from 410-1,590 cells/mm3 in adults and teens. Sometimes results are expressed as a percent of total lymphocytes (CD4 percent). (NCT00734344)
Timeframe: 3 months after baseline
Intervention | cells/mm3 (Mean) |
---|
Raltegravir Plus Truvada | 716.4 |
Efavirenz Plus Truvada | 671.7 |
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Mean Platelet Count Between Treatment Groups at 2 Months
The mean platelet count between treament groups at 2 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 100 per liter). (NCT00734344)
Timeframe: 2 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 232600 |
Efavirenz Plus Truvada | 225600 |
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Mean Hematocrit Between Treatment Groups at 8 Months
Mean hematocrit of all subjects at 8 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 8 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 40.3 |
Efavirenz Plus Truvada | 41.2 |
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Mean Platelet Count Between Treatment Groups at 4 Months
The mean platelet count between treatment groups at 4 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 4 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 210800 |
Efavirenz Plus Truvada | 197300 |
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Mean Platelet Count Between Treatment Groups at 6 Months
The mean platelet count between treatment groups at 6 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 6 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 230000 |
Efavirenz Plus Truvada | 224800 |
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Mean Platelet Count Between Treatment Groups at 8 Months
The mean platelet count between treatment groups at 8 months after starting study drug. The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter (cmm) of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels. Platelet counts are usually done by laboratory machines that also count other blood elements such as the white and red cells. They can also be counted by use of a microscope. Normal platelet counts are in the range of 150,000 to 400,000 per microliter (or 150 - 400 x 109 per liter). (NCT00734344)
Timeframe: 8 months after baseline
Intervention | count per microliter (Mean) |
---|
Raltegravir Plus Truvada | 215700 |
Efavirenz Plus Truvada | 208100 |
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Mean White Blood Cell Count Between Treatment Groups at 10 Months
Mean WBC count of all subjects as determined by standard lab procedures at 10 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 10 months after baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 5230 |
Efavirenz Plus Truvada | 4615 |
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Mean White Blood Cell Count Between Treatment Groups at 12 Months
Mean WBC count of all subjects as determined by standard lab procedures at 12 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: 12 months after baseline
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 6320 |
Efavirenz Plus Truvada | 4868 |
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Mean Hematocrit Between Treatment Groups at 12 Months
Mean hematocrit of all subjects at 12 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 12 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 41 |
Efavirenz Plus Truvada | 43.5 |
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Mean Hematocrit Between Treatment Groups at 14 Months
Mean hematocrit of all subjects at 14 months after starting study drug. The hematocrit, also known as packed cell volume (PCV) or erythrocyte volume fraction (EVF), is the volume percentage (%) of red blood cells in blood. It is normally 45% for men and 40% for women. (NCT00734344)
Timeframe: 14 months after baseline
Intervention | percentage (Mean) |
---|
Raltegravir Plus Truvada | 36 |
Efavirenz Plus Truvada | 39.7 |
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Mean White Blood Cell Count Between Treatment Groups at 2 Months
Mean WBC count for all subjects as determined by standard lab procedures at 2 months after starting study drug as well as range. The normal number of WBCs in the blood is 4,500-10,000 white blood cells per microliter (mcL). (NCT00734344)
Timeframe: baseline to 2 months
Intervention | white blood cells per microliter (mcL). (Mean) |
---|
Raltegravir Plus Truvada | 5904 |
Efavirenz Plus Truvada | 4918 |
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Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48
Blood samples from study participants were collected for measuring HBV DNA via PCR method. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
Tenofovir DF | 73 |
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Summary of Resistance Surveillance for Participants Without Virologic Breakthrough
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| No changes in HBV pol/RT | Changes at polymorphic sites | Changes at conserved sites | Unable to genotype |
---|
Tenofovir DF | 6 | 1 | 2 | 1 |
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Summary of Resistance Surveillance for Participants With Virologic Breakthrough
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| No changes in HBV pol/RT | Changes at polymorphic sites | Changes at conserved sites | Unable to genotype |
---|
Tenofovir DF | 2 | 0 | 0 | 0 |
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Summary of Resistance Surveillance for Participants Who Discontinued the Study Early
Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| No changes in HBV pol/RT | Changes at polymorphic sites | Changes at conserved sites | Unable to genotype |
---|
Tenofovir DF | 1 | 0 | 0 | 1 |
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Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion
HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| HBsAg+ at baseline | HBsAg- at baseline | HBsAg+ at Week 48 | HBsAg data missing at Week 48 | HBeAg+ at baseline | HBeAg- at baseline | HBeAg loss by Week 48 | Anti-HBe+ seroconversion by Week 48 |
---|
Tenofovir DF | 90 | 0 | 88 | 2 | 53 | 37 | 6 | 6 |
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Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL)
Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
Tenofovir DF | 74 |
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Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48
Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
Tenofovir DF | 55 |
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Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48
A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L) (NCT00736190)
Timeframe: Week 48
Intervention | participants (Number) |
---|
Tenofovir DF | 40 |
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Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48
Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48 (NCT00736190)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
Tenofovir DF | 59 |
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Change From Baseline in FibroTest Value
The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. (NCT00736190)
Timeframe: Baseline and Week 48
Intervention | Scores on a scale (Mean) |
---|
Tenofovir DF | -0.006 |
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To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary. (NCT00752856)
Timeframe: Baseline, days 2, 7, 10, 14
Intervention | log(10)/day (Median) |
---|
1 - Kaletra + Isentress Taken Twice Daily | 0.47 |
2 - Atripla Taken Once Daily | 0.55 |
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Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48
To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: 48 weeks
Intervention | cells/mm^3 (Mean) |
---|
1 - Kaletra + Isentress Taken Twice Daily | -2.24 |
2 - Atripla Taken Once Daily | -5.65 |
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Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.
To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: Baseline to Week 4
Intervention | cells/mm^3 (Mean) |
---|
1 - Kaletra + Isentress Taken Twice Daily | -3.81 |
2 - Atripla Taken Once Daily | -1.18 |
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Viral Suppression Efficacy at 48 Weeks
To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load (NCT00752856)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
1 - Kaletra + Isentress Taken Twice Daily | 86 |
2 - Atripla Taken Once Daily | 87.5 |
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Change From Baseline in Glucose at Week 12 and 48.
Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=33,30) | Change at Week 12 (n=30,29) | Change at Week 48 (n=28,24) |
---|
Atazanavir | 89.7 | 5.8 | 6.4 |
,Darunavir | 88.5 | 1.5 | 2.8 |
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Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n= 28, 27) | Change at Week 12 (n= 27, 27) | Change at Week 48 (n= 26, 22) |
---|
Atazanavir | 165.1 | 4.6 | 11.8 |
,Darunavir | 141.8 | 20.3 | 22.3 |
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Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance). (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | HOMA-IR score (Mean) |
---|
| Baseline (n=27,22) | Change at Week 12 (n=20,21) | Change at Week 48 (n=19,14) |
---|
Atazanavir | 2.943 | 0.105 | -1.236 |
,Darunavir | 1.624 | -0.483 | 0.035 |
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Change From Baseline in Insulin at Week 12 and 48.
Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | IU/mL (Mean) |
---|
| Baseline (n=33,30) | Change at Week 12 (n=30,29) | Change at Week 48 (n=28,24) |
---|
Atazanavir | 8.59 | 0.70 | -2.88 |
,Darunavir | 5.96 | -1.07 | 0.95 |
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Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | cells/uL (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=34,31) | Change at Week 48 (n=34,31) |
---|
Atazanavir | 326.7 | 74.6 | 187.7 |
,Darunavir | 268.3 | 103.4 | 194.9 |
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Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | Log10 HIV RNA (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,30) | Change at Week 48 (n=29,24) |
---|
Atazanavir | 4.562 | -2.605 | -2.902 |
,Darunavir | 5.016 | -2.955 | -3.269 |
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Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 45.0 | 2.2 | 3.7 |
,Darunavir | 37.9 | 6.6 | 6.0 |
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Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Observed values. (NCT00757783)
Timeframe: Baseline, Week 12
Intervention | milligram per deciliters (mg/dL) (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) |
---|
Atazanavir | 114.2 | 8.1 |
,Darunavir | 113.7 | 22.0 |
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Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | cells/micro L (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,29) | Change at Week 48 (n=29,25) |
---|
Atazanavir | 326.7 | 68.3 | 205.3 |
,Darunavir | 268.3 | 111.1 | 217.4 |
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Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | g/L (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 0.8 | -0.05 | 0.0 |
,Darunavir | 0.7 | -0.004 | 0.0 |
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Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | grams per liters (g/L) (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 1.3 | -0.007 | 0.0 |
,Darunavir | 1.1 | 0.1 | 0.1 |
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Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL. (NCT00757783)
Timeframe: Week 12 and 48
Intervention | number of participants (Number) |
---|
| Week12: HIV-1 RNA Less Than (<) 50 copies/mL | Week 12: HIV-1 RNA < 400 copies/mL | Week 48: HIV-1 RNA < 50 copies/mL | Week 48: HIV-1 RNA < 400 copies/mL |
---|
Atazanavir | 19 | 29 | 22 | 24 |
,Darunavir | 13 | 28 | 25 | 28 |
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Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=28, 27) | Change at Week 12 (n=27, 27) | Change at Week 48 (n=26, 22) |
---|
Atazanavir | 100.2 | 9.6 | 13.9 |
,Darunavir | 84.6 | 13.6 | 14.7 |
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Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed. (NCT00757783)
Timeframe: Week 12 and 48
Intervention | number of participants (Number) |
---|
| Week 12: HIV-1 RNA Less Than (<) 50 copies/mL | Week 12: HIV-1 RNA < 400 copies/mL | Week 48: HIV-1 RNA < 50 copies/mL | Week 48: HIV-1 RNA < 400 copies/mL |
---|
Atazanavir | 19 | 28 | 22 | 24 |
,Darunavir | 13 | 28 | 25 | 28 |
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Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | percentage of CD4 cells (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,30) | Change at Week 48 (n=29,25) |
---|
Atazanavir | 21.4 | 4.5 | 8.5 |
,Darunavir | 18.6 | 5.9 | 9.6 |
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Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | ratio (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 3.9 | -0.1 | -0.1 |
,Darunavir | 4.1 | -0.1 | 0.1 |
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Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | pg/mL (Mean) |
---|
Raltegravir | -2.71 |
Atazanavir | -4.47 |
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Change From Baseline in Homocysteine at 6 Months
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | umol/L (Mean) |
---|
Raltegravir | 0.53 |
Atazanavir | 0.10 |
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Change From Baseline in CD4 Count at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | cells/uL (Mean) |
---|
Raltegravir | 192 |
Atazanavir | 205 |
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Change From Baseline in Lipids at 48 Weeks
(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 |
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Change From Baseline in Log HIV Viral Load at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | copies/mL (Mean) |
---|
Raltegravir | -3.05 |
Atazanavir | -3.29 |
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Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)
Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Hyperkalemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperclycemia | Hypoglycemia | Creatine kinase | Albumin |
---|
Atazanavir + Raltegravir | 2 | 1 | 0 | 3 | 8 | 6 | 21 | 3 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 | 1 | 0 | 1 | 5 | 4 | 7 | 2 |
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Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 3506.5 |
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Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Hematocrit | Hemoglobin | Platelets | Prothrombin Time | White Blood Cells |
---|
Atazanavir + Raltegravir | 1 | 2 | 1 | 12 | 22 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 1 | 7 | 14 |
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Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed (NCT00768989)
Timeframe: At Week 24 from Baseline
Intervention | Participants (Number) |
---|
| NC=F (n= 63, 30) | NC=M (n=58, 27) | VR-OC (n=52, 25) |
---|
Atazanavir + Raltegravir | 52 | 52 | 46 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 26 | 26 | 24 |
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Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC). (NCT00768989)
Timeframe: At Week 24 from Baseline
Intervention | Participants (Number) |
---|
| NC=F (n=63, 30) | NC=M (n=58, 27) | VR-OC (n=52, 25) |
---|
Atazanavir + Raltegravir | 47 | 47 | 41 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 19 | 19 | 19 |
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Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 687.1 |
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Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Geometric Mean) |
---|
Atazanavir + Raltegravir | 3.0 |
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Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Total Bilirubin | AST/SGOT | ALT/ SGPT | Lipase | Proteinurea | Creatine kinase |
---|
Atazanavir + Raltegravir | 62 | 11 | 10 | 11 | 14 | 21 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 28 | 8 | 8 | 13 | 11 | 7 |
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Atazanavir Terminal Elimination Half Life
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Mean) |
---|
Atazanavir + Raltegravir | 5.0 |
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Atazanavir Individual Inhibitory Quotient (IQ)
Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Units on a Scale (Geometric Mean) |
---|
Atazanavir + Raltegravir | 23.47 |
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Raltegravir Cmin 12 Hours Postdose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 76.2 |
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Raltegravir Cmax in 1 Dosing Interval
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 1577.0 |
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Raltegravir AUC (0-12h) in 1 Dosing Interval
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 6446.4 |
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Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases. (NCT00768989)
Timeframe: At Weeks 48 and 96 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 37 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 19 |
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Atazanavir Cmin Prior to the Morning Dose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng*h / mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 879.25 |
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Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval
AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 39806.7 |
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Raltegravir Cmin Prior to the Morning Dose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 445.42 |
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Raltegravir Terminal Elimination Half Life
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Mean) |
---|
Atazanavir + Raltegravir | 2.9 |
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Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 19903.4 |
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Raltegravir Tmax
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Geometric Mean) |
---|
Atazanavir + Raltegravir | 2.08 |
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Baseline and Mean Change From Baseline in Total Cholesterol Levels
The mean change from baseline in participant fasting lipids was determined using fasting serum samples. (NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=56, 26) | Mean change from Baseline at Week 24 (n=51, 20) | Mean change from Baseline at Week 48 (n=38, 20) |
---|
Atazanavir + Raltegravir | 164.6 | 14.7 | 18.0 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 169.6 | 15.1 | 17.1 |
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Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Blood urea nitrogen | Creatinine | Hypercarbia | Hypocarbia | Hypercalcemia | Hypocalcemia | Hyperchloremia | Hypochloremia | Hyperkalemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperclycemia | Hypoglycemia |
---|
Atazanavir + Raltegravir | 0 | 3 | 1 | 15 | 2 | 1 | 0 | 1 | 2 | 6 | 0 | 3 | 8 | 6 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 | 2 | 1 | 7 | 1 | 1 | 0 | 1 | 0 | 5 | 0 | 1 | 5 | 4 |
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Mean Change From Baseline in Electrocardiogram Findings
The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24. (NCT00768989)
Timeframe: From Baseline to Week 24
Intervention | msec (Mean) |
---|
| QRS Interval | QTc Friderica Interval | PR Interval |
---|
Atazanavir + Raltegravir | 8.9 | -2.7 | 17.6 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 3.6 | 6.0 | 4.9 |
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Mean Change From Baseline in Total Bilirubin Level
(NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48
Intervention | mg/dL (Mean) |
---|
| Mean change from Baseline at Week 24 | Mean change from Baseline at Week 48 |
---|
Atazanavir + Raltegravir | 2.15 | 2.08 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1.71 | 1.52 |
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Number of Nonresponders at Week 8
Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL. (NCT00768989)
Timeframe: At Week 8 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 0 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 |
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Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
(NCT00768989)
Timeframe: At Week 48 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 45 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 25 |
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation
AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event. (NCT00768989)
Timeframe: Week 1 to Week 96, continuously
Intervention | Participants (Number) |
---|
| AEs | SAEs | Deaths | AEs leading to discontinuation | SAEs leading to discontinuation |
---|
Atazanavir + Raltegravir | 60 | 7 | 0 | 4 | 1 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 29 | 2 | 0 | 1 | 0 |
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Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
(NCT00768989)
Timeframe: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24
Intervention | cells/mm^3 (Mean) |
---|
| Mean change from Baseline at Week 2 (n=59, 26) | Mean change from Baseline at Week 4 (n=62, 27) | Mean change from Baseline at Week 8 (n=60, 29) | Mean change from Baseline at Week 12 (n=62, 28) | Mean change from Baseline at Week 16 (n=58, 27) | Mean change from Baseline at Week 20 (n=58, 24) | Mean change from Baseline at Week 24 (n=55, 24) |
---|
Atazanavir + Raltegravir | 81.1 | 82.7 | 111.5 | 128.6 | 143.6 | 166.5 | 166.0 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 63.1 | 100.1 | 111.9 | 129.3 | 127.6 | 140.7 | 127.0 |
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Percentage of Patients Who Are Polymerase Chain Reaction(PCR)Negative at Week 12
Polymerase Chain Reaction (PCR) Negative is defined as HBV DNA levels <25 copies/ml. (NCT00805675)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
Telbivudine 600 mg Monotherapy | 0.0 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 0.0 |
Telbivudine 600 mg and Tenofovir 300 mg | 0.0 |
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Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Weeks 2, 4 and 8.
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay. (NCT00805675)
Timeframe: Baseline, Week 2, Week 4, Week 8
Intervention | log10 copies/mL (Mean) |
---|
| Week 2 | Week 4 | Week 8 |
---|
Telbivudine 600 mg and Tenofovir 300 mg | -2.689 | -3.225 | -3.845 |
,Telbivudine 600 mg Monotherapy | -2.657 | -2.985 | -3.474 |
,Tenofovir Disproxil Fumarate 300 mg Monotherapy | -2.541 | -3.060 | -3.621 |
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Characterization of Very Early Viral Kinetics Through Efficiency Factor of Blocking Virus Production.
"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t) I(t) (1 ) (T I(t))V(t) I(t) where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise allinfected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12
Intervention | Percentage (Mean) |
---|
Telbivudine 600 mg Monotherapy | 98.8 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 99.0 |
Telbivudine 600 mg and Tenofovir 300 mg | 99.1 |
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"Percentage of Patients Who Achieve Hepatitis B e Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 12"
"HBeAg loss is defined as the loss of detectable serum HBeAg in a patient who was HBeAg positive at baseline. HBeAg seroconversion is defined as HBeAg loss with detectable Hepatitis B 'e' antibody (HBeAb). HBeAg stands for hepatitis B e antigen. This antigen is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the person is infectious and is able to spread the virus to other people." (NCT00805675)
Timeframe: Week 12
Intervention | Percentage of Participants (Number) |
---|
Telbivudine 600 mg Monotherapy | 0 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 0 |
Telbivudine 600 mg and Tenofovir 300 mg | 0 |
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Change in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12.
Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA. Serum HBV DNA determinations were performed at a central laboratory through use of the COBAS TaqMan™ HBV DNA assay (Roche Molecular Systems, Pleasanton, CA, USA) which utilized the Real-time polymerase chain reaction (PCR) method and automated extraction by Cobas Ampliprep (threshold for detection 12 IU/mL). The Screening serum HBV DNA values must be ≥ 7 log10 copies/mL by COBAS TaqMan™ HBV DNA assay. (NCT00805675)
Timeframe: Baseline, Week 12
Intervention | log10 copies/mL (Mean) |
---|
Telbivudine 600 mg Monotherapy | -3.852 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | -4.175 |
Telbivudine 600 mg and Tenofovir 300 mg | -4.374 |
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Characterization of Very Early Viral Kinetics Through Estimated Viral Load
"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12
Intervention | log10 copies/ml (Mean) |
---|
Telbivudine 600 mg Monotherapy | 8.9 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 8.7 |
Telbivudine 600 mg and Tenofovir 300 mg | 8.7 |
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Characterization of Very Early Viral Kinetics Through Half-live of Free Virus
"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12
Intervention | Hours (Mean) |
---|
Telbivudine 600 mg Monotherapy | 18.1 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 16.4 |
Telbivudine 600 mg and Tenofovir 300 mg | 18.9 |
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Characterization of Very Early Viral Kinetics Through Rate of Infected Cell Loss
"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12
Intervention | day^-1 (Mean) |
---|
Telbivudine 600 mg Monotherapy | 0.04 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 0.06 |
Telbivudine 600 mg and Tenofovir 300 mg | 0.05 |
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Characterization of Very Early Viral Kinetics Through Viral Clearance
"The underlying bi-phasic model of viral kinetics can be described as follows:~V(t) (1 )pI(t) cV(t)I(t) (1 ) (T I(t))V(t) I(t)where V denotes serum viral load, I productively infected cells, ε the efficiency factor of blocking virus production, p the viral production rate, c the viral clearance rate, η the efficiency factor of blocking de novo infection, β the de novo infection rate, Tg comprise all infected and uninfected target cells, and δ the rate of infected cell loss" (NCT00805675)
Timeframe: Week 12
Intervention | day^-1 (Mean) |
---|
Telbivudine 600 mg Monotherapy | 0.98 |
Tenofovir Disproxil Fumarate 300 mg Monotherapy | 1.19 |
Telbivudine 600 mg and Tenofovir 300 mg | 1.08 |
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Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96
"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit." (NCT00811954)
Timeframe: From study entry to week 96
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 |
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Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96
The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. (NCT00811954)
Timeframe: From study entry to week 96
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 |
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Cumulative Incidence of First Adverse Event by Week 96
"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up." (NCT00811954)
Timeframe: From study entry to week 96
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 |
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Cumulative Probability of First Virologic Failure by Week 96
"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry." (NCT00811954)
Timeframe: From study entry to week 96
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 |
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Incidence of Death or AIDS Defining Events (CDC Category C)
The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable
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 |
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Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 0 |
Arm B: RAL + FTC/TDF | 0 |
Arm C: DRV/RTV + FTC/TDF | 0 |
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Presence of Mutations Associated With INI Resistance
The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 1 |
Arm B: RAL + FTC/TDF | 1 |
Arm C: DRV/RTV + FTC/TDF | 1 |
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Presence of Mutations Associated With NRTI Resistance
The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 8 |
Arm B: RAL + FTC/TDF | 7 |
Arm C: DRV/RTV + FTC/TDF | 3 |
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Change in Waist Circumference From Baseline
Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Change in Framingham 10-year Risk of MI or Coronary Death From Baseline
"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk." (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Change in Fasting Triglycerides Level From Baseline
Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Change in Fasting Total Cholesterol Level From Baseline
Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Change in Fasting Plasma Glucose Level From Baseline
Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Change in Fasting HDL Cholesterol Level From Baseline
Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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CD4+ T-cell Count Changes From Baseline
Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count (NCT00811954)
Timeframe: Study entry to weeks 24, 48, 96, and 144
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 |
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CD4+ T-cell Count
The absolute levels of CD4+ T-cell counts (cells/mm3) (NCT00811954)
Timeframe: At Weeks 24, 48, 96, and 144
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 |
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Change in Waist:Height Ratio From Baseline
Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
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 |
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Self-reported Adherence
Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144. (NCT00811954)
Timeframe: At Weeks 4, 24, 48, 96, and 144
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 |
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Number of Participants With Phenotypic Resistance
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure
Intervention | Participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 0 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 0 |
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Time-Averaged Difference (TAD) in log10 Viral Load
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL). (NCT00827112)
Timeframe: Week 16, Week 24, Week 48, Week 96
Intervention | log10 copies/mL (Mean) |
---|
| Week 16 | Week 24 | Week 48 | Week 96 |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | -2.402 | -2.626 | -2.868 | -3.001 |
,Maraviroc+ Atazanavir / Ritonavir | -2.459 | -2.663 | -2.897 | -2.998 |
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Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Intervention | Percentage of participants (Number) |
---|
| Week 2 (n= 55, 60) | Week 4 (n= 57, 60) | Week 8 (n= 57, 59) | Week 12 (n= 55, 59) | Week 16 (n= 54, 58) | Week 20 (n= 56, 57) | Week 24 (n= 56, 58) | Week 32 (n= 55, 57) | Week 40 (n= 54, 55) | Week 48 (n= 53, 54) | Week 60 (n= 52, 53) | Week 72 (n= 52, 53) | Week 84 (n= 50, 52) | Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 6.60 | 21.30 | 42.60 | 62.30 | 73.80 | 83.61 | 88.52 | 88.52 | 88.52 | 83.61 | 85.25 | 81.97 | 83.61 | 81.97 |
,Maraviroc+ Atazanavir / Ritonavir | 0 | 8.50 | 47.50 | 61.00 | 72.90 | 71.20 | 81.36 | 79.66 | 81.36 | 74.58 | 67.80 | 74.58 | 76.27 | 67.80 |
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Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | cells/microliter (cells/mcL) (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 54, 57) | Change at Week 48 (n= 52, 53) | Change at Week 96 (n= 50, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 390.00 | 139.80 | 173.30 | 226.60 | 298.50 |
,Maraviroc+ Atazanavir / Ritonavir | 357.70 | 169.60 | 188.90 | 215.70 | 287.50 |
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Number of Participants With Genotypic Resistance
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure
Intervention | Participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 0 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 0 |
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Average Observed Plasma Concentration (Cavg) of Maraviroc
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). (NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | ng/mL (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 185.10 |
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HIV-1 RNA Levels at Baseline
(NCT00827112)
Timeframe: Baseline
Intervention | copies/mL (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 84982 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 114827 |
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Minimum Observed Plasma Concentration (Cmin) of Maraviroc
(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | ng/mL (Median) |
---|
Maraviroc+ Atazanavir / Ritonavir | 37.0 |
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Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Intervention | Percentage of participants (Number) |
---|
| Week 2 (n= 55, 60) | Week 4 (n= 57, 60) | Week 8 (n= 57, 59) | Week 12 (n= 55, 59) | Week 16 (n= 54, 58) | Week 20 (n= 56, 57) | Week 24 (n= 56, 58) | Week 32 (n= 55, 57) | Week 40 (n= 54, 55) | Week 48 (n= 53, 54) | Week 60 (n= 52, 53) | Week 72 (n= 52, 53) | Week 84 (n= 50, 52) | Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 34.43 | 52.46 | 77.05 | 88.52 | 91.80 | 93.44 | 93.44 | 93.44 | 90.16 | 86.89 | 86.89 | 85.25 | 85.25 | 83.61 |
,Maraviroc+ Atazanavir / Ritonavir | 27.12 | 50.85 | 79.66 | 89.83 | 88.14 | 89.83 | 91.53 | 89.83 | 91.53 | 89.83 | 86.44 | 86.44 | 81.36 | 77.97 |
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Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population. (NCT00827112)
Timeframe: Baseline to Week 96 or Time of treatment Failure
Intervention | Participants (Number) |
---|
| Baseline | Week 96 or Time of treatment Failure |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 61 | 0 |
,Maraviroc+ Atazanavir / Ritonavir | 60 | 0 |
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Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | log10 copies/ml (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 56, 58) | Change at Week 48 (n= 53, 54) | Change at Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 114827 | -107684.6 | -110498.1 | -115582.9 | -99662.6 |
,Maraviroc+ Atazanavir / Ritonavir | 84982 | -89859.1 | -87241.2 | -82343.4 | -80117.7 |
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Time to Loss of Virological Response (TLOVR)
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. (NCT00827112)
Timeframe: Baseline through Week 96
Intervention | Days (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 436.2 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 463.8 |
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Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only. (NCT00827112)
Timeframe: Baseline , Days 4, 7, 10 and 14
Intervention | copies/mL (Mean) |
---|
| Change at Day 4 | Change at Day 7 | Change at Day 10 | Change at Day 14 |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | -46479.40 | -52137.10 | -54925.90 | -55449.90 |
,Maraviroc+ Atazanavir / Ritonavir | 1800.00 | -36947.90 | -58595.80 | -47271.60 |
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Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
(NCT00827112)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 74.60 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 83.60 |
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Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | cells/mcL (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 54, 57) | Change at Week 48 (n= 52, 53) | Change at Week 96 (n= 50, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 1125.60 | -153.80 | -178.00 | -267.60 | -231.40 |
,Maraviroc+ Atazanavir / Ritonavir | 931.10 | 63.70 | 6.20 | -76.80 | -63.00 |
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Maximum Observed Plasma Concentration (Cmax) of Maraviroc
(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | nanogram (ng)/mL (Median) |
---|
Maraviroc+ Atazanavir / Ritonavir | 650 |
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Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
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 |
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Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
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 |
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Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. (NCT00851799)
Timeframe: Study entry, weeks 24, 48, 96 and 144
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 |
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Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
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 |
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Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, week 24
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 |
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Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
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 |
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Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. (NCT00851799)
Timeframe: Study entry, weeks 4, 24 and 48
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 |
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Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, weeks 4 and 48
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 |
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Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Percent Change in Lean Mass From Study Entry to Week 96
Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). (NCT00851799)
Timeframe: Study entry to weeks 24, 48, 96, and 144
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 |
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Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Percent Change in Total Limb Fat From Study Entry to Week 96
Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Percent Change in Trunk Fat From Study Entry to Week 96
Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Fold Change in D-dimer From Study Entry to Weeks 48 and 96
D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
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 |
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Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
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 |
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Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
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 |
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Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
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 |
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Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
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 |
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Self-reported Methamphetamine Use in Previous 30 Days.
Mean number of days (of the past 30) of methamphetamine use. (NCT00856323)
Timeframe: 3-months after baseline
Intervention | days (Mean) |
---|
PEP/CM | 1.6 |
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Post-Exposure Prophylaxis Medication Adherence
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 |
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Description of Incident STI Infections.
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 |
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Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz
The area under the concentration time curve for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days
Intervention | mg*hr/mL (Geometric Mean) |
---|
| Efavirenz AUC | Emtricitabine AUC | Tenofovir AUC |
---|
Atripla Liquid | 56.7 | 10.8 | 2.2 |
,Atripla Tablet | 58.7 | 10.9 | 1.8 |
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Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz
The maximum concentration for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days
Intervention | mg/L (Geometric Mean) |
---|
| Efavirenz Cmax | Emtricitabine Cmax | Tenofovir Cmax |
---|
Atripla Liquid | 1.3 | 2.1 | 0.2 |
,Atripla Tablet | 1.5 | 1.8 | 0.3 |
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Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 23.9 |
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Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 6.7 |
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Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing to 24 hours after dose administered
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 2.4 |
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Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing tp 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 2.2 |
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Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 7.2 |
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Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 10.2 |
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Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 11.2 |
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Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 22.4 |
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IL-10
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 |
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IL-4
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 |
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IL-6
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 |
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IL-7
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 |
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IL-8
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 |
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INF Gamma
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 |
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TNF Alpha
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 |
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Symptom Score
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 |
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SF-12 Physical Capacity Score
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 |
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SF-12 Mental Capacity Score
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 |
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IL-1 Beta
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 |
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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for AUC24hr)
The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng.h/mL (Mean) |
---|
ATV/Rtv 300/100 mg (Reference) | 74210 |
ATV/Rtv 300/100 mg (Test) | 72220 |
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Pharmacokinetic Results of Etravirine (ETR) (Results for AUC12hr)
The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the area under the plasma concentration-time curve from time of intake to 12 hours after dosing (AUC12hr). (NCT00896051)
Timeframe: Week 2
Intervention | ng.h/mL (Mean) |
---|
ATV/Rtv 300/100 mg (Treatment A) | 7629 |
ATV/Rtv 400/100 mg (Treatment B) | 5171 |
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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for AUC24hr)
The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng.h/ml (Mean) |
---|
ATV/Rtv 300/100 mg (Reference) | 12560 |
ATV/Rtv 300/100 mg (Test) | 11120 |
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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for AUC24hr)
The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng.h/ml (Mean) |
---|
ATV/Rtv 300/100 mg (Reference) | 13880 |
ATV/Rtv 300/100 mg (Test) | 13660 |
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Change From Pre-Baseline in Log10 Viral Load Over Time
The table below shows the mean change from prebaseline over time in log10 (Copies/mL) plasma viral load using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Pre-Baseline, Baseline, Weeks 4, 12, 24, 48
Intervention | log10 (Copies/mL) (Mean) |
---|
| Baseline | Week 4 | Week 12 | Week 24 | Week 48 |
---|
ATV/Rtv 300/100 mg (Treatment A) | -1.4 | -1.9 | -1.7 | -1.8 | -1.4 |
,ATV/Rtv 400/100 mg (Treatment B) | -1.4 | -1.8 | -2.0 | -1.8 | -1.4 |
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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for C0h, Cmin, and Cmax)
The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)
Intervention | ng/ml (Mean) |
---|
| C0h, ng/ml (Reference, n=21; Test, n=19) | Cmin, ng/ml (Reference, n=20; Test, n=18) | Cmax, ng/ml (Reference, n=20; Test, n=19) |
---|
ATV/Rtv 300/100 mg (Reference) | 1339 | 1104 | 5652 |
,ATV/Rtv 300/100 mg (Test) | 845.7 | 758.6 | 5232 |
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Pharmacokinetic Results of Etravirine (ETR) (Results for C0h, Cmin, and Cmax)
The table below shows pharmacokinetic (PK) results of ETR in the current study expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin) and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Week 2
Intervention | ng/ml (Mean) |
---|
| C0h (Treatment B, n=19) | Cmin (Treatment A, n=16; Treatment B, n=18) | Cmax (Treatment A, n=18; Treatment B, n=18) |
---|
ATV/Rtv 300/100 mg (Treatment A) | 422.2 | 425.1 | 773.0 |
,ATV/Rtv 400/100 mg (Treatment B) | 316.6 | 286.5 | 628.7 |
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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment A: Atazanavir (ATV)/Rtv 300/100 mg (Results for C0h, Cmin, and Cmax)
The table below shows the pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), and maximum plasma concentration (Cmax). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng/ml (Mean) |
---|
| C0h, ng/ml (Reference, n=21; Test, n=19) | Cmin, ng/ml (Reference, n=20; Test, n=18) | Cmax, ng/ml (Reference, n=20; Test, n=19) |
---|
ATV/Rtv 300/100 mg (Reference) | 143.4 | 60.42 | 1834 |
,ATV/Rtv 300/100 mg (Test) | 102.5 | 43.97 | 1740 |
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Pharmacokinetic Results of Low-Dose Ritonavir (Rtv): Treatment B: Atazanavir (ATV)/Rtv 400/100 mg (Results for C0h, Cmin, and Cmax)
The table below shows pharmacokinetic (PK) results of low-dose ritonavir (rtv) when administered as atazanavir (ATV)/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng/ml (Mean) |
---|
| C0h, ng/ml (Reference, n=22; Test, n=20) | Cmin, ng/ml | Cmax, ng/ml (Reference, n=22) |
---|
ATV/Rtv 300/100 mg (Reference) | 109.2 | 64.70 | 1882 |
,ATV/Rtv 400/100 mg (Test) | 163.4 | 75.68 | 1847 |
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The Percentage of Participants With a Virologic Response (Plasma Viral Load < 50 Copies/mL) at Week 48 Using the Snapshot Analysis Method
The table below provides the results from the snapshot analysis method that includes the percentage of participants with virologic response (<50 copies/mL), the percentage of participants who were virologic failures (VF) (>50 copies/mL, discontinued prior to time X for reasons of VF or for other reasons, except for VF or adverse event, with a last viral load >50 copies/mL), and the percentage of participants with no viral load (VL) data available at Week 48. (NCT00896051)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
| Virologic Response | Virologic Failure | No VL Data Available |
---|
ATV/Rtv 300/100 mg (Treatment A) | 50.0 | 31.8 | 18.2 |
,ATV/Rtv 400/100 mg (Treatment B) | 45.5 | 36.4 | 18.2 |
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The Percentage of Participants With a Virologic Response Using the Non-Completing = Failure (NC=F) Imputation Method
The table below shows the percentage of participants per time point with a virologic response defined as having a plasma viral load (VL) <50 copies/mL, and with plasma VL <400 copies/mL using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their Baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48
Intervention | Percentage of Participants (Number) |
---|
| <50 copies/mL, Baseline | <50 copies/mL, Week 4 | <50 copies/mL, Week 12 | <50 copies/mL, Week 24 | <50 copies/mL, Week 48 | <400 copies/mL, Baseline | <400 copies/mL, Week 4 | <400 copies/mL, Week 12 | <400 copies/mL, Week 24 | <400 copies/mL, Week 48 |
---|
ATV/Rtv 300/100 mg (Treatment A) | 9.1 | 31.8 | 59.1 | 63.6 | 50.0 | 40.9 | 77.3 | 68.2 | 72.7 | 50.0 |
,ATV/Rtv 400/100 mg (Treatment B) | 9.1 | 36.4 | 59.1 | 63.6 | 45.5 | 40.9 | 77.3 | 81.8 | 72.7 | 59.1 |
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The Percentage of Participants With a Virologic Response Using the Time to Loss of Virologic Response (TLOVR) Imputation Method
The table below shows the percentage of participants with a virologic response defined as a viral load <50 Copies/mL and <400 Copies/mL per time point calculated using the time to loss of virologic response (TLOVR) imputation method. (NCT00896051)
Timeframe: Baseline, Weeks 4, 12, 24, 48
Intervention | Percentage of Particpants (Number) |
---|
| <50 copies/mL, Baseline | <50 copies/mL, Week 4 | <50 copies/mL, Week 12 | <50 copies/mL, Week 24 | <50 copies/mL, Week 48 | <400 copies/mL, Baseline | <400 copies/mL, Week 4 | <400 copies/mL, Week 12 | <400 copies/mL, Week 24 | <400 copies/mL, Week 48 |
---|
ATV/Rtv 300/100 mg (Treatment A) | 9.1 | 31.8 | 59.1 | 63.6 | 45.5 | 36.4 | 77.3 | 68.2 | 68.2 | 59.1 |
,ATV/Rtv 400/100 mg (Treatment A) | 4.5 | 36.4 | 54.5 | 59.1 | 50.0 | 40.9 | 77.3 | 86.4 | 68.2 | 54.5 |
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Time to Confirmed Virologic Response
The table below provides the time in days it took participants to reach a confirmed virologic response defined as a plasma viral load (VL) <50 copies/mL, and plasma VL <400 copies/mL analyzed according to the Time to Loss of Virologic Response (TLOVR) imputation method. (NCT00896051)
Timeframe: Prebaseline to Week 48
Intervention | Days (Median) |
---|
| Plasma VL < 50 copies/mL | Plasma VL < 400 copies/mL |
---|
ATV/Rtv 300/100 mg (Treatment A) | 71.0 | 28.0 |
,ATV/Rtv 400/100 mg (Treatment B) | 76.0 | 28.0 |
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Time to Virologic Failure
The table below shows the number of days to virologic failure defined as a plasma viral load (VL) > 50 copies/mL for participants who had been virologic responders (ie, having a plasma VL <50, and <400 copies/mL according to the time to loss of virologic response [TLOVR] imputation method). Time to virologic failure was the time to subsequent loss of virologic response, and the time was calculated from Prebaseline (Week -2). Participants who never achieved a virologic response were defined as nonresponders and counted as virologic failures on Day 1. (NCT00896051)
Timeframe: Prebaseline to Week 48
Intervention | Days (Median) |
---|
| Virologic Responders (Plasma VL < 50 copies/mL) | Virologic Responders (Plasma VL < 400 copies/mL) |
---|
ATV/Rtv 300/100 mg (Treatment A) | 318.0 | NA |
,ATV/Rtv 400/100 mg (Treatment B) | NA | NA |
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Pharmacokinetic Results of Atazanavir (ATV): Treatment B: ATV/Low-Dose Ritonavir (Rtv) 400/100 mg (Results for C0h, Cmin, and Cmax)
The table below shows pharmacokinetic (PK) results of atazanavir (ATV) when administered as ATV/ritonavir (rtv) 300/100 mg pretreatment (Reference) and when administered as ATV/rtv 400/100 mg at Week 2 after treatment (Test). Results are expressed as the predose plasma concentration (C0h), minimum plasma concentration (Cmin), maximum plasma concentration (Cmax), and area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Reference); Week 2 (Test)
Intervention | ng/ml (Mean) |
---|
| C0h, ng/ml (Reference, n=22; Test, n=20) | Cmin, ng/ml (Reference, n=21;Test, n=18) | Cmax, ng/ml (Reference, n=22; Test, n=20) |
---|
ATV/Rtv 300/100 mg (Reference) | 1898 | 1671 | 6419 |
,ATV/Rtv 400/100 mg (Test) | 1545 | 1107 | 6950 |
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Change From Prebaseline in CD4+ Cell Count Over Time
The table below shows the mean change from prebaseline over time in CD4+ cell count using the Non-Completing = Failure (NC=F) imputation method. (NCT00896051)
Timeframe: Prebaseline, Baseline, Weeks 4, 12, 24, 48
Intervention | CD4+ cell count (Mean) |
---|
| Baseline | Week 4 | Week 12 | Week 24 | Week 48 |
---|
ATV/Rtv 300/100 mg (Treatment A) | 16 | 55 | 31 | 54 | 105 |
,ATV/Rtv 400/100 mg (Treatment B) | 8 | 46 | 72 | 83 | 132 |
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Pharmacokinetic Results of Atazanavir (ATV): Treatment A: ATV/Low-Dose Ritonavir (Rtv) 300/100 mg (Results for AUC24hr)
The table below shows pharmacokinetic (PK) results of atazanavir (ATZ) when administered as ATV/rtv 300/100 mg pretreatment (Reference) and at Week 2 after treatment (Test). Results are expressed as the area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr). (NCT00896051)
Timeframe: Day -1 (Pretreatment); Week 2 (Test)
Intervention | ng.h/mL (Mean) |
---|
ATV/Rtv 300/100 mg (Reference) | 60030 |
ATV/Rtv 300/100 mg (Test) | 55070 |
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Percentage of Participants With Undetectable Plasma Viral Load (VL) Values (<50 Copies/mL) at Week 48
The table below shows the percentage of participants wih undetectable plasma viral load (VL) values (<50 copies/mL) at Week 48 using the Non-Completing = Failure (NC=F) imputation method (ie, participants who discontinued early were counted as nonresponders by having their VL values after discontinuation imputed with their baseline value, thus resulting in a 0 change). (NCT00896051)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
ATV/Rtv 300/100 mg (Treatment A) | 50.0 |
ATV/Rtv 400/100 mg (Treatment B) | 45.5 |
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Number of Participants Without Virologic Failure at Week 48
HIV RNA level <50 copies/mL at week 48 (NCT00924898)
Timeframe: HIV RNA level at week 48 following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 71 |
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Number of Participants Without Virologic Failure at Week 24
Number of participants with a HIV RNA level <200 copies/mL at week 24 (NCT00924898)
Timeframe: HIV RNA level prior to or at week 24 following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 81 |
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Number of Participants With HIV RNA Suppression at Week 96
Number of participants wtih HIV RNA level <50 copies/mL at week 96 (NCT00924898)
Timeframe: HIV RNA level at 96 weeks following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 65 |
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Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 71 |
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Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 17 |
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Time to HIV RNA Suppression <50 Copies/mL
Number of days from ART initiation to HIV RNA suppression <50 copies/mL (NCT00924898)
Timeframe: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
Intervention | days (Median) |
---|
Acute HIV Infection Treatment Group | 105 |
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Patients With Plasma HIV RNA < 200 Copies/ml
number of patients with plasma HIV RNA below 200 copies/ml (NCT00928187)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
Arm A | 130 |
Arm B | 118 |
Arm C | 127 |
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Number of Patients With Resistance Mutations
number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) (NCT00928187)
Timeframe: between W12 and W48
Intervention | participants (Number) |
---|
Arm A | 0 |
Arm B | 0 |
Arm C | 0 |
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Number of Patients With Plasma HIV RNA < 50 Copies/mL
(NCT00928187)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
Arm A | 105 |
Arm B | 92 |
Arm C | 97 |
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Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Arm A | 90 |
Arm B | 81 |
Arm C | 97 |
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Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
number of patients having a plasma viral load below 200 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Arm A | 127 |
Arm B | 117 |
Arm C | 129 |
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Tolerance: Neuropathies (Grade 1 to 4)
any symptom of peripheral neuropathy (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 5 |
Arm B | 11 |
Arm C | 8 |
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Adherence
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 |
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Gain in CD4 Cells Between Baseline and W48
median gain in circulating CD4 cells between baseline and W48 (NCT00928187)
Timeframe: between baseline and 48 weeks
Intervention | cell/mm3 (Median) |
---|
Arm A | 133 |
Arm B | 136 |
Arm C | 115 |
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Number of Patients Discontinuing Study Treatment
number of patients discounting treatment because of adverse events (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 0 |
Arm B | 4 |
Arm C | 1 |
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Tolerance: Gastrointestinal Complains
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 |
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Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 28 |
Arm B | 14 |
Arm C | 19 |
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Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment. (NCT00931801)
Timeframe: baseline and 48 weeks
Intervention | units on a scale (Mean) |
---|
| Mean Quality of Life Score at Baseline | Mean Quality of Life Score at Week 48 | Change in Quality of Life |
---|
Control Arm | 92.9 | 90.5 | -2.5 |
,Intervention Arm No.1 | 77.4 | 78.2 | 0.8 |
,Intervention Arm No.2 | 82.5 | 81.3 | -1.3 |
,Total | 84.2 | 83.3 | -0.9 |
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The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits. (NCT00931801)
Timeframe: Baseline and Week 48
Intervention | percentage of prescribed doses (Mean) |
---|
| 3 Day Adherence Recall at Baseline | 3 Day Adherence Recall at Week 48 | Change in 3 Day Adherence Recall |
---|
Control Arm | 100 | 100 | 0 |
,Intervention Arm No.1 | 97.5 | 97.5 | 0 |
,Intervention Arm No.2 | 96.7 | 95.0 | -1.7 |
,Total | 98.1 | 97.6 | -0.5 |
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The Difference in CD4 From Baseline to Week 48
Change in mean CD4 from Baseline to Week 48. (NCT00931801)
Timeframe: Baseline and Week 48
Intervention | cells/mm3 (Mean) |
---|
| CD4 at Baseline | CD4 at Week 48 | CD4 Change |
---|
Control Arm | 535.8 | 611.2 | 75.4 |
,Intervention Arm No.1 | 514.1 | 526.3 | 12.1 |
,Intervention Arm No.2 | 539.1 | 507.2 | -31.9 |
,Total | 528.3 | 549.3 | 21.0 |
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Maintenance of Virologic Suppression
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL. (NCT00931801)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
| Virologic Response | Confirmed Virologic Failures | Withdrawal Due to AE; HIV RNA < 50 copies/mL | Other Withdrawal; HIV RNA < 50 copies/mL |
---|
Control Arm | 13 | 0 | 0 | 1 |
,Intervention Arm No.1 | 14 | 0 | 0 | 1 |
,Intervention Arm No.2 | 10 | 3 | 1 | 0 |
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Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks
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 |
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Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults
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 |
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Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results
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 |
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Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State
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 |
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Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy
"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 |
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Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24
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 |
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Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
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 |
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Change in Peak Oxygen Uptake.
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months
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 |
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Mean Change From Baseline in HBV-DNA log10
An acute virologic response was determined by change from baseline in HBV-DNA log10. (NCT00962871)
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Intervention | IU/mL (Mean) |
---|
| Day 2 | Day 3 | Day 5 | Day 8 | Day 10 | Day 14 | Week 3 | Week 4 | Week 5 | Week 6 |
---|
Delayed Treatment | 0.08 | 0.04 | -0.06 | -0.07 | -0.09 | -0.26 | -1.80 | -2.17 | NA | NA |
,PEG-IFN Alfa-2a 360 μg | -0.14 | -0.46 | -0.64 | -0.54 | -0.57 | -0.61 | -0.79 | -0.98 | -1.22 | -1.30 |
,Tenofovir 300 mg | -0.61 | -1.04 | -1.53 | -2.16 | -2.37 | -2.7 | -0.76 | -0.84 | NA | NA |
,Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg | -0.46 | -0.75 | -1.45 | -1.93 | -2.11 | -2.46 | -2.88 | -1.49 | -1.37 | -1.73 |
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Mean Change From Baseline in Viral Quantitative e Antibody
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data. (NCT00962871)
Timeframe: Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)
Intervention | Cut-off index (C.O.I.) (Mean) |
---|
| Day 1 | Day 3 | Day 5 | Day 8 | Day 10 | Day 14 | Week 3 | Week 4 | Week 6 |
---|
Delayed Treatment | 0.03 | -0.10 | 0.07 | 0.04 | 0.03 | -0.00 | NA | -0.40 | NA |
,PEG-IFN Alfa-2a 360 μg | 0.02 | -0.13 | -0.15 | -0.09 | -0.12 | -0.13 | -0.22 | -0.29 | -0.31 |
,Tenofovir 300 mg | 0.07 | 0.00 | -0.02 | -0.05 | -0.13 | -0.02 | NA | -0.04 | NA |
,Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg | 0.15 | 0.03 | 0.04 | 0.07 | 0.04 | 0.03 | 0.01 | -0.05 | -0.21 |
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Change in Small Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Small artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the small (and large) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease that predicts risk for future cardiovascular events. (NCT00998582)
Timeframe: Change from baseline to 24 weeks
Intervention | ml/mmHg x100 (Median) |
---|
Abacavir | 0.2 |
Tenofovir | -1.3 |
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Outcome Was Change in Large Artery Elasticity (mL/mmHg x100) From Baseline to Week 24
Large artery elasticity is a measure of vascular function, estimated through analysis of the blood pressure waveform. A sensor is placed on wrist over the radial pulse. The blood pressure waveform of the pulse is recorded and analyzed the elasticity, or compliance, of the large (and small) vasculature. Impaired artery elasticity, or increased stiffness, is an early sign of vascular disease. (NCT00998582)
Timeframe: Change from baseline to 24 weeks
Intervention | ml/mmHg x10 (Median) |
---|
Abacavir | -0.2 |
Tenofovir | -0.4 |
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Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24
The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to < 5 copies/mL. (NCT01025427)
Timeframe: 24 weeks
Intervention | fold decrease in signal/cutoff ratio (Mean) |
---|
HIV Controller | 66 |
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Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 90.59 | 4.71 | 1.18 | 3.53 |
,Placebo Pill Control | 96.77 | 0.00 | 2.15 | 1.08 |
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Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 68.24 | 24.71 | 4.71 | 2.35 |
,Placebo Pill Control | 86.02 | 6.45 | 4.30 | 3.23 |
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Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 83.53 | 12.94 | 0.00 | 3.53 |
,Placebo Pill Control | 92.47 | 2.15 | 3.23 | 2.15 |
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Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 73.33 | 20.00 | 6.67 | 0.00 | 0.00 |
,No Pill Control | 43.75 | 18.75 | 25.00 | 12.50 | 0.00 |
,Placebo Pill Control | 81.25 | 6.25 | 6.25 | 0.00 | 6.25 |
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Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 46.67 | 13.33 | 13.33 | 13.33 | 13.33 |
,No Pill Control | 25.00 | 25.00 | 18.75 | 18.75 | 12.50 |
,Placebo Pill Control | 68.75 | 6.25 | 18.75 | 6.25 | 0.00 |
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Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 33.33 | 6.67 | 0.00 | 0.00 |
,No Pill Control | 68.75 | 18.75 | 12.50 | 0.00 | 0.00 |
,Placebo Pill Control | 93.75 | 0.00 | 6.25 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 25.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 42.86 | 28.57 | 14.29 | 7.14 | 7.14 |
,Placebo Pill Control | 80.00 | 6.67 | 13.33 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 53.85 | 15.38 | 23.08 | 7.69 | 0.00 |
,No Pill Control | 42.86 | 42.86 | 7.14 | 0.00 | 7.14 |
,Placebo Pill Control | 93.33 | 0.00 | 6.67 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.33 | 33.33 | 8.33 | 0.00 | 0.00 |
,No Pill Control | 35.71 | 21.43 | 28.57 | 0.00 | 14.29 |
,Placebo Pill Control | 80.00 | 6.67 | 13.33 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 46.15 | 15.38 | 15.38 | 7.69 | 15.38 |
,No Pill Control | 42.86 | 14.29 | 7.14 | 21.43 | 14.29 |
,Placebo Pill Control | 66.67 | 6.67 | 6.67 | 20.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 64.29 | 0.00 | 21.43 | 14.29 | 0.00 |
,No Pill Control | 43.75 | 18.75 | 18.75 | 18.75 | 0.00 |
,Placebo Pill Control | 68.75 | 12.50 | 12.50 | 6.25 | 0.00 |
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Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 25.00 | 0.00 | 8.33 | 0.00 |
,No Pill Control | 71.43 | 7.14 | 7.14 | 7.14 | 7.14 |
,Placebo Pill Control | 93.33 | 6.67 | 0.00 | 0.00 | 0.00 |
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Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 82.35 | 9.41 | 0.00 | 8.24 |
,Placebo Pill Control | 91.40 | 3.23 | 2.15 | 3.23 |
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Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 16.67 | 0.00 | 8.33 | 0.00 |
,No Pill Control | 61.54 | 23.08 | 7.69 | 7.69 | 0.00 |
,Placebo Pill Control | 92.86 | 7.14 | 0.00 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 25.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 38.46 | 15.38 | 15.38 | 23.08 | 7.69 |
,Placebo Pill Control | 78.57 | 7.14 | 7.14 | 7.14 | 0.00 |
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Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 25.00 | 8.33 | 0.00 | 0.00 |
,No Pill Control | 53.85 | 23.08 | 15.38 | 7.69 | 0.00 |
,Placebo Pill Control | 78.57 | 14.29 | 7.14 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 8.33 | 8.33 | 0.00 | 8.33 |
,No Pill Control | 61.54 | 15.38 | 7.69 | 7.69 | 7.69 |
,Placebo Pill Control | 71.43 | 21.43 | 0.00 | 7.14 | 0.00 |
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Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 91.67 | 8.33 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 61.54 | 30.77 | 7.69 | 0.00 | 0.00 |
,Placebo Pill Control | 92.86 | 7.14 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 40.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 46.15 | 15.38 | 23.08 | 7.69 | 7.69 |
,Placebo Pill Control | 83.33 | 16.67 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 30.00 | 10.00 | 0.00 | 10.00 |
,No Pill Control | 46.15 | 15.38 | 23.08 | 15.38 | 0.00 |
,Placebo Pill Control | 83.33 | 16.67 | 0.00 | 0.00 | 0.00 |
[back to top]
Actual Number of Study Visits Completed by 24 Weeks
This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. (NCT01033942)
Timeframe: 24 weeks
Intervention | Visits (Least Squares Mean) |
---|
FTC/TDF as PrEP | 3.5927 |
Placebo Pill Control | 4.6263 |
No Pill Control | 4.6374 |
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Number of Missed Doses Based on Medication Refill Dates-Overall
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 20 Weeks
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
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Number of Missed Doses Based on Medication Refill Dates-Week 12
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 16
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 20
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 4
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 4
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
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Number of Missed Doses Based on Medication Refill Dates-Week 8
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 12
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 6.5 |
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Number of Missed Doses Based on Self-Report Calendar Data-Week 16
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 5 |
Placebo Pill Control | 19 |
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Number of Missed Doses Based on Self-Report Calendar Data-Week 20
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 5 |
Placebo Pill Control | 10 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 24
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 24
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 17 |
Placebo Pill Control | 5.5 |
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Number of Missed Doses Based on Self-Report Calendar Data-Week 4
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 4 weeks
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 10 |
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Number of Missed Doses Based on Self-Report Calendar Data-Week 8
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 14 |
Placebo Pill Control | 8 |
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Number of Missed Doses Over Time Based on Self-Report Calendar Data
The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. (NCT01033942)
Timeframe: 24 weeks
Intervention | Doses (Least Squares Mean) |
---|
FTC/TDF as PrEP | 0.4752 |
Placebo Pill Control | 0.4021 |
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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Baseline
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 11 |
Placebo Pill Control | 11 |
No Pill Control | 12 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
(NCT01033942)
Timeframe: Week 8
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 8 | 5 | 4 | 0 |
,Placebo Pill Control | 9 | 2 | 7 | 0 |
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Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 12
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 13 |
Placebo Pill Control | 14 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 16
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 11 |
Placebo Pill Control | 13 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 20
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 9 |
Placebo Pill Control | 11 |
No Pill Control | 10 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 9 |
Placebo Pill Control | 7 |
No Pill Control | 10 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 4
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 15 |
Placebo Pill Control | 14 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 8
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 12 |
No Pill Control | 10 |
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Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Baseline
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 60 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 53.8 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 41.7 |
Placebo Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 20 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 63.2 |
Placebo Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 47.1 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
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Acceptability of Being Randomly Assigned to a Group
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 1 | 3 | 4 | 1 | 11 |
,No Pill Control | 0 | 2 | 5 | 6 | 6 |
,Placebo Pill Control | 4 | 2 | 4 | 2 | 7 |
[back to top]
Acceptability of Having an HIV Test at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 0 | 10 | 10 |
,No Pill Control | 0 | 1 | 12 | 6 |
,Placebo Pill Control | 1 | 3 | 8 | 7 |
[back to top]
Acceptability of Health Clinic for Study Visits
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 4 | 6 | 10 |
,No Pill Control | 0 | 3 | 10 | 6 |
,Placebo Pill Control | 2 | 4 | 6 | 7 |
[back to top]
Acceptability of Participating in Group Sessions
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 0 | 9 | 10 |
,No Pill Control | 0 | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 2 | 2 | 7 | 7 |
[back to top]
Acceptability of Physical Examination by a Doctor
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 2 | 7 | 10 |
,No Pill Control | 0 | 0 | 3 | 10 | 6 |
,Placebo Pill Control | 3 | 0 | 3 | 6 | 7 |
[back to top]
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 81.18 | 11.76 | 4.71 | 2.35 |
,Placebo Pill Control | 89.25 | 5.38 | 3.23 | 2.15 |
[back to top]
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 62.35 | 25.53 | 7.06 | 7.06 |
,Placebo Pill Control | 70.97 | 15.05 | 10.75 | 3.23 |
[back to top]
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 92.94 | 7.06 | 0.00 | 0.00 |
,Placebo Pill Control | 95.70 | 2.15 | 1.08 | 1.08 |
[back to top]
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 94.12 | 4.71 | 0.00 | 1.18 |
,Placebo Pill Control | 97.85 | 1.08 | 1.08 | 0.00 |
[back to top]
Frequency of Missing Study Pills Because Participant Simply Forgot
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 38.82 | 40.00 | 9.41 | 11.76 |
,Placebo Pill Control | 60.22 | 16.13 | 15.05 | 8.60 |
[back to top]
Frequency of Missing Study Pills Because Participant Was Away From Home
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 31.76 | 34.12 | 16.47 | 17.65 |
,Placebo Pill Control | 48.39 | 20.43 | 26.88 | 4.30 |
[back to top]
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 47.06 | 30.59 | 15.29 | 7.06 |
,Placebo Pill Control | 58.06 | 16.13 | 21.51 | 4.30 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
(NCT01033942)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 6 | 3 | 5 | 0 |
,Placebo Pill Control | 6 | 2 | 8 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
(NCT01033942)
Timeframe: Week 16
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 6 | 2 | 4 | 0 |
,Placebo Pill Control | 5 | 1 | 9 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
(NCT01033942)
Timeframe: Week 20
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 4 | 3 | 4 | 0 |
,Placebo Pill Control | 6 | 2 | 6 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 2 | 3 | 4 | 0 |
,Placebo Pill Control | 8 | 0 | 4 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
(NCT01033942)
Timeframe: Week 4
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 9 | 4 | 5 | 1 |
,Placebo Pill Control | 10 | 1 | 6 | 1 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 57.14 | 28.57 | 7.14 | 7.14 | 0.00 |
,No Pill Control | 50.00 | 18.75 | 25.00 | 6.25 | 0.00 |
,Placebo Pill Control | 81.25 | 12.50 | 6.25 | 0.00 | 0.00 |
[back to top]
Acceptability of Questions About Sexual Behavior at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 0 | 1 | 9 | 10 |
,No Pill Control | 0 | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 1 | 4 | 6 | 7 |
[back to top]
Acceptability of Risk Reduction Counseling at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 9 | 10 |
,No Pill Control | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 5 | 6 | 7 |
[back to top]
Acceptability of Size of Pill
(NCT01033942)
Timeframe: Week 24
Intervention | Participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 3 | 3 | 3 | 1 | 10 |
,Placebo Pill Control | 3 | 3 | 6 | 0 | 7 |
[back to top]
Acceptability of Taking Part in the Study
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 2 | 0 | 0 | 8 | 10 |
,No Pill Control | 0 | 0 | 1 | 12 | 6 |
,Placebo Pill Control | 0 | 1 | 2 | 9 | 7 |
[back to top]
Acceptability of Taking the Pill Everyday
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 3 | 3 | 2 | 2 | 10 |
,Placebo Pill Control | 1 | 7 | 4 | 0 | 7 |
[back to top]
Acceptability of the Color of the Pill
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 1 | 2 | 4 | 3 | 10 |
,Placebo Pill Control | 1 | 3 | 5 | 3 | 7 |
[back to top]
Acceptability of the Taste of the Pill
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 4 | 1 | 4 | 1 | 10 |
,Placebo Pill Control | 3 | 4 | 5 | 0 | 7 |
[back to top]
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 87.06 | 5.88 | 3.53 | 3.53 |
,Placebo Pill Control | 95.70 | 2.15 | 0.00 | 2.15 |
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Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 88.24 | 5.88 | 2.35 | 3.53 |
,Placebo Pill Control | 92.47 | 4.30 | 0.00 | 3.23 |
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Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 30.00 | 10.00 | 10.00 | 0.00 |
,No Pill Control | 53.85 | 15.38 | 15.38 | 15.38 | 0.00 |
,Placebo Pill Control | 83.33 | 8.33 | 8.33 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 10.00 | 10.00 | 10.00 | 20.00 |
,No Pill Control | 30.77 | 15.38 | 15.38 | 30.77 | 7.69 |
,Placebo Pill Control | 66.67 | 16.67 | 8.33 | 8.33 | 0.00 |
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Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 80.00 | 20.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 53.85 | 23.08 | 23.08 | 0.00 | 0.00 |
,Placebo Pill Control | 91.67 | 0.00 | 0.00 | 8.33 | 0.00 |
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Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 57.89 | 26.32 | 15.79 | 0.00 | 0.00 |
,No Pill Control | 50.00 | 27.78 | 16.67 | 0.00 | 5.56 |
,Placebo Pill Control | 66.67 | 22.22 | 5.56 | 5.56 | 0.00 |
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Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 5.56 | 11.11 | 11.11 | 5.56 |
,No Pill Control | 55.56 | 11.11 | 16.67 | 16.67 | 0.00 |
,Placebo Pill Control | 55.56 | 27.78 | 5.56 | 5.56 | 5.56 |
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Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 63.16 | 5.26 | 10.53 | 21.05 | 0.00 |
,No Pill Control | 55.56 | 27.78 | 5.56 | 5.56 | 5.56 |
,Placebo Pill Control | 66.67 | 16.67 | 5.56 | 11.11 | 0.00 |
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Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 63.16 | 5.26 | 10.53 | 21.05 | 0.00 |
,No Pill Control | 44.44 | 5.56 | 22.22 | 22.22 | 5.56 |
,Placebo Pill Control | 50.00 | 16.67 | 0.00 | 27.78 | 5.56 |
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Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 84.21 | 5.26 | 10.53 | 0.00 | 0.00 |
,No Pill Control | 94.44 | 0.00 | 5.56 | 0.00 | 0.00 |
,Placebo Pill Control | 83.33 | 5.56 | 0.00 | 5.56 | 5.56 |
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Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 47.06 | 23.53 | 23.53 | 0.00 | 5.88 |
,No Pill Control | 35.29 | 41.18 | 23.53 | 0.00 | 0.00 |
,Placebo Pill Control | 83.33 | 11.11 | 5.56 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 47.06 | 29.41 | 17.65 | 5.88 | 0.00 |
,No Pill Control | 35.29 | 35.29 | 11.76 | 17.65 | 0.00 |
,Placebo Pill Control | 66.67 | 5.56 | 27.78 | 0.00 | 0.00 |
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Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.82 | 17.65 | 17.65 | 0.00 | 5.88 |
,No Pill Control | 35.29 | 23.53 | 11.76 | 29.41 | 0.00 |
,Placebo Pill Control | 66.67 | 11.11 | 16.67 | 5.56 | 0.00 |
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Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 52.94 | 5.88 | 17.65 | 5.88 | 17.65 |
,No Pill Control | 23.53 | 17.65 | 23.53 | 17.65 | 17.65 |
,Placebo Pill Control | 61.11 | 11.11 | 5.56 | 5.56 | 16.67 |
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Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 68.75 | 25.00 | 6.25 | 0.00 | 0.00 |
,No Pill Control | 64.71 | 29.41 | 5.88 | 0.00 | 0.00 |
,Placebo Pill Control | 100.00 | 0.00 | 0.00 | 0.00 | 0.00 |
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Perceived Risk of Becoming HIV Positive at Week 12
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 40.00 | 40.00 | 20.00 | 0.00 | 0.00 |
,No Pill Control | 31.25 | 37.50 | 12.50 | 6.25 | 12.50 |
,Placebo Pill Control | 75.00 | 6.25 | 6.25 | 12.50 | 0.00 |
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Perceived Risk of Becoming HIV Positive at Week 16
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of partcipants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.33 | 16.67 | 8.33 | 8.33 | 8.33 |
,No Pill Control | 42.86 | 21.43 | 21.43 | 0.00 | 14.29 |
,Placebo Pill Control | 80.00 | 13.33 | 6.67 | 0.00 | 0.00 |
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Perceived Risk of Becoming HIV Positive at Week 20
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 16.67 | 0.00 | 16.67 | 0.00 |
,No Pill Control | 30.77 | 23.08 | 23.08 | 7.69 | 15.38 |
,Placebo Pill Control | 78.57 | 21.43 | 0.00 | 0.00 | 0.00 |
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Perceived Risk of Becoming HIV Positive at Week 24
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 20.00 | 0.00 | 10.00 | 10.00 |
,No Pill Control | 38.46 | 23.08 | 15.38 | 7.69 | 15.38 |
,Placebo Pill Control | 75.00 | 8.33 | 16.67 | 0.00 | 0.00 |
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Perceived Risk of Becoming HIV Positive at Week 4
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 52.63 | 21.05 | 10.53 | 15.79 | 0.00 |
,No Pill Control | 33.33 | 22.22 | 27.78 | 0.00 | 16.67 |
,Placebo Pill Control | 38.89 | 33.33 | 11.11 | 11.11 | 5.56 |
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Perceived Risk of Becoming HIV Positive at Week 8
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 29.41 | 17.65 | 23.53 | 23.53 | 5.88 |
,No Pill Control | 58.82 | 11.76 | 11.76 | 11.76 | 5.88 |
,Placebo Pill Control | 66.67 | 27.78 | 0.00 | 5.56 | 0.00 |
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Patients Without HIV Re-bound
HIV Viral load blood test at week 24 (NCT01044771)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Viral Rebound | 2 |
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Patients With Reduced or Resolved Proteinuria
Measurement of Protein in Urine samples at end of study visit (NCT01044771)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Change From Tenofovir to Raltegravir | 20 |
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Maternal Health Component: Other Targeted Medical Conditions
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 |
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Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
"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 |
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Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
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 |
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Maternal Health Component: Incidence of Tuberculosis
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 |
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Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
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 |
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Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
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 |
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Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
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 |
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Maternal Health Component: Incidence of Death
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 |
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Maternal Health Component: Incidence of AIDS-defining Illness
"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 |
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Antepartum Component: Number of Infant HIV Infections
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 |
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Antepartum Component: Number of Confirmed Infant HIV Infections
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 |
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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
Composite outcome (NCT01061151)
Timeframe: Measured at birth
Intervention | Participants (Count of Participants) |
---|
| Period 2 |
---|
Antepartum Arm C | 111 |
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Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
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 |
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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
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 |
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Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
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 |
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Antepartum Component: Number of Mothers With Obstetrical Complications
"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 |
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Antepartum Component: Number of Mothers With Obstetrical Complications
"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 |
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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
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 |
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Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
"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 |
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Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
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 |
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Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
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 |
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Postpartum Component: Incidence of Confirmed Infant HIV Infection
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 |
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Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
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 |
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Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
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 |
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Percentage of Participants With a Virologic Response at Week 48 - Treated Population
Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 48 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay, in a central laboratory. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. (NCT01063036)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
Entecavir + Tenofovir | 76.1 |
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Change From Baseline in Mean log10 HBV DNA at Weeks 12, 24, 48, and 96 - Treated Evaluable Population
HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in log 10 IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. Baseline was Day 1, prior to study drug administration. (NCT01063036)
Timeframe: Baseline to Weeks 12, 24, 48, 96
Intervention | log10 IU/mL (Mean) |
---|
| Week 12 (n=89) | Week 24 (n=89) | Week 48 (n=88) | Week 96 (n=84) |
---|
Entecavir + Tenofovir | -2.230 | -2.581 | -2.829 | -2.965 |
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Number of Participants on Treatment With Study Drug With Laboratory Test Abnormalities Meeting Selected Criteria on Treatment - Treated Population
Selected criteria presented in each category. Upper limit of normal among all laboratory ranges (ULN); Baseline (BL); alanine transaminase (ALT); milligram per deciliter (mg/dL); milliliters per minute (mL/min); greater than (>);greater than, equal to (>=); less than (<). Creatinine data presented below were confirmed, ie, at least 2 consecutive values. On-treatment = after Day 1 through last dose of study therapy + 5 days. (NCT01063036)
Timeframe: Day 1 to last dose of study drug plus 5 days; up to Week 96
Intervention | participants (Number) |
---|
| ALT > 2*Baseline(N=90) | ALT > 3*Baseline(N=90) | Total bilirubin >2*Baseline (N=90) | Total bilirubin >3*Baseline (N=90) | Lipase > 3*Baseline (N=90) | Creatinine increase from BL >= 20%(N=91) | Creatinine >1.5 mg/dL (N=91) | Creatinine clearance < 50 mL/min (N=91) | Phosphate < 2.0 mg/dL (N=90) | Phosphate < 2.3 mg/dL (N=90) |
---|
Entecavir + Tenofovir | 9 | 2 | 11 | 3 | 4 | 4 | 2 | 1 | 2 | 8 |
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Number of Participants With Emergence of Genotypic Resistance to Study Drugs at Weeks 48 and 96- Treated Population
Testing of HBV genotype was performed at baseline for all treated patients and for participants at Weeks 48 and 96 with primary non-response or virologic breakthrough. Emergent genotypic resistance to study drugs was defined as follows: Emergent = not detected at baseline; entecavir (ETV) resistance (ETVr): participant's sample was to have rtM204V/I/S and any substitution at rtT184, rtS202, or rtM250; tenofovir (TDF) resistance (TDFr) which was based on adefovir (ADV)-mutations: participant's sample was to have rtA181T/V, rtN236T, or (rtA194T and rtM204V/I/S). Primary non-response was defined as < 1 log10 decrease in HBV DNA from baseline on treatment at or after Week 12. Virologic breakthrough was defined as ≥ 1 log10 increase in HBV DNA over nadir on treatment, either confirmed or last on-treatment followed by discontinuation of study therapy. (NCT01063036)
Timeframe: Baseline to Weeks 48, 96
Intervention | participants (Number) |
---|
| Week 48 (n=5) | Week 96 (n=7) |
---|
Entecavir + Tenofovir | 0 | 0 |
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Percentage of Participants With a Virologic Response at Week 24 and at Week 96 - Treated Population
Virologic response was defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) less than 50 international units per milliliter (IU/mL); approximately 300 copies/mL. Percentage was calculated as number of participants with virologic response at Week 24, Week 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). The HBV DNA by polymerase chain reaction (PCR) was measured using the Roche COBAS(REGISTERED) TaqMan - High Pure System (HPS) assay. The results were reported in IU/mL, with the limit of quantification (LOQ) = 29 IU/mL and lower limit of detection (LLD) = 6 IU/mL. HBV DNA measurements were transformed by the log10 scale when analyzed as a continuous variable, using log10(LOQ-1) for values below LOQ. (NCT01063036)
Timeframe: Week 24, Week 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=92) | Week 96 (n=92) |
---|
Entecavir + Tenofovir | 64.1 | 84.8 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBsAg-Positive at Baseline
HBsAg seroconversion was defined as being both HBsAg-negative and HBsAb-positive at Weeks 24, 48, and 96 in those participants who had been HBsAg-positive at baseline. Percentage was calculated as number of participants with HBs seroconversion at Weeks 24 and 48 divided by the number of treated participants who were HBsAg-positive at baseline. Positive result for HBsAg was one of the inclusion criteria. Treated participants (HBsAg positive at baseline) were evaluated using NC=F. The method used was an Immunoassay testing - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma [potassium ethylenediaminetetraacetic acid (EDTA), lithium or sodium heparinized]. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, and 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=92) | Week 48 (n=92) | Week 96 (n=92) |
---|
Entecavir + Tenofovir | 1.1 | 0 | 1.1 |
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Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 24, 48, 96 - Treated Population Who Were HBsAg-Positive at Baseline
Loss of HBsAg was defined as being HBsAg-negative at Weeks 24, 48, 96 in those participants who had been HBsAg-positive at baseline. The method used: Immunoassay - ADVIA CENTAUR from SIEMENS: in vitro diagnostic immunoassay for the qualitative and quantitative determination of HBsAg in human serum and plasma (potassium ethylene diamine tetraacetic acid, lithium or sodium heparinized). Percentage calculated as number of participants with a HBsAg loss at Weeks 24, 48, and 96 divided by the number of treated participants who were HBsAg-positive at baseline (participants were not enrolled into the study unless they were positive for HBsAg). Treated participants (HBsAg-positive at baseline) were evaluated using NC=F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=92) | Week 48 (n=92) | Week 96 (n=92) |
---|
Entecavir + Tenofovir | 1.1 | 0 | 2.2 |
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg Positive at Baseline
Loss of HBeAg was defined as being HBeAg-negative at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used for HBeAg was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBeAg loss at Weeks 24 and 48 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline to Weeks 24, 48, and 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=56) | Week 48 (n=56) | Week 96 (n=56) |
---|
Entecavir + Tenofovir | 3.6 | 5.4 | 8.9 |
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Percentage of Participants With HBV DNA Less Than the Lower Limit of Detection (LLD) at Weeks 24, 48, and 96 - Treated Population
HBV DNA less than (<) LLD (6 IU/mL) was defined/measured by the COBAS(REGISTERED) TaqMan HPS assay at Weeks 24, 48, and 96. Percentage was calculated as number of participants with HBV DNA < LLD at Weeks 24, 48, 96 divided by the number of treated participants. Treated participants were evaluated using non-completer (NC) = failure (F). (NCT01063036)
Timeframe: Weeks 24, 48, 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=92) | Week 48 (n=92) | Week 96 (n=92) |
---|
Entecavir + Tenofovir | 12.0 | 18.5 | 16.3 |
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Percentage of Participants With HBe Seroconversion at Weeks 24, 48, and 96 - Treated Population Who Were HBeAg-positive at Baseline
HBe seroconversion was defined as being both HBeAg-negative and HBeAb-positive at Weeks 24, 48, and 96 in those participants who had been HBeAg-positive at baseline. Method used was DiaSorin - Anti HBe enzyme immunoassay kit - procedure for qualitative determination of antibodies to HBeAg in human serum or plasma samples. Percentage was calculated as number of participants with HBe seroconversion at Weeks 24, 48, and 96 divided by the number of treated participants who were HBeAg-positive at baseline. Treated participants (HBeAg-positive at baseline) were evaluated using NC = F. Baseline was Day 1, before start of study drug. (NCT01063036)
Timeframe: Baseline, Weeks 24, 48, and 96
Intervention | percentage of participants (Number) |
---|
| Week 24 (n=56) | Week 48 (n=56) | Week 96 (n=56) |
---|
Entecavir + Tenofovir | 3.6 | 3.6 | 1.8 |
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Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) on Treatment, and Discontinuation of Study Drug Due to Adverse Events (AE) - Treated Population
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. On-treatment = on Day 1 through last dose of study therapy + 5 days. (NCT01063036)
Timeframe: Day 1 to last dose of study drug plus 5 days; up to Week 96
Intervention | participants (Number) |
---|
| Treatment emergent SAE | Discontinuation of treatment due to AE |
---|
Entecavir + Tenofovir | 6 | 1 |
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Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
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 |
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Course Completion
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 |
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Medication Adherence
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 |
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Time From Exposure to Truvada Initiation
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 |
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Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen. (NCT01154673)
Timeframe: Baseline to Week 48
Intervention | HIV DNA copies/ million CD4 cells (Median) |
---|
Intensive HAART | 279 |
Placebo Arm | 244 |
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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment
To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) (NCT01195467)
Timeframe: 4 weeks
Intervention | percentage improvement in CNS score (Number) |
---|
Single Arm | 26 |
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The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment
"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)" (NCT01195467)
Timeframe: baseline to week 12
Intervention | percentage of improvement in sleep score (Number) |
---|
Single Arm | 25 |
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Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study
(NCT01214759)
Timeframe: 28 days
Intervention | participants (Number) |
---|
Truvada and Raltegravir | 85 |
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Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. (NCT01214759)
Timeframe: 6 months
Intervention | participants (Number) |
---|
Truvada and Raltegravir | 0 |
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Number of Participants With Abnormalities in Laboratory Test Results
PreRX=pretreatment; ULN=upper limit of normal. Neutrophils, (absolute), low (10*3 c/uL): <0.85*PreRx, if PreRx <1.5; <1.5 if PreRx ≥1.5. Alanine aminotransferase, high (U/L): >1.25*PreRx if PreRx >ULN; >1.25*ULN if PreRx ≤ULN. Bilirubin, direct (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. Bilirubin, total (mg/dL), high: >1.1*ULN if PreRx ≤ULN;> 1.1*ULN if PreRx is missing; >1.25*PreRx if PreRx >ULN. (NCT01232127)
Timeframe: Days 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | Participants (Number) |
---|
| WBC differential count (low) | Neutrophils (absolute) (low) | Alanine aminotransferase (high) | Aspartate aminotransferase (high) | Bilirubin, direct (high) | Bilirubin, total (high) |
---|
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 1 | 0 | 0 | 0 | 1 | 3 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 0 | 1 | 1 | 0 | 0 | 7 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 0 | 0 | 0 | 1 | 0 | 5 |
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Time of Maximum Observed Plasma Concentration (Tmax) for Atazanavir and Ritonavir
(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | Hours (Median) |
---|
| Atazanavir Tmax | Ritonavir Tmax |
---|
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 3.0 | 4.0 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 3.0 | 4.00 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 3.0 | 4.0 |
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Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, AES, and AEs of Clinical Interest
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01232127)
Timeframe: Days 1 through 25 (end of study), continuously, and at study discharge for those who discontinued prematurely.
Intervention | Participants (Number) |
---|
| Deaths | SAEs | AEs leading to discontinuation | AEs | AEs of clinical interest: Nausea | AEs of clinical interest: Diarrhea |
---|
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 0 | 0 | 0 | 6 | 0 | 0 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 0 | 0 | 0 | 7 | 2 | 3 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 0 | 0 | 0 | 5 | 0 | 0 |
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Number of Participants With Abnormalities in Vital Signs
Vital signs include temperature, respiratory rate, seated blood pressure, and heart rate. (NCT01232127)
Timeframe: Days 1, 11, 18, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | Participants (Number) |
---|
| Isolated decrease in heart rate | Sporadic respiration rate >16 bpm |
---|
All Treated | 2 | 11 |
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Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings
ECG findings include heart rate, ECG intervals (including PR, QRS, QT, and corrections to QT using both Bazett's and Fridericia's formulae), and Investigator-identified ECG abnormalities. (NCT01232127)
Timeframe: Days 1 and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | Participants (Number) |
---|
| Nonspecific ST/T wave abnormality | Short PR interval |
---|
All Treated | 1 | 1 |
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Maximum Observed Plasma Concentration (Cmax) and Trough Observed Plasma Concentration (Ctrough) for Atazanavir and Ritonavir
(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | ng/mL (Geometric Mean) |
---|
| Atazanavir Cmax | Atazanavir Ctrough | Ritonavir Cmax | Ritonavir Ctrough |
---|
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 3512 | 496 | 1141 | 45.8 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 4131 | 602 | 1148 | 49.2 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 3322 | 494 | 1096 | 47.3 |
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Area Under the Plasma Concentration-time Curve in 1 Dosing Interval (Time 0 to 24 Hours Postdose) (AUC[TAU]) for Atazanavir and Ritonavir
(NCT01232127)
Timeframe: Days 10, 11, 17, 18, 24, and 25 (end of study) and at study discharge for those who discontinued prematurely.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Atazanavir AUC | Ritonavir AUC |
---|
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI | 32562 | 7317 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20) | 37894 | 7430 |
,Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40) | 31481 | 7052 |
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Change in Serum Levels of Vitamin D
Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body (NCT01270802)
Timeframe: Baseline and 24 weeks
Intervention | ng/mL (Mean) |
---|
Continued Tenofovir/Emtricitabine/Efavirenz | 0.06 |
Switch to Tenofovir/Emtricitabine Plus Raltegravir | 0.14 |
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Number of Participants Reporting Suggestions Regarding Ease of Use or Comfort
"Participants were asked if they could suggest ways that would make each applicator easier or more comfortable to use. Response categories were yes and no. If yes, participants were asked to describe how they would make the applicator easier and/or more comfortable to use." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No |
---|
Prefilled Applicator | 5 | 20 |
,User-Filled Applicator | 7 | 18 |
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Number of Participants Reporting Applicator Preference (User-filled or Prefilled) Across a Variety of Factors
"Participants were asked about their preference for either the user-filled or prefilled applicator with regard to several use factors as well as in relation to disposal, storage, and overall comfort and preference.~Response categories included user-filled, prefilled, and same." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | responses (Number) |
---|
| Ease of use | Ease of insertion | Ease of dispensing gel | Ease of disposal | Ease of storage | Overall comfort | Overall applicator preference |
---|
Prefilled Applicator | 11 | 10 | 8 | 0 | 16 | 10 | 10 |
,Same | 4 | 3 | 9 | 6 | 6 | 4 | 0 |
,User-Filled Applicator | 10 | 12 | 8 | 19 | 3 | 11 | 15 |
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Number of Participants Reporting Applicator Easy to Insert
"Participants were asked to describe the insertion of the applicator into the vagina for each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Easy | Moderately difficult | Difficult |
---|
Prefilled Applicator | 22 | 3 | 0 |
,User-Filled Applicator | 21 | 2 | 2 |
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Number of Participants Reporting Applicator Easy to Fill
"Participants were asked to describe the process of filling the user-filled applicator.~Response categories included easy, moderately difficult, and difficult.~Since ease of filling only applies to the user-filled applicator, this question was not applicable for the prefilled applicator." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Easy | Moderately difficult | Difficult |
---|
User-Filled Applicator | 25 | 0 | 0 |
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Number of Participants Reporting That They Would Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
"Participants were asked if they would use the user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No | In some circumstances |
---|
Entire Study Population | 24 | 0 | 1 |
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Number of Colposcopic Findings (Baseline and After One Week of Product Use)
Comparison of colposcopic findings between baseline visits and after one week of twice-daily application of Tenofovir 1% gel with either a user-filled or prefilled applicator (NCT01283555)
Timeframe: 7 days
Intervention | colposcopic findings (Number) |
---|
| Petechiae | Laceration external genitalia | Peeling cervic or vagina | Petechiae (iatrogenic) | Ecchymosis left lateral vaginal wall (iatrogenic) |
---|
Baseline Colposcopic Findings | 3 | 2 | 1 | 1 | 1 |
,Colposcopic Findings After 7 Days of Product Use | 0 | 0 | 3 | 1 | 0 |
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Number of Respondents Reporting Confidence With Filling the User-filled Applicator
"Participants were asked when using the user-filled applicator, how confident did they feel that they at inserted the correct amount of gel into the applicator.~Response categories included very confident, confident, and not confident.~(Note: this question does not apply to the prefilled applicator.)" (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Very confident | Confident | Not confident |
---|
User-Filled Applicator | 4 | 21 | 0 |
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Reasons Given by Participants for Knowing When the Applicator Was Filled Correctly
"Participants were asked how did they know when the applicator was filled correctly (that is, with the right amount of gel). More than one answer was allowed.~Response categories included plunger automatically stopped, the 'FULL' line was reached, and other.~Note: this question does not apply to the prefilled applicator." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Plunger automatically stopped | The fill line/arrow was reached | Other |
---|
User-Filled Applicator | 9 | 18 | 2 |
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Number of Participants Reporting That Both Applicators Were Acceptable
"Participants were asked if both applicators were acceptable to them. Responses were either yes or no." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No |
---|
Entire Study Population | 24 | 1 |
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Filling Precision (5% Range)
A 5% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-5% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | doses (Number) |
---|
User-Filled Applicator | 69 |
Prefilled Applicator | 75 |
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Filling Precision (10% Range)
A 10% range was calculated around the average filled volumes to determine how many applicators were filled within this range (+/-10% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | doses (Number) |
---|
User-Filled Applicator | 74 |
Prefilled Applicator | 75 |
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Number of Participants Reporting That the Instructions for Use Were Helpful
"For each applicator type, participants were asked if the instructions were helpful to you.~Response categories were yes and no." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No |
---|
Prefilled Applicator | 25 | 0 |
,User-Filled Applicator | 25 | 0 |
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Filled Volume
At each dose delivery visit, the applicator was weighed, prior to vaginal insertion. For the user-filled applicator, the participant handed the applicator to the investigator after filling with gel from the multidose tube. The applicator was then weighed and returned to the participant for insertion. For the prefilled applicator, the participant inserted the plunger into the barrel, and then handed the applicator to the investigator for weighing. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | ml (Mean) |
---|
User-Filled Applicator | 4.22 |
Prefilled Applicator | 4.11 |
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Dosing Volume (Expressed Volume)
At each dose delivery visit, the applicator was weighed prior to vaginal insertion and after use. The volume of gel expressed was measured using the following data: weight of filled applicator, weight of emptied applicator, the average weight of an empty applicator, and gel density. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | ml (Mean) |
---|
User-Filled Applicator | 3.83 |
Prefilled Applicator | NA |
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Dosing Precision, 5% (Expressed Volume)
A 5% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-5% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | doses (Number) |
---|
User-Filled Applicator | 48 |
Prefilled Applicator | NA |
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Dosing Precision, 10% (Expressed Volume)
A 10% range was calculated around the average expressed volume of 3.83ml to determine how many applicators delivered a dose within this range (+/-10% of average volume) (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | doses (Number) |
---|
User-Filled Applicator | 64 |
Prefilled Applicator | NA |
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Filling Accuracy (% of Target Dose)
The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The filled volume for each applicator was compared with the intended target dose of 4.0ml. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | % of target dose filled into applicator (Number) |
---|
User-Filled Applicator | 105.5 |
Prefilled Applicator | 102.8 |
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Dosing Accuracy (% of Target Dose Delivered)
The target dose for Tenofovir gel in this study was 4.0ml, which is the volume of Tenofovir being used in current microbicide clinical trials. The average dose delivered for each applicator was compared with the intended target dose of 4.0ml. (NCT01283555)
Timeframe: 3 dose delivery measurements during 1 week of product use
Intervention | percent of target dose delivered (Number) |
---|
User-Filled Applicator | 96 |
Prefilled Applicator | NA |
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Number of Participants Reporting That the Gel Was Easy to Dispense
"Participants were asked to describe the dispensing of the gel into the vagina with each applicator (user-filled and prefilled).~Response categories included easy, moderately difficult, and difficult." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Easy | Moderately difficult | Difficult |
---|
Prefilled Applicator | 23 | 2 | 0 |
,User-Filled Applicator | 24 | 1 | 0 |
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Number of Participants Reporting That They Would Not Want to Use the User-filled Applicator in the Future if it Came With a Gel for HIV Prevention
"Participants were asked if there were any reasons that they would not want to use this user-filled applicator in the future if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No | In some circumstances |
---|
Entire Study Population | 2 | 23 | 0 |
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Number of Participants Reporting That They Would Recommend the User-filled Applicator for HIV Prevention
"Participants were asked if they would recommend the user-filled applicator to other women if it came with a gel that helped prevent HIV infection.~Response categories included yes, no, and in some circumstances." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No | In some circumstances |
---|
Entire Study Population | 25 | 0 | 0 |
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Number of Participants Reporting That the Cost of the Applicator Would Influence Their Choice of Applicator
"Participants were asked if the cost of the applicator would influence their choice of applicator.~Response categories were yes, no, and maybe." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Yes | No | Maybe |
---|
Entire Study Population | 6 | 12 | 7 |
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Number of Participants Reporting That Applicator Was Comfortable to Use
"Participants were asked to describe the comfort of use for each applicator type(user-filled and prefilled).~Response categories included comfortable, neutral, and uncomfortable." (NCT01283555)
Timeframe: Final study visit (after completing both study arms)
Intervention | participants (Number) |
---|
| Comfortable | Neutral | Uncomfortable |
---|
Prefilled Applicator | 20 | 5 | 0 |
,User-Filled Applicator | 19 | 6 | 0 |
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HCV RNA
HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg. (NCT01285050)
Timeframe: 48 hours after interferon administration
Intervention | log IU/ml (Median) |
---|
Pre ART HCV RNA Decline | 0.65 |
Post ART HCV Decline | 0.81 |
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Number of HBeAg-negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192, 240
HBsAg loss is defined as a negative HBsAg result for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Intervention | Participants (Number) |
---|
| Week 24, HBsAg loss | Week 24, HBsAg seroconversion | Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBsAg loss | Week 144, HBsAg seroconversion | Week 192, HBsAg loss | Week 192, HBsAg seroconversion | Week 240, HBsAg loss | Week 240, HBsAg seroconversion |
---|
ADV-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Histological Improvement at Weeks 48 and 240 Who Had a Baseline Knodell Necroinflammatory Score (KNS) >=2.
Histological improvement is defined as a reduction of >=2 points in the KNS with no increase in fibrosis at Week 48 and Week 240 in participants with Baseline KNS >=2 which was derived from the American Association for the Study of Liver Diseases Practice Guidelines for Management of Chronic Hepatitis B (2009) and the European Association for the Study of the Liver Clinical Practice Guidelines Management of chronic hepatitis B virus infection (2012). The Knodell scale consists of 5 domains: periportal +/- bridging necrosis (scored from best to worst: 0, 1, 3, 4, 5, 6, or 10); intralobular degeneration and focal necrosis (0 to 4); portal inflammation (0 to 4); and fibrosis (0 to 4). The necroinflammatory score (ranging from 0 [best] to 14 [worst]) is the combined score for necrosis (0 to 10) plus inflammation (0 to 4; the participant is scored for only one inflammatory condition). Liver biopsy slides within 6 months prior to randomization could be accepted as Baseline evaluation. (NCT01300234)
Timeframe: Baseline; Week 48 and Week 240
Intervention | Participants (Number) |
---|
| Week 48, HBeAg-positive, n=38, 49 | Week 48, HBeAg-negative, n=45, 50 | Week 240, HBeAg-positive, n=38, 49 | Week 240, HBeAg-negative, n=45, 50 |
---|
ADV-TDF | 39 | 34 | 2 | 4 |
,TDF-TDF | 31 | 32 | 5 | 8 |
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Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/Milliliter (mL) at Week 48
"The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) <400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
| HBeAg-positive, n=103, 99 | HBeAg-negative, n=154, 153 |
---|
ADV 10 mg | 18 | 109 |
,TDF 300 mg | 79 | 149 |
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Number of Participants in the Indicated Category for Renal Laboratory Abnormalities
"The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was used for grading. Confirmed is defined as two consecutive visits. mg=milligrams. dL=deciliter, G= Grade." (NCT01300234)
Timeframe: Up to Week 240
Intervention | Participants (Number) |
---|
| Creatinine increase of 0.5 mg/dL above Baseline | Confirmed creatinine >=2.0 mg/dL | Confirmed clearance <50 milliliters/minute | Confirmed phosphorus G 3/4 abnormality, <2.0 mg/dL |
---|
ADV-TDF | 0 | 0 | 0 | 0 |
,TDF-TDF | 1 | 0 | 0 | 3 |
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Number of Participants With the Indicated Grade 3 and Grade 4 Treatment-emergent (TE) Laboratory Abnormalities (LAs)
TE grade 3 or grade 4 LAs are defined as values that increase by >=1 grade from Baseline (Day 0) to Grade 3 (severe) or 4 (potentially life threatening) at any post-Baseline value. The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Laboratory parameters assessed included Sodium for hyponatremia and hypernatremia; Potassium for hypokalemia and hyperkalemia; glucose for hypoglycemia and hyperglycemia non-fasting; Phosphate for hypophosphatemia; alanine aminotransferase/aspartate aminotransferase, bilirubin, creatinine kinase, hemoglobin, platelets, neutrophils, lymphocytes, prothrombin time and amylase. (NCT01300234)
Timeframe: Up to Week 240
Intervention | participants (Number) |
---|
| Sodium | Phosphate | Alanine aminotransferase | Aspartate aminotransferase | Bilirubin | Creatine kinase | Hemoglobin | Platelets | Neutrophils | Prothrombin time | Potassium | Glucose | Lymphocytes | Amylase |
---|
ADV-TDF | 0 | 3 | 14 | 6 | 1 | 4 | 5 | 3 | 4 | 17 | 0 | 2 | 3 | 2 |
,TDF-TDF | 2 | 2 | 19 | 10 | 1 | 6 | 4 | 4 | 6 | 10 | 1 | 1 | 2 | 1 |
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Participants With HBV DNA <400 Copies/mL at Weeks 96, 144, 192, and 240
"The number of participants with HBV DNA <400 copies/mL in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. Week 96, 144, 192, and 240 data are not yet available, as this report includes data up to and including Week 48. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Weeks 96, 144, 192, and 240
Intervention | Participants (Number) |
---|
| Week 96, HBeAg-positive, n=103, 99 | Week 96, HBeAg-negative, n=154, 153 | Week 144, HBeAg-positive, n=103, 99 | Week 144, HBeAg-negative, n=154,153 | Week 192, HBeAg-positive, n=103,99 | Week 192,HBeAg-negative, n=154,153 | Week 240, HBeAg-positive, n=103,99 | Week 240, HBeAg-negative, n=154,153 |
---|
ADV-TDF | 92 | 143 | 95 | 145 | 93 | 141 | 87 | 137 |
,TDF-TDF | 95 | 144 | 97 | 144 | 94 | 144 | 87 | 138 |
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Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is Grade 4 (life threatening or disabling). Participants with any non-serious AEs and SAEs has been reported. (NCT01300234)
Timeframe: Up to Week 240 treatment period and 24 weeks follow-up visit off treatment
Intervention | Participants (Number) |
---|
| Non-serious AE | SAE |
---|
ADV-TDF | 121 | 20 |
,TDF-TDF | 140 | 12 |
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Number of Participants With the Indicated Treatment-emergent Laboratory Abnormalities for Serum Creatinine and Serum Phosphorus
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, version 21, September 2011 was referred for grading. Serum creatinine: Grade 1, > 133 to 177 micromoles per Liter (µmoles/Liter), Grade 2, >177 to 265 µmoles/Liter, Grade 3, >265 to 530 µmoles/Liter, Grade 4, >530 µmoles/Liter. Serum phosphorus: Grade 2, 0.63 to <0.80 millimoles per Liter (mmoles/L), Grade 3, 0.31 to <0.63 mmoles/L, Grade 4, <0.31 mmoles/L. The normal range for serum phosphorus was 0.8 to 1.45 mmoles/L; the upper limit for a Grade 2 abnormality is 0.80 mmoles/L. Therefore, no Grade 1 abnormalities could be attributed, as values were contained within the normal range. NA indicates the value was not available for the indicated time point. (NCT01300234)
Timeframe: Up to Week 240
Intervention | Participants (Number) |
---|
| Serum creatinine, Grade 1 | Serum creatinine, Grade 2 | Serum creatinine, Grade 3 | Serum creatinine, Grade 4 | Serum phosphorus, Grade 1 | Serum phosphorus, Grade 2 | Serum phosphorus, Grade 3 | Serum phosphorus, Grade 4 |
---|
ADV-TDF | 1 | 0 | 0 | 0 | NA | 55 | 3 | 0 |
,TDF-TDF | 0 | 0 | 0 | 0 | NA | 42 | 2 | 0 |
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Number of Participants With Virological Breakthrough at Weeks 48, 96, 144, 192 and 240
"The number of HBeAg-positive and HBeAg-negative participants who had virological breakthrough at Weeks 48, 96, 144, 192 and 240 were assessed. Virological breakthrough is defined by >= one log increase in HBV DNA from NADIR (as determined by two sequential HBV DNA measurements at least one month apart or last on treatment measurement). A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Weeks 48, 96, 144, 192 and 240
Intervention | Participants (Number) |
---|
| Week 48,HBeAg-Positive, n=103, 99 | Week 48, HBeAg-Negative, n=154, 153 | Week 96, HBeAg-positive, n=103, 99 | Week 96, HBeAg-negative, n=154, 153 | Week 144, HBeAg-positive, n=103, 99 | Week 144, HBeAg-negative, n=154, 153 | Week 192, HBeAg-positive, n=103, 99 | Week 192, HBeAg-negative, n=154, 153 | Week 240, HBeAg-positive, n=103, 99 | Week 240, HBeAg-negative, n=154, 153 |
---|
ADV-TDF | 4 | 2 | 4 | 3 | 7 | 4 | 7 | 5 | 11 | 8 |
,TDF-TDF | 0 | 0 | 0 | 2 | 0 | 3 | 0 | 3 | 4 | 3 |
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Change From Baseline of Log 10 Copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240
"Change from Baseline of log 10 copies/mL HBV DNA at Weeks 48, 96, 144, 192 and 240 in the HBeAg-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually a negative result indicates that the participant has lower levels of virus in the blood and less infectious. Values at Day 0 were considered as Baseline values. Change from Baseline was calculated as post Baseline values minus Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline, Weeks 48, 96, 144, 192 and 240
Intervention | log10 copies/mL (Mean) |
---|
| Week 48,HBeAg-positive, n=102, 97 | Week 48,HBeAg-negative, n=151, 148 | Week 96, HBeAg-positive, n=101, 97 | Week 96, HBeAg-negative, n=147,148 | Week 144, HBeAg-postive, n=100, 96 | Week 144, HBeAg-negative, n=145, 146 | Week 192, HBeAg-positive, n=97,93 | Week 192, HBeAg-negative, n=145,145 | Week 240, HBeAg-positive, n=91,90 | Week 240, HBeAg-negative, n=138,138 |
---|
ADV-TDF | -4.4 | -4.3 | -6.5 | -4.8 | -6.5 | -4.9 | -6.6 | -4.8 | -6.5 | -4.9 |
,TDF-TDF | -6.4 | -4.9 | -6.5 | -4.9 | -6.6 | -4.9 | -6.6 | -4.9 | -6.6 | -4.9 |
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Number of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, 144, 192 and 240 in Participants Who Had Abnormal ALT at Baseline
"Participants who had abnormal ALT at Baseline and had normalized ALT at Weeks 48, 96, 144, 192 and 240 were assessed. This report includes data up to and including Weeks 48, 96, 144, 192 and 240. An increased level of ALT is referred to as abnormal ALT (the normal range is 0 to 48 units per liter [U/L]). Values at Day 0 were considered as Baseline values. A non-completers equal failures approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed." (NCT01300234)
Timeframe: Baseline; Weeks 48, 96, 144, 192 and 240
Intervention | Participants (Number) |
---|
| Week 48, HBeAg-positive, n=102, 97 | Week 48, HBeAg-negative, n=136, 132 | Week 96, HBeAg-positive, n=102, 97 | Week 96, HBeAg-negative, n=136,132 | Week 144, HBeAg-positive, n=102, 97 | Week 144, HBeAg-negative, n=136, 132 | Week 192, HBeAg-positive, n=102, 97 | Week 192, HBeAg-negative, n=136,132 | Week 240, HBeAg-positive, n=102, 97 | Week 240, HBeAg-negative, n=136,132 |
---|
ADV-TDF | 83 | 116 | 88 | 118 | 87 | 119 | 79 | 118 | 80 | 111 |
,TDF-TDF | 88 | 120 | 93 | 126 | 92 | 123 | 89 | 125 | 82 | 119 |
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Number of Participants Achieving Durable HBsAg Loss From Weeks 96 to Week 240
"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart from Week 96 to 240. This report includes data up to and including Week 240. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 96 to Week 240
Intervention | Participants (Number) |
---|
| HBeAg-positive, n= 88, 90 | HBeAg-negative, n = 132, 137 |
---|
ADV-TDF | 0 | 1 |
,TDF-TDF | 1 | 0 |
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Number of Participants Achieving Durable HBsAg Loss From Weeks 24 to Week 48
"Durable HBsAg loss is defined as the loss of HBsAg and no detectable HBV DNA and ALT normalization at any three consecutive visits at least 12 Weeks apart. This report includes data up to and including Week 48. A non-completers equal failures approach was used for the analysis in ITT population." (NCT01300234)
Timeframe: Week 24 to Week 48
Intervention | Participants (Number) |
---|
| HBeAg-positive, n =100, 97 | HBeAg-negative, n=150, 147 |
---|
ADV 10 mg | 0 | 0 |
,TDF 300 mg | 0 | 0 |
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Number of HBeAg-positive Participants Achieving Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240
HBsAg loss is defined as negative HBsAg results for those participants with who were HBsAg positive at Baseline. Seroconversion to anti-HBs is defined as HBsAg loss and a positive anti-HBs result. This report includes data up to and including Week 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Intervention | Participants (Number) |
---|
| Week 24, HBsAg loss | Week 24, HBsAg seroconversion | Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBsAg loss | Week 144, HBaAg seroconversion | Week 192, HBsAg, loss | Week 192, HBsAg, seroconversion | Week 240, HBsAg loss | Week 240 HBsAg seroconversion |
---|
ADV-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
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Number of HBeAg-positive Participants Achieving HBeAg Loss and HBeAg Seroconversion at Weeks 24, 48, 96, 144, 192 and 240.
HBeAg loss is defined as a negative HBeAg result for those participants who were HBeAg positive at Baseline. Seroconversion to anti-HBe is defined as HBeAg loss and a positive anti-HBe result. This report includes data up to and including Weeks 24, 48, 96, 144, 192 and 240. (NCT01300234)
Timeframe: Weeks 24, 48, 96, 144, 192 and 240
Intervention | Participants (Number) |
---|
| Week 24, HBeAg loss | Week 24, HBeAg seroconversion | Week 48, HBeAg loss | Week 48, HBeAg seroconversion | Week 96, HBeAg loss | Week 96, HBeAg seroconversion | Week 144, HBeAg loss | Week 144, HBeAg seroconversion | Week 192, HBeAg loss | Week 192, HBeAg seroconversion | Week 240, HBeAg loss | Week 240, HBeAg seroconversion |
---|
ADV-TDF | 4 | 4 | 10 | 9 | 21 | 18 | 24 | 20 | 31 | 24 | 36 | 28 |
,TDF-TDF | 15 | 14 | 18 | 16 | 37 | 32 | 37 | 33 | 43 | 33 | 43 | 33 |
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A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Blood and lymphatic system disorders : Mild72291137 | Blood and lymphatic system disorders : Mild72291143 | Blood and lymphatic system disorders : Mild72291138 | Blood and lymphatic system disorders : Mild72291139 | Blood and lymphatic system disorders : Mild72291140 | Blood and lymphatic system disorders : Mild72291141 | Blood and lymphatic system disorders : Mild72291142 | Blood and lymphatic system disorders : Mild72291144 | Blood and lymphatic system disorders : Mild72291145 | Cardiac disorders72291137 | Cardiac disorders72291143 | Cardiac disorders72291138 | Cardiac disorders72291139 | Cardiac disorders72291140 | Cardiac disorders72291141 | Cardiac disorders72291142 | Cardiac disorders72291144 | Cardiac disorders72291145 | Ear and labyrinth disorders72291137 | Ear and labyrinth disorders72291143 | Ear and labyrinth disorders72291144 | Ear and labyrinth disorders72291142 | Ear and labyrinth disorders72291138 | Ear and labyrinth disorders72291139 | Ear and labyrinth disorders72291140 | Ear and labyrinth disorders72291141 | Ear and labyrinth disorders72291145 | Eye disorders72291137 | Eye disorders72291143 | Eye disorders72291138 | Eye disorders72291139 | Eye disorders72291140 | Eye disorders72291141 | Eye disorders72291142 | Eye disorders72291144 | Eye disorders72291145 | Gastrointestinal disorders72291137 | Gastrointestinal disorders72291143 | Gastrointestinal disorders72291142 | Gastrointestinal disorders72291138 | Gastrointestinal disorders72291139 | Gastrointestinal disorders72291140 | Gastrointestinal disorders72291141 | Gastrointestinal disorders72291144 | Gastrointestinal disorders72291145 | General disorders and administration site conditio72291137 | General disorders and administration site conditio72291142 | General disorders and administration site conditio72291143 | General disorders and administration site conditio72291140 | General disorders and administration site conditio72291138 | General disorders and administration site conditio72291139 | General disorders and administration site conditio72291141 | General disorders and administration site conditio72291144 | General disorders and administration site conditio72291145 | Hepatobiliary disorders72291137 | Hepatobiliary disorders72291142 | Hepatobiliary disorders72291143 | Hepatobiliary disorders72291138 | Hepatobiliary disorders72291139 | Hepatobiliary disorders72291140 | Hepatobiliary disorders72291141 | Hepatobiliary disorders72291144 | Hepatobiliary disorders72291145 | Immune system disorders72291137 | Immune system disorders72291142 | Immune system disorders72291143 | Immune system disorders72291138 | Immune system disorders72291139 | Immune system disorders72291140 | Immune system disorders72291141 | Immune system disorders72291144 | Immune system disorders72291145 | Infections and infestations72291137 | Infections and infestations72291142 | Infections and infestations72291143 | Infections and infestations72291138 | Infections and infestations72291139 | Infections and infestations72291140 | Infections and infestations72291141 | Infections and infestations72291144 | Infections and infestations72291145 | Injury, poisoning and procedural complications72291137 | Injury, poisoning and procedural complications72291142 | Injury, poisoning and procedural complications72291138 | Injury, poisoning and procedural complications72291139 | Injury, poisoning and procedural complications72291140 | Injury, poisoning and procedural complications72291141 | Injury, poisoning and procedural complications72291143 | Injury, poisoning and procedural complications72291144 | Injury, poisoning and procedural complications72291145 | Investigations72291137 | Investigations72291142 | Investigations72291138 | Investigations72291139 | Investigations72291140 | Investigations72291141 | Investigations72291143 | Investigations72291144 | Investigations72291145 | Metabolism and nutrition disorders72291137 | Metabolism and nutrition disorders72291142 | Metabolism and nutrition disorders72291141 | Metabolism and nutrition disorders72291138 | Metabolism and nutrition disorders72291139 | Metabolism and nutrition disorders72291140 | Metabolism and nutrition disorders72291143 | Metabolism and nutrition disorders72291144 | Metabolism and nutrition disorders72291145 | Musculoskeletal and connective tissue disorders72291137 | Musculoskeletal and connective tissue disorders72291142 | Musculoskeletal and connective tissue disorders72291138 | Musculoskeletal and connective tissue disorders72291139 | Musculoskeletal and connective tissue disorders72291140 | Musculoskeletal and connective tissue disorders72291141 | Musculoskeletal and connective tissue disorders72291143 | Musculoskeletal and connective tissue disorders72291144 | Musculoskeletal and connective tissue disorders72291145 | Nervous system disorders72291137 | Nervous system disorders72291142 | Nervous system disorders72291141 | Nervous system disorders72291138 | Nervous system disorders72291139 | Nervous system disorders72291140 | Nervous system disorders72291143 | Nervous system disorders72291144 | Nervous system disorders72291145 | Pregnancy, puerperium and perinatal conditions72291137 | Pregnancy, puerperium and perinatal conditions72291142 | Pregnancy, puerperium and perinatal conditions72291140 | Pregnancy, puerperium and perinatal conditions72291144 | Pregnancy, puerperium and perinatal conditions72291141 | Pregnancy, puerperium and perinatal conditions72291138 | Pregnancy, puerperium and perinatal conditions72291139 | Pregnancy, puerperium and perinatal conditions72291143 | Pregnancy, puerperium and perinatal conditions72291145 | Psychiatric disorders72291141 | Psychiatric disorders72291142 | Psychiatric disorders72291137 | Psychiatric disorders72291144 | Psychiatric disorders72291143 | Psychiatric disorders72291138 | Psychiatric disorders72291139 | Psychiatric disorders72291140 | Psychiatric disorders72291145 | Renal and urinary disorders72291137 | Renal and urinary disorders72291142 | Renal and urinary disorders72291139 | Renal and urinary disorders72291138 | Renal and urinary disorders72291140 | Renal and urinary disorders72291141 | Renal and urinary disorders72291143 | Renal and urinary disorders72291144 | Renal and urinary disorders72291145 | Reproductive system and breast disorders72291137 | Reproductive system and breast disorders72291140 | Reproductive system and breast disorders72291142 | Reproductive system and breast disorders72291138 | Reproductive system and breast disorders72291139 | Reproductive system and breast disorders72291143 | Reproductive system and breast disorders72291145 | Reproductive system and breast disorders72291141 | Reproductive system and breast disorders72291144 | Respiratory, thoracic and mediastinal disorders72291137 | Respiratory, thoracic and mediastinal disorders72291142 | Respiratory, thoracic and mediastinal disorders72291145 | Respiratory, thoracic and mediastinal disorders72291140 | Respiratory, thoracic and mediastinal disorders72291138 | Respiratory, thoracic and mediastinal disorders72291139 | Respiratory, thoracic and mediastinal disorders72291141 | Respiratory, thoracic and mediastinal disorders72291143 | Respiratory, thoracic and mediastinal disorders72291144 | Skin and subcutaneous tissue disorders72291137 | Skin and subcutaneous tissue disorders72291138 | Skin and subcutaneous tissue disorders72291142 | Skin and subcutaneous tissue disorders72291140 | Skin and subcutaneous tissue disorders72291139 | Skin and subcutaneous tissue disorders72291141 | Skin and subcutaneous tissue disorders72291143 | Skin and subcutaneous tissue disorders72291144 | Skin and subcutaneous tissue disorders72291145 | Social circumstances72291142 | Social circumstances72291145 | Social circumstances72291137 | Social circumstances72291138 | Social circumstances72291139 | Social circumstances72291140 | Social circumstances72291141 | Social circumstances72291143 | Social circumstances72291144 | Vascular disorders72291142 | Vascular disorders72291137 | Vascular disorders72291141 | Vascular disorders72291140 | Vascular disorders72291144 | Vascular disorders72291138 | Vascular disorders72291139 | Vascular disorders72291143 | Vascular disorders72291145 | Neoplasms benign, malignant, and unspecified72291144 | Neoplasms benign, malignant, and unspecified72291139 | Neoplasms benign, malignant, and unspecified72291141 | Neoplasms benign, malignant, and unspecified72291138 | Neoplasms benign, malignant, and unspecified72291140 | Neoplasms benign, malignant, and unspecified72291143 | Neoplasms benign, malignant, and unspecified72291137 | Neoplasms benign, malignant, and unspecified72291142 | Neoplasms benign, malignant, and unspecified72291145 |
---|
| Severe | Potentically Life Threatening | Death | None | Mild | Moderate |
---|
Daily Dosing, Cape Town | 1 |
Time-driven Dosing, Harlem | 2 |
Daily Dosing, Cape Town | 0 |
Daily Dosing, Cape Town | 57 |
Time-driven Dosing, Harlem | 58 |
Daily Dosing, Cape Town | 59 |
Daily Dosing, Bangkok | 58 |
Time-driven Dosing, Harlem | 60 |
Time-driven Dosing, Harlem | 0 |
Daily Dosing, Cape Town | 58 |
Daily Dosing, Cape Town | 2 |
Daily Dosing, Cape Town | 55 |
Time-driven Dosing, Cape Town | 57 |
Event-driven Dosing, Harlem | 58 |
Daily Dosing, Cape Town | 18 |
Event-driven Dosing, Cape Town | 18 |
Time-driven Dosing, Bangkok | 22 |
Event-driven Dosing, Bangkok | 23 |
Daily Dosing, Harlem | 28 |
Time-driven Dosing, Harlem | 27 |
Event-driven Dosing, Harlem | 28 |
Daily Dosing, Cape Town | 8 |
Time-driven Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 6 |
Event-driven Dosing, Bangkok | 0 |
Daily Dosing, Cape Town | 33 |
Time-driven Dosing, Cape Town | 32 |
Event-driven Dosing, Cape Town | 32 |
Daily Dosing, Bangkok | 30 |
Time-driven Dosing, Bangkok | 35 |
Event-driven Dosing, Bangkok | 32 |
Daily Dosing, Harlem | 30 |
Time-driven Dosing, Harlem | 31 |
Event-driven Dosing, Harlem | 31 |
Daily Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 10 |
Time-driven Dosing, Bangkok | 16 |
Event-driven Dosing, Bangkok | 11 |
Event-driven Dosing, Harlem | 8 |
Event-driven Dosing, Cape Town | 5 |
Event-driven Dosing, Bangkok | 1 |
Daily Dosing, Cape Town | 50 |
Time-driven Dosing, Bangkok | 43 |
Event-driven Dosing, Bangkok | 47 |
Time-driven Dosing, Cape Town | 58 |
Time-driven Dosing, Bangkok | 58 |
Event-driven Dosing, Bangkok | 59 |
Event-driven Dosing, Cape Town | 58 |
Time-driven Dosing, Bangkok | 59 |
Time-driven Dosing, Harlem | 59 |
Event-driven Dosing, Harlem | 59 |
Daily Dosing, Cape Town | 11 |
Time-driven Dosing, Cape Town | 10 |
Event-driven Dosing, Cape Town | 15 |
Daily Dosing, Bangkok | 22 |
Time-driven Dosing, Bangkok | 33 |
Event-driven Dosing, Bangkok | 28 |
Daily Dosing, Harlem | 22 |
Time-driven Dosing, Harlem | 21 |
Event-driven Dosing, Harlem | 21 |
Daily Dosing, Cape Town | 25 |
Time-driven Dosing, Cape Town | 25 |
Event-driven Dosing, Cape Town | 21 |
Time-driven Dosing, Bangkok | 6 |
Event-driven Dosing, Bangkok | 10 |
Event-driven Dosing, Bangkok | 2 |
Daily Dosing, Cape Town | 23 |
Time-driven Dosing, Cape Town | 24 |
Event-driven Dosing, Cape Town | 24 |
Daily Dosing, Bangkok | 27 |
Time-driven Dosing, Bangkok | 19 |
Event-driven Dosing, Bangkok | 19 |
Daily Dosing, Harlem | 37 |
Time-driven Dosing, Harlem | 39 |
Event-driven Dosing, Harlem | 37 |
Daily Dosing, Cape Town | 7 |
Daily Dosing, Bangkok | 16 |
Time-driven Dosing, Bangkok | 15 |
Event-driven Dosing, Bangkok | 14 |
Daily Dosing, Harlem | 17 |
Time-driven Dosing, Harlem | 18 |
Event-driven Dosing, Harlem | 14 |
Daily Dosing, Cape Town | 3 |
Daily Dosing, Cape Town | 48 |
Daily Dosing, Bangkok | 44 |
Time-driven Dosing, Bangkok | 41 |
Event-driven Dosing, Bangkok | 44 |
Daily Dosing, Harlem | 38 |
Event-driven Dosing, Harlem | 45 |
Daily Dosing, Cape Town | 13 |
Time-driven Dosing, Cape Town | 15 |
Event-driven Dosing, Cape Town | 13 |
Daily Dosing, Bangkok | 18 |
Time-driven Dosing, Bangkok | 9 |
Event-driven Dosing, Bangkok | 7 |
Event-driven Dosing, Harlem | 6 |
Daily Dosing, Cape Town | 5 |
Time-driven Dosing, Cape Town | 6 |
Daily Dosing, Bangkok | 5 |
Time-driven Dosing, Bangkok | 2 |
Event-driven Dosing, Bangkok | 3 |
Event-driven Dosing, Harlem | 2 |
Daily Dosing, Cape Town | 41 |
Time-driven Dosing, Cape Town | 38 |
Daily Dosing, Bangkok | 35 |
Time-driven Dosing, Bangkok | 47 |
Event-driven Dosing, Bangkok | 48 |
Daily Dosing, Harlem | 50 |
Event-driven Dosing, Cape Town | 7 |
Time-driven Dosing, Bangkok | 1 |
Daily Dosing, Harlem | 3 |
Daily Dosing, Cape Town | 6 |
Event-driven Dosing, Cape Town | 10 |
Time-driven Dosing, Harlem | 3 |
Event-driven Dosing, Harlem | 4 |
Time-driven Dosing, Bangkok | 0 |
Time-driven Dosing, Cape Town | 49 |
Event-driven Dosing, Cape Town | 43 |
Event-driven Dosing, Bangkok | 58 |
Daily Dosing, Harlem | 52 |
Time-driven Dosing, Harlem | 53 |
Daily Dosing, Bangkok | 13 |
Event-driven Dosing, Bangkok | 13 |
Daily Dosing, Harlem | 13 |
Time-driven Dosing, Harlem | 11 |
Event-driven Dosing, Harlem | 9 |
Daily Dosing, Bangkok | 4 |
Time-driven Dosing, Cape Town | 51 |
Daily Dosing, Bangkok | 43 |
Time-driven Dosing, Harlem | 49 |
Event-driven Dosing, Harlem | 51 |
Daily Dosing, Cape Town | 17 |
Time-driven Dosing, Cape Town | 14 |
Event-driven Dosing, Cape Town | 19 |
Daily Dosing, Bangkok | 17 |
Time-driven Dosing, Bangkok | 18 |
Event-driven Dosing, Bangkok | 22 |
Daily Dosing, Harlem | 16 |
Time-driven Dosing, Harlem | 10 |
Event-driven Dosing, Harlem | 17 |
Daily Dosing, Cape Town | 15 |
Event-driven Dosing, Cape Town | 12 |
Daily Dosing, Bangkok | 3 |
Daily Dosing, Cape Town | 27 |
Event-driven Dosing, Cape Town | 29 |
Daily Dosing, Bangkok | 39 |
Event-driven Dosing, Bangkok | 36 |
Daily Dosing, Harlem | 42 |
Time-driven Dosing, Harlem | 47 |
Event-driven Dosing, Harlem | 43 |
Time-driven Dosing, Bangkok | 10 |
Event-driven Dosing, Bangkok | 8 |
Daily Dosing, Harlem | 10 |
Time-driven Dosing, Harlem | 9 |
Event-driven Dosing, Cape Town | 2 |
Time-driven Dosing, Harlem | 1 |
Time-driven Dosing, Cape Town | 56 |
Event-driven Dosing, Cape Town | 56 |
Daily Dosing, Bangkok | 52 |
Time-driven Dosing, Bangkok | 49 |
Event-driven Dosing, Bangkok | 51 |
Daily Dosing, Harlem | 46 |
Time-driven Dosing, Harlem | 48 |
Daily Dosing, Cape Town | 10 |
Time-driven Dosing, Cape Town | 11 |
Event-driven Dosing, Cape Town | 11 |
Daily Dosing, Bangkok | 1 |
Time-driven Dosing, Bangkok | 3 |
Daily Dosing, Harlem | 12 |
Time-driven Dosing, Harlem | 6 |
Event-driven Dosing, Harlem | 7 |
Daily Dosing, Cape Town | 4 |
Event-driven Dosing, Cape Town | 3 |
Time-driven Dosing, Harlem | 4 |
Event-driven Dosing, Harlem | 1 |
Daily Dosing, Cape Town | 45 |
Time-driven Dosing, Cape Town | 46 |
Event-driven Dosing, Cape Town | 46 |
Daily Dosing, Bangkok | 59 |
Time-driven Dosing, Bangkok | 55 |
Event-driven Dosing, Bangkok | 56 |
Daily Dosing, Harlem | 47 |
Time-driven Dosing, Harlem | 50 |
Event-driven Dosing, Harlem | 52 |
Time-driven Dosing, Cape Town | 17 |
Event-driven Dosing, Cape Town | 17 |
Daily Dosing, Harlem | 1 |
Event-driven Dosing, Harlem | 3 |
Daily Dosing, Cape Town | 39 |
Time-driven Dosing, Cape Town | 34 |
Event-driven Dosing, Cape Town | 34 |
Event-driven Dosing, Bangkok | 57 |
Daily Dosing, Harlem | 58 |
Event-driven Dosing, Harlem | 57 |
Time-driven Dosing, Cape Town | 5 |
Event-driven Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 36 |
Time-driven Dosing, Bangkok | 23 |
Event-driven Dosing, Bangkok | 29 |
Daily Dosing, Harlem | 18 |
Time-driven Dosing, Harlem | 19 |
Event-driven Dosing, Harlem | 18 |
Time-driven Dosing, Cape Town | 2 |
Daily Dosing, Cape Town | 49 |
Time-driven Dosing, Cape Town | 52 |
Event-driven Dosing, Cape Town | 50 |
Daily Dosing, Bangkok | 24 |
Time-driven Dosing, Bangkok | 36 |
Daily Dosing, Harlem | 41 |
Time-driven Dosing, Harlem | 41 |
Event-driven Dosing, Harlem | 42 |
Time-driven Dosing, Cape Town | 8 |
Event-driven Dosing, Cape Town | 8 |
Daily Dosing, Bangkok | 8 |
Daily Dosing, Harlem | 8 |
Time-driven Dosing, Harlem | 5 |
Event-driven Dosing, Harlem | 5 |
Event-driven Dosing, Cape Town | 4 |
Daily Dosing, Bangkok | 2 |
Time-driven Dosing, Cape Town | 48 |
Event-driven Dosing, Cape Town | 48 |
Daily Dosing, Bangkok | 50 |
Time-driven Dosing, Bangkok | 44 |
Event-driven Dosing, Bangkok | 46 |
Daily Dosing, Harlem | 51 |
Time-driven Dosing, Harlem | 55 |
Event-driven Dosing, Harlem | 55 |
Time-driven Dosing, Cape Town | 59 |
Event-driven Dosing, Cape Town | 60 |
Daily Dosing, Harlem | 59 |
Time-driven Dosing, Cape Town | 3 |
Event-driven Dosing, Cape Town | 1 |
Daily Dosing, Harlem | 2 |
Time-driven Dosing, Cape Town | 1 |
Daily Dosing, Bangkok | 0 |
Time-driven Dosing, Cape Town | 0 |
Event-driven Dosing, Cape Town | 0 |
Daily Dosing, Harlem | 0 |
Event-driven Dosing, Harlem | 0 |
Daily Dosing, Cape Town | 56 |
Time-driven Dosing, Cape Town | 55 |
Event-driven Dosing, Cape Town | 59 |
Daily Dosing, Bangkok | 60 |
Daily Dosing, Harlem | 57 |
Event-driven Dosing, Harlem | 60 |
[back to top]
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week (NCT01327651)
Timeframe: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
Intervention | Participants (Count of Participants) |
---|
| Week 10 | Week 18 | Week 30 |
---|
Daily Dosing, Bangkok | 31 | 28 | 22 |
,Daily Dosing, Cape Town | 33 | 29 | 19 |
,Daily Dosing, Harlem | 13 | 11 | 9 |
,Event-driven Dosing, Bangkok | 30 | 24 | 13 |
,Event-driven Dosing, Cape Town | 25 | 10 | 12 |
,Event-driven Dosing, Harlem | 5 | 3 | 3 |
,Time-driven Dosing, Bangkok | 29 | 30 | 18 |
,Time-driven Dosing, Cape Town | 16 | 16 | 13 |
,Time-driven Dosing, Harlem | 8 | 10 | 3 |
[back to top]
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
"Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm." (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | percentage of sexual exposures (Number) |
---|
| % completely covered | % pre-exposure coverage | % post-exposure coverage | % uncovered |
---|
Daily Dosing, Bangkok | 85 | 11 | 1 | 3 |
,Daily Dosing, Cape Town | 75 | 21 | 1 | 3 |
,Daily Dosing, Harlem | 66 | 24 | 2 | 8 |
,Event-driven Dosing, Bangkok | 74 | 19 | 5 | 3 |
,Event-driven Dosing, Cape Town | 52 | 33 | 8 | 7 |
,Event-driven Dosing, Harlem | 52 | 29 | 6 | 13 |
,Time-driven Dosing, Bangkok | 84 | 12 | 3 | 1 |
,Time-driven Dosing, Cape Town | 56 | 30 | 9 | 5 |
,Time-driven Dosing, Harlem | 47 | 30 | 8 | 15 |
[back to top]
Self-reported Side Effect or Symptom Scores
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | percent of visits between week 6 to 30 (Number) |
---|
| Neurologic side effect | Gastrointestinal side effects |
---|
Daily Dosing, Bangkok | 14.2 | 13.1 |
,Daily Dosing, Cape Town | 12.4 | 10.6 |
,Daily Dosing, Harlem | 6.1 | 8 |
,Event-driven Dosing, Bangkok | 13.3 | 10.5 |
,Event-driven Dosing, Cape Town | 7.8 | 5.4 |
,Event-driven Dosing, Harlem | 4.5 | 7.1 |
,Time-driven Dosing, Bangkok | 14.3 | 8.5 |
,Time-driven Dosing, Cape Town | 6.0 | 8.8 |
,Time-driven Dosing, Harlem | 3.3 | 5.8 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study. (NCT01327651)
Timeframe: From enrollment to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Before Randomization72291147 | Before Randomization72291146 | Before Randomization72291148 | After Randomization (Daily dosing)72291146 | After Randomization (Daily dosing)72291147 | After Randomization (Daily dosing)72291148 | After Randomization (Time-driven dosing)72291147 | After Randomization (Time-driven dosing)72291146 | After Randomization (Time-driven dosing)72291148 | After Randomization (Event-driven dosing)72291147 | After Randomization (Event-driven dosing)72291146 | After Randomization (Event-driven dosing)72291148 |
---|
| Drug Resistance | No Drug Resistance |
---|
Cape Town, South Africa | 1 |
Bangkok, Thailand | 0 |
Harlem, United States | 1 |
Cape Town, South Africa | 190 |
Bangkok, Thailand | 193 |
Harlem, United States | 237 |
Harlem, United States | 0 |
Cape Town, South Africa | 59 |
Bangkok, Thailand | 60 |
Harlem, United States | 59 |
Cape Town, South Africa | 58 |
Harlem, United States | 60 |
Cape Town, South Africa | 0 |
Cape Town, South Africa | 60 |
Bangkok, Thailand | 59 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 |
---|
Harlem, United States, Seroconverted Participant #2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #6 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 |
---|
Cape Town, South Africa, Seroconverted Participant #1 | 0 | 1 |
,Harlem, United States, Seroconverted Participant #1 | 0 | 1 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Bangkok, Thailand, Seroconverted Participant #1 | 40 | 749590 | 92960 | 1799950 | 119720 | 127330 | 178070 | 96180 | 36140 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 5 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #2 | 400 | 3667690 | 3938670 | 93040 | 93660 | 114520 | 178210 | 89970 | 35210 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 6 | Week 10 | Week 14 | Week 18 | Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #4 | 400 | 400 | 400 | 650 | 400 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #6 | 2100 | 3710 | 127480 | 220830 | 193130 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Day 3 | Week 4 | Week 5 | Week 10 |
---|
Cape Town, South Africa, Seroconverted Participant #1 | 20 | 400 | 3460 | 5732050 | 416070 |
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A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm. (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Blood and lymphatic system disorders | Cardiac disorders | Ear and labyrinth disorders | Eye disorders | Gastrointestinal disorders | General disorders and administration site conditio | Hepatobiliary disorders | Immune system disorders | Infections and infestations | Injury, poisoning and procedural complications | Investigations | Metabolism and nutrition disorders | Musculoskeletal and connective tissue disorders | Neoplasms benign, malignant, and unspecified | Nervous system disorders | Pregnancy, puerperium and perinatal conditions | Psychiatric disorders | Renal and urinary disorders | Reproductive system and breast disorders | Respiratory, thoracic and mediastinal disorders | Skin and subcutaneous tissue disorders | Social circumstances | Vascular disorders |
---|
Daily Dosing, Bangkok | 0 | 1 | 0 | 1 | 9 | 1 | 0 | 0 | 0 | 10 | 23 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 |
,Daily Dosing, Cape Town | 0 | 0 | 0 | 0 | 18 | 4 | 0 | 0 | 1 | 3 | 10 | 2 | 1 | 0 | 17 | 0 | 3 | 10 | 1 | 2 | 4 | 0 | 0 |
,Daily Dosing, Harlem | 0 | 0 | 0 | 0 | 13 | 3 | 0 | 0 | 0 | 13 | 9 | 4 | 0 | 0 | 7 | 0 | 2 | 8 | 0 | 2 | 1 | 0 | 1 |
,Event-driven Dosing, Bangkok | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 10 | 10 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 |
,Event-driven Dosing, Cape Town | 0 | 0 | 0 | 0 | 24 | 6 | 0 | 1 | 2 | 7 | 12 | 6 | 0 | 0 | 21 | 0 | 1 | 10 | 1 | 2 | 3 | 0 | 0 |
,Event-driven Dosing, Harlem | 1 | 0 | 0 | 0 | 16 | 4 | 0 | 0 | 0 | 10 | 7 | 5 | 3 | 0 | 5 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 0 |
,Time-driven Dosing, Bangkok | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 7 | 12 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Time-driven Dosing, Cape Town | 2 | 0 | 0 | 0 | 17 | 1 | 0 | 0 | 0 | 4 | 13 | 5 | 0 | 0 | 17 | 0 | 1 | 5 | 0 | 1 | 5 | 0 | 0 |
,Time-driven Dosing, Harlem | 2 | 0 | 0 | 0 | 13 | 9 | 0 | 0 | 0 | 16 | 9 | 5 | 0 | 0 | 4 | 0 | 2 | 9 | 0 | 0 | 2 | 0 | 0 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 5 | Week 6 |
---|
Bangkok, Thailand, Seroconverted Participant #2 | 78450 | 710 | 1570 | 5070 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 6 |
---|
Harlem, United States, Seroconverted Participant #1 | 400 | 40900 | 83260 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #3 | 503950 | 10910 |
,Cape Town, South Africa, Seroconverted Participant #8 | 400 | 400 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 14 | Week 18 |
---|
Harlem, United States, Seroconverted Participant #2 | 1567040 | 73030 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #5 | 5887760 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 |
---|
Cape Town, South Africa, Seroconverted Participant #3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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The Total Pills Actually Used Over the Follow-up Period
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Number of pills actually used (Number) |
---|
Daily Dosing, Cape Town | 7349 |
Time-driven Dosing, Cape Town | 2852 |
Event-driven Dosing, Cape Town | 2000 |
Daily Dosing, Bangkok | 8285 |
Time-driven Dosing, Bangkok | 3713 |
Event-driven Dosing, Bangkok | 2157 |
Daily Dosing, Harlem | 5507 |
Time-driven Dosing, Harlem | 2468 |
Event-driven Dosing, Harlem | 2356 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 |
---|
Bangkok, Thailand, Seroconverted Participant #2 | 0 | 0 | 0 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 6 |
---|
Bangkok, Thailand, Seroconverted Participant #1 | 0 | 0 | 0 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 |
---|
Cape Town, South Africa, Seroconverted Participant #2 | 0 | 0 | 0 | 0 |
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The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
(NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | % of Correctly Timed Adherence (Number) |
---|
Daily Dosing, Cape Town | 75 |
Time-driven Dosing, Cape Town | 65 |
Event-driven Dosing, Cape Town | 53 |
Daily Dosing, Bangkok | 85 |
Time-driven Dosing, Bangkok | 79 |
Event-driven Dosing, Bangkok | 65 |
Daily Dosing, Harlem | 65 |
Time-driven Dosing, Harlem | 47 |
Event-driven Dosing, Harlem | 41 |
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The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
"Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)" (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Number of pills needed for 100% coverage (Number) |
---|
Daily Dosing, Cape Town | 2097 |
Time-driven Dosing, Cape Town | 1552 |
Event-driven Dosing, Cape Town | 1906 |
Daily Dosing, Bangkok | 1746 |
Time-driven Dosing, Bangkok | 1573 |
Event-driven Dosing, Bangkok | 1268 |
Daily Dosing, Harlem | 1244 |
Time-driven Dosing, Harlem | 1390 |
Event-driven Dosing, Harlem | 1582 |
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A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #7 | 83010 | 136310 | 25020 | 29390 |
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Mean Changes in Fasting Lipid Levels From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein. (NCT01332227)
Timeframe: From Baseline to Week 48
Intervention | mg/dL (Mean) |
---|
| Fasting total cholesterol | Fasting LDL cholesterol | Fasting HDL cholesterol | Fasting non-HDL cholesterol | Fasting triglycerides |
---|
Atazanavir/Ritonavir + Raltegravir | 11.7 | 7.7 | 2.7 | 9.0 | 14.7 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | -10.2 | -5.4 | -0.3 | -9.8 | -17.6 |
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. (NCT01332227)
Timeframe: From Day 1 to Week 24
Intervention | Percentage of participants (Number) |
---|
Atazanavir/Ritonavir + Raltegravir | 80.6 |
Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 94.6 |
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. (NCT01332227)
Timeframe: From Day 1 to Week 48
Intervention | Percentage of participants (Number) |
---|
Atazanavir/Ritonavir + Raltegravir | 69.4 |
Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 86.5 |
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 48
Intervention | Participants (Number) |
---|
| Genotypable (GI)/phenotypable isolates (PI) | Emergent genotypic substitutions in GI pts (n=5,0) | Phenotypic resistance in PI pts (n=5,0) |
---|
Atazanavir/Ritonavir + Raltegravir | 5 | 5 | 1 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 0 |
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Number of Participants With Virologic Rebound at Weeks 24 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. (NCT01332227)
Timeframe: Day 1 to Weeks 28 and 48
Intervention | Participants (Number) |
---|
| Week 24: Virologic rebound | Week 48: Virologic rebound |
---|
Atazanavir/Ritonavir + Raltegravir | 7 | 9 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 1 | 1 |
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 24
Intervention | Participants (Number) |
---|
| Genotypable (GI)/phenotypable isolates (PI) | Emergent genotypic substitutions in GI pts (n=4,0) | Phenotypic resistance in PI pts (n=4,0) |
---|
Atazanavir/Ritonavir + Raltegravir | 4 | 4 | 1 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 0 |
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Cerebral Function; Changes in Global Cognitive Z-score
"Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.~Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion." (NCT01335620)
Timeframe: 6 months
Intervention | score on a scale (Mean) |
---|
Truvada Plus Raltegravir | 0.91 |
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Drug Levels in Blood
rategravir concentration (NCT01335620)
Timeframe: Day 28
Intervention | ng/ml (Geometric Mean) |
---|
Truvada Plus Raltegravir | 1732 |
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Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22
Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Intervention | ng/mL (Geometric Mean) |
---|
Tenofovir/Faldaprevir | 31000 |
Faldaprevir | 40000 |
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Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Intervention | ng*h/mL (Geometric Mean) |
---|
Tenofovir | 2700 |
Tenofovir/Faldaprevir | 3290 |
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Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22
Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Intervention | ng*h/mL (Geometric Mean) |
---|
Tenofovir/Faldaprevir | 418000 |
Faldaprevir | 523000 |
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Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG
"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.~Preferred term of relevant AE: Presyncope" (NCT01340196)
Timeframe: From drug administration up to 32 days.
Intervention | participants (Number) |
---|
Tenofovir | 1 |
Tenofovir/Faldaprevir | 0 |
Faldaprevir | 0 |
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Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22
Maximum measured concentration of analyte in plasma (Cmax), at steady state. (NCT01340196)
Timeframe: 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22
Intervention | ng/mL (Geometric Mean) |
---|
Tenofovir/Faldaprevir | 41700 |
Faldaprevir | 50400 |
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Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15
Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15
Intervention | ng/mL (Geometric Mean) |
---|
Tenofovir | 54.0 |
Tenofovir/Faldaprevir | 79.4 |
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Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15
Maximum measured concentration of analyte in plasma (Cmax), at steady state. (NCT01340196)
Timeframe: 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15
Intervention | ng/mL (Geometric Mean) |
---|
Tenofovir | 300 |
Tenofovir/Faldaprevir | 284 |
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The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
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 |
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Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
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 |
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Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
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 |
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Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
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 |
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Tropism Change Between Screening or Baseline and PDTF
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 |
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Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
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 |
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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
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 |
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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
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 |
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Severity of Abnormal Laboratory Values
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 |
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Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
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 |
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Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
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 |
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Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
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 |
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Number of Participants With Abnormal Laboratory Values
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 |
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Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
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 |
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Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
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 |
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Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
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 |
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Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
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 |
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Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
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 |
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Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
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 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
"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 |
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Number of Participants With Treatment-emergent Serious Adverse Events
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 |
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Number of Participants With Grade 3 or 4 AEs
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 |
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Number of Participants Who Discontinued Due to AEs
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 |
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Frequency of Adverse Events (AE).
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 |
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Percentage of Participants With Etoposide Dose Modification
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 |
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Percentage of Participants With ARV Dose Modification
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 |
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Change in Peripheral Blood CD4+ Lymphocyte Cell Count
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 |
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Change in Peripheral Blood CD4+ Lymphocyte Cell Count
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 |
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Number of Participants With Grade 3 or Higher Adverse Events
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 |
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Cumulative Incidence of KS-IRIS
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 |
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Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A
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 |
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Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A
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 |
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Cumulative Incidence of Initial KS Progressive Disease by Week 96
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 |
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Cumulative Incidence of Initial KS Partial or Complete Response by Week 96
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 |
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Percentage of Participants With HIV-1 RNA Suppression
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 |
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Percentage of Participants With HIV-1 RNA Suppression
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 |
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Number of Participants With a New AIDS-defining Events or Death
AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 15 |
Arm B: LPV/r Plus Best Available NRTIs | 17 |
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Number of Participants Discontinuing Randomized Treatment for Toxicity
Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. (NCT01352715)
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 3 |
Arm B: LPV/r Plus Best Available NRTIs | 3 |
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Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. (NCT01352715)
Timeframe: From study entry through to week 96
Intervention | participants (Number) |
---|
| No new IAS mutations | 1-2 new IAS mutations | 3 new IAS mutations |
---|
Arm A: LPV/r Plus RAL | 29 | 9 | 1 |
,Arm B: LPV/r Plus Best Available NRTIs | 32 | 13 | 0 |
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Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
Fasting was for 8 hours and the metabolic panel was drawn locally. (NCT01352715)
Timeframe: Study entry and week 48
Intervention | mg/dL (Mean) |
---|
| total cholesterol change | high-density lipoprotein (HDL) cholesterol change | low-density lipoprotein (LDL) cholesterol change | triglycerides change | glucose change |
---|
Arm A: LPV/r Plus RAL | 31 | 4 | 17 | 80 | 2 |
,Arm B: LPV/r Plus Best Available NRTIs | 15 | 2 | 10 | 31 | 3 |
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Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. (NCT01352715)
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 62 |
Arm B: LPV/r Plus Best Available NRTIs | 81 |
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Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 7 |
Arm B: LPV/r Plus Best Available NRTIs | 7 |
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Change in CD4+ Cell Count From Baseline to Week 48
Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. (NCT01352715)
Timeframe: Study entry and week 48
Intervention | cells/mm^3 (Mean) |
---|
Arm A: LPV/r Plus RAL | 199 |
Arm B: LPV/r Plus Best Available NRTIs | 190 |
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Cumulative Probability of Virologic Failure by Week 48
The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. (NCT01352715)
Timeframe: From study entry to week 48
Intervention | cumulative probability per 100 persons (Number) |
---|
Arm A: LPV/r Plus RAL | 10.3 |
Arm B: LPV/r Plus Best Available NRTIs | 12.4 |
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Percentage of Time Spent in Hospital
The percentage of total study time that participants were in hospital. (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | percentage of time spent in hospital (Number) |
---|
Arm A: LPV/r Plus RAL | 0.08 |
Arm B: LPV/r Plus Best Available NRTIs | 0.12 |
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Number of Participants With HBV DNA<1000 IU/mL at Week 192
Number of participants with HBV DNA <1000 IU/mL at week 192 (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 95 |
Peginterferon-alfa 2a and Tenofovir | 90 |
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Number of Participants With HBsAg Seroconversion at Week 240
Number of participants who became HBsAg negative and developed anti-HBs at week 240 (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 2 |
Peginterferon-alfa 2a and Tenofovir | 4 |
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Number of Participants With HBsAg Seroconversion at Week 192
Number of participants who became with HBsAg negative and developed anti-HBs at week 192 (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 1 |
Peginterferon-alfa 2a and Tenofovir | 4 |
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Number of Participants With HBeAg Seroconversion at Week 240
Number of participants who became HBeAg negative and developed anti-HBe at week 240 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 14 |
Peginterferon-alfa 2a and Tenofovir | 15 |
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Number of Participants With HBeAg Seroconversion at Week 192
Number of participants who became HBeAg negative and developed anti-HBe at week 192 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 8 |
Peginterferon-alfa 2a and Tenofovir | 16 |
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Number of Participants With HBeAg Loss at Week 240
Number of participants who became HBeAg negative at week 240 among HBeAg positive participants at baseline (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 19 |
Peginterferon-alfa 2a and Tenofovir | 28 |
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Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192
Number of participants with alanine transaminase(ALT) levels <= 38 U/L for males and <=25 for females at week 192. The cut-offs 38 and 25 are approximately 1.25 times the upper limit of normal (30 U/L for males and 20 U/L for females) respectively. (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 58 |
Peginterferon-alfa 2a and Tenofovir | 72 |
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Cumulative Percent of Participants With HBsAg Loss at Week 192
Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method (NCT01369212)
Timeframe: Week 192
Intervention | Cumulative percentage of participants (Number) |
---|
Tenofovir | 1.0 |
Peginterferon-alfa 2a and Tenofovir | 5.2 |
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Number of Participants With Adverse Events
Number of participants with at least one adverse event between randomization and week 240 (NCT01369212)
Timeframe: up to 240 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 50 |
Peginterferon-alfa 2a and Tenofovir | 60 |
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Cumulative Percent of Participants With HBsAg Loss at Week 240
Cumulative percent of participants with HBsAg loss at week 240 estimated using Kaplan-Meier method (NCT01369212)
Timeframe: Week 240
Intervention | percentage of participants (Number) |
---|
Tenofovir | 4.1 |
Peginterferon-alfa 2a and Tenofovir | 5.2 |
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Number of Participants With Serious Adverse Events
Number of participants with at least one serious adverse event between randomization and week 240 (NCT01369212)
Timeframe: Up to 240 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 11 |
Peginterferon-alfa 2a and Tenofovir | 7 |
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Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
Estimated percent of participants who became HBsAg negative by week 240 from randomization (NCT01369212)
Timeframe: Week 240
Intervention | Percentage of participants (Number) |
---|
Tenofovir | 4.1 |
Peginterferon-alfa 2a and Tenofovir | 5.2 |
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Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240
Number of participants with normal alanine transaminase (ALT) levels [males ≤30 U/L, for females ≤20 U/L] at week 240 (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 38 |
Peginterferon-alfa 2a and Tenofovir | 41 |
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Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192
Number of participants with normal alanine transaminase (ALT) levels at week 192 (Normal ALT for males ≤30 U/L, for females ≤20 U/L) (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 37 |
Peginterferon-alfa 2a and Tenofovir | 51 |
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Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192
Number of participants who became Hepatitis B e antigen (HBeAg) negative at week 192 among HBeAg positive participants at randomization (baseline) (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 14 |
Peginterferon-alfa 2a and Tenofovir | 29 |
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Number of Participants With HBV DNA<20 IU/mL at Week 240
Number of participants with HBV DNA<20 IU/mL at week 240 (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 46 |
Peginterferon-alfa 2a and Tenofovir | 48 |
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Number of Participants With HBV DNA<20 IU/mL at Week 192
Number of participants with HBV DNA<20 IU/mL at week 192 (NCT01369212)
Timeframe: week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 82 |
Peginterferon-alfa 2a and Tenofovir | 87 |
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Number of Participants With HBV DNA<1000 IU/mL at Week 240
Number of participants with HBV DNA <1000 IU/mL at week 240 (NCT01369212)
Timeframe: week 240
Intervention | Participants (Count of Participants) |
---|
Tenofovir | 66 |
Peginterferon-alfa 2a and Tenofovir | 65 |
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eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study
eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population. (NCT01379508)
Timeframe: Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks
Intervention | mL/min/1.73 m2 (Mean) |
---|
| Week 24 change (97,22,119,108,11,119) | Week 52 change(97,22,119,108,11,119) | Week 104 change(97,22,119,108,11,119) | Week 156 change(62,17,79,79,10,89) | Baseline actual(98,22,120,109,11,120) | Week 24 actual(97,22,119,108,11,119) | Week 52 actual(97,22,119,108,11,119) | Week 104 actual (97,22,119,108,11,119) | Week 156 actual(62,17,79,79,10,89) |
---|
LdT Mono at Week 24 | 1.43 | 5.18 | 5.19 | 8.07 | 94.71 | 96.43 | 100.18 | 100.20 | 101.33 |
,LdT Overall | -1.07 | 2.96 | 3.16 | 3.99 | 97.47 | 96.67 | 100.70 | 100.90 | 101.20 |
,LdT+TDF at Week 24 | -12.06 | -6.80 | -5.77 | -10.89 | 109.79 | 97.73 | 102.99 | 104.02 | 100.70 |
,TDF + LdT at Week 24 | -7.17 | -8.39 | -8.69 | -6.67 | 94.50 | 87.33 | 86.12 | 85.81 | 87.93 |
,TDF Mono at Week 24 | -2.41 | -2.70 | -3.83 | -5.34 | 95.91 | 93.61 | 93.32 | 92.19 | 88.83 |
,TDF Overall | -2.85 | -3.22 | -4.28 | -5.49 | 95.78 | 93.03 | 92.66 | 91.60 | 88.73 |
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Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) -
"The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the treating missing as failure analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as missing data." (NCT01379508)
Timeframe: week 52
Intervention | percentage of participants (Number) |
---|
| Missing DNA data at Wk 52=failure | Imputing +/- 7 days DNA for Wk 52 | Imputing LOCF DNA for Wk 52 | Imputing within +28d DNA for Wk 52 |
---|
LdT Overall | 91.0 | 91.9 | 95.4 | 92.7 |
,TDF Overall | 95.0 | 95.0 | 99.2 | 95.0 |
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Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT)
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline (NCT01379508)
Timeframe: 156 weeks
Intervention | percentage of participants (Number) |
---|
| HBV DNA < 300 Week 156 | HBV DNA < 300 Wk156 LOCF | ALT normalization Wk 156 | ALT normalization Wk 156 LOCF | HBSAg loss/ seroconversion | Cum VB Wk104-156 LOCF | Cum VB BL to Wk 156 LOCF | Cum tx emerg resist Week 156 LOCF | HBV DNA < 300 Wk156 <7 log at BL | HBV DNA <300 Wk156 <7 log LOCF | Cum tx-emerg resist Wk156 <7log LOCF |
---|
LdT Mono at Week 24 | 17.7 | 88.7 | 14.3 | 85.7 | 0 | 16.1 | 21.0 | 14.0 | 17.6 | 88.2 | 8.7 |
,LdT Overall | 16.5 | 91.1 | 12.0 | 88.0 | 0 | 12.7 | 16.5 | 10.8 | 16.7 | 88.9 | 8.2 |
,LdT+TDF at Week 24 | 11.8 | 100.0 | 6.7 | 93.3 | 0 | 0 | 0 | 0 | 0 | 100.0 | 0.0 |
,TDF + LdT at Week 24 | 20.0 | 100.0 | 28.6 | 85.7 | 0 | 0 | 0 | 0 | 50.0 | 100.0 | 0.0 |
,TDF Mono at Week 24 | 13.9 | 100.0 | 10.5 | 86.8 | 0 | 1.3 | 1.3 | 0 | 11.7 | 100.0 | 0.0 |
,TDF Overall | 14.6 | 100.00 | 13.3 | 86.7 | 0 | 1.1 | 1.1 | 0 | 12.9 | 100.0 | 0.0 |
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Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT)
To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance (NCT01379508)
Timeframe: week 24, 52, 104
Intervention | percentage of particiipants (Number) |
---|
| HBV DNA <300 Week 24 | HBV DNA <300 Week 104 | HBV DNA <300 Week 24 LOCF | HBV DNA <300 Wk104 LOCF | ALT Normalization Wk 52 | ALT Normalization Week 104 | ALT Normalization Wk 52 LOCF | ALT Normalization Wk 104 LOCF | HBsAg loss Week 52 | HBsAg loss Week 104 | HBsAg conversion Week 52 | HBsAg conversion Week 104 | Cum virol break BaseL to Wk 24 | Cum virol break Wk 24 to Wk 52 | Cum virol break Wk 52 to Wk 104 | Cum virol break BaseLto Wk 104 | Cum vir break BL to Wk24 LOCF | Cum virol break Wk 24 to Wk 52 LOCF | Cum virol break Wk52-Wk104 LOCF | Cum virol break BLto Wk 104 LOCF | Cum tx emergent resistance Wk 52 | Ccum tx emergent resistance Wk 104 | Cum tx emergent resist Wk52 LOCF | Cum tx emergent resist Wk 104 LOCF | <7 log at BL HBV DNA <300 Wk52 | <7 log HBV DNA <300 Wk104 | <7 log HBV DNA <300 Wk 52 LOCF | <7 log HBV DNA <300 Wk 104 LOCF |
---|
LdT Mono at Week 24 | 98.9 | 69.6 | 100.0 | 92.4 | 84.0 | 70.0 | 88.0 | 92.0 | 0 | 0 | 0 | 0 | 0 | 3.3 | 12.0 | 14.1 | 0 | 3.3 | 12.0 | 14.1 | 3.3 | 9.2 | 3.3 | 9.2 | 93.4 | 68.4 | 97.4 | 92.1 |
,LdT Overall | 80.5 | 70.8 | 81.4 | 93.8 | 83.8 | 70.6 | 86.8 | 89.7 | 0 | 0 | 0 | 0 | 0.9 | 2.7 | 9.7 | 12.4 | 0.9 | 2.7 | 9.7 | 12.4 | 2.7 | 7.4 | 2.7 | 7.4 | 92.5 | 67.5 | 97.5 | 92.5 |
,LdT+TDF at Week 24 | 0.0 | 76.2 | 0 | 100.0 | 83.3 | 72.2 | 83.3 | 83.3 | 0 | 0 | 0 | 0 | 4.8 | 0 | 0 | 4.8 | 4.8 | 0 | 0 | 4.8 | 0 | 0 | 0 | 0 | 75.0 | 50.0 | 100.0 | 100.0 |
,TDF + LdT at Week 24 | 0 | 81.8 | 0 | 100.0 | 85.7 | 85.7 | 85.7 | 85.7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100.0 | 66.7 | 100.0 | 100.0 |
,TDF Mono at Week 24 | 99.1 | 74.5 | 100.0 | 99.1 | 82.5 | 61.4 | 87.7 | 86.0 | 0 | 0 | 0 | 0 | 0 | 0 | 1.9 | 1.9 | 0 | 0 | 1.9 | 1.9 | 0 | 0 | 0 | 0 | 95.0 | 76.3 | 100.0 | 98.8 |
,TDF Overall | 89.7 | 75.2 | 90.6 | 99.1 | 82.8 | 64.1 | 87.5 | 85.9 | 0 | 0 | 0 | 0 | 0 | 0 | 1.7 | 1.7 | 0 | 0 | 1.7 | 1.7 | 0 | 0 | 0 | 0 | 95.2 | 75.9 | 100.0 | 98.8 |
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Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy
Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8
Intervention | cells per cubic millimeter (Mean) |
---|
| CD4+ | CD8+ |
---|
FTR 1200 mg QD/RAL/TDF | 63.4 | 67.6 |
,FTR 400 mg BID/RAL/TDF | 58.4 | 134.2 |
,FTR 600 mg QD/RAL/TDF | 71.8 | 188.0 |
,FTR 800 mg BID/RAL/TDF | 134.8 | 216.3 |
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Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period
Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period
Intervention | log10 c/mL (Mean) |
---|
| Day 2, n=7, 5, 10, 9 | Day 5, n=7, 4, 10, 10 | Day 6, n=7, 5, 10, 10 | Day 7, n=6, 5, 10, 10 | Day 8, n=6, 4, 9, 9 |
---|
FTR 1200 mg QD/RAL/TDF | 0.126 | -0.767 | -1.053 | -1.198 | -1.470 |
,FTR 400 mg BID/RAL/TDF | 0.220 | -0.340 | -0.530 | -0.556 | -0.691 |
,FTR 600 mg QD/RAL/TDF | 0.126 | -0.593 | -0.822 | -1.086 | -1.218 |
,FTR 800 mg BID/RAL/TDF | 0.149 | -0.811 | -1.082 | -1.443 | -1.372 |
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Number of Participants With Newly-emergent Genotypic Substitutions at Week 24
Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| PI substitution | RT substitution | Integrase substitution |
---|
ATV/r/RAL/TDF | 0 | 0 | 0 |
,FTR 1200 mg QD/RAL/TDF | 0 | 1 | 1 |
,FTR 400 mg BID/RAL/TDF | 0 | 0 | 0 |
,FTR 600 mg QD/RAL/TDF | 0 | 0 | 1 |
,FTR 800 mg BID/RAL/TDF | 0 | 0 | 0 |
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Number of Participants With Newly-emergent Genotypic Substitutions at Week 96
Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 96
Intervention | Participants (Count of Participants) |
---|
| PI substitution | RT substitution | Integrase RAL substitution |
---|
ATV/r/RAL/TDF | 0 | 1 | 0 |
,FTR 1200 mg QD/RAL/TDF | 2 | 2 | 3 |
,FTR 400 mg BID/RAL/TDF | 3 | 2 | 2 |
,FTR 600 mg QD/RAL/TDF | 2 | 2 | 1 |
,FTR 800 mg BID/RAL/TDF | 1 | 1 | 2 |
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Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period
Intervention | Participants (Count of Participants) |
---|
| SAE | AEs leading to discontinuation |
---|
FTR 1200 mg QD/RAL/TDF | 0 | 0 |
,FTR 400 mg BID/RAL/TDF | 0 | 0 |
,FTR 600 mg QD/RAL/TDF | 0 | 0 |
,FTR 800 mg BID/RAL/TDF | 0 | 0 |
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Number of Participants With SAE and Discontinuation Due to AEs During Primary Study
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window. (NCT01384734)
Timeframe: Weeks 48 and 96
Intervention | Participants (Count of Participants) |
---|
| SAE, Week 48 | SAE, Week 96 | AEs leading to discontinuation, Week 48 | AEs leading to discontinuation, Week 96 |
---|
ATV/r/RAL/TDF | 5 | 7 | 3 | 5 |
,FTR 1200 mg QD/RAL/TDF | 2 | 4 | 1 | 2 |
,FTR 400 mg BID/RAL/TDF | 3 | 5 | 1 | 1 |
,FTR 600 mg QD/RAL/TDF | 4 | 6 | 0 | 0 |
,FTR 800 mg BID/RAL/TDF | 5 | 7 | 2 | 2 |
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Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window. (NCT01384734)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| SAE | AEs leading to discontinuation |
---|
ATV/r/RAL/TDF | 5 | 2 |
,FTR 1200 mg QD/RAL/TDF | 2 | 1 |
,FTR 400 mg BID/RAL/TDF | 3 | 1 |
,FTR 600 mg QD/RAL/TDF | 4 | 0 |
,FTR 800 mg BID/RAL/TDF | 4 | 2 |
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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study
Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. (NCT01384734)
Timeframe: Weeks 48 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 48 | Week 96 |
---|
ATV/r/RAL/TDF | 71 | 57 |
,FTR 1200 mg QD/RAL/TDF | 68 | 58 |
,FTR 400 mg BID/RAL/TDF | 82 | 78 |
,FTR 600 mg QD/RAL/TDF | 69 | 63 |
,FTR 800 mg BID/RAL/TDF | 61 | 49 |
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Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period
Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Up to Day 8 of the monotherapy period
Intervention | Percentage of Participants (Number) |
---|
FTR 400 mg BID/RAL/TDF | 0 |
FTR 800 mg BID/RAL/TDF | 0 |
FTR 600 mg QD/RAL/TDF | 0 |
FTR 1200 mg QD/RAL/TDF | 11 |
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Number of Participants With Newly-emergent Genotypic Substitutions at Week 48
Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL. (NCT01384734)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| PI substitution | RT substitution | Integrase substitution |
---|
ATV/r/RAL/TDF | 0 | 0 | 0 |
,FTR 1200 mg QD/RAL/TDF | 1 | 2 | 2 |
,FTR 400 mg BID/RAL/TDF | 1 | 0 | 1 |
,FTR 600 mg QD/RAL/TDF | 0 | 0 | 1 |
,FTR 800 mg BID/RAL/TDF | 0 | 0 | 1 |
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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48
Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 48
Intervention | IC50 Fold Change (Mean) |
---|
FTR 400 mg BID/RAL/TDF | -2.624 |
FTR 800 mg BID/RAL/TDF | 586.776 |
FTR 600 mg QD/RAL/TDF | 81.729 |
FTR 1200 mg QD/RAL/TDF | 449.092 |
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Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96
Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 96
Intervention | IC50 Fold Change (Mean) |
---|
FTR 400 mg BID/RAL/TDF | 25.480 |
FTR 800 mg BID/RAL/TDF | 419.901 |
FTR 600 mg QD/RAL/TDF | 46.351 |
FTR 1200 mg QD/RAL/TDF | 777.818 |
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Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24
Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and up to Week 24
Intervention | IC50 Fold Change (Mean) |
---|
FTR 400 mg BID/RAL/TDF | -2.350 |
FTR 800 mg BID/RAL/TDF | 1014.748 |
FTR 600 mg QD/RAL/TDF | 101.627 |
FTR 1200 mg QD/RAL/TDF | 39.030 |
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Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA
Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline. (NCT01384734)
Timeframe: Baseline and up to Day 8 of the monotherapy period
Intervention | log10 c/mL (Mean) |
---|
FTR 400 mg BID/RAL/TDF | -0.770 |
FTR 800 mg BID/RAL/TDF | -1.524 |
FTR 600 mg QD/RAL/TDF | -1.250 |
FTR 1200 mg QD/RAL/TDF | -1.399 |
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Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24
Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment. (NCT01384734)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
FTR 400 mg BID/RAL/TDF | 80 |
FTR 800 mg BID/RAL/TDF | 69 |
FTR 600 mg QD/RAL/TDF | 76 |
FTR 1200 mg QD/RAL/TDF | 72 |
ATV/r/RAL/TDF | 75 |
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Change From Baseline in CD4+ T-cell Count
Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). (NCT01384734)
Timeframe: Baseline and Weeks 24, 48 and 96
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 24, n=41, 38, 48, 42, 40 | Week 48, n=43, 34, 43, 41, 41 | Week 96, n=42, 28, 35, 28, 31 |
---|
ATV/r/RAL/TDF | 119.4 | 178.7 | 250.1 |
,FTR 1200 mg QD/RAL/TDF | 124.5 | 155.4 | 211.7 |
,FTR 400 mg BID/RAL/TDF | 134.3 | 199.1 | 264.6 |
,FTR 600 mg QD/RAL/TDF | 109.5 | 140.5 | 175.7 |
,FTR 800 mg BID/RAL/TDF | 111.0 | 158.7 | 210.8 |
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Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy
Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed. (NCT01384734)
Timeframe: Baseline and Day 8
Intervention | cells per cubic millimeter (Mean) |
---|
| CD4+ | CD8+ |
---|
FTR 1200 mg QD/RAL/TDF | 0.014 | -0.021 |
,FTR 400 mg BID/RAL/TDF | -0.005 | -0.003 |
,FTR 600 mg QD/RAL/TDF | 0.008 | -0.009 |
,FTR 800 mg BID/RAL/TDF | 0.023 | -0.040 |
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Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation
Difference between 12 months and randomisation CD4+ count was calculated and then summarised (NCT01387022)
Timeframe: Measured at 12 months post ART initiation
Intervention | cells/uL (Median) |
---|
Tenofovir-containing Regimen | 217 |
Tenofovir-sparing Regimen | 174 |
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Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables
(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death
Intervention | Participants (Count of Participants) |
---|
Tenofovir-containing Regimen | 7 |
Tenofovir-sparing Regimen | 12 |
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Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations
(NCT01387022)
Timeframe: From randomisation until either time of termination or time of death
Intervention | Participants (Count of Participants) |
---|
Tenofovir-containing Regimen | 1 |
Tenofovir-sparing Regimen | 1 |
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The Antiretroviral Treatment Failure Rate at 12 Months.
Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death (NCT01387022)
Timeframe: 12 months post ART intiation or until time of death
Intervention | participants (Number) |
---|
Tenofovir-containing Regimen | 4 |
Tenofovir-sparing Regimen | 5 |
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Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48
percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm: DRV/r + MVC + FTC + TDF Placebo | -59.5 |
TDF Arm: DRV/r + TDF + FTC + MVC Placebo | -60.9 |
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Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -52.1 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -48.6 |
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Percent Change in Lumbar Spine Bone Mineral Density (BMD)
The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -0.88 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -2.35 |
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Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48
percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -20.7 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -17.0 |
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Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -3.5 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -4.6 |
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Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 11.9 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 14.0 |
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Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)
The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -1.51 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -2.40 |
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Number of Participants Who Died During the Study
Number of participants who died during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 0 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 0 |
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Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events
"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)" (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 16 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 22 |
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Change in CD4 Count From Baseline to Week 24
Change in CD4 count from baseline (week 0) to week 24 (NCT01400412)
Timeframe: Week 0, week 24
Intervention | cells/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 165 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 127 |
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Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -9.1 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -11.2 |
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CD8+ T-cell Change From Baseline to Week 48
CD8+ T-cell change from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | cell/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -6 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -109 |
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Change in Level of IP-10 From Baseline to Week 48
Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | pg/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -198 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -170 |
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Change in Levels of D-dimer From Baseline
Change in levels of D-dimer from baseline (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -82 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -61 |
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Change in Levels of IL-6 From Baseline to Week 48
Change in levels of Interleukin 6 (IL-6) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | pg/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -0.21 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -0.12 |
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Change in Levels of sCD14 From Baseline
Change in levels of soluble CD14 from baseline (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -103 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -10 |
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Number of Participants Who Experienced Bone Fractures
Number of participants who experienced bone fractures during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 2 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 2 |
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Change in Levels of sCD163 From Baseline to Week 48
Change in levels of soluble CD163 from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -250 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -258 |
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Cumulative Probability of Virologic Failure by Week 48
"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group." (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | cumulative probability per 100 persons (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 6 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 5 |
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Change in CD4 Count From Baseline to Week 48
Change in CD4 count from baseline (week 0) to week 48 (NCT01400412)
Timeframe: Week 0, week 48
Intervention | cells/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 234 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 188 |
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Self-reported Adherence to ART Therapy
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 |
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Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
"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 |
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Number of Participants With Peripheral Neuropathy (PN)
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 |
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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
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 |
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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
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 |
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Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 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 |
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Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
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 |
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Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
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 |
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Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART
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 |
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Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART
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 |
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Number of Participants With Objective Response for ET+ART vs. PTX+ART
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 |
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Number of Participants With Objective Response for BV+ART vs. PTX+ART
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 |
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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART
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 |
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Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART
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 |
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Duration of Objective Response for ET+ART vs. PTX+ART
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 |
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Duration of Objective Response for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART
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 |
[back to top]
Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART
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 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART
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 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART
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 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of Death for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of Death for BV+ART vs PTX+ART
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 |
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Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART
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 |
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Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART
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 |
[back to top]
Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART
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 |
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Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART
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 |
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HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo
The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms. (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Intervention | percentage of swabs positive (%) (Number) |
---|
| Lead-in Phase | Treatment Phase |
---|
Oral Placebo + Vaginal Placebo | 21.3 | 20.4 |
,Oral Placebo + Vaginal TFV Gel | 13.8 | 12.0 |
,Oral TDF + Vaginal Placebo Gel | 22.9 | 19.5 |
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Within-person Changes in Log-copy Numbers of HSV
"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Intervention | log-copy number of HSV DNA shed (Mean) |
---|
| Lead-in Phase | Treatment Phase |
---|
Oral Placebo + Vaginal Tenofovir 1% Gel | 4.47 | 4.40 |
,Oral TDF + Vaginal Placebo Gel | 4.02 | 4.11 |
,Placebo Oral + Placebo Vaginal Gel | 3.71 | 4.22 |
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Genital Lesion Rate
"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Intervention | percentage of days with lesions (%) (Number) |
---|
| Lead-in Phase | Treatment Phase |
---|
Oral Placebo + Vaginal Tenofovir 1% Gel | 8.7 | 7.1 |
,Oral TDF + Vaginal Placebo Gel | 11.8 | 11.6 |
,Placebo Oral + Placebo Vaginal Gel | 13.6 | 14.7 |
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Asymptomatic Shedding (Shedding on Days Without Genital Lesions)
"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment." (NCT01448616)
Timeframe: Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase
Intervention | % days with asymptomatic shedding (Number) |
---|
| Lead-in Phase | Treatment Phase |
---|
Oral Placebo + Vaginal Tenofovir 1% Gel | 7.6 | 8.2 |
,Oral TDF + Vaginal Placebo Gel | 17.5 | 13.7 |
,Placebo Oral + Placebo Vaginal Gel | 14.4 | 12.1 |
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Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 52 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 1.0 |
Behavioral Intervention Plus ARV | 0.3 |
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Number of Adverse Events
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 |
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Unprotected Sex Acts in Previous One Week - 52 Weeks
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 |
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Number of Partners Reporting for HIV Testing
Number of partners per index reporting for HIV testing at any time during follow-up (NCT01450189)
Timeframe: 52 weeks
Intervention | partners per index participant (Mean) |
---|
Standard Counseling Arm | 0.4 |
Behavioral Intervention Arm Only | 0.4 |
Behavioral Intervention Plus ARV | 0.4 |
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Proportion of Participants Completing Full Course of ARVs in Arm BIA
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that (NCT01450189)
Timeframe: 1 year
Intervention | proportion of BIA participants (Number) |
---|
Behavioral Intervention Plus Antiretrovirals (BIA) | 0.917 |
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Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms. (NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants (Number) |
---|
Combined Behavioral Intervention Arms | 0.216 |
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Proportion of Partners Reporting for HIV Testing
Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants (NCT01450189)
Timeframe: 52 weeks
Intervention | proportion of sex partners (Number) |
---|
Standard Counseling Arm | 0.1 |
Behavioral Intervention Arm Only | 0.1 |
Behavioral Intervention Plus ARV | 0.1 |
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Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
(NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants screened (Number) |
---|
Overall | 0.622 |
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Proportion of Persons Completing All Scheduled Visits in Each Study Arm
(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 |
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Prevalence of AHI Among Persons Screened
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. (NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants (Number) |
---|
Overall | 0.0073 |
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Genital HIV RNA Concentration - Week 26, Women
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 |
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Proportion of Persons With AHI Successfully Recruited Into the Study
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization. (NCT01450189)
Timeframe: 1 year
Intervention | Proportion of persons with AHI recruited (Number) |
---|
Overall | 0.69 |
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Suppression of HIV RNA to <1000c/ml at 12 Weeks
Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks (NCT01450189)
Timeframe: 12 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 0.25 |
Behavioral Intervention Plus ARV | 0.72 |
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Genital HIV RNA Concentration - Week 52, Women
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 |
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Genital HIV RNA Concentration - Week 52, Men
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 |
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Genital HIV RNA Concentration - Week 26, Men
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 |
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Genital HIV RNA Concentration - Week 12, Women
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 |
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Genital HIV RNA Concentration - Week 12, Men
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 |
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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 26 weeks
Intervention | proportion of participants (Number) |
---|
Standard Counseling Arm | 0.14 |
Behavioral Intervention Arm Only | 0.33 |
Behavioral Intervention Plus ARV | 0.12 |
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Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
At least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 52 weeks
Intervention | proportion of participants (Number) |
---|
Standard Counseling Arm | 0.14 |
Behavioral Intervention Arm Only | 0.42 |
Behavioral Intervention Plus ARV | 0.15 |
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Unprotected Sex Acts in Previous One Month - 52 Weeks
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 |
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Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 26 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 0.5 |
Behavioral Intervention Plus ARV | 0.25 |
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Blood HIV RNA Concentration at Week 52
(NCT01450189)
Timeframe: 52 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 3248.5 |
Behavioral Intervention Arm Only | 6467.5 |
Behavioral Intervention Plus ARV | 10876 |
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Blood HIV RNA Concentration at Week 26
(NCT01450189)
Timeframe: 26 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 8661 |
Behavioral Intervention Arm Only | 58504 |
Behavioral Intervention Plus ARV | 6788 |
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Blood HIV RNA Concentration at Week 12
(NCT01450189)
Timeframe: 12 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 19411 |
Behavioral Intervention Arm Only | 22734 |
Behavioral Intervention Plus ARV | 20 |
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Time to HIV RNA Suppression <1000 c/ml
median time to viral load suppression (<1000 c/ml) (NCT01450189)
Timeframe: From date of randomization until viral load suppression, up to 52 weeks
Intervention | weeks (Median) |
---|
Standard Counseling Arm | 39 |
Behavioral Intervention Arm Only | 26 |
Behavioral Intervention Plus ARV | 16 |
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Unprotected Sex Acts in Previous One Month - 12 Weeks
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 |
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Unprotected Sex Acts in Previous One Month - 26 Weeks
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 |
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Unprotected Sex Acts in Previous One Week - 12 Weeks
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 |
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Unprotected Sex Acts in Previous One Week - 26 Weeks
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 |
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Occurrence of Grade 3 or Higher Adverse Events (AEs)
participants had Occurrence of Grade 3 or higher adverse events (AEs) (NCT01505114)
Timeframe: Through Week 48
Intervention | Participants (Count of Participants) |
---|
Arm 1 | 18 |
Arm 2 | 24 |
Arm 3 | 20 |
Arm 4 | 28 |
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Cmax of Deleobuvir (BI 207127)
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | nmol/L (Geometric Mean) |
---|
| Day 9 (N=0, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | NA | 27000 | 10100 |
,Group B | 10900 | 31400 | 16000 |
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Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 5.57 | 6.50 | 6.46 | 5.05 |
,Group B | 6.68 | 6.52 | 5.02 | 4.67 |
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Cmax of Tolbutamide
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 152000 | 146000 | 130000 | 110000 |
,Group B | 170000 | 158000 | 126000 | 127000 |
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Cmax of Midazolam
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 21.1 | 29.9 | 31.9 | 21.3 |
,Group B | 23.8 | 29.8 | 28.8 | 23.2 |
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Cmax of Faldaprevir (BI 201335)
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | ng/mL (Geometric Mean) |
---|
| Day 9 (N=15,0) | Day 17 (N=14,14) | Day 66 (N=13,15) |
---|
Group A | 3520 | 8780 | 4410 |
,Group B | NA | 9950 | 6690 |
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Cmax of Caffeine
Maximum concentration of an analyte in plasma (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | ng/mL (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 5170 | 4890 | 4830 | 5590 |
,Group B | 5340 | 7220 | 6530 | 6450 |
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C6hr of Deleobuvir (BI 207127)
Concentration of an analyte in plasma at 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | nmol/L (Geometric Mean) |
---|
| Day 9 (N=0, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 14) |
---|
Group A | NA | 17900 | 5080 |
,Group B | 5800 | 20800 | 10100 |
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C24hr of Faldaprevir (BI 201335)
Concentration of an analyte in plasma at 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | ng/mL (Geometric Mean) |
---|
| Day 9 (N=15,0) | Day 17 (N=14,19) | Day 66 (N=13,14) |
---|
Group A | 983 | 3670 | 1140 |
,Group B | NA | 5410 | 2580 |
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AUC 0-infinity of Tolbutamide
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol*h/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=13, 17) | Day 17 (N=14, 18) | Day 66 (N=12, 15) |
---|
Group A | 1940000 | 1800000 | 1520000 | 1330000 |
,Group B | 2220000 | 1940000 | 1410000 | 1390000 |
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AUC 0-infinity of Midazolam
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol*h/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 79.7 | 117 | 127 | 75.5 |
,Group B | 107 | 130 | 140 | 95.6 |
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AUC 0-infinity of Caffeine
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 15) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | 54900 | 42100 | 71900 | 120000 |
,Group B | 77500 | 142000 | 170000 | 159000 |
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AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity. (NCT01525628)
Timeframe: 5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.
Intervention | nmol*h/L (Geometric Mean) |
---|
| Day 1 (N=16, 19) | Day 9 (N=15, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 13) |
---|
Group A | 23.6 | 24.2 | 23.5 | 18.3 |
,Group B | 26.0 | 28.5 | 22.8 | 20.8 |
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AUC 0-6hr of Deleobuvir (BI 207127)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | nmol*h/L (Geometric Mean) |
---|
| Day 9 (N=0, 17) | Day 17 (N=14, 19) | Day 66 (N=13, 15) |
---|
Group A | NA | 119000 | 36200 |
,Group B | 41100 | 135000 | 59200 |
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Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (NCT01525628)
Timeframe: PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.
Intervention | ng*h/mL (Geometric Mean) |
---|
| Day 9 (N=15,0) | Day 17 (N=14,19) | Day 66 (N=13,15) |
---|
Group A | 45600 | 138000 | 56200 |
,Group B | NA | 173000 | 97300 |
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Number of Participants With Sustained Virological Response (SVR12)
Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12. (NCT01525628)
Timeframe: 12 weeks post treatment
Intervention | Participants (Number) |
---|
Group A | 13 |
Group B | 13 |
Group C | 11 |
Group D | 10 |
Group E | 3 |
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Number of Participants With Treatment Switch or Discontinuation
Overall (regardless of the molecule) (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 4 |
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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
(NCT01605890)
Timeframe: at Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 3 |
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Percentage of Participants in Therapeutic Success
"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee" (NCT01605890)
Timeframe: at Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 40 |
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Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
(NCT01605890)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 5 |
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Number of Clinical and Biological Events
(NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | clinical and biological events (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 61 |
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Number of Participants With Clinical Progression
"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death." (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 0 |
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Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
(NCT01605890)
Timeframe: between Week 0 and Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 96.4 |
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Number of Virological Failure Participants With Resistance Mutations
Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 1 |
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Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
(NCT01605890)
Timeframe: from Week 4 to Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 76 |
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Change in log10(Pf Gametocyte Density) From Entry to Day 30
"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 |
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Number of Participants With Detectable Pf Gametocyte Density
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 |
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Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance
"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 |
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Change in log10(Pf Parasite Density) From Entry to Day 30
"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 |
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Number of Participants With Uncomplicated Clinical Malaria
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 |
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Time to First Pf SCP Clearance
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 |
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Log10(Pf Parasite Density)
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 |
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Change From Baseline in Fasting Values of Total Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
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 |
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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
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 |
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Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Change From Baseline in Fasting Values of Glucose
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
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 |
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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
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 |
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Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Change From Baseline in CD4+ T-cell Count
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 72 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.69 |
Standard of Care (SOC) | 0.62 |
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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 72 weeks after the date of entry
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 |
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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 48 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.66 |
Standard of Care (SOC) | 0.62 |
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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 48 weeks after the date of entry
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 |
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Time to First Dose Modification Due to Grade 3 or 4 Toxicity
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to the First of Death or Hospitalization.
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Number of Weeks of Follow-up [CPI+SOC v SOC]
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
Intervention | weeks (Median) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 72 |
Standard of Care (SOC) | 72 |
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Number of Weeks of Follow-up
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
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 |
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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 20 |
Standard of Care (SOC) | 32 |
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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 66 |
Standard of Care (SOC) | 89 |
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Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24.9 |
Standard of Care (SOC) | 32.2 |
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Percent of Participants With Confirmed Virologic Failure by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 to Week 48
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 |
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Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 1.2 |
Standard of Care (SOC) | 0 |
[back to top]
Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to week 48
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 |
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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.4 |
Standard of Care (SOC) | 1.1 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 24 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.68 |
Standard of Care (SOC) | 0.61 |
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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
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 |
[back to top]
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 7.8 |
Standard of Care (SOC) | 12.1 |
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Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
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 |
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Percent of Participants With Death or Hospitalization by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
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 |
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Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 10.6 |
Standard of Care (SOC) | 10.6 |
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Percent of Participants With Treatment Modification or Discontinuation by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
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 |
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Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 19.1 |
Standard of Care (SOC) | 13.6 |
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Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.8 |
Standard of Care (SOC) | 2.3 |
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Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 45.7 | NA |
,Standard of Care (SOC) | NA | NA |
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Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 24 weeks after the date of entry
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 |
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Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Change From Baseline in Fasting Values of Triglycerides
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
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 |
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Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
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 |
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Time From Study Entry/Randomization to Death
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | NA | NA |
,Standard of Care (SOC) | 25.0 | NA |
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Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
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 |
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Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to week 48
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 |
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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 8.2 |
Standard of Care (SOC) | 6.5 |
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Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
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 |
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Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.9 |
Standard of Care (SOC) | 1.5 |
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Percent of Participants Experiencing Death by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
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 |
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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 180; n=1, 0, 0, 0 |
---|
GSK1265744 10 mg | -3.0 | -1.4 | 5.5 | 2.2 | 8.0 | -2.7 | -2.6 | 2.2 | 1.0 |
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Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 456.5 | 487.0 | 509.9 | 531.4 | 564.3 | 594.4 | 607.7 | 599.5 | 625.7 | 635.7 | 663.8 | 651.5 | 687.9 | 732.6 | 733.9 | 722.5 | 744.7 | 747.8 |
,GSK1265744 10 mg | 445.5 | 544.0 | 580.5 | 576.6 | 588.4 | 608.3 | 607.3 | 614.6 | 632.8 | 652.2 | 638.1 | 638.7 | 650.2 | 677.3 | 668.1 | 683.2 | 718.3 | 726.2 |
,GSK1265744 30 mg | 444.9 | 525.1 | 522.0 | 555.2 | 599.0 | 595.8 | 607.4 | 626.5 | 629.5 | 635.9 | 650.8 | 658.6 | 658.5 | 687.2 | 720.9 | 651.3 | 736.9 | 722.9 |
,GSK1265744 60 mg | 459.0 | 549.3 | 545.8 | 544.3 | 596.6 | 599.7 | 636.6 | 658.0 | 645.8 | 653.3 | 665.2 | 720.3 | 667.6 | 713.8 | 719.8 | 710.9 | 735.0 | 743.1 |
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Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | International Units per Liter (Mean) |
---|
| ALT; Baseline; n=60, 60, 61, 62 | ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | AST; Baseline; n=60, 60, 61, 62 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 51 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | CK; Baseline; n=60, 60, 61, 62 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 30.5 | 30.0 | 31.4 | 25.0 | 25.7 | 30.4 | 27.0 | 25.7 | 28.3 | 24.2 | 23.1 | 23.5 | 23.4 | 22.6 | 24.9 | 22.7 | 27.1 | 24.3 | 31.5 | 32.8 | 29.0 | 24.4 | 24.4 | 36.7 | 28.7 | 26.1 | 25.8 | 23.7 | 25.4 | 26.3 | 23.0 | 23.7 | 24.9 | 22.9 | 29.9 | 27.7 | 349.8 | 512.1 | 236.2 | 152.9 | 161.2 | 646.5 | 528.2 | 247.4 | 163.5 | 154.7 | 254.7 | 303.1 | 150.2 | 146.3 | 168.0 | 120.5 | 258.6 | 281.1 |
,GSK1265744 10 mg | 23.9 | 24.0 | 23.1 | 25.4 | 25.0 | 26.0 | 22.3 | 20.9 | 24.2 | 20.4 | 19.5 | 23.4 | 22.7 | 18.4 | 21.4 | 19.9 | 20.1 | 22.0 | 25.0 | 25.6 | 24.0 | 28.7 | 26.3 | 24.2 | 26.0 | 23.3 | 28.4 | 22.6 | 21.9 | 29.2 | 24.7 | 21.4 | 23.4 | 21.8 | 22.3 | 23.6 | 197.3 | 237.9 | 196.7 | 413.3 | 316.1 | 195.1 | 342.7 | 226.0 | 344.1 | 213.4 | 205.6 | 528.4 | 259.5 | 203.5 | 315.7 | 182.5 | 204.3 | 542.7 |
,GSK1265744 30 mg | 28.1 | 26.3 | 25.6 | 29.3 | 31.4 | 28.5 | 24.9 | 27.5 | 26.6 | 26.5 | 26.9 | 24.7 | 24.6 | 24.8 | 25.9 | 30.7 | 29.9 | 48.7 | 27.5 | 26.6 | 25.0 | 29.5 | 29.0 | 29.2 | 24.2 | 27.2 | 26.9 | 26.7 | 26.5 | 25.4 | 24.5 | 24.3 | 25.3 | 31.0 | 29.2 | 47.7 | 295.9 | 276.1 | 221.8 | 427.2 | 314.7 | 427.3 | 202.1 | 306.3 | 267.7 | 276.8 | 248.8 | 242.9 | 225.4 | 219.3 | 215.5 | 354.0 | 329.2 | 272.8 |
,GSK1265744 60 mg | 28.5 | 27.2 | 30.3 | 35.9 | 26.6 | 26.9 | 30.3 | 28.6 | 23.5 | 24.8 | 23.2 | 24.2 | 25.8 | 24.8 | 28.1 | 26.3 | 25.3 | 25.5 | 28.1 | 26.8 | 28.3 | 32.8 | 25.5 | 26.5 | 31.7 | 28.6 | 24.5 | 25.5 | 25.6 | 26.4 | 26.5 | 24.2 | 30.4 | 26.4 | 25.2 | 25.9 | 181.2 | 184.8 | 180.5 | 451.7 | 211.8 | 213.3 | 485.3 | 243.0 | 242.5 | 290.4 | 311.3 | 255.2 | 292.6 | 219.8 | 399.6 | 247.7 | 195.0 | 199.7 |
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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. (NCT01641809)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 80 |
GSK1265744 30 mg | 80 |
GSK1265744 60 mg | 87 |
Efavirenz 600 mg | 71 |
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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 2 |
GSK1265744 30 mg | 4 |
GSK1265744 60 mg | 2 |
Efavirenz 600 mg | 2 |
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Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 0 |
GSK1265744 30 mg | 2 |
GSK1265744 60 mg | 5 |
Efavirenz 600 mg | 13 |
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Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 7 |
GSK1265744 30 mg | 7 |
GSK1265744 60 mg | 7 |
Efavirenz 600 mg | 15 |
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
GSK1265744 10 mg | 25 |
GSK1265744 30 mg | 19 |
GSK1265744 60 mg | 15 |
Efavirenz 600 mg | 10 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. (NCT01641809)
Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
Efavirenz 600 mg | 96 | 87 | 91 | 91 | 94 | 89 | 94 | 89 | 89 | 89 | 83 |
,GSK1265744 10 mg | 96 | 90 | 98 | 96 | 98 | 96 | 92 | 90 | 83 | 83 | 79 |
,GSK1265744 30 mg | 94 | 85 | 89 | 91 | 92 | 92 | 91 | 83 | 83 | 85 | 85 |
,GSK1265744 60 mg | 96 | 95 | 95 | 96 | 95 | 95 | 96 | 95 | 95 | 95 | 93 |
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Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
Intervention | Micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 1.45 |
GSK1265744 30 mg | 4.34 |
GSK1265744 60 mg | 5.83 |
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Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Intervention | Hours*micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 45.69 |
GSK1265744 30 mg | 133.74 |
GSK1265744 60 mg | 227.58 |
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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 4.424 | 1.883 | 1.706 | 1.695 | 1.643 | 1.619 | 1.623 | 1.615 | 1.595 | 1.591 | 1.609 | 1.604 | 1.612 | 1.686 | 1.648 | 1.625 | 1.645 | 1.681 | 1.634 | 1.638 | 1.646 | 1.682 | 1.634 | 1.665 | 1.613 | 1.689 | 1.628 | 1.591 | 1.591 | 1.596 | 1.591 | 1.591 | 1.591 | 1.591 | 1.601 | 1.597 | 1.591 |
,GSK1265744 30 mg | 4.270 | 1.984 | 1.731 | 1.666 | 1.618 | 1.602 | 1.596 | 1.597 | 1.602 | 1.607 | 1.620 | 1.610 | 1.618 | 1.654 | 1.598 | 1.697 | 1.643 | 1.603 | 1.609 | 1.591 | 1.631 | 1.698 | 1.603 | 1.642 | 1.591 | 1.591 | 1.595 | 1.592 | 1.591 | 1.601 | 1.599 | 1.591 | 1.591 | 1.592 | 1.591 | 1.600 | 1.591 |
,GSK1265744 60 mg | 4.428 | 1.939 | 1.725 | 1.666 | 1.641 | 1.616 | 1.599 | 1.603 | 1.594 | 1.591 | 1.618 | 1.606 | 1.608 | 1.598 | 1.594 | 1.591 | 1.592 | 1.596 | 1.591 | 1.618 | 1.591 | 1.630 | 1.619 | 1.603 | 1.600 | 1.699 | 1.634 | 1.634 | 1.625 | 1.591 | 1.593 | 1.617 | 1.618 | 1.591 | 1.625 | 1.591 | 1.591 |
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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 60; n=0, 0, 0, 1 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | -0.7 | -0.1 | 0.0 | 3.4 | 4.0 | 4.8 | 0.4 | 16.0 | 5.1 |
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Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 60 | 4 |
,GSK1265744 10 mg | 57 | 13 |
,GSK1265744 30 mg | 57 | 12 |
,GSK1265744 60 mg | 60 | 11 |
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Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 59 | 2 |
,GSK1265744 10 mg | 54 | 2 |
,GSK1265744 30 mg | 54 | 0 |
,GSK1265744 60 mg | 55 | 2 |
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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 |
---|
Efavirenz 600 mg | 8 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 7 | 2 | 3 | 2 | 8 | 1 | 0 | 0 | 9 | 10 | 6 | 0 | 5 | 0 | 4 | 5 | 1 | 1 | 0 | 0 | 12 | 6 | 0 | 1 | 8 | 7 | 4 | 0 | 10 | 7 | 1 | 0 | 8 | 9 | 2 | 0 | 4 | 1 | 0 | 0 | 11 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
,GSK1265744 10 mg | 9 | 6 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 7 | 6 | 2 | 2 | 6 | 1 | 0 | 0 | 17 | 7 | 3 | 0 | 9 | 2 | 3 | 7 | 1 | 1 | 0 | 0 | 19 | 14 | 0 | 0 | 14 | 7 | 4 | 0 | 11 | 9 | 5 | 2 | 5 | 11 | 2 | 0 | 14 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 7 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 30 mg | 12 | 6 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 13 | 8 | 0 | 1 | 14 | 0 | 0 | 0 | 17 | 12 | 0 | 0 | 10 | 4 | 2 | 6 | 1 | 0 | 0 | 0 | 18 | 10 | 0 | 0 | 17 | 11 | 2 | 0 | 9 | 8 | 2 | 0 | 3 | 11 | 1 | 0 | 7 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 4 | 0 | 0 |
,GSK1265744 60 mg | 19 | 5 | 0 | 2 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 15 | 5 | 4 | 0 | 9 | 0 | 0 | 0 | 19 | 15 | 3 | 0 | 12 | 4 | 4 | 5 | 2 | 0 | 0 | 0 | 21 | 11 | 2 | 0 | 13 | 14 | 7 | 0 | 9 | 11 | 6 | 2 | 10 | 6 | 5 | 0 | 8 | 0 | 0 | 0 | 16 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 3 | 3 | 1 |
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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 |
---|
Efavirenz 600 mg | 6 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 5 | 2 | 3 | 2 | 8 | 1 | 0 | 0 | 9 | 10 | 4 | 0 | 5 | 0 | 3 | 5 | 1 | 0 | 0 | 0 | 11 | 5 | 0 | 0 | 8 | 6 | 4 | 0 | 9 | 7 | 0 | 0 | 7 | 9 | 2 | 0 | 4 | 1 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 10 mg | 9 | 6 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 5 | 2 | 2 | 6 | 1 | 0 | 0 | 17 | 6 | 3 | 0 | 8 | 2 | 3 | 6 | 1 | 1 | 0 | 0 | 17 | 14 | 0 | 0 | 14 | 6 | 4 | 0 | 9 | 9 | 5 | 2 | 5 | 10 | 2 | 0 | 12 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 7 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 30 mg | 12 | 6 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 13 | 8 | 0 | 1 | 14 | 0 | 0 | 0 | 17 | 12 | 0 | 0 | 9 | 4 | 2 | 6 | 1 | 0 | 0 | 0 | 17 | 10 | 0 | 0 | 16 | 11 | 2 | 0 | 9 | 8 | 1 | 0 | 3 | 11 | 1 | 0 | 7 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 4 | 0 | 0 |
,GSK1265744 60 mg | 17 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 13 | 5 | 2 | 0 | 9 | 0 | 0 | 0 | 19 | 15 | 3 | 0 | 11 | 4 | 4 | 5 | 2 | 0 | 0 | 0 | 20 | 11 | 2 | 0 | 13 | 14 | 7 | 0 | 8 | 11 | 6 | 2 | 9 | 5 | 5 | 0 | 8 | 0 | 0 | 0 | 16 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 3 | 3 | 1 |
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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 264; n=0, 0, 1, 0 |
---|
GSK1265744 60 mg | -4.9 | 7.0 | -2.7 | -5.8 | -4.5 | -9.0 | -143.0 |
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Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 26; n=0, 1, 0, 0 | Week 40; n=0, 1, 0, 0 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 204; n=0, 1, 0, 0 | Week 252; n=0, 1, 0, 0 |
---|
GSK1265744 30 mg | -10.0 | -3.7 | -1.0 | 0.2 | -6.4 | -7.0 | -95.0 | -1.1 | -2.4 | -23.0 | 0.0 |
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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | Creatinine; Week 108; n=43, 46, 48, 0 | Creatinine; Week 120; n=40, 45, 48, 0 | Creatinine; Week 132; n=40, 46, 49, 0 | Creatinine; Week 144; n=37, 45, 47, 0 | Creatinine; Week 156; n=37, 42, 49, 0 | Creatinine; Week 168; n=35, 43, 47, 0 | Creatinine; Week 180; n=36, 41, 47, 0 | Creatinine; Week 192; n=36, 39, 47, 0 | Creatinine; Week 204; n=34, 39, 47, 0 | Creatinine; Week 216; n=33, 39, 46, 0 | Creatinine; Week 228; n=32, 39, 47, 0 | Creatinine; Week 240; n=30, 39, 46, 0 | Creatinine; Week 252; n=31, 38, 46, 0 | Creatinine; Week 264; n=32, 38, 47, 0 | Creatinine; Week 276; n=31, 38, 45, 0 | Creatinine; Week 288; n=31, 38, 45, 0 | Creatinine; Week 300; n=30, 37, 44, 0 | Creatinine; Week 312; n=31, 34, 43, 0 | Creatinine; Week 324; n=3, 4, 3, 0 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Week 108; n=43, 46, 48, 0 | T. Bilirubin; Week 120; n=40, 45, 48, 0 | T. Bilirubin; Week 132; n=40, 46, 49, 0 | T. Bilirubin; Week 144; n=37, 45, 47, 0 | T. Bilirubin; Week 156; n=37, 42, 49, 0 | T. Bilirubin; Week 168; n=35, 43, 47, 0 | T. Bilirubin; Week 180; n=36, 41, 47, 0 | T. Bilirubin; Week 192; n=36, 39, 47, 0 | T. Bilirubin; Week 204; n=34, 39, 47, 0 | T. Bilirubin; Week 216; n=33, 39, 46, 0 | T. Bilirubin; Week 228; n=32, 39, 47, 0 | T. Bilirubin; Week 240; n=30, 39, 46, 0 | T. Bilirubin; Week 252; n=31, 38, 46, 0 | T. Bilirubin; Week 264; n=32, 38, 47, 0 | T. Bilirubin; Week 276; n=31, 38, 45, 0 | T. Bilirubin; Week 288; n=31, 38, 45, 0 | T. Bilirubin; Week 300; n=30, 37, 44, 0 | T. Bilirubin; Week 312; n=31, 34, 43, 0 | T. Bilirubin; Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 3.36 | 2.24 | 2.38 | 3.39 | 2.91 | 2.54 | 2.52 | 2.74 | 2.22 | 3.36 | 3.11 | 2.83 | 2.75 | 3.28 | 3.89 | 4.58 | 1.90 | 5.87 | 4.41 | 3.76 | 5.99 | 5.28 | 6.57 | 5.89 | 6.90 | 6.21 | 8.34 | 7.16 | 8.48 | 6.96 | 5.97 | 7.89 | 8.81 | 10.49 | 7.98 | 15.90 | 0.0 | 0.1 | 0.0 | 0.4 | 0.4 | -0.1 | 0.5 | 1.1 | 1.1 | 0.7 | 1.2 | 1.6 | 0.9 | 1.9 | 1.5 | 2.3 | 1.0 | 0.7 | 0.9 | 1.0 | 0.7 | 1.6 | 1.1 | 1.1 | 0.7 | 1.1 | 0.5 | 1.6 | 1.2 | 1.4 | 0.4 | 0.7 | 0.5 | 1.1 | 1.4 | 5.3 |
,GSK1265744 30 mg | 2.58 | 2.50 | 2.06 | 1.59 | 1.10 | 0.85 | 2.44 | 1.80 | 2.80 | 1.69 | 3.41 | 2.36 | 2.18 | 2.30 | 4.71 | 3.80 | 5.34 | 5.18 | 4.15 | 4.02 | 5.80 | 6.36 | 5.62 | 5.08 | 7.91 | 6.46 | 9.31 | 7.19 | 7.33 | 7.52 | 7.10 | 5.84 | 7.84 | 9.16 | 7.86 | 9.75 | -0.3 | -0.3 | -0.5 | -0.9 | -1.2 | -0.7 | 0.2 | 0.5 | 0.7 | 0.2 | 0.6 | 1.7 | 0.1 | 0.0 | 0.1 | 0.1 | 0.0 | 1.4 | 1.1 | 2.0 | 1.1 | 1.0 | 0.8 | 0.0 | 0.3 | 0.7 | 0.8 | 0.5 | 0.9 | 2.0 | 2.9 | 2.8 | 1.9 | 1.7 | 1.1 | 5.5 |
,GSK1265744 60 mg | 4.15 | 4.08 | 3.44 | 3.79 | 2.09 | 5.29 | 4.45 | 6.03 | 5.01 | 5.00 | 6.00 | 4.76 | 4.47 | 4.46 | 6.59 | 6.53 | 7.76 | 7.26 | 6.78 | 4.99 | 5.07 | 5.16 | 6.82 | 5.91 | 5.90 | 5.16 | 7.42 | 6.61 | 7.08 | 7.64 | 6.99 | 6.19 | 6.20 | 8.19 | 7.10 | 5.03 | -0.4 | -0.8 | -0.6 | -0.5 | -0.2 | -0.4 | -0.7 | 1.0 | 0.5 | 0.9 | 1.4 | 1.5 | -0.3 | 0.9 | 0.6 | 1.2 | 1.7 | 0.8 | 1.3 | 1.1 | 0.4 | 1.0 | 1.4 | 1.0 | 0.9 | 0.6 | 0.3 | -0.3 | -0.1 | 0.2 | -0.1 | 0.9 | 0.0 | 0.9 | 0.8 | 0.7 |
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Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | 0.65 | -0.32 | -0.92 | -1.42 | -2.92 | -3.26 | -2.03 | -2.67 | -3.42 | -3.50 | -3.26 | -2.83 | -2.73 | -3.87 | -4.48 | -2.48 | -2.28 | -3.0 | -3.4 | -3.4 | -2.4 | -2.4 | -2.6 | -2.9 | -2.7 | -2.8 | -2.6 | -2.7 | -2.9 | -2.6 | -2.2 | -2.7 | -2.6 | -2.5 |
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Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 46, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=35, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=32, 39, 47, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 46, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=30, 37, 44, 0 | Week 312; n=30, 34, 43, 0 | Week 324; n=3, 4, 3, 0 |
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GSK1265744 10 mg | 92.6 | 136.4 | 129.9 | 140.5 | 159.3 | 165.2 | 172.5 | 186.4 | 205.0 | 191.4 | 192.0 | 203.6 | 235.1 | 217.7 | 232.0 | 261.5 | 269.4 | 296.2 | 266.1 | 297.1 | 330.7 | 334.5 | 338.1 | 338.0 | 300.8 | 369.5 | 397.0 | 331.8 | 356.5 | 400.3 | 344.4 | 398.3 | 411.0 | 437.7 | 335.0 | 402.0 |
,GSK1265744 30 mg | 79.5 | 76.9 | 117.8 | 140.8 | 142.2 | 153.8 | 180.9 | 177.7 | 188.1 | 205.2 | 213.0 | 212.8 | 241.6 | 269.4 | 201.4 | 287.0 | 267.5 | 304.3 | 279.3 | 305.2 | 308.9 | 319.2 | 332.4 | 348.6 | 351.0 | 332.9 | 373.4 | 366.5 | 395.9 | 343.7 | 365.0 | 350.3 | 383.5 | 404.4 | 433.0 | 276.0 |
,GSK1265744 60 mg | 91.7 | 88.2 | 90.5 | 145.2 | 148.3 | 182.6 | 204.0 | 194.7 | 193.3 | 209.9 | 265.0 | 212.3 | 259.0 | 266.1 | 254.0 | 278.1 | 286.2 | 288.4 | 307.2 | 313.2 | 322.4 | 320.4 | 361.3 | 384.2 | 342.3 | 340.0 | 357.8 | 383.7 | 408.4 | 383.1 | 391.8 | 362.2 | 337.1 | 353.5 | 407.0 | 272.0 |
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Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 |
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Efavirenz 600 mg | 24.8 | 46.0 | 65.6 | 103.4 | 135.5 | 149.0 | 143.4 | 166.4 | 178.2 | 197.4 | 185.2 | 221.5 | 262.5 | 263.8 | 257.1 | 279.4 | 281.7 |
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Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | International Units per Liter (Mean) |
---|
| ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 50 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | -1.3 | 0.1 | -6.3 | -6.3 | -1.6 | -4.8 | -6.0 | -3.7 | -8.1 | -8.6 | -8.2 | -8.0 | -8.6 | -6.3 | -8.5 | -4.0 | -7.6 | 0.9 | -2.9 | -7.3 | -7.9 | 4.4 | -3.6 | -2.1 | -2.6 | -5.1 | -2.8 | -1.9 | -5.1 | -4.4 | -3.2 | -4.6 | 2.3 | -0.3 | 159.8 | -120.3 | -212.8 | -220.1 | 269.7 | 135.3 | 103.9 | 21.2 | 4.1 | 110.3 | 158.7 | 3.8 | 2.8 | 24.5 | -14.3 | 123.9 | 143.9 |
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Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | International Units per Liter (Mean) |
---|
| ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | ALT; Week 108; n=43, 46, 48, 0 | ALT; Week 120; n=40, 45, 48, 0 | ALT; Week 132; n=40, 46, 49, 0 | ALT; Week 144; n=37, 45, 47, 0 | ALT; Week 156; n=37, 42, 49, 0 | ALT; Week 168; n=35, 43, 47, 0 | ALT; Week 180; n=36, 41, 47, 0 | ALT; Week 192; n=36, 39, 47, 0 | ALT; Week 204; n=34, 39, 47, 0 | ALT; Week 216; n=33, 39, 46, 0 | ALT; Week 228; n=32, 39, 47, 0 | ALT; Week 240; n=30, 39, 46, 0 | ALT; Week 252; n=31, 38, 46, 0 | ALT; Week 264; n=32, 38, 47, 0 | ALT; Week 276; n=31, 38, 45, 0 | ALT; Week 288; n=31, 38, 45, 0 | ALT; Week 300; n=30, 37, 44, 0 | ALT; Week 312; n=31, 34, 43, 0 | ALT; Week 324; n=3, 4, 3, 0 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 50 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | AST; Week 108; n=43, 46, 48, 0 | AST; Week 120; n=40, 45, 48, 0 | AST; Week 132; n=40, 46, 49, 0 | AST; Week 144; n=37, 45, 47, 0 | AST; Week 156; n=37, 42, 49, 0 | AST; Week 168; n=35, 43, 47, 0 | AST; Week 180; n=36, 41, 47, 0 | AST; Week 192; n=36, 39, 47, 0 | AST; Week 204; n=34, 39, 47, 0 | AST; Week 216; n=33, 39, 46, 0 | AST; Week 228; n=32, 39, 47, 0 | AST; Week 240; n=30, 39, 46, 0 | AST; Week 252; n=31, 38, 46, 0 | AST; Week 264; n=32, 38, 47, 0 | AST; Week 276; n=31, 38, 45, 0 | AST; Week 288; n=31, 38, 45, 0 | AST; Week 300; n=30, 37, 44, 0 | AST; Week 312; n=31, 34, 43, 0 | AST; Week 324; n=3, 4, 3, 0 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 | CK; Week 108; n=43, 46, 48, 0 | CK; Week 120; n=40, 45, 48, 0 | CK; Week 132; n=40, 46, 49, 0 | CK; Week 144; n=37, 45, 47, 0 | CK; Week 156; n=37, 42, 49, 0 | CK; Week 168; n=35, 43, 47, 0 | CK; Week 180; n=36, 41, 47, 0 | CK; Week 192; n=36, 39, 47, 0 | CK; Week 204; n=34, 39, 47, 0 | CK; Week 216; n=33, 39, 46, 0 | CK; Week 228; n=32, 39, 47, 0 | CK; Week 240; n=30, 39, 46, 0 | CK; Week 252; n=31, 38, 46, 0 | CK; Week 264; n=32, 38, 47, 0 | CK; Week 276; n=31, 38, 45, 0 | CK; Week 288; n=31, 38, 45, 0 | CK; Week 300; n=30, 37, 44, 0 | CK; Week 312; n=31, 34, 43, 0 | CK; Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 0.1 | -0.7 | 2.2 | 1.2 | 2.1 | -0.7 | -2.1 | 1.1 | -2.3 | -3.1 | 0.8 | 0.1 | -4.1 | -1.0 | -2.8 | -2.4 | -0.4 | 0.5 | 4.4 | 4.3 | 0.1 | -0.5 | 2.3 | 1.7 | 4.9 | 1.9 | 1.7 | 36.8 | 5.3 | 2.0 | 3.3 | 3.3 | 6.6 | 4.8 | 5.5 | 17.7 | 0.7 | -1.0 | 4.2 | 1.3 | -0.7 | 1.3 | -1.4 | 3.3 | -2.0 | -2.7 | 4.6 | 0.1 | -3.3 | -0.9 | -2.7 | -2.2 | -0.8 | -1.0 | 0.1 | -0.2 | -3.4 | -3.0 | -0.8 | -1.9 | -1.5 | -1.7 | -2.7 | 13.5 | -1.0 | -2.2 | -1.6 | -1.5 | -1.4 | -2.0 | 11.7 | 2.7 | 40.0 | -2.3 | 216.9 | 120.6 | -2.0 | 144.2 | 27.5 | 133.7 | 9.8 | 3.1 | 325.9 | 57.1 | -1.3 | 115.4 | -19.8 | -0.7 | 335.4 | 64.2 | 11.5 | 30.6 | 10.6 | -5.3 | 27.7 | 22.4 | 5.2 | 79.1 | 43.2 | 64.0 | 1.2 | 24.6 | 1.9 | 39.9 | 21.6 | 25.3 | 727.5 | -1.3 |
,GSK1265744 30 mg | -2.1 | -2.6 | 0.5 | 2.7 | 0.1 | -3.6 | -1.2 | -2.6 | -2.3 | -1.7 | -4.2 | -4.1 | -3.8 | -2.6 | 2.7 | 1.9 | 20.6 | -2.7 | -2.6 | -3.0 | -3.4 | -1.8 | -1.1 | -2.8 | -3.3 | -1.7 | -3.0 | -1.1 | -0.1 | 2.8 | 0.7 | 2.9 | 1.2 | -1.4 | 7.6 | 1.3 | -1.3 | -2.8 | 1.5 | 1.6 | 1.9 | -3.1 | -0.3 | -0.9 | -0.2 | -1.0 | -2.1 | -2.9 | -3.2 | -2.0 | 3.7 | 2.0 | 20.5 | -4.0 | -2.5 | -3.9 | -4.3 | -3.2 | -3.4 | -4.2 | -5.3 | -4.8 | -4.9 | -5.9 | -5.3 | -2.1 | -4.3 | -3.3 | -3.6 | -5.3 | -2.3 | -5.3 | -32.2 | -82.0 | 115.8 | 39.8 | 156.3 | -68.9 | 32.4 | -16.3 | 74.1 | -25.1 | -33.6 | -48.6 | -54.7 | -80.1 | 53.8 | 33.6 | -22.8 | -88.5 | -48.9 | -41.3 | -72.4 | -87.9 | -60.7 | -16.4 | -98.5 | -101.8 | -74.4 | -129.0 | -108.1 | -110.1 | -31.3 | -126.5 | -98.5 | -100.7 | -141.3 | -195.0 |
,GSK1265744 60 mg | -1.5 | 1.7 | 8.0 | -0.6 | -0.3 | 3.0 | 1.4 | -1.7 | -2.9 | -4.0 | -3.0 | -1.4 | -2.4 | 0.5 | -0.9 | -2.0 | -1.7 | -0.7 | -3.7 | -3.8 | -1.8 | -2.2 | -3.6 | -1.2 | 1.3 | -3.4 | -2.7 | 0.5 | -0.7 | -1.6 | 2.0 | 1.1 | 1.9 | -1.8 | 0.0 | 1.0 | -1.6 | 0.1 | 5.3 | -1.7 | -0.6 | 4.6 | 1.5 | -1.7 | -1.9 | -1.4 | -0.6 | -0.5 | -3.0 | 3.0 | -0.5 | -1.8 | -1.0 | 0.6 | -2.4 | 0.7 | -3.9 | -4.1 | -3.8 | -2.9 | 0.1 | -4.5 | -4.3 | -2.8 | -3.4 | -3.9 | -2.9 | -1.4 | -2.2 | -4.1 | -0.3 | -6.7 | 0.4 | -2.9 | 266.7 | 27.1 | 28.6 | 298.9 | 55.9 | 54.4 | 96.8 | 122.1 | 66.1 | 103.5 | 28.6 | 206.2 | 67.6 | 14.9 | 19.6 | 100.3 | 61.4 | 649.6 | 68.7 | 73.3 | 74.4 | 62.8 | 98.6 | 48.3 | 41.9 | 40.4 | 92.0 | 62.5 | 38.9 | 146.4 | 43.4 | 56.0 | 209.4 | 102.7 |
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Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Chloride; Grade 1 | Chloride; Grade 2 | Chloride; Grade 3 | Chloride; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | HDL cholesterol; Grade 1 | HDL cholesterol; Grade 2 | HDL cholesterol; Grade 3 | HDL cholesterol; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 | Urea/BUN; Grade 1 | Urea/BUN; Grade 2 | Urea/BUN; Grade 3 | Urea/BUN; Grade 4 |
---|
Efavirenz 600 mg | 8 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 6 | 1 | 2 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 9 | 6 | 0 | 4 | 1 | 2 | 4 | 1 | 1 | 0 | 0 | 6 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 8 | 2 | 0 | 6 | 5 | 1 | 0 | 6 | 8 | 2 | 0 | 2 | 1 | 0 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 3 | 0 | 0 | 7 | 2 | 3 | 2 | 0 | 1 | 0 | 0 | 10 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 4 | 0 | 0 | 9 | 6 | 2 | 0 | 5 | 6 | 1 | 0 | 7 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 30 mg | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 8 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 2 | 0 | 0 | 5 | 2 | 1 | 4 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 1 | 0 | 0 | 3 | 1 | 1 | 0 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 60 mg | 13 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 7 | 1 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 3 | 2 | 0 | 6 | 3 | 1 | 2 | 0 | 0 | 0 | 0 | 13 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 3 | 0 | 5 | 7 | 4 | 1 | 7 | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
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Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Giga cells per liter (Mean) |
---|
| T. neutrophils; Baseline; n=60, 60, 61, 62 | T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | Platelet count; Baseline; n=60, 60, 61, 62 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | WBC count; Baseline; n=60, 60, 61, 62 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC count; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 |
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Efavirenz 600 mg | 2.441 | 3.207 | 2.848 | 2.746 | 2.979 | 2.858 | 3.187 | 3.142 | 2.886 | 2.916 | 3.174 | 2.914 | 3.187 | 3.134 | 3.269 | 3.361 | 3.259 | 3.297 | 200.1 | 216.2 | 216.0 | 209.8 | 213.7 | 211.4 | 214.9 | 220.9 | 214.4 | 215.4 | 212.6 | 209.8 | 217.7 | 220.3 | 230.5 | 225.9 | 216.5 | 214.0 | 4.70 | 5.45 | 5.02 | 5.02 | 5.27 | 5.13 | 5.50 | 5.34 | 5.08 | 5.14 | 5.48 | 5.17 | 5.51 | 5.53 | 5.75 | 5.84 | 5.78 | 5.75 |
,GSK1265744 10 mg | 2.643 | 2.723 | 2.685 | 2.899 | 2.812 | 3.078 | 2.958 | 3.151 | 2.885 | 3.183 | 2.797 | 3.162 | 3.155 | 3.138 | 3.164 | 3.197 | 3.245 | 3.466 | 212.5 | 225.0 | 225.2 | 224.5 | 227.2 | 230.0 | 231.3 | 226.1 | 224.9 | 223.3 | 220.5 | 220.0 | 224.9 | 225.6 | 232.5 | 234.0 | 224.8 | 237.1 | 5.06 | 5.32 | 5.24 | 5.44 | 5.41 | 5.56 | 5.46 | 5.57 | 5.30 | 5.71 | 5.30 | 5.64 | 5.63 | 5.51 | 5.73 | 5.80 | 5.91 | 6.14 |
,GSK1265744 30 mg | 2.891 | 2.776 | 2.771 | 2.802 | 2.933 | 2.716 | 2.904 | 2.996 | 2.958 | 3.005 | 3.036 | 2.916 | 3.065 | 3.132 | 3.333 | 3.131 | 3.385 | 3.540 | 202.3 | 222.0 | 222.4 | 228.4 | 216.4 | 212.4 | 215.5 | 219.7 | 215.5 | 217.0 | 214.0 | 212.1 | 210.1 | 221.2 | 219.8 | 224.4 | 218.8 | 221.8 | 5.19 | 5.30 | 5.17 | 5.30 | 5.50 | 5.20 | 5.41 | 5.53 | 5.50 | 5.53 | 5.63 | 5.48 | 5.61 | 5.72 | 5.93 | 5.71 | 6.11 | 6.15 |
,GSK1265744 60 mg | 2.487 | 2.598 | 2.649 | 2.738 | 2.822 | 2.665 | 2.989 | 2.884 | 2.830 | 2.989 | 3.167 | 3.010 | 3.050 | 3.004 | 3.200 | 3.163 | 3.512 | 3.494 | 190.0 | 204.8 | 204.6 | 211.5 | 209.2 | 209.5 | 205.4 | 210.9 | 199.4 | 209.8 | 207.8 | 204.2 | 199.3 | 209.9 | 212.2 | 212.2 | 210.1 | 210.6 | 4.72 | 5.02 | 5.02 | 5.04 | 5.34 | 4.97 | 5.39 | 5.28 | 5.29 | 5.38 | 5.57 | 5.56 | 5.45 | 5.41 | 5.63 | 5.73 | 6.05 | 6.01 |
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Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
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Efavirenz 600 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 0 | 0 | 0 |
,GSK1265744 10 mg | 5 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 7 | 5 | 1 | 1 | 2 | 1 | 0 | 0 |
,GSK1265744 30 mg | 5 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 9 | 2 | 0 | 1 | 5 | 1 | 0 | 0 |
,GSK1265744 60 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 10 | 3 | 1 | 3 | 2 | 1 | 1 | 0 |
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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Basophils; Grade 1 | Basophils; Grade 2 | Basophils; Grade 3 | Basophils; Grade 4 | Eosinophils; Grade 1 | Eosinophils; Grade 2 | Eosinophils; Grade 3 | Eosinophils; Grade 4 | Hematocrit; Grade 1 | Hematocrit; Grade 2 | Hematocrit; Grade 3 | Hematocrit; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Lymphocytes; Grade 1 | Lymphocytes; Grade 2 | Lymphocytes; Grade 3 | Lymphocytes; Grade 4 | MCV; Grade 1 | MCV; Grade 2 | MCV; Grade 3 | MCV; Grade 4 | Monocytes; Grade 1 | Monocytes; Grade 2 | Monocytes; Grade 3 | Monocytes; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | RBC; Grade 1 | RBC; Grade 2 | RBC; Grade 3 | RBC; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
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Efavirenz 600 mg | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 0 |
,GSK1265744 10 mg | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 30 mg | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 0 | 2 | 1 | 0 | 0 |
,GSK1265744 60 mg | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 1 | 2 | 0 | 0 | 0 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | 0 | 14 | 26 | 55 | 76 | 87 | 91 | 96 | 93 | 96 | 96 | 98 | 93 | 98 | 95 | 100 | 100 | 98 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
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GSK1265744 10 mg | 0 | 51 | 83 | 92 | 95 | 95 | 91 | 93 | 98 | 100 | 96 | 98 | 96 | 92 | 94 | 91 | 91 | 89 | 95 | 95 | 95 | 92 | 95 | 94 | 97 | 94 | 97 | 100 | 100 | 97 | 100 | 100 | 100 | 100 | 97 | 100 | 100 |
,GSK1265744 30 mg | 0 | 54 | 82 | 89 | 88 | 94 | 98 | 98 | 94 | 94 | 94 | 96 | 96 | 92 | 96 | 92 | 94 | 98 | 96 | 100 | 96 | 93 | 95 | 95 | 100 | 100 | 97 | 100 | 100 | 97 | 97 | 100 | 100 | 100 | 100 | 97 | 100 |
,GSK1265744 60 mg | 0 | 53 | 73 | 93 | 91 | 93 | 98 | 95 | 98 | 100 | 96 | 95 | 95 | 98 | 98 | 100 | 100 | 98 | 100 | 98 | 100 | 98 | 98 | 98 | 98 | 96 | 98 | 98 | 98 | 100 | 98 | 98 | 96 | 100 | 95 | 100 | 100 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 |
---|
Efavirenz 600 mg | 0 | 13 | 24 | 48 | 61 | 74 | 74 | 66 | 69 | 69 | 71 | 68 | 71 | 68 | 68 | 68 | 63 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 0 | 48 | 80 | 90 | 88 | 90 | 87 | 78 | 85 | 83 | 85 | 83 | 80 | 78 | 72 | 72 | 68 | 68 | 65 | 62 | 58 | 58 | 57 | 58 | 57 | 55 | 55 | 53 | 50 | 52 | 53 | 52 | 50 | 52 | 52 |
,GSK1265744 30 mg | 0 | 50 | 78 | 83 | 75 | 83 | 85 | 75 | 78 | 80 | 82 | 82 | 80 | 73 | 73 | 75 | 75 | 72 | 73 | 70 | 67 | 63 | 65 | 67 | 65 | 62 | 63 | 63 | 62 | 62 | 62 | 62 | 62 | 60 | 52 |
,GSK1265744 60 mg | 0 | 51 | 70 | 87 | 82 | 87 | 87 | 85 | 85 | 87 | 85 | 85 | 87 | 85 | 85 | 85 | 84 | 80 | 80 | 80 | 77 | 80 | 75 | 75 | 74 | 75 | 77 | 75 | 74 | 75 | 75 | 70 | 74 | 70 | 70 |
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Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
---|
Efavirenz 600 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 0 | 0 | 0 |
,GSK1265744 10 mg | 5 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 7 | 5 | 1 | 1 | 2 | 1 | 0 | 0 |
,GSK1265744 30 mg | 5 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 9 | 2 | 0 | 1 | 5 | 1 | 0 | 0 |
,GSK1265744 60 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 10 | 3 | 1 | 3 | 2 | 1 | 1 | 0 |
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Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
Efavirenz 600 mg | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 1 | 0 | 0 | 0 |
,GSK1265744 30 mg | 1 | 0 | 0 | 1 |
,GSK1265744 60 mg | 0 | 0 | 0 | 1 |
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Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| Any INI mutation | Any mutation to other classes |
---|
Efavirenz 600 mg | 0 | 0 |
,GSK1265744 10 mg | 3 | 4 |
,GSK1265744 30 mg | 0 | 0 |
,GSK1265744 60 mg | 1 | 1 |
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Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| INI, GSK1265744; Resistant; n=5, 1, 2, 2 | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | INI, RAL; Resistant; n=5, 1, 2, 2 | INI, RAL; Sensitive; n=5, 1, 2, 2 | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | NRTI, ABC; Resistant; n=6, 2, 2, 5 | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | NRTI, FTC; Resistant; n=6, 2, 2, 5 | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | NRTI, TDF; Resistant; n=6, 2, 2, 5 | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | NRTI, d4T; Resistant; n=6, 2, 2, 5 | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | NRTI, ddI; Resistant; n=6, 2, 2, 5 | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | PI, ATV/r; Resistant; n=6, 2, 2, 5 | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | PI, DRV/r; Resistant; n=6, 2, 2, 5 | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | PI, FPV/r; Resistant; n=6, 2, 2, 5 | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | PI, IDV/r; Resistant; n=6, 2, 2, 5 | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | PI, LPV/r; Resistant; n=6, 2, 2, 5 | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | PI, NFV; Resistant; n=6, 2, 2, 5 | PI, NFV; Sensitive; n=6, 2, 2, 5 | PI, RTV; Resistant; n=6, 2, 2, 5 | PI, RTV; Sensitive; n=6, 2, 2, 5 | PI, SQV/r; Resistant; n=6, 2, 2, 5 | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | PI, TPV/r; Resistant; n=6, 2, 2, 5 | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, TPV/r; Sensitive; n=6, 2, 2, 5 |
---|
Efavirenz 600 mg | 0 | 2 | 0 | 2 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 |
,GSK1265744 10 mg | 2 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 0 | 3 | 3 | 3 | 3 | 3 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 1 | 5 | 2 | 4 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 6 |
,GSK1265744 30 mg | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 |
,GSK1265744 60 mg | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Week 16 and Week 24
Intervention | Percentage of participants (Number) |
---|
| Week 16 | Week 24 |
---|
Efavirenz 600 mg | 74 | 74 |
,GSK1265744 10 mg | 90 | 87 |
,GSK1265744 30 mg | 83 | 85 |
,GSK1265744 60 mg | 87 | 87 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 35 | 2 |
,GSK1265744 10 mg | 40 | 5 |
,GSK1265744 30 mg | 50 | 5 |
,GSK1265744 60 mg | 50 | 5 |
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Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
---|
| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 | Week 96; n=31, 36, 33, 0 | Week 108; n=23, 23, 29, 0 | Week 120; n=30, 38, 41, 0 | Week 132; n=29, 32, 40, 0 | Week 144; n=33, 34, 43, 0 | Week 156; n=31, 28, 39, 0 | Week 168; n=29, 33, 41, 0 | Week 180; n=26, 29, 39, 0 | Week 192; n=30, 30, 39, 0 | Week 204; n=29, 32, 38, 0 | Week 216; n=29, 30, 37, 0 | Week 228; n=27, 34, 40, 0 | Week 240; n=28, 26, 41, 0 | Week 252; n=23, 26, 33, 0 | Week 264; n=15, 18, 24, 0 | Week 276; n=14, 14, 21, 0 | Week 288; n=12, 14, 18, 0 | Week 300; n=12, 13, 20, 0 | Week 312; n=1, 1, 0, 0 |
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GSK1265744 10 mg | 53 | 46 | 49 | 44 | 44 | 45 | 47 | 45 | 46 | 40 | 33 | 32 | 37 | 32 | 34 | 25 | 21 | 28 | 28 | 32 | 30 | 29 | 24 | 28 | 27 | 29 | 25 | 28 | 18 | 12 | 13 | 12 | 11 | 1 |
,GSK1265744 30 mg | 51 | 49 | 45 | 40 | 45 | 40 | 41 | 46 | 42 | 43 | 30 | 33 | 35 | 35 | 36 | 32 | 20 | 36 | 30 | 29 | 25 | 24 | 24 | 27 | 26 | 27 | 28 | 22 | 21 | 16 | 13 | 10 | 7 | 1 |
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Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 4.290 | 2.415 | 2.201 | 1.950 | 1.758 | 1.697 | 1.649 | 1.610 | 1.610 | 1.600 | 1.614 | 1.607 | 1.607 | 1.596 | 1.657 | 1.592 | 1.591 | 1.598 |
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Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Grams per liter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 145.4 | 146.4 | 146.6 | 148.1 | 149.2 | 147.6 | 147.2 | 148.5 | 148.2 | 145.9 | 145.9 | 145.0 | 145.1 | 145.4 | 147.6 | 147.7 | 147.0 | 147.0 |
,GSK1265744 10 mg | 141.9 | 142.0 | 141.9 | 144.9 | 144.3 | 143.5 | 144.3 | 144.8 | 144.4 | 143.7 | 144.6 | 142.3 | 142.2 | 142.9 | 144.5 | 143.9 | 145.6 | 144.9 |
,GSK1265744 30 mg | 143.2 | 142.8 | 143.5 | 147.7 | 147.4 | 146.5 | 146.9 | 147.8 | 145.8 | 146.8 | 146.1 | 145.9 | 145.2 | 145.7 | 148.3 | 148.1 | 147.7 | 147.1 |
,GSK1265744 60 mg | 146.6 | 145.9 | 147.3 | 148.6 | 149.1 | 148.7 | 149.8 | 150.4 | 149.8 | 149.3 | 150.5 | 149.8 | 149.2 | 146.5 | 149.8 | 149.6 | 150.3 | 150.8 |
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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
Efavirenz 600 mg | 0 | 68 | 68 | 79 | 73 | 81 | 79 | 71 | 73 | 73 | 73 | 73 | 73 | 71 | 68 | 68 | 65 |
,GSK1265744 10 mg | 0 | 87 | 93 | 93 | 90 | 93 | 93 | 80 | 85 | 87 | 87 | 87 | 83 | 80 | 77 | 77 | 75 |
,GSK1265744 30 mg | 0 | 80 | 93 | 92 | 85 | 87 | 87 | 80 | 83 | 85 | 85 | 85 | 85 | 77 | 75 | 77 | 77 |
,GSK1265744 60 mg | 0 | 84 | 93 | 92 | 89 | 93 | 92 | 87 | 85 | 89 | 90 | 90 | 89 | 87 | 85 | 85 | 85 |
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Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | 0 | 71 | 74 | 91 | 92 | 96 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 100 | 100 |
,GSK1265744 10 mg | 0 | 91 | 97 | 95 | 97 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 96 | 98 | 100 | 96 |
,GSK1265744 30 mg | 0 | 86 | 98 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 96 | 98 | 100 |
,GSK1265744 60 mg | 0 | 86 | 97 | 98 | 98 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
---|
GSK1265744 10 mg | 131.0 | 96.0 | 129.3 | 125.0 | 132.4 | 137.0 | 127.9 | 127.0 | 130.8 |
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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
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GSK1265744 60 mg | 128.3 | 122.4 | 143.0 | 123.9 | 120.7 | 122.3 | 116.6 |
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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
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| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 26; n=0, 1, 0, 0 | Week 40; n=0, 1, 0, 0 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
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GSK1265744 30 mg | 135.2 | 106.0 | 132.5 | 124.0 | 139.4 | 132.8 | 147.0 | 180.0 | 139.2 | 137.7 |
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Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
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| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 60; n=0, 0, 0, 1 | Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | 125.6 | 99.0 | 127.0 | 101.0 | 132.3 | 122.0 | 135.1 | 131.0 | 144.0 | 134.8 |
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Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Micromoles per liter (Mean) |
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| Creatinine; Baseline; n=60, 60, 61, 62 | Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 |
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Efavirenz 600 mg | 83.1 | 83.8 | 83.1 | 82.4 | 81.1 | 79.6 | 79.5 | 80.0 | 78.6 | 78.5 | 78.1 | 78.4 | 79.2 | 79.0 | 77.9 | 77.7 | 79.7 | 81.0 | 9.7 | 6.8 | 6.4 | 6.3 | 7.0 | 7.0 | 6.8 | 6.6 | 6.8 | 6.4 | 6.6 | 6.5 | 6.3 | 6.6 | 7.0 | 6.5 | 6.6 | 6.8 |
,GSK1265744 10 mg | 80.4 | 83.8 | 82.9 | 82.9 | 83.8 | 83.4 | 83.2 | 83.2 | 83.4 | 83.0 | 83.8 | 83.5 | 83.3 | 83.4 | 83.9 | 84.5 | 85.0 | 82.0 | 9.2 | 9.2 | 9.4 | 9.3 | 9.5 | 9.6 | 9.0 | 9.6 | 10.6 | 10.3 | 9.8 | 10.3 | 10.8 | 10.0 | 11.2 | 10.8 | 11.7 | 10.3 |
,GSK1265744 30 mg | 80.5 | 83.3 | 83.0 | 82.2 | 82.7 | 82.3 | 82.0 | 83.3 | 82.6 | 83.8 | 82.6 | 84.6 | 83.2 | 83.1 | 83.0 | 86.1 | 84.8 | 86.4 | 9.4 | 9.1 | 9.3 | 9.0 | 8.9 | 8.5 | 9.0 | 9.8 | 9.9 | 10.2 | 9.8 | 10.1 | 11.2 | 9.6 | 9.8 | 10.0 | 9.9 | 9.9 |
,GSK1265744 60 mg | 79.9 | 84.6 | 84.2 | 83.5 | 84.1 | 82.4 | 86.1 | 85.2 | 87.0 | 85.6 | 85.7 | 86.7 | 85.4 | 85.0 | 85.2 | 87.3 | 87.3 | 88.5 | 10.5 | 10.0 | 9.8 | 10.1 | 10.2 | 10.4 | 10.4 | 10.0 | 12.0 | 11.4 | 11.7 | 12.2 | 12.3 | 10.4 | 11.6 | 11.4 | 12.0 | 12.5 |
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Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
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| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 | Week 96; n=31, 36, 33, 0 | Week 108; n=23, 23, 29, 0 | Week 120; n=30, 38, 41, 0 | Week 132; n=29, 32, 40, 0 | Week 144; n=33, 34, 43, 0 | Week 156; n=31, 28, 39, 0 | Week 168; n=29, 33, 41, 0 | Week 180; n=26, 29, 39, 0 | Week 192; n=30, 30, 39, 0 | Week 204; n=29, 32, 38, 0 | Week 216; n=29, 30, 37, 0 | Week 228; n=27, 34, 40, 0 | Week 240; n=28, 26, 41, 0 | Week 252; n=23, 26, 33, 0 | Week 264; n=15, 18, 24, 0 | Week 276; n=14, 14, 21, 0 | Week 288; n=12, 14, 18, 0 | Week 300; n=12, 13, 20, 0 |
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GSK1265744 60 mg | 55 | 52 | 53 | 46 | 50 | 51 | 48 | 48 | 52 | 48 | 41 | 41 | 37 | 41 | 39 | 30 | 27 | 39 | 35 | 41 | 35 | 35 | 34 | 35 | 33 | 31 | 35 | 35 | 29 | 21 | 18 | 17 | 18 |
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Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
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| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 |
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Efavirenz 600 mg | 48 | 44 | 47 | 43 | 42 | 41 | 39 | 35 | 37 | 36 | 34 | 33 | 35 | 27 | 29 |
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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Giga cells per liter (Mean) |
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| T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 |
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Efavirenz 600 mg | 0.716 | 0.375 | 0.273 | 0.525 | 0.367 | 0.740 | 0.637 | 0.449 | 0.446 | 0.717 | 0.414 | 0.730 | 0.665 | 0.800 | 0.892 | 0.790 | 0.831 | 17.1 | 15.6 | 10.3 | 11.2 | 9.3 | 17.1 | 23.9 | 17.5 | 17.2 | 13.8 | 12.3 | 18.9 | 20.6 | 30.8 | 28.3 | 18.9 | 17.5 | 0.69 | 0.29 | 0.27 | 0.54 | 0.36 | 0.78 | 0.55 | 0.35 | 0.39 | 0.71 | 0.36 | 0.75 | 0.73 | 0.95 | 1.02 | 0.95 | 0.92 |
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Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Giga cells per liter (Mean) |
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| T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | T. neutrophils; Week 108; n=43, 46, 49, 0 | T. neutrophils; Week 120; n=41, 46, 49, 0 | T. neutrophils; Week 132; n=40, 46, 49, 0 | T. neutrophils; Week 144; n=37, 45, 46, 0 | T. neutrophils; Week 156; n=37, 42, 49, 0 | T. neutrophils; Week 168; n=35, 43, 47, 0 | T. neutrophils; Week 180; n=36, 41, 47, 0 | T. neutrophils; Week 192; n=35, 40, 47, 0 | T. neutrophils; Week 204; n=34, 39, 47, 0 | T. neutrophils; Week 216; n=32, 39, 43, 0 | T. neutrophils; Week 228; n=30, 39, 47, 0 | T. neutrophils; Week 240; n=32, 39, 47, 0 | T. neutrophils; Week 252; n=31, 36, 45, 0 | T. neutrophils; Week 264; n=32, 38, 46, 0 | T. neutrophils; Week 276; n=31, 38, 45, 0 | T. neutrophils; Week 288; n=30, 38, 44, 0 | T. neutrophils; Week 300; n=30, 37, 43, 0 | T. neutrophils; Week 312; n=31, 33, 41, 0 | T. neutrophils; Week 324; n=3, 4, 2, 0 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | Platelet count; Week 108; n=43, 46, 49, 0 | Platelet count; Week 120; n=41, 46, 49, 0 | Platelet count; Week 132; n=40, 46, 48, 0 | Platelet count; Week 144; n=37, 45, 44, 0 | Platelet count; Week 156; n=37, 42, 47, 0 | Platelet count; Week 168; n=35, 43, 46, 0 | Platelet count; Week 180; n=36, 41, 46, 0 | Platelet count; Week 192; n=35, 40, 46, 0 | Platelet count; Week 204; n=34, 39, 45, 0 | Platelet count; Week 216; n=32, 39, 44, 0 | Platelet count; Week 228; n=31, 39, 46, 0 | Platelet count; Week 240; n=32, 39, 47, 0 | Platelet count; Week 252; n=31, 36, 44, 0 | Platelet count; Week 264; n=32, 38, 45, 0 | Platelet count; Week 276; n=31, 38, 45, 0 | Platelet count; Week 288; n=30, 38, 43, 0 | Platelet count; Week 300; n=30, 37, 40, 0 | Platelet count; Week 312; n=31, 33, 41, 0 | Platelet count; Week 324; n=3, 4, 2, 0 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 | WBC count; Week 108; n=43, 46, 49, 0 | WBC count; Week 120; n=41, 46, 49, 0 | WBC count; Week 132; n=40, 46, 49, 0 | WBC count; Week 144; n=37, 45, 46, 0 | WBC count; Week 156; n=37, 42, 49, 0 | WBC count; Week 168; n=35, 43, 47, 0 | WBC count; Week 180; n=36, 41, 47, 0 | WBC count; Week 192; n=35, 40, 47, 0 | WBC count; Week 204; n=34, 39, 47, 0 | WBC count; Week 216; n=32, 39, 43, 0 | WBC count; Week 228; n=31, 39, 47, 0 | WBC count; Week 240; n=32, 39, 47, 0 | WBC count; Week 252; n=31, 36, 45, 0 | WBC count; Week 264; n=32, 38, 46, 0 | WBC count; Week 276; n=31, 38, 45, 0 | WBC count; Week 288; n=30, 38, 44, 0 | WBC count; Week 300; n=30, 37, 43, 0 | WBC count; Week 312; n=31, 33, 41, 0 | WBC count; Week 324; n=3, 4, 2, 0 |
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GSK1265744 10 mg | 0.042 | 0.038 | 0.251 | 0.138 | 0.388 | 0.270 | 0.462 | 0.120 | 0.496 | 0.071 | 0.420 | 0.430 | 0.386 | 0.374 | 0.383 | 0.410 | 0.631 | 0.623 | 0.372 | 0.777 | 0.672 | 0.762 | 0.588 | 0.769 | 0.490 | 0.618 | 0.543 | 0.780 | 0.508 | 0.268 | 0.475 | 0.400 | 0.456 | 0.139 | 0.243 | 0.860 | 11.0 | 9.9 | 10.3 | 13.7 | 16.5 | 17.2 | 12.0 | 8.3 | 6.6 | 7.7 | 5.2 | 11.1 | 12.5 | 20.9 | 23.7 | 13.6 | 25.9 | 24.5 | 23.8 | 16.8 | 27.1 | 26.6 | 34.9 | 28.4 | 34.7 | 33.9 | 28.1 | 28.7 | 27.2 | 15.9 | 27.9 | 48.4 | 44.1 | 28.5 | 27.3 | 31.7 | 0.19 | 0.16 | 0.37 | 0.32 | 0.45 | 0.36 | 0.47 | 0.19 | 0.67 | 0.25 | 0.56 | 0.57 | 0.43 | 0.60 | 0.63 | 0.71 | 0.95 | 0.89 | 0.59 | 0.92 | 0.91 | 1.05 | 0.97 | 1.07 | 0.61 | 0.98 | 0.88 | 0.98 | 0.79 | 0.66 | 0.62 | 0.92 | 0.92 | 0.58 | 0.57 | 1.97 |
,GSK1265744 30 mg | -0.084 | -0.083 | -0.066 | 0.040 | -0.156 | 0.032 | 0.109 | 0.052 | 0.213 | 0.149 | 0.029 | 0.178 | 0.245 | 0.458 | 0.274 | 0.528 | 0.698 | 0.570 | 0.650 | 0.405 | 0.468 | 0.418 | 0.534 | 0.405 | 0.594 | 0.648 | 0.588 | 0.789 | 0.813 | 0.761 | 0.761 | 0.627 | 0.673 | 0.455 | 0.417 | 0.315 | 16.6 | 20.1 | 25.9 | 14.6 | 11.3 | 14.5 | 18.4 | 11.2 | 15.8 | 11.6 | 10.8 | 8.9 | 20.0 | 18.7 | 22.8 | 17.2 | 20.8 | 24.6 | 26.9 | 21.0 | 23.2 | 30.6 | 36.4 | 27.6 | 24.6 | 26.4 | 25.2 | 27.1 | 26.2 | 15.4 | 23.2 | 34.5 | 35.5 | 26.8 | 30.9 | 8.3 | 0.13 | 0.02 | 0.15 | 0.28 | 0.02 | 0.23 | 0.34 | 0.26 | 0.42 | 0.45 | 0.30 | 0.42 | 0.53 | 0.76 | 0.56 | 0.96 | 1.01 | 0.90 | 1.01 | 0.71 | 0.82 | 0.75 | 0.97 | 0.69 | 0.89 | 0.95 | 1.01 | 1.13 | 1.15 | 1.10 | 1.21 | 1.04 | 1.13 | 0.77 | 0.70 | 0.53 |
,GSK1265744 60 mg | 0.104 | 0.155 | 0.341 | 0.359 | 0.203 | 0.525 | 0.406 | 0.375 | 0.502 | 0.692 | 0.535 | 0.575 | 0.534 | 0.711 | 0.666 | 1.006 | 0.997 | 1.006 | 0.769 | 0.671 | 0.831 | 1.095 | 1.011 | 0.840 | 0.722 | 0.821 | 0.914 | 0.819 | 1.083 | 0.812 | 1.176 | 1.106 | 0.913 | 0.699 | 0.564 | 0.960 | 14.3 | 14.1 | 18.4 | 17.7 | 17.9 | 13.7 | 19.3 | 10.3 | 17.8 | 15.4 | 11.8 | 7.8 | 17.6 | 26.6 | 22.7 | 21.1 | 21.7 | 33.1 | 20.4 | 32.2 | 33.5 | 41.2 | 40.0 | 45.4 | 27.9 | 37.6 | 33.5 | 29.1 | 27.4 | 30.8 | 32.8 | 45.8 | 46.7 | 45.4 | 35.3 | 2.0 | 0.31 | 0.30 | 0.48 | 0.73 | 0.36 | 0.77 | 0.64 | 0.66 | 0.69 | 0.93 | 0.92 | 0.81 | 0.78 | 1.04 | 1.09 | 1.43 | 1.38 | 1.35 | 1.16 | 1.02 | 1.22 | 1.64 | 1.58 | 1.33 | 1.11 | 1.24 | 1.37 | 1.31 | 1.53 | 1.17 | 1.66 | 1.57 | 1.32 | 1.02 | 0.95 | -0.05 |
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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | -2.534 | -2.731 | -2.733 | -2.793 | -2.823 | -2.823 | -2.831 | -2.788 | -2.784 | -2.763 | -2.768 | -2.760 | -2.682 | -2.729 | -2.745 | -2.722 | -2.670 | -2.723 | -2.712 | -2.705 | -2.690 | -2.737 | -2.680 | -2.747 | -2.671 | -2.750 | -2.787 | -2.770 | -2.798 | -2.787 | -2.780 | -2.786 | -2.768 | -2.776 | -2.780 | -2.488 |
,GSK1265744 30 mg | -2.306 | -2.550 | -2.611 | -2.634 | -2.659 | -2.665 | -2.659 | -2.662 | -2.663 | -2.636 | -2.646 | -2.638 | -2.602 | -2.613 | -2.514 | -2.568 | -2.608 | -2.632 | -2.650 | -2.610 | -2.555 | -2.645 | -2.592 | -2.628 | -2.641 | -2.632 | -2.636 | -2.636 | -2.627 | -2.601 | -2.659 | -2.659 | -2.659 | -2.664 | -2.569 | -2.215 |
,GSK1265744 60 mg | -2.504 | -2.718 | -2.741 | -2.790 | -2.815 | -2.834 | -2.830 | -2.792 | -2.791 | -2.781 | -2.792 | -2.790 | -2.799 | -2.787 | -2.783 | -2.782 | -2.778 | -2.743 | -2.717 | -2.743 | -2.703 | -2.716 | -2.700 | -2.767 | -2.667 | -2.718 | -2.718 | -2.726 | -2.736 | -2.758 | -2.734 | -2.764 | -2.775 | -2.730 | -2.789 | -2.438 |
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Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | -1.875 | -2.092 | -2.344 | -2.533 | -2.602 | -2.666 | -2.694 | -2.733 | -2.714 | -2.672 | -2.679 | -2.679 | -2.676 | -2.615 | -2.738 | -2.739 | -2.731 |
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Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Grams per liter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 46, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=35, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=32, 39, 44, 0 | Week 228; n=31, 39, 47, 0 | Week 240; n=32, 39, 47, 0 | Week 252; n=31, 36, 45, 0 | Week 264; n=32, 38, 46, 0 | Week 276; n=31, 38, 46, 0 | Week 288; n=30, 38, 44, 0 | Week 300; n=30, 37, 43, 0 | Week 312; n=31, 33, 42, 0 | Week 324; n=3, 4, 2, 0 |
---|
GSK1265744 10 mg | 0.1 | -0.2 | 2.7 | 2.0 | 1.1 | 2.1 | 2.6 | 1.8 | 1.7 | 1.6 | 0.3 | 0.5 | 1.2 | 2.6 | 1.8 | 3.3 | 2.7 | 4.0 | 4.2 | 3.5 | 4.0 | 4.0 | 6.3 | 5.5 | 3.3 | 4.5 | 4.7 | 5.1 | 6.2 | 6.2 | 6.3 | 6.6 | 7.3 | 4.6 | 7.0 | 4.3 |
,GSK1265744 30 mg | 0.0 | 0.5 | 4.8 | 3.9 | 3.5 | 3.8 | 4.8 | 3.4 | 4.0 | 3.1 | 2.9 | 2.2 | 2.7 | 4.7 | 4.5 | 4.0 | 3.3 | 3.4 | 4.7 | 3.0 | 2.6 | 5.1 | 6.0 | 4.0 | 3.5 | 4.7 | 4.1 | 4.8 | 5.8 | 6.4 | 6.0 | 5.5 | 6.8 | 5.1 | 6.1 | 10.0 |
,GSK1265744 60 mg | -0.7 | 0.6 | 2.0 | 2.6 | 2.3 | 3.1 | 3.6 | 2.5 | 1.5 | 3.5 | 2.7 | 2.1 | -0.5 | 2.2 | 2.4 | 3.0 | 3.6 | 3.0 | 2.1 | 2.5 | 2.3 | 2.7 | 4.8 | 2.7 | 3.0 | 3.2 | 3.4 | 3.1 | 2.1 | 5.8 | 5.5 | 5.4 | 6.9 | 5.5 | 8.0 | 20.5 |
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Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Grams per liter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 0.7 | 0.7 | 2.0 | 2.8 | 1.1 | 0.8 | 1.9 | 2.2 | 0.1 | 0.6 | -0.8 | -0.2 | 0.0 | 2.3 | 2.4 | 1.7 | 1.9 |
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Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Intervention | Micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 2.77 |
GSK1265744 30 mg | 7.49 |
GSK1265744 60 mg | 13.12 |
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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48
(NCT01651403)
Timeframe: Baseline; Week 48
Intervention | Participants (Count of Participants) |
---|
TDF (Blinded Randomized Phase) | 5 |
Placebo (Blinded Randomized Phase) | 7 |
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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96
(NCT01651403)
Timeframe: Baseline; Week 96
Intervention | Participants (Count of Participants) |
---|
TDF to TDF | 1 |
Placebo to TDF | 2 |
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Percent Change From Baseline in BMD of Spine at Week 192
(NCT01651403)
Timeframe: Baseline; Week 192
Intervention | Percent change in spine BMD (Mean) |
---|
TDF to TDF | 19.168 |
Placebo to TDF | 26.085 |
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Percent Change From Baseline in BMD of Spine at Week 48
(NCT01651403)
Timeframe: Baseline; Week 48
Intervention | Percent change in spine BMD (Mean) |
---|
TDF (Blinded Randomized Phase) | 3.798 |
Placebo (Blinded Randomized Phase) | 7.557 |
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Percentage of Participants With ≥ 4% Decrease From Baseline in Spine BMD at Week 192
(NCT01651403)
Timeframe: Baseline; Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 18.3 |
Placebo to TDF | 6.9 |
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Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density (BMD) at Week 48
(NCT01651403)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 18.3 |
Placebo (Blinded Randomized Phase) | 6.9 |
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Percentage of Participants With HBsAg Loss at Week 192
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 10.0 |
Placebo to TDF | 0 |
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Percentage of Participants With HBsAg Loss at Week 48
HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 3.3 |
Placebo (Blinded Randomized Phase) | 3.4 |
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Percentage of Participants With HBsAg Seroconversion at Week 192
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 0 |
Placebo to TDF | 0 |
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Percentage of Participants With HBsAg Seroconversion at Week 48
HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 0 |
Placebo (Blinded Randomized Phase) | 0 |
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Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48
(NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 71.7 |
Placebo (Blinded Randomized Phase) | 6.9 |
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Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48
HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 25.0 |
Placebo (Blinded Randomized Phase) | 24.1 |
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Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48, Based on the American Association for the Study of Liver Diseases (AASLD) Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 51.7 |
Placebo (Blinded Randomized Phase) | 17.2 |
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Percentage of Participants With Normal ALT at Week 192, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 71.7 |
Placebo to TDF | 51.7 |
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Percentage of Participants With Normal ALT at Week 192, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 80.0 |
Placebo to TDF | 62.1 |
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Percentage of Participants With Normal ALT at Week 48, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 65.0 |
Placebo (Blinded Randomized Phase) | 17.2 |
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Percentage of Participants With Normalized ALT at Week 192, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 71.7 |
Placebo to TDF | 50.0 |
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Percentage of Participants With Normalized ALT at Week 192, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 79.3 |
Placebo to TDF | 59.3 |
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Percentage of Participants With Normalized ALT at Week 48, Based on the AASLD Normal Range
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 51.7 |
Placebo (Blinded Randomized Phase) | 17.9 |
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Percentage of Participants With Normalized ALT at Week 48, Based on the Central Lab Normal Range
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 65.5 |
Placebo (Blinded Randomized Phase) | 14.8 |
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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Excluded Approach)
(NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 83.6 |
Placebo (Blinded Randomized Phase) | 7.7 |
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Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48 (Missing = Failure Approach)
(NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 76.7 |
Placebo (Blinded Randomized Phase) | 6.9 |
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Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 192
(NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 81.7 |
Placebo to TDF | 62.1 |
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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 192
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 70.0 |
Placebo to TDF | 42.9 |
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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on AASLD Normal Range) at Week 48
Normal ALT was defined as ≤ 30 U/L for males and females 0-12 years based on the AASLD pediatric normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 46.7 |
Placebo (Blinded Randomized Phase) | 7.1 |
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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 192
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 192
Intervention | percentage of participants (Number) |
---|
TDF to TDF | 75.9 |
Placebo to TDF | 55.6 |
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Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT (Based on Central Lab Normal Range) at Week 48
Normal ALT was defined as ≤ 34 U/L for females aged 2-15 years old or males aged 1-9 years old, and ≤ 43 U/L for males aged 10-15 years old based on the central lab normal range. 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 postbaseline visit. (NCT01651403)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF (Blinded Randomized Phase) | 53.4 |
Placebo (Blinded Randomized Phase) | 7.4 |
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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144
(NCT01651403)
Timeframe: Baseline; Week 144
Intervention | Participants (Count of Participants) |
---|
TDF to TDF | 1 |
Placebo to TDF | 0 |
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Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 192
(NCT01651403)
Timeframe: Baseline; Week 192
Intervention | Participants (Count of Participants) |
---|
TDF to TDF | 0 |
Placebo to TDF | 0 |
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Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue
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 |
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Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue
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 |
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Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
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 |
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Safety: Grade 2 or Higher Adverse Events
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 |
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Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
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 |
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Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
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 |
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Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
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 |
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Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
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 |
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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
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 |
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Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
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 |
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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
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 |
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Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
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 |
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Human Papillomavirus Incidence Rates
For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months
Intervention | Incidence rate/100 women years (Number) |
---|
Intervention | 1.0 |
Control | 3.0 |
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Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up
Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable. (NCT01691768)
Timeframe: All participants with drug levels at 12 months of follow-up
Intervention | percentage of participants (Number) |
---|
Intervention | 39.5 |
Control | 43.6 |
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Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)
The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days. (NCT01691768)
Timeframe: Between 2012 to 2015, up to 28 months
Intervention | Used gel applicators per month (Least Squares Mean) |
---|
| Intent to treat analyses | Per protocol analyses |
---|
Control | 5.7 | 5.8 |
,Intervention | 5.2 | 5.5 |
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Pregnancy Incidence Rates
Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months
Intervention | Incidence rate/100 women years (Number) |
---|
Intervention | 4.9 |
Control | 5.1 |
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Percentage of Participants Achieving Adherence >80%.
Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months
Intervention | percentage of participants (Number) |
---|
Intervention | 70.2 |
Control | 65.2 |
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Product Acceptability
This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire. (NCT01691768)
Timeframe: At study completion, up to 28 months
Intervention | Participants (Count of Participants) |
---|
Intervention | 180 |
Control | 170 |
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HIV Viral Load Among HIV Seroconverters
This is mean log transformed HIV viral load measured at the first visit post HIV infection. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months
Intervention | log10 copies/ml (Mean) |
---|
Intervention | 4.4 |
Control | 4.8 |
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HIV Incidence Rates
Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one. (NCT01691768)
Timeframe: Between 2012 and 2015, up to 28 months
Intervention | Incidence rate/100 women years (Number) |
---|
Intervention | 3.5 |
Control | 3.6 |
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Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 93.9 |
TDF/FTC/EFV | 96.2 |
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Percentage of Participant With Treatment Adherence Based on Tablet Count
In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively). (NCT01709084)
Timeframe: Up to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 97.2 |
TDF/FTC/EFV | 97.6 |
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Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups. (NCT01709084)
Timeframe: Up to Week 48
Intervention | Participants (Number) |
---|
TDF/FTC/RPV | 0 |
TDF/FTC/EFV | 0 |
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Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 93.9 |
TDF/FTC/EFV | 96.2 |
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Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 0.5 |
TDF/FTC/EFV | 0.5 |
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Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 1.5 |
TDF/FTC/EFV | 1.0 |
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Percentage of Infants With Hepatitis B Infection at or After 6 Months Through 12 Months of Age
Infants will be considered HBV infected if at any time point at or after 6 months through 12 months of age, a sample tests positive for HBsAg and HBV DNA (NCT01745822)
Timeframe: at or after 6 months through 12 months of age
Intervention | Participants (Count of Participants) |
---|
Tenofovir Disoproxil Fumarate | 0 |
Placebo | 3 |
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Percentage of Participants With Flares After Study Treatment Interruption
Flare, or acute exacerbation of hepatitis B, after study treatment interruption is defined as an Alanine Aminotransferase plasma level above 300 IU/mL (NCT01745822)
Timeframe: Following planned discontinuation of study treatment up to 12 months postpartum
Intervention | Participants (Count of Participants) |
---|
Tenofovir Disoproxil Fumarate | 9 |
Placebo | 5 |
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Percentage of Participants With Adverse Events
Occurrence of maternal and infant adverse events, including maternal and infants Serious Adverse Events (as defined by the International Conference on Harmonization Good Clinical Practice) and NIH Division of AIDS grade 3/4 signs and symptoms, regardless of their relatedness to the study treatment. (NCT01745822)
Timeframe: from enrollment (28 weeks' gestation) to 12 months postpartum
Intervention | Participants (Count of Participants) |
---|
| Maternal | Infant |
---|
Placebo | 44 | 38 |
,Tenofovir Disoproxil Fumarate | 41 | 43 |
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Weight, Height and Head Circumference for Age
Weight, length/height and head circumference WHO Z scores are measures of relative weight, height and head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. (NCT01745822)
Timeframe: assessed at 6 months and 12 months of age, 6 months reported
Intervention | Z-score (Mean) |
---|
| Weight for age | Length for age | Head circumference for age |
---|
Placebo | -0.2 | -0.2 | -0.6 |
,Tenofovir Disoproxil Fumarate | -0.4 | -0.2 | -0.6 |
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Percentage of Infants With Hepatitis B Infection at 6 Months of Age
Infection is defined as a HBsAg positive test confirmed by detectable HBV DNA (NCT01745822)
Timeframe: 6 months of age
Intervention | Participants (Count of Participants) |
---|
Tenofovir Disoproxil Fumarate | 0 |
Placebo | 3 |
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Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
"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 |
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Number of Participants Using Text Messaging Reminders
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 |
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Number of Participants With Decrease in Bone Mineral Density
"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 |
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Acceptability of PrEP Regimen and Study Visits
"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 |
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Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
"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 |
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Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
"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 |
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Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
"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 |
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Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
"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 |
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Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
"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 |
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Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
"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 |
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Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
"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 |
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Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
"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 |
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Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
"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 |
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Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
Total number of subjects who signed up for text message reminders (NCT01772823)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
All Study Participants | 76 |
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Lumbar Spine Bone Mineral Density at Baseline and at Week 48
"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 |
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Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
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 |
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Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
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 |
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Femoral Neck Bone Mineral Density at Baseline and at Week 48
"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 |
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Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
"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 |
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Number of Participants With Unprotected Sex Acts
"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 |
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Number of Sex Partners
"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 |
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Total Body Bone Mineral Density at Baseline and at Week 48
"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 |
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Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
"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 |
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Total Hip Bone Mineral Density at Baseline and at Week 48
"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 |
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Number of Participants With Serum Creatinine Event of Grade 1 or Higher
"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 |
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Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
"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 |
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Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
"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 |
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Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL) (NCT01777997)
Timeframe: At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART
Intervention | proportion of participants (Number) |
---|
| Pre-ART | Week 0 on ART | Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 36 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.19 | 0.19 | 0.61 | 0.90 | 0.93 | 0.92 | 0.96 |
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Change in Quality of Life (QoL) Index
"QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates no problems/no discomfort, 1 indicates some problems/moderate discomfort and 2 indicates unable to perform activities/extreme discomfort. Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)" (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Intervention | units on a scale (Median) |
---|
| Week 4 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0 | -0.1 | 0 |
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Change in Levels of D-dimer
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Intervention | log10(ng/mL) (Median) |
---|
| Week 4 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.01 | 0.01 | 0.02 |
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Change in Levels of CD8+ T-cell Activation
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | % of CD8+ T-cells (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | -0.7 | -1.6 | -2.2 | -4.7 |
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Change in CD4+ T-cell Count
Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART
Intervention | cells/mm^3 (Median) |
---|
| Week 12 on ART | Week 24 on ART | Week 36 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | -15 | -5 | 25 | 19 |
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Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | % of CD4+ T-cells (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.1 | -0.1 | -0.2 | -0.2 |
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Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)
Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening. (NCT01777997)
Timeframe: From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
Intervention | participants (Number) |
---|
FTC/RPV/TDF | 18 |
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Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART
Mean change from baseline (pre-ART [study entry] and week 0 on ART [study week 12]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART
Intervention | % of CD8+ T-cells (Mean) |
---|
FTC/RPV/TDF | -4.01 |
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Change in Levels of Interleukin (IL)-6
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | log10(pg/mL) (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.05 | 0.01 | 0.02 | 0 |
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Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort. (NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
Cohort H (PrEP) | 230 |
Cohort LM (PEP) | 0 |
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Number of HIV Seroconversions by Cohort.
(NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
Cohort H (PrEP) | 1 |
Cohort LM (PEP) | 0 |
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Cohort H PrEP Engagement by Study Visit
Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days). (NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 |
---|
Cohort H (PrEP) | 246 | 247 | 224 | 212 | 194 |
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Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Cells/microliter (Mean) |
---|
| CD4+ | CD8+ |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -89 | -147 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -133.2 | -442.8 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -106.4 | -466.1 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 33 | -216.3 |
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Maximum Observed Plasma Concentrations (Cmax) - Part B
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1493.336 | 3159.181 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 695.596 | 1667.817 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 770.975 | 1852 |
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Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 79.376 | 170.778 |
,Part A-Group 10: BMS-955176 (120 mg) | 1515.389 | 2809.671 |
,Part A-Group 2: BMS-955176 (10 mg) | 201.498 | 337.379 |
,Part A-Group 3: BMS-955176 (20 mg) | 349.466 | 705.073 |
,Part A-Group 4: BMS-955176 (40 mg) | 791.317 | 1476.166 |
,Part A-Group 9: BMS-955176 (80 mg) | 1155.448 | 2466.447 |
,Part C-Group 13: BMS-955176 (120 mg) | 1907.747 | 3377.967 |
,Part C-Group 8: BMS-955176 (40 mg) | 793.569 | 1560.122 |
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Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Cells/microliter (Mean) |
---|
| CD4+ | CD8+ |
---|
Part A-Group 1: BMS-955176 (5 mg) | -21.8 | -95 |
,Part A-Group 10: BMS-955176 (120 mg) | -56.7 | -161.3 |
,Part A-Group 2: BMS-955176 (10 mg) | 14.6 | -8.3 |
,Part A-Group 3: BMS-955176 (20 mg) | -70.1 | -107.4 |
,Part A-Group 4: BMS-955176 (40 mg) | -23.6 | -57.3 |
,Part A-Group 9: BMS-955176 (80 mg) | -43.8 | -194.6 |
,Part C-Group 13: BMS-955176 (120 mg) | 24.5 | -155.8 |
,Part C-Group 8: BMS-955176 (40 mg) | -53.7 | -214.4 |
,Placebo Clade B | -77.3 | -93.1 |
,Placebo Clade C | 18 | -136.3 |
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Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Nanogram*hour/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 24478.35 | 59915.72 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 12147.23 | 31406.32 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 12954.8 | 34225.08 |
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Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Nanogram*hour/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 1151.062 | 2720.237 |
,Part A-Group 10: BMS-955176 (120 mg) | 21872.72 | 44182.4 |
,Part A-Group 2: BMS-955176 (10 mg) | 2869.626 | 5168.553 |
,Part A-Group 3: BMS-955176 (20 mg) | 5132.951 | 11751.82 |
,Part A-Group 4: BMS-955176 (40 mg) | 10088.23 | 22984.83 |
,Part A-Group 9: BMS-955176 (80 mg) | 17057.26 | 39341.11 |
,Part C-Group 13: BMS-955176 (120 mg) | 26753.74 | 53972.71 |
,Part C-Group 8: BMS-955176 (40 mg) | 10936.9 | 25556.64 |
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Accumulation Index (AI): Part A and C
Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1. (NCT01803074)
Timeframe: Baseline and Day 10
Intervention | Ratio (Geometric Mean) |
---|
| Cmax | C24 | AUC |
---|
Part A-Group 1: BMS-955176 (5 mg) | 2.152 | 2.336 | 2.363 |
,Part A-Group 10: BMS-955176 (120 mg) | 1.854 | 2.063 | 2.02 |
,Part A-Group 2: BMS-955176 (10 mg) | 1.674 | 1.757 | 1.801 |
,Part A-Group 3: BMS-955176 (20 mg) | 2.018 | 2.11 | 2.289 |
,Part A-Group 4: BMS-955176 (40 mg) | 1.856 | 2.491 | 2.278 |
,Part A-Group 9: BMS-955176 (80 mg) | 2.135 | 2.385 | 2.306 |
,Part C-Group 13: BMS-955176 (120 mg) | 1.771 | 1.953 | 2.017 |
,Part C-Group 8: BMS-955176 (40 mg) | 1.966 | 2.298 | 2.337 |
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Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Hours (Median) |
---|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 624 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 636.05 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 588 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 636.05 |
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Plasma Half-life: Part A and C
Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Hours (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 32.134 |
Part A-Group 2: BMS-955176 (10 mg) | 31.967 |
Part A-Group 3: BMS-955176 (20 mg) | 27.382 |
Part A-Group 4: BMS-955176 (40 mg) | 33.475 |
Part A-Group 9: BMS-955176 (80 mg) | 29.171 |
Part A-Group 10: BMS-955176 (120 mg) | 34.574 |
Part C-Group 8: BMS-955176 (40 mg) | 31.565 |
Part C-Group 13: BMS-955176 (120 mg) | 35.278 |
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Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) and Day 11 after the final dose with BMS-955176
Intervention | Log10 copies per milliliter (c/mL) (Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | -0.138 |
Part A-Group 2: BMS-955176 (10 mg) | -0.567 |
Part A-Group 3: BMS-955176 (20 mg) | -0.889 |
Part A-Group 4: BMS-955176 (40 mg) | -1.279 |
Part A-Group 9: BMS-955176 (80 mg) | -1.339 |
Part A-Group 10: BMS-955176 (120 mg) | -1.326 |
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -1.216 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -1.431 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | -1.544 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -1.521 |
Part C-Group 8: BMS-955176 (40 mg) | -1.29 |
Part C-Group 13: BMS-955176 (120 mg) | -0.938 |
Placebo Clade B | 0.118 |
Placebo Clade C | -0.172 |
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Apparent Total Body Clearance: Part A and C
Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Milliliters/minute (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 30.635 |
Part A-Group 2: BMS-955176 (10 mg) | 32.246 |
Part A-Group 3: BMS-955176 (20 mg) | 28.364 |
Part A-Group 4: BMS-955176 (40 mg) | 29.005 |
Part A-Group 9: BMS-955176 (80 mg) | 33.892 |
Part A-Group 10: BMS-955176 (120 mg) | 45.267 |
Part C-Group 8: BMS-955176 (40 mg) | 26.086 |
Part C-Group 13: BMS-955176 (120 mg) | 37.056 |
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Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 113.326 |
Part A-Group 2: BMS-955176 (10 mg) | 215.111 |
Part A-Group 3: BMS-955176 (20 mg) | 489.507 |
Part A-Group 4: BMS-955176 (40 mg) | 956.222 |
Part A-Group 9: BMS-955176 (80 mg) | 1639.471 |
Part A-Group 10: BMS-955176 (120 mg) | 1841.413 |
Part C-Group 8: BMS-955176 (40 mg) | 1065.435 |
Part C-Group 13: BMS-955176 (120 mg) | 2256.793 |
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Degree of Fluctuation (DF): Part A and C
DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Ratio (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0.766 |
Part A-Group 2: BMS-955176 (10 mg) | 0.912 |
Part A-Group 3: BMS-955176 (20 mg) | 0.758 |
Part A-Group 4: BMS-955176 (40 mg) | 0.78 |
Part A-Group 9: BMS-955176 (80 mg) | 0.779 |
Part A-Group 10: BMS-955176 (120 mg) | 0.818 |
Part C-Group 8: BMS-955176 (40 mg) | 0.723 |
Part C-Group 13: BMS-955176 (120 mg) | 0.727 |
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Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Log10 copies/mL (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | -0.498 |
Part A-Group 2: BMS-955176 (10 mg) | -0.976 |
Part A-Group 3: BMS-955176 (20 mg) | -1.115 |
Part A-Group 4: BMS-955176 (40 mg) | -1.701 |
Part A-Group 9: BMS-955176 (80 mg) | -1.555 |
Part A-Group 10: BMS-955176 (120 mg) | -1.654 |
Part C-Group 8: BMS-955176 (40 mg) | -1.352 |
Part C-Group 13: BMS-955176 (120 mg) | -1.257 |
Placebo Clade B | -0.381 |
Placebo Clade C | -0.419 |
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Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Log10 copies/mL (Median) |
---|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -1.858 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -2.202 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | -2.39 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -2.228 |
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Number of Participants With Clinically Significant Changes in Heart Rate
Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 |
Part A-Group 2: BMS-955176 (10 mg) | 0 |
Part A-Group 3: BMS-955176 (20 mg) | 0 |
Part A-Group 4: BMS-955176 (40 mg) | 0 |
Part A-Group 9: BMS-955176 (80 mg) | 0 |
Part A-Group 10: BMS-955176 (120 mg) | 0 |
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 1 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 |
Part C-Group 8: BMS-955176 (40 mg) | 0 |
Part C-Group 13: BMS-955176 (120 mg) | 2 |
Placebo Clade B | 1 |
Placebo Clade C | 0 |
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Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Hours (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 168 |
Part A-Group 2: BMS-955176 (10 mg) | 216 |
Part A-Group 3: BMS-955176 (20 mg) | 203.9 |
Part A-Group 4: BMS-955176 (40 mg) | 240.15 |
Part A-Group 9: BMS-955176 (80 mg) | 204 |
Part A-Group 10: BMS-955176 (120 mg) | 240.2 |
Part C-Group 8: BMS-955176 (40 mg) | 228.05 |
Part C-Group 13: BMS-955176 (120 mg) | 215.8 |
Placebo Clade B | 216.2 |
Placebo Clade C | 132.05 |
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Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Tmax was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Hours (Median) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 5 | 4.5 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 5.01 | 4.5 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 5.05 | 5 |
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Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Time to reach the maximum plasma concentration was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Hours (Median) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 3 | 3 |
,Part A-Group 10: BMS-955176 (120 mg) | 3 | 2.5 |
,Part A-Group 2: BMS-955176 (10 mg) | 2.51 | 3 |
,Part A-Group 3: BMS-955176 (20 mg) | 3 | 4 |
,Part A-Group 4: BMS-955176 (40 mg) | 4 | 3 |
,Part A-Group 9: BMS-955176 (80 mg) | 3.5 | 3 |
,Part C-Group 13: BMS-955176 (120 mg) | 3.53 | 3 |
,Part C-Group 8: BMS-955176 (40 mg) | 3.5 | 3 |
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Plasma Concentration 24 Hours Post-Dose (C24) - Part B
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 899.364 | 2010.679 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 462.312 | 1099.313 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 520.048 | 1163.177 |
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Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 34.946 | 81.642 |
,Part A-Group 10: BMS-955176 (120 mg) | 624.745 | 1288.985 |
,Part A-Group 2: BMS-955176 (10 mg) | 79.002 | 138.775 |
,Part A-Group 3: BMS-955176 (20 mg) | 154.5 | 325.934 |
,Part A-Group 4: BMS-955176 (40 mg) | 286.268 | 713.077 |
,Part A-Group 9: BMS-955176 (80 mg) | 482.349 | 1150.397 |
,Part C-Group 13: BMS-955176 (120 mg) | 865.867 | 1691.306 |
,Part C-Group 8: BMS-955176 (40 mg) | 339.173 | 779.438 |
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Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Percent change (Mean) |
---|
| CD4+ | CD8+ |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -0.75 | -1.25 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 2.4 | -2.8 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 3.25 | -6.25 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 4.75 | -3.75 |
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Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Percent change (Mean) |
---|
| CD4+ | CD8+ |
---|
Part A-Group 1: BMS-955176 (5 mg) | 2.33 | 1.17 |
,Part A-Group 10: BMS-955176 (120 mg) | 0.29 | -2.29 |
,Part A-Group 2: BMS-955176 (10 mg) | 0.29 | 0.43 |
,Part A-Group 3: BMS-955176 (20 mg) | -1.29 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0.86 | 1 |
,Part A-Group 9: BMS-955176 (80 mg) | 2.13 | -0.25 |
,Part C-Group 13: BMS-955176 (120 mg) | 3.17 | -4.25 |
,Part C-Group 8: BMS-955176 (40 mg) | 0.5 | 0 |
,Placebo Clade B | -0.22 | 1.75 |
,Placebo Clade C | 2.75 | -1.33 |
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Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. (NCT01803074)
Timeframe: Day 1 to up to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| Neutrophils (Absolute) | Bilirubin (Total) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 1 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 2 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 | 5 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 3 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 0 |
,Placebo Clade B | 0 | 0 |
,Placebo Clade C | 0 | 0 |
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Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| SBP | DBP |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 1 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 1 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 | 1 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 1 | 1 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 1 |
,Placebo Clade B | 0 | 1 |
,Placebo Clade C | 0 | 0 |
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Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| PR > 200 msec | QRS > 120 msec | QT > 500 msec | QTcB > 450 msec | QTcF > 450 msec |
---|
Part A-Group 1: BMS-955176 (5 mg) | 1 | 0 | 0 | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 2 | 0 | 0 | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 1 | 0 | 0 | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 1 | 0 | 0 | 0 | 1 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 | 0 | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 | 0 | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1 | 0 | 0 | 0 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 1 | 0 | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 1 | 0 | 0 | 0 | 0 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 1 | 0 | 0 | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 | 0 | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 1 | 0 | 0 | 0 | 0 |
,Placebo Clade B | 0 | 0 | 0 | 0 | 0 |
,Placebo Clade C | 0 | 0 | 0 | 1 | 0 |
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Number of Participants With Abnormal Changes in Physical Examination
Participants with abnormal changes in physical examination is presented. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| Height | Weight | Body mass index |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 0 | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 0 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 | 0 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 | 0 | 0 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 0 | 0 |
,Placebo Clade B | 0 | 0 | 0 |
,Placebo Clade C | 0 | 0 | 0 |
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Number of Participants With Self-Reported Missed Doses
self-reported missed doses (NCT01855867)
Timeframe: Day 30
Intervention | Participants (Count of Participants) |
---|
Stribild | 29 |
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nPEP Failure (HIV Infection During Study Participation)
nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90 (NCT01855867)
Timeframe: 90 days
Intervention | reactive test (Number) |
---|
Stribild | 0 |
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Number of Adverse Event Occurrences
The number of adverse events reported (NCT01855867)
Timeframe: 90 days
Intervention | events (Number) |
---|
| Diarrhea | Fatigue | Nausea/Vomiting | Headache | Dizziness/Lightheadness | Body Aches/Muscle and Joint Pain |
---|
Stribild | 38 | 28 | 28 | 14 | 6 | 2 |
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ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | ng/mL (Median) |
---|
| Cmax day 0 | Cmax day 21 |
---|
NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 4291.0 | 3583.0 |
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Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.
This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry. (NCT01903031)
Timeframe: Study days 0, 7, 14, 21 and 28
Intervention | proportion of participants (Number) |
---|
| Proportion with progesterone >5 at day 0 | Proportion with progesterone >5 at day 7 | Proportion with progesterone >5 at day 14 | Proportion with progesterone >5 at day 21 | Proportion with progesterone >5 at day 28 |
---|
NuvaRing and no ART | 0.08 | 0.08 | 0.00 | 0.00 | 0.00 |
,NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.25 | 0.08 | 0.00 | 0.00 | 0.00 |
,NuvaRing With EFV Plus ≥2 NRTIs | 0.04 | 0.24 | 0.04 | 0.00 | 0.00 |
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Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | h*ng/mL (Median) |
---|
| AUC0-24h day 0 | AUC0-24h day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 10740.0 | 7210.7 |
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RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | hour (Median) |
---|
| CLss/F day 0 | CLss/F day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 9.3 | 13.9 |
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RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | ng/mL (Median) |
---|
| Cmax day 0 | Cmax day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 1437.0 | 1063.0 |
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RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | hour (Median) |
---|
| Tmax day 0 | Tmax day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3.0 | 3.0 |
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Ethinyl Estradiol Concentrations at Study Day 21
This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Day 21
Intervention | pg/mL (Median) |
---|
NuvaRing and no ART | 21.30 |
NuvaRing With EFV Plus ≥2 NRTIs | 11.40 |
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 16.05 |
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Etonogestrel Concentrations at Study Day 21
This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Day 21
Intervention | pg/mL (Median) |
---|
NuvaRing and no ART | 1860.00 |
NuvaRing With EFV Plus ≥2 NRTIs | 429.00 |
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3290.00 |
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ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | h*ng/mL (Median) |
---|
| AUC0-24h day 0 | AUC0-24h day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 44313.7 | 36764.7 |
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ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | L/h (Median) |
---|
| CLss/F day 0 | CLss/F day 21 |
---|
NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 6.8 | 8.2 |
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RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)
Intervention | ng/mL (Median) |
---|
| Cmin day 0 | Cmin day 21 |
---|
NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 70.0 | 51.9 |
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ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | ng/mL (Median) |
---|
| Cmin day 0 | Cmin day 21 |
---|
NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 796.7 | 599.4 |
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ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C
This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated. (NCT01903031)
Timeframe: Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | hour (Median) |
---|
| Tmax day 0 | Tmax day 21 |
---|
NuvaRing With ATV/r Plus TDF ≥1 NRTIs | 2.9 | 3.0 |
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EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h). (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | h*ng/mL (Median) |
---|
| AUC0-24h day 0 | AUC0-24h day 21 |
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NuvaRing With EFV Plus ≥2 NRTIs | 68949.1 | 57795.9 |
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EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | L/h (Median) |
---|
| CLss/F day 0 | CLss/F day 21 |
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NuvaRing With EFV Plus ≥2 NRTIs | 8.7 | 10.4 |
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EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | ng/mL (Median) |
---|
| Cmax day 0 | Cmax day 21 |
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NuvaRing With EFV Plus ≥2 NRTIs | 4541.0 | 3786.0 |
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EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B
This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval. (NCT01903031)
Timeframe: Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).
Intervention | ng/mL (Median) |
---|
| Cmin day 0 | Cmin day 21 |
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NuvaRing With EFV Plus ≥2 NRTIs | 2121.5 | 1766.0 |
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Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.
This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14
Intervention | pg/mL (Median) |
---|
| Concentration at Day 7 | Concentration at Day 14 |
---|
NuvaRing and no ART | 18.05 | 19.70 |
,NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 15.70 | 16.55 |
,NuvaRing With EFV Plus ≥2 NRTIs | 9.98 | 10.50 |
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Etonogestrel Concentrations Obtained on Study Days 7 and 14
This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL). (NCT01903031)
Timeframe: Study days 7 and 14
Intervention | pg/mL (Median) |
---|
| Concentration at Day 7 | Concentration at Day 14 |
---|
NuvaRing and no ART | 1970.00 | 2070.00 |
,NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 3250.00 | 3530.00 |
,NuvaRing With EFV Plus ≥2 NRTIs | 427.00 | 437.00 |
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Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL
This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required. (NCT01903031)
Timeframe: Study day 0 and study day 21
Intervention | proportion of participants (Number) |
---|
| Proportion with HIV-1 RNA <40 copies/mL at day 0 | Proportion with HIV-1 RNA <40 copies/mL at day 21 |
---|
NuvaRing and no ART | 0.22 | 0.17 |
,NuvaRing With ATV/r Plus TDF and ≥1 NRTIs | 0.89 | 0.85 |
,NuvaRing With EFV Plus ≥2 NRTIs | 0.93 | 0.85 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Age, <50 Years, n=212, 212 | Age, >=50 Years, n=36, 35 | Race, White, n=115, 107 | Race, Non-White, n=133,140 | Race, African-American/African Heritage, n=102,108 | Non-African-American/African Heritage, n=146, 139 | BPHR, <1000, n=5, 10 | BPHR, 1000 to <10,000, n=66, 62 | BPHR, 10,000 to <50,000, n=83, 81 | BPHR, 50,000 to <=100,000, n=25, 28 | BPHR, >100,000, n=69, 66 | BCCC, <200, n=64, 49 | BCCC, >=200, n=184, 198 | BCCC, <50, n=9, 15 | BCCC, 50 to <200, n=55, 34 | BCCC, 200 to <350, n=66, 74 | BCCC, 350 to <500, n=56, 65 | BCCC, >=500, n=62, 59 | CDC category, A, n=210, 208 | CDC category, B, n=27, 30 | CDC category, C, n=11, 9 | HIV-1 subtype: B vs Non-B, B, n=95, 111 | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | Argentina, n=24, 20 | Canada, n=11, 9 | France, n=7, 8 | Italy, n=17, 11 | Mexico, n=6, 5 | Portugal, n=4, 5 | Russia, n=28, 22 | South Africa, n=33, 33 | Spain, n=23, 31 | Thailand, n=19, 21 | USA, n=62, 69 | United Kingdom, n=14, 11 |
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DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 80 | 92 | 86 | 78 | 74 | 88 | 60 | 83 | 84 | 80 | 80 | 81 | 82 | 67 | 84 | 89 | 79 | 77 | 81 | 81 | 91 | 80 | 84 | 92 | 91 | 100 | 88 | 100 | 75 | 89 | 67 | 70 | 95 | 74 | 93 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Percentage of participants (Number) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 100 | 100 |
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Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Percentage of participants (Number) |
---|
| HIV-1 RNA <50 c/mL, Baseline (Day 1) | HIV-1 RNA <50 c/mL, Week 4 | HIV-1 RNA <50 c/mL, Week 12 | HIV-1 RNA <50 c/mL, Week 24 | HIV-1 RNA <50 c/mL, Week 36 | HIV-1 RNA <50 c/mL, Week 48 | HIV-1 RNA <400 c/mL, Baseline (Day 1) | HIV-1 RNA <400 c/mL, Week 4 | HIV-1 RNA <400 c/mL, Week 12 | HIV-1 RNA <400 c/mL, Week 24 | HIV-1 RNA <400 c/mL, Week 36 | HIV-1 RNA <400 c/mL, Week 48 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0 | 13 | 49 | 77 | 77 | 71 | 1 | 54 | 84 | 82 | 81 | 76 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0 | 64 | 81 | 85 | 85 | 82 | 1 | 90 | 91 | 88 | 86 | 83 |
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Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 432
Intervention | Participants (Count of Participants) |
---|
| INSTI; n= 6 | NNRTI; n=8 | NRTI; n=8 | PI; n=8 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD | 0 | 1 | 1 | 0 |
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Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 48
Intervention | Participants (Count of Participants) |
---|
| INSTI; n= 3 | NNRTI; n=4 | NRTI; n=4 | PI; n=4 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase | 1 | 0 | 1 | 0 |
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Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 48
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 4 | 2 | 0 | 1 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 5 | 1 | 0 | 1 |
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Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 432
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD | 6 | 1 | 0 | 2 |
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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 21 | 3 | 1 | 0 | 6 | 2 | 0 | 0 | 12 | 9 | 2 | 1 | 1 | 2 | 0 | 0 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 7 | 2 | 1 | 0 | 5 | 1 | 0 | 0 | 15 | 7 | 0 | 1 | 6 | 0 | 1 | 0 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Age, <50 Years, n=212, 212 | Age, >=50 Years, n=36, 35 | Race, White, n=115, 107 | Race, Non-White, n=133,140 | Race, African-American/African Heritage, n=102,108 | Non-African-American/African Heritage, n=146, 139 | BPHR, <1000, n=5, 10 | BPHR, 1000 to <10,000, n=66, 62 | BPHR, 10,000 to <50,000, n=83, 81 | BPHR, 50,000 to <=100,000, n=25, 28 | BPHR, >100,000, n=69, 66 | BCCC, <200, n=64, 49 | BCCC, >=200, n=184, 198 | BCCC, <50, n=9, 15 | BCCC, 50 to <200, n=55, 34 | BCCC, 200 to <350, n=66, 74 | BCCC, 350 to <500, n=56, 65 | BCCC, >=500, n=62, 59 | CDC category, A, n=210, 208 | CDC category, B, n=27, 30 | CDC category, C, n=11, 9 | HIV-1 subtype: B vs Non-B, B, n=95, 111 | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | Argentina, n=24, 20 | Canada, n=11, 9 | France, n=7, 8 | Italy, n=17, 11 | Mexico, n=6, 5 | Portugal, n=4, 5 | Puerto Rico, n=0, 2 | Russia, n=28, 22 | South Africa, n=33, 33 | Spain, n=23, 31 | Thailand, n=19, 21 | USA, n=62, 69 | United Kingdom, n=14, 11 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 71 | 74 | 80 | 64 | 67 | 75 | 80 | 77 | 74 | 64 | 64 | 69 | 72 | 60 | 74 | 73 | 74 | 68 | 71 | 77 | 56 | 69 | 73 | 80 | 89 | 75 | 64 | 60 | 60 | 100 | 82 | 76 | 77 | 52 | 67 | 64 |
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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Millimoles per liter (Mean) |
---|
| Carbon Dioxide, Week 4, n= 244, 237 | Carbon Dioxide, Week 12, n= 236, 226 | Carbon Dioxide, Week 24, n= 224, 212 | Carbon Dioxide, Week 36, n= 219, 204 | Carbon Dioxide, Week 48, n= 208, 192 | Chloride, Week 4, n= 245, 237 | Chloride, Week 12, n= 236, 226 | Chloride, Week 24, n= 225, 212 | Chloride, Week 36, n= 219, 204 | Chloride, Week 48, n= 208, 192 | CHLS, Week 4, n= 1, 3 | CHLS, Week 12, n= 224, 221 | CHLS, Week 24, n= 218, 201 | CHLS, Week 36, n= 205, 191 | CHLS, Week 48, n= 195, 175 | Glucose, Week 12, n= 226, 224 | Glucose, Week 24, n= 219, 204 | Glucose, Week 36, n= 211, 196 | Glucose, Week 48, n= 197, 180 | HDL CHLS, Direct, Week 4, n= 1, 3 | HDL CHLS, Direct, Week 12, n= 224, 221 | HDL CHLS, Direct, Week 24, n= 218, 201 | HDL CHLS, Direct, Week 36, n= 205, 191 | HDL CHLS, Direct, Week 48, n= 195, 175 | Hyperglycaemia, Week 12, n= 226, 224 | Hyperglycaemia, Week 24, n= 219, 204 | Hyperglycaemia, Week 36, n= 211, 196 | Hyperglycaemia, Week 48, n= 197, 180 | Hyperkalemia, Week 4, n= 244, 237 | Hyperkalemia, Week 12, n= 236, 226 | Hyperkalemia, Week 24, n= 224, 212 | Hyperkalemia, Week 36, n= 219, 204 | Hyperkalemia, Week 48, n= 208, 192 | Hypernatremia, Week 4, n= 245, 237 | Hypernatremia, Week 12, n= 236, 226 | Hypernatremia, Week 24, n= 225, 212 | Hypernatremia, Week 36, n= 219, 204 | Hypernatremia, Week 48, n= 208, 192 | Hypoglycaemia, Week 12, n= 226, 224 | Hypoglycaemia, Week 24, n= 219, 204 | Hypoglycaemia, Week 36, n= 211, 196 | Hypoglycaemia, Week 48, n= 197, 180 | Hypokalemia, Week 4, n= 244, 237 | Hypokalemia, Week 12, n= 236, 226 | Hypokalemia, Week 24, n= 224, 212 | Hypokalemia, Week 36, n= 219, 204 | Hypokalemia, Week 48, n= 208, 192 | Hyponatremia, Week 4, n= 245, 237 | Hyponatremia, Week 12, n= 236, 226 | Hyponatremia, Week 24, n= 225, 212 | Hyponatremia, Week 36, n= 219, 204 | Hyponatremia, Week 48, n= 208, 192 | LDL CHLS Calculation, Week 4, n= 1, 3 | LDL CHLS Calculation, Week 12, n= 221, 219 | LDL CHLS Calculation, Week 24, n= 213, 201 | LDL CHLS Calculation, Week 36, n= 201, 188 | LDL CHLS Calculation, Week 48, n= 190, 175 | LDL CHLS, Direct, Week 12, n= 0, 1 | Phosphate, Week 4, n= 245, 237 | Phosphate, Week 12, n= 236, 226 | Phosphate, Week 24, n= 225, 212 | Phosphate, Week 36, n= 219, 204 | Phosphate, Week 48, n= 208, 192 | Potassium, Week 4, n= 244, 237 | Potassium, Week 12, n= 236, 226 | Potassium, Week 24, n= 224, 212 | Potassium, Week 36, n= 219, 204 | Potassium, Week 48, n= 208, 192 | Sodium, Week 4, n= 245, 237 | Sodium, Week 12, n= 236, 226 | Sodium, Week 24, n= 225, 212 | Sodium, Week 36, n= 219, 204 | Sodium, Week 48, n= 208, 192 | Triglycerides, Week 4, n= 1, 3 | Triglycerides, Week 12, n= 224, 221 | Triglycerides, Week 24, n= 218, 201 | Triglycerides, Week 36, n= 205, 191 | Triglycerides, Week 48, n= 195, 175 | Urea, Week 4, n= 245, 237 | Urea, Week 12, n= 236, 226 | Urea, Week 24, n= 225, 212 | Urea, Week 36, n= 219, 204 | Urea, Week 48, n= 208, 192 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.6 | 0.8 | 0.3 | 0.6 | 0.4 | -0.5 | 0.2 | -0.1 | 0 | 0 | -0.017 | -0.058 | -0.001 | 0 | 0.109 | 0.22 | 0.26 | 0.34 | 0.24 | 0 | 0.005 | 0.053 | 0.036 | 0.081 | 0.22 | 0.26 | 0.34 | 0.24 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | 0.22 | 0.26 | 0.34 | 0.24 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | -0.123 | -0.14 | -0.111 | -0.099 | -0.021 | -0.44 | -0.032 | 0.026 | 0.026 | 0.009 | 0 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | 0.237 | 0.167 | 0.125 | 0.157 | 0.107 | 0.1 | 0.16 | 0.12 | -0.03 | 0.02 |
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Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Micrograms per liter (Mean) |
---|
| BSAP, Week 24, n=219, 207 | BSAP, Week 48, n=202, 184 | Osteocalcin, Week 24, n=209, 197 | Osteocalcin, Week 48, n=194, 178 | PTP, Week 24, n=223, 206 | PTP, Week 48, n=205, 186 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 6.00 | 7.60 | 14.38 | 16.30 | 32.0 | 34.1 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.33 | 2.64 | 3.73 | 5.15 | 10.1 | 11.2 |
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Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin, Week 4, n= 244, 237 | Bilirubin, Week 12, n= 236, 226 | Bilirubin, Week 24, n= 225, 212 | Bilirubin, Week 36, n= 219, 204 | Bilirubin, Week 48, n= 208, 192 | Creatinine, Week 4, n= 245, 237 | Creatinine, Week 12, n= 236, 226 | Creatinine, Week 24, n= 225, 212 | Creatinine, Week 36, n= 219, 204 | Creatinine, Week 48, n= 208, 192 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 27.2 | 22.8 | 25 | 23.8 | 23.7 | 4.89 | 5.83 | 5.8 | 5.37 | 5.86 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.8 | -0.6 | -0.2 | -0.2 | -0.3 | 8.4 | 9.2 | 9.16 | 10.08 | 9.29 |
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Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | 10^9 cells per liter (Mean) |
---|
| Basophils, Week 4, n= 241, 234 | Basophils, Week 12, n= 228, 216 | Basophils, Week 24, n= 221, 208 | Basophils, Week 36, n= 214, 203 | Basophils, Week 48, n= 206, 189 | Eosinophils, Week 4, n= 241, 234 | Eosinophils, Week 12, n= 228, 216 | Eosinophils, Week 24, n= 221, 208 | Eosinophils, Week 36, n= 214, 203 | Eosinophils, Week 48, n= 206, 189 | Lymphocytes, Week 4, n= 241, 234 | Lymphocytes, Week 12, n= 228, 216 | Lymphocytes, Week 24, n= 221, 208 | Lymphocytes, Week 36, n= 214, 203 | Lymphocytes, Week 48, n= 206, 189 | Monocytes, Week 4, n= 241, 234 | Monocytes, Week 12, n= 228, 216 | Monocytes, Week 24, n= 221, 208 | Monocytes, Week 36, n= 214, 203 | Monocytes, Week 48, n= 206, 189 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.003 | 0.003 | 0.003 | 0.003 | 0.006 | 0.021 | -0.001 | 0.005 | 0.014 | 0.007 | 0.119 | 0.156 | 0.192 | 0.178 | 0.261 | -0.015 | -0.031 | -0.015 | -0.028 | -0.024 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.003 | 0.002 | 0.004 | 0.004 | 0.005 | 0.040 | 0.037 | 0.028 | 0.048 | 0.030 | 0.208 | 0.257 | 0.317 | 0.362 | 0.359 | -0.001 | -0.010 | 0.008 | -0.006 | 0.001 |
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Change From Baseline in Albumin at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Grams per liter (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.5 | 0.1 | 0.8 | 0.6 | 1.3 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.1 | 0.5 | 1.4 | 1.4 | 1.7 |
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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline (Day 1), n=248, 247 | Week 4, n=245, 237 | Week 12, n=236, 224 | Week 24, n=226, 210 | Week 36, n=219, 204 | Week 48, n=208, 191 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 380.3 | 455.1 | 506.2 | 542.5 | 569.2 | 608.5 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 369.7 | 465.0 | 509.5 | 563.8 | 592.8 | 608.8 |
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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Log10 copies/mL (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 1.591 | 1.590 |
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Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Log10 copies/mL (Mean) |
---|
| Baseline (Day 1), n=248, 247 | Week 4, n=245, 238 | Week 12, n=236, 226 | Week 24, n=225, 212 | Week 36, n=221, 204 | Week 48, n=207, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 4.441 | 2.516 | 1.908 | 1.710 | 1.658 | 1.657 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 4.481 | 1.895 | 1.748 | 1.724 | 1.666 | 1.619 |
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Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | International units per liter (Mean) |
---|
| Alanine aminotransferase, Week 4, n= 245, 237 | Alanine aminotransferase, Week 12, n= 236, 226 | Alanine aminotransferase, Week 24, n= 225, 212 | Alanine aminotransferase, Week 36, n= 219, 204 | Alanine aminotransferase, Week 48, n= 208, 192 | Alkaline phosphatase, Week 4, n= 245, 237 | Alkaline phosphatase, Week 12, n= 236, 226 | Alkaline phosphatase, Week 24, n= 225, 212 | Alkaline phosphatase, Week 36, n= 219, 204 | Alkaline phosphatase, Week 48, n= 208, 192 | Aspartate aminotransferase, Week 4, n= 244, 237 | Aspartate aminotransferase, Week 12, n= 236, 226 | Aspartate aminotransferase, Week 24, n= 224, 212 | Aspartate aminotransferase, Week 36, n= 219, 204 | Aspartate aminotransferase, Week 48, n= 208, 192 | Creatine Kinase, Week 4, n= 245, 237 | Creatine Kinase, Week 12, n= 236, 226 | Creatine Kinase, Week 24, n= 225, 212 | Creatine Kinase, Week 36, n= 219, 204 | Creatine Kinase, Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -3.4 | -2.3 | -3.7 | -5.3 | -1.5 | 9.4 | 15.1 | 22.4 | 20.4 | 21.9 | -3.6 | -4 | -5.1 | -6.5 | -3.7 | 35.6 | 7.3 | 5.8 | 7.2 | 3.8 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -3.3 | -5.2 | -5.4 | -4.9 | -5.7 | -1.5 | -2.1 | 0.5 | 0.6 | 2.9 | -3.3 | -6.2 | -6.3 | -6.4 | -7.5 | -0.3 | 6.9 | 10.3 | 11.9 | 23.8 |
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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96, Week 432
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 286.5 | 254.7 |
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Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Ratio (Number) |
---|
| BSAP, n=202, 183 | PTP, n=202, 184 | Osteocalcin, n=194, 178 | Type 1 Collagen C-Telopeptide, n=202, 184 | Vitamin D, n=206, 186 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 1.629 | 1.752 | 2.039 | 1.918 | 1.158 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.188 | 1.214 | 1.282 | 1.257 | 0.987 |
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Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Score on a scale (Mean) |
---|
| Total Score, Week 48, n=205, 192 | MCS, Week 48, n=205, 192 | PCS, Week 48, n=205, 192 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.1 | 2.329 | 1.444 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.0 | 2.397 | 1.905 |
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Change From Baseline in TC/HDL Ratio at Week 48
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Ratio (Least Squares Mean) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.264 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.158 |
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Change From Baseline in Triglycerides at Week 48
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Millimoles per liter (Least Squares Mean) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.045 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.070 |
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Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 4 |
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Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 10 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 17 |
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Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 82 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 71 |
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Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Absolute values in CD4+ cell count were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 635.3 | 553.0 |
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Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 4, n=245, 237 | Week 12, n=236, 224 | Week 24, n=226, 210 | Week 36, n=219, 204 | Week 48, n=208, 191 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 73.7 | 124.4 | 163.0 | 191.4 | 230.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 94.9 | 143.8 | 200.6 | 230.7 | 248.8 |
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Number of Participants With AEs by Maximum Toxicity-Continuation Phase
Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 32 | 48 | 7 | 6 |
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Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Millimoles per liter (Mean) |
---|
| Carbon Dioxide, Week 4, n= 244, 237 | Carbon Dioxide, Week 12, n= 236, 226 | Carbon Dioxide, Week 24, n= 224, 212 | Carbon Dioxide, Week 36, n= 219, 204 | Carbon Dioxide, Week 48, n= 208, 192 | Chloride, Week 4, n= 245, 237 | Chloride, Week 12, n= 236, 226 | Chloride, Week 24, n= 225, 212 | Chloride, Week 36, n= 219, 204 | Chloride, Week 48, n= 208, 192 | CHLS, Week 4, n= 1, 3 | CHLS, Week 12, n= 224, 221 | CHLS, Week 24, n= 218, 201 | CHLS, Week 36, n= 205, 191 | CHLS, Week 48, n= 195, 175 | Glucose, Week 12, n= 226, 224 | Glucose, Week 24, n= 219, 204 | Glucose, Week 36, n= 211, 196 | Glucose, Week 48, n= 197, 180 | HDL CHLS, Direct, Week 4, n= 1, 3 | HDL CHLS, Direct, Week 12, n= 224, 221 | HDL CHLS, Direct, Week 24, n= 218, 201 | HDL CHLS, Direct, Week 36, n= 205, 191 | HDL CHLS, Direct, Week 48, n= 195, 175 | Hyperglycaemia, Week 12, n= 226, 224 | Hyperglycaemia, Week 24, n= 219, 204 | Hyperglycaemia, Week 36, n= 211, 196 | Hyperglycaemia, Week 48, n= 197, 180 | Hyperkalemia, Week 4, n= 244, 237 | Hyperkalemia, Week 12, n= 236, 226 | Hyperkalemia, Week 24, n= 224, 212 | Hyperkalemia, Week 36, n= 219, 204 | Hyperkalemia, Week 48, n= 208, 192 | Hypernatremia, Week 4, n= 245, 237 | Hypernatremia, Week 12, n= 236, 226 | Hypernatremia, Week 24, n= 225, 212 | Hypernatremia, Week 36, n= 219, 204 | Hypernatremia, Week 48, n= 208, 192 | Hypoglycaemia, Week 12, n= 226, 224 | Hypoglycaemia, Week 24, n= 219, 204 | Hypoglycaemia, Week 36, n= 211, 196 | Hypoglycaemia, Week 48, n= 197, 180 | Hypokalemia, Week 4, n= 244, 237 | Hypokalemia, Week 12, n= 236, 226 | Hypokalemia, Week 24, n= 224, 212 | Hypokalemia, Week 36, n= 219, 204 | Hypokalemia, Week 48, n= 208, 192 | Hyponatremia, Week 4, n= 245, 237 | Hyponatremia, Week 12, n= 236, 226 | Hyponatremia, Week 24, n= 225, 212 | Hyponatremia, Week 36, n= 219, 204 | Hyponatremia, Week 48, n= 208, 192 | LDL CHLS Calculation, Week 4, n= 1, 3 | LDL CHLS Calculation, Week 12, n= 221, 219 | LDL CHLS Calculation, Week 24, n= 213, 201 | LDL CHLS Calculation, Week 36, n= 201, 188 | LDL CHLS Calculation, Week 48, n= 190, 175 | LDL CHLS, Direct, Week 24, n= 1, 0 | LDL CHLS, Direct, Week 36, n= 1, 0 | Phosphate, Week 4, n= 245, 237 | Phosphate, Week 12, n= 236, 226 | Phosphate, Week 24, n= 225, 212 | Phosphate, Week 36, n= 219, 204 | Phosphate, Week 48, n= 208, 192 | Potassium, Week 4, n= 244, 237 | Potassium, Week 12, n= 236, 226 | Potassium, Week 24, n= 224, 212 | Potassium, Week 36, n= 219, 204 | Potassium, Week 48, n= 208, 192 | Sodium, Week 4, n= 245, 237 | Sodium, Week 12, n= 236, 226 | Sodium, Week 24, n= 225, 212 | Sodium, Week 36, n= 219, 204 | Sodium, Week 48, n= 208, 192 | Triglycerides, Week 4, n= 1, 3 | Triglycerides, Week 12, n= 224, 221 | Triglycerides, Week 24, n= 218, 201 | Triglycerides, Week 36, n= 205, 191 | Triglycerides, Week 48, n= 195, 175 | Urea, Week 4, n= 245, 237 | Urea, Week 12, n= 236, 226 | Urea, Week 24, n= 225, 212 | Urea, Week 36, n= 219, 204 | Urea, Week 48, n= 208, 192 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.4 | -0.2 | -0.5 | 0 | -0.6 | 0.6 | 1 | 0.7 | 0.9 | 0.7 | -0.1 | 0.298 | 0.317 | 0.33 | 0.447 | 0.3 | 0.17 | 0.17 | 0.18 | -0.1 | 0.182 | 0.201 | 0.204 | 0.231 | 0.3 | 0.17 | 0.17 | 0.18 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | 0.3 | 0.17 | 0.17 | 0.18 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | 0.08 | 0.125 | 0.111 | 0.112 | 0.213 | -0.64 | -0.23 | 0 | 0.02 | 0.021 | 0.029 | 0.016 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | -0.18 | -0.04 | 0.036 | 0.037 | 0.018 | -0.04 | 0.08 | 0.03 | 0.08 | 0.1 |
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Change From Baseline in Creatinine Clearance at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Milliliter per minute (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -7.5 | -7 | -9.1 | -7.5 | -7.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -16.3 | -17.3 | -16.2 | -16.8 | -15.9 |
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Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Femtoliter (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.5 | 1.9 | 3.1 | 3.1 | 3.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.9 | 3.4 | 5.5 | 6.0 | 7.1 |
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Change From Baseline in Erythrocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | 10^12 cells per liter (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.07 | -0.09 | -0.09 | -0.08 | -0.05 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.04 | -0.07 | -0.08 | -0.10 | -0.10 |
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Change From Baseline in Hematocrit Count at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.0042 | 0.0000 | 0.0051 | 0.0062 | 0.0107 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.0003 | 0.0081 | 0.0157 | 0.0167 | 0.0212 |
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Change From Baseline in Lipase at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Units per liter (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.3 | -2.1 | -6 | -6.3 | -7.8 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -1.2 | -2.2 | -6 | -6.3 | -6.5 |
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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96 and Week 432
Intervention | Log10 copies/mL (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | -2.911 | -3.107 |
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Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Log10 copies/mL (Mean) |
---|
| Week 4, n=245, 238 | Week 12, n=236, 226 | Week 24, n=225, 212 | Week 36, n=221, 204 | Week 48, n=207, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.923 | -2.541 | -2.726 | -2.772 | -2.752 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -2.591 | -2.756 | -2.789 | -2.838 | -2.874 |
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Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Ratio (Mean) |
---|
| Week 4, n= 1, 4 | Week 12, n= 233, 223 | Week 24, n= 224, 209 | Week 36, n= 212, 198 | Week 48, n= 207, 186 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.2159 | -0.1092 | -0.1922 | -0.1433 | -0.1444 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.1264 | -0.2736 | -0.3098 | -0.3286 | -0.2886 |
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Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Nanograms per liter (Mean) |
---|
| Week 24, n=221, 207 | Week 48, n=202, 185 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 272.4 | 267.9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 89.8 | 75.9 |
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Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 24 and Week 48
Intervention | milligrams per millimole (Mean) |
---|
| Week 24, n= 179, 186 | Week 48, n= 170, 164 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.03 | -0.10 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -1.15 | -0.68 |
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Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Nanomoles per liter (Mean) |
---|
| Vitamin D, Week 24, n=223, 208 | Vitamin D, Week 48, n=206, 186 | Vitamin D2, Week 24, n=223, 208 | Vitamin D2, Week 48, n=206, 186 | Vitamin D3, Week 24, n=223, 208 | Vitamin D3, Week 48, n=206, 186 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 16.3 | 8.9 | 1.0 | 0.9 | 15.2 | 7.9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.8 | -1.9 | 0.3 | 0.1 | 1.5 | -1.9 |
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HIVTSQs Total Score at Indicated Timepoints
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. (NCT01910402)
Timeframe: Weeks 4, 12, 24 and 48
Intervention | Score on a scale (Mean) |
---|
| Week 4, n=243, 239 | Week 12, n=236, 226 | Week 24, n=225, 211 | Week 48, n=206, 191 |
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ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 51.9 | 53.6 | 54.3 | 55.4 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 54.0 | 56.1 | 56.8 | 57.0 |
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Number of Participants With AEs by Maximum Toxicity-Randomized Phase
Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 60 | 91 | 37 | 9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 79 | 94 | 18 | 3 |
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Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 197 | 20 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 195 | 12 |
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Number of Participants With Any AEs, and SAEs in Continuation Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 93 | 13 |
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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Hyperglycaemia, Grade 1, n=143 | Hyperglycaemia, Grade 2, n=143 | Hyperglycaemia, Grade 3, n=143 | Hyperglycaemia, Grade 4, n=143 | Hypernatremia, Grade 1, n=146 | Hypernatremia, Grade 2, n=146 | Hypernatremia, Grade 3, n=146 | Hypernatremia, Grade 4, n=146 | Hypoglycaemia, Grade 1, n=143 | Hypoglycaemia, Grade 2, n=143 | Hypoglycaemia, Grade 3, n=143 | Hypoglycaemia, Grade 4, n=143 | Hypokalemia, Grade 1, n=146 | Hypokalemia, Grade 2, n=146 | Hypokalemia, Grade 3, n=146 | Hypokalemia, Grade 4, n=146 | Hyponatremia, Grade 1, n=146 | Hyponatremia, Grade 2, n=146 | Hyponatremia, Grade 3, n=146 | Hyponatremia, Grade 4, n=146 | Alanine aminotransferase, Grade 1, n=146 | Alanine aminotransferase, Grade 2, n=146 | Alanine aminotransferase, Grade 3, n=146 | Alanine aminotransferase, Grade 4, n=146 | Alkaline phosphatase, Grade 1, n=146 | Alkaline phosphatase, Grade 2, n=146 | Alkaline phosphatase, Grade 3, n=146 | Alkaline phosphatase, Grade 4, n=146 | Aspartate aminotransferase, Grade 1, n=146 | Aspartate aminotransferase, Grade 2, n=146 | Aspartate aminotransferase, Grade 3, n=146 | Aspartate aminotransferase, Grade 4, n=146 | Bilirubin, Grade 1, n=146 | Bilirubin, Grade 2, n=146 | Bilirubin, Grade 3, n=146 | Bilirubin, Grade 4, n=146 | Carbon dioxide, Grade 1, n=146 | Carbon dioxide, Grade 2, n=146 | Carbon dioxide, Grade 3, n=146 | Carbon dioxide, Grade 4, n=146 | Cholesterol, Grade 1, n=71 | Cholesterol, Grade 2, n=71 | Cholesterol, Grade 3, n=71 | Cholesterol, Grade 4, n=71 | Creatine kinase, Grade 1, n=146 | Creatine kinase, Grade 2, n=146 | Creatine kinase, Grade 3, n=146 | Creatine kinase, Grade 4, n=146 | Creatinine, Grade 1, n=146 | Creatinine, Grade 2, n=146 | Creatinine, Grade 3, n=146 | Creatinine, Grade 4, n=146 | LDL cholesterol calculation, Grade 1, n=70 | LDL cholesterol calculation, Grade 2, n=70 | LDL cholesterol calculation, Grade 3, n=70 | LDL cholesterol calculation, Grade 4, n=70 | LDL cholesterol direct, Grade 1, n=2 | LDL cholesterol direct, Grade 2, n=2 | LDL cholesterol direct, Grade 3, n=2 | LDL cholesterol direct, Grade 4, n=2 | Lipase, Grade 1, n=146 | Lipase, Grade 2, n=146 | Lipase, Grade 3, n=146 | Lipase, Grade 4, n=146 | Phosphate, Grade 1, n=146 | Phosphate, Grade 2, n=146 | Phosphate, Grade 3, n=146 | Phosphate, Grade 4, n=146 | Potassium, Grade 1, n=146 | Potassium, Grade 2, n=146 | Potassium, Grade 3, n=146 | Potassium, Grade 4, n=146 | Sodium, Grade 1, n=146 | Sodium, Grade 2, n=146 | Sodium, Grade 3, n=146 | Sodium, Grade 4, n=146 | Triglycerides, Grade 1, n=71 | Triglycerides, Grade 2, n=71 | Triglycerides, Grade 3, n=71 | Triglycerides, Grade 4, n=71 | Glucose, Grade 1, n=143 | Glucose, Grade 2, n=143 | Glucose, Grade 3, n=143 | Glucose, Grade 4, n=143 |
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DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 24 | 9 | 3 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 13 | 0 | 0 | 0 | 36 | 0 | 0 | 0 | 7 | 3 | 0 | 2 | 5 | 0 | 0 | 0 | 10 | 2 | 0 | 2 | 4 | 1 | 3 | 0 | 58 | 7 | 0 | 0 | 9 | 9 | 3 | 0 | 6 | 1 | 1 | 1 | 5 | 0 | 0 | 1 | 5 | 8 | 2 | 0 | 1 | 0 | 0 | 0 | 9 | 6 | 1 | 1 | 2 | 15 | 2 | 0 | 13 | 0 | 0 | 0 | 37 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 24 | 9 | 3 | 1 |
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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Hyperglycaemia, Grade 1 | Hyperglycaemia, Grade 2 | Hyperglycaemia, Grade 3 | Hyperglycaemia, Grade 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypoglycaemia, Grade 1 | Hypoglycaemia, Grade 2 | Hypoglycaemia, Grade 3 | Hypoglycaemia, Grade 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | Alanine aminotransferase, Grade 1 | Alanine aminotransferase, Grade 2 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | Alkaline phosphatase, Grade 1 | Alkaline phosphatase, Grade 2 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Aspartate aminotransferase, Grade 1 | Aspartate aminotransferase, Grade 2 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | Carbon dioxide, Grade 1 | Carbon dioxide, Grade 2 | Carbon dioxide, Grade 3 | Carbon dioxide, Grade 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | Creatine kinase, Grade 1 | Creatine kinase, Grade 2 | Creatine kinase, Grade 3 | Creatine kinase, Grade 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | LDL cholesterol calculation, Grade 1 | LDL cholesterol calculation, Grade 2 | LDL cholesterol calculation, Grade 3 | LDL cholesterol calculation, Grade 4 | LDL cholesterol direct, Grade 1 | LDL cholesterol direct, Grade 2 | LDL cholesterol direct, Grade 3 | LDL cholesterol direct, Grade 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Potassium, Grade 1 | Potassium, Grade 2 | Potassium, Grade 3 | Potassium, Grade 4 | Sodium, Grade 1 | Sodium, Grade 2 | Sodium, Grade 3 | Sodium, Grade 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Glucose, Grade 1 | Glucose, Grade 2 | Glucose, Grade 3 | Glucose, Grade 4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 11 | 9 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 19 | 0 | 0 | 0 | 57 | 0 | 0 | 0 | 7 | 4 | 2 | 0 | 2 | 2 | 0 | 0 | 14 | 1 | 0 | 0 | 7 | 4 | 2 | 0 | 52 | 86 | 57 | 5 | 54 | 3 | 0 | 0 | 31 | 9 | 2 | 0 | 5 | 1 | 0 | 1 | 7 | 3 | 0 | 0 | 21 | 9 | 2 | 0 | 1 | 0 | 0 | 0 | 7 | 3 | 2 | 1 | 11 | 9 | 2 | 0 | 19 | 1 | 0 | 0 | 57 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 15 | 10 | 3 | 0 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 17 | 16 | 4 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 3 | 1 | 0 | 17 | 1 | 0 | 0 | 44 | 1 | 0 | 0 | 5 | 6 | 1 | 1 | 3 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 12 | 4 | 1 | 1 | 2 | 0 | 0 | 0 | 65 | 4 | 0 | 0 | 52 | 28 | 4 | 0 | 3 | 1 | 3 | 0 | 3 | 0 | 1 | 0 | 38 | 13 | 7 | 0 | 3 | 1 | 0 | 0 | 12 | 5 | 3 | 0 | 5 | 7 | 1 | 0 | 18 | 1 | 0 | 0 | 45 | 1 | 0 | 0 | 0 | 5 | 2 | 0 | 22 | 19 | 4 | 1 |
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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 5 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 10 | 2 | 1 | 1 | 3 | 1 | 0 | 0 |
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Neurocognitive Changes
"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80." (NCT01929759)
Timeframe: week 0 and week 8
Intervention | units on a scale (Mean) |
---|
| pre-switch WAIS | post-switch WAIS | pre-switch FRSBE | post-switch FRSBE | pre-switch HAMD | post-switch HAMD | pre-switch DASS depression | post-switch DASS depression | pre-swtich STAI | post-switch STAI |
---|
Drug Switching | 49.3 | 53.4 | 77.5 | 70.4 | 5.5 | 2.8 | 7.6 | 3.4 | 28.8 | 24.2 |
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Fasting Lipid Profile
Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen. (NCT01929759)
Timeframe: 8 weeks
Intervention | mg/dl (Mean) |
---|
| pre-switch Total cholesterol | post-switch Total cholesterol | pre-switch HDL | post-switch HDL | pre-switch LDL | post-switch LDL | pre-switch triglyceride | post-switch triglyceride |
---|
Drug Switching | 178.8 | 168.5 | 52.6 | 52.3 | 106.1 | 97.4 | 101.3 | 94.5 |
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Markers of Immune Activation
Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6) (NCT01929759)
Timeframe: week 0 and week 8
Intervention | pg/ML (Mean) |
---|
| pre-switch sCD14 | post-switch sCD14 | pre-switch IP-10 | post-switch IP-10 | pre-switch sCD163 | post-switch sCD163 | pre-switch MCP-1 | post-switch MCP-1 | pre-switch IL-6 | post-switch IL-6 | pre-switch TNFR1 | post-switch TNFR1 |
---|
Drug Switching | 3329000 | 2879000 | 237.3 | 224.2 | 732000 | 599500 | 102.2 | 91.39 | 1.255 | 1.301 | 833.2 | 878.1 |
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Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest. (NCT01929759)
Timeframe: week 0 and week 8
Intervention | z-score (Number) |
---|
| PreVsPostXNegVsNeuXNoGoVsGo: aFP | PreVsPostXNegVsNeuXNoGoVsGo: pCG | PreVsPostXNegVsNeuXNoGoVsGo: daCG | PreVsPostXNegVsNeuXNoGoVsGo:LHC | Pre: NegVsNeuXNoGoVsGo: aFP | Pre: NegVsNeuXNoGoVsGo:pCG | Pre: NegVsNeuXNoGoVsGo: daCG | Pre: NegVsNeuXNoGoVsGo: LHC | Post: NegVsNeuXNoGoVsGo: aFP | Post: NegVsNeuXNoGoVsGo: pCG | Post: NegVsNeuXNoGoVsGo: daCG | Post: NegVsNeuXNoGoVsGo: LHC |
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Drug Switching | 3.42 | 3.90 | -2.76 | -2.96 | 3.39 | 3.61 | -3.15 | -2.27 | -3.17 | -2.66 | 3.69 | 3.47 |
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Sleep Quality
Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse). (NCT01929759)
Timeframe: week 0 and week 8
Intervention | units on a scale (Mean) |
---|
| pre-switch PSQI index | post-switch PSQI index |
---|
Drug Switching | 4.8 | 3.1 |
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Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada
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 |
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Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. (NCT02116660)
Timeframe: Baseline and Week 48
Intervention | mL/min (Mean) |
---|
Raltegravir Plus Nevirapine Plus Lamivudine | -1.1 |
Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine | -5.5 |
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Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 4.3 |
TDF + GS-4774 40 YU | 9.5 |
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Mean Change in Serum HBsAg From Baseline to Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs). (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | log10 IU/mL (Least Squares Mean) |
---|
TDF 48 Weeks | -0.079 |
TDF + GS-4774 2 YU | -0.096 |
TDF + GS-4774 10 YU | -0.016 |
TDF + GS-4774 40 YU | -0.135 |
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Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available
Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | Participants (Count of Participants) |
---|
TDF 48 Weeks | 0 |
TDF + GS-4774 2 YU | 0 |
TDF + GS-4774 10 YU | 0 |
TDF + GS-4774 40 YU | 0 |
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Percentage of Participants Experiencing Virologic Breakthrough at Week 24
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 1.8 |
TDF + GS-4774 10 YU | 1.8 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants Experiencing Virologic Breakthrough at Week 48
Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 3.7 |
TDF + GS-4774 2 YU | 5.3 |
TDF + GS-4774 10 YU | 5.4 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants With HBeAg Loss at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 4.3 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants With HBeAg Loss at Week 48
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 4.5 |
TDF + GS-4774 10 YU | 8.7 |
TDF + GS-4774 40 YU | 9.5 |
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Percentage of Participants With HBsAg Loss at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 0.0 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants With HBsAg Loss at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 0.0 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants With HBV DNA < LLOQ at Week 48
The LLOQ was defined as 20 IU/mL. (NCT02174276)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 70.4 |
TDF + GS-4774 2 YU | 69.6 |
TDF + GS-4774 10 YU | 69.2 |
TDF + GS-4774 40 YU | 76.4 |
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Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24
The LLOQ was defined as 20 IU/mL. (NCT02174276)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 50.0 |
TDF + GS-4774 2 YU | 58.9 |
TDF + GS-4774 10 YU | 58.5 |
TDF + GS-4774 40 YU | 63.6 |
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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 12
Intervention | percentage of participants (Number) |
---|
| ≥ 0.5 and < 1.0 log10 IU/mL Decline | ≥ 1.0 and < 2.0 log10 IU/mL Decline | ≥ 2.0 log10 IU/mL Decline |
---|
TDF + GS-4774 10 YU | 1.8 | 0.0 | 0.0 |
,TDF + GS-4774 2 YU | 3.5 | 3.5 | 0.0 |
,TDF + GS-4774 40 YU | 5.5 | 0.0 | 1.8 |
,TDF 48 Weeks | 3.7 | 0.0 | 0.0 |
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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
| ≥ 0.5 and < 1.0 log10 IU/mL Decline | ≥ 1.0 and < 2.0 log10 IU/mL Decline | ≥ 2.0 log10 IU/mL Decline |
---|
TDF + GS-4774 10 YU | 7.1 | 1.8 | 0.0 |
,TDF + GS-4774 2 YU | 1.8 | 5.3 | 0.0 |
,TDF + GS-4774 40 YU | 7.3 | 1.8 | 1.8 |
,TDF 48 Weeks | 11.1 | 0.0 | 0.0 |
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Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24
HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 4.3 |
TDF + GS-4774 40 YU | 0.0 |
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Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24
HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
| ≥ 0.5 and < 1.0 log10 IU/mL Decline | ≥ 1.0 and < 2.0 log10 IU/mL Decline | ≥ 2.0 log10 IU/mL Decline |
---|
TDF + GS-4774 10 YU | 1.8 | 0.0 | 0.0 |
,TDF + GS-4774 2 YU | 1.8 | 5.3 | 0.0 |
,TDF + GS-4774 40 YU | 7.3 | 1.8 | 1.8 |
,TDF 48 Weeks | 0.0 | 0.0 | 0.0 |
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Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 24
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 0.0 |
TDF + GS-4774 40 YU | 0.0 |
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Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
TDF 48 Weeks | 0.0 |
TDF + GS-4774 2 YU | 0.0 |
TDF + GS-4774 10 YU | 0.0 |
TDF + GS-4774 40 YU | 0.0 |
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Mean Change in HBsAg From Baseline to Week 12
The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. (NCT02174276)
Timeframe: Baseline to Week 12
Intervention | log10 IU/mL (Least Squares Mean) |
---|
TDF 48 Weeks | -0.060 |
TDF + GS-4774 2 YU | -0.061 |
TDF + GS-4774 10 YU | -0.012 |
TDF + GS-4774 40 YU | -0.095 |
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Mean Change in HBsAg From Baseline to Week 48
The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs. (NCT02174276)
Timeframe: Baseline to Week 48
Intervention | log10 IU/mL (Least Squares Mean) |
---|
TDF 48 Weeks | -0.145 |
TDF + GS-4774 2 YU | -0.136 |
TDF + GS-4774 10 YU | -0.086 |
TDF + GS-4774 40 YU | -0.165 |
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Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
(NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| >50 copies/mL | >400 copies/mL |
---|
Open Label Prospective Single Arm Study of Stribild | 1 | 0 |
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Interim 24 Weeks Analysis of Death
(NCT02180438)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Grade 3 or 4 Adverse Events
Adverse event per NIH/DAIDS criteria (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Lab: Grade 3 or 4 | Clinical: Grade 3 or 4 |
---|
Open Label Prospective Single Arm Study of Stribild | 7 | 1 |
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Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 1 |
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< 50 CD4 T-cell Increase at 48 Weeks From Baseline
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 2 |
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CD4 T-cell Count at 48 Weeks < Baseline
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Death
Number of Participants Experiencing Death within the study period (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Switching Off Stribild Prior to 48 Weeks
(NCT02180438)
Timeframe: 48 Weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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New WHO Stage 3 or 4 Event
New AIDS defining event per WHO criteria (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event
(NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Interim Analysis at 24 Weeks of HIV-2 Virologic Failure
Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) (NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
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Change From Baseline in Hemoglobin (Hb)
Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144
Intervention | Grams per liter (Mean) |
---|
| Week 24, n=208 | Week 48, n=208 | Week 72, n=207 | Week 96, n=207 | Week 120, n=204 | Week 144, n=204 |
---|
Tenofovir Disoproxil Fumerate 300 mg | 2.4 | -0.2 | -0.2 | -1.0 | -1.0 | -0.2 |
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Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96
HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV <20 IU/mL and <69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA <20 IU/mL and <69 IU/mL at Weeks 48 and 96 have been presented. (NCT02195518)
Timeframe: At Weeks 48 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 48, HBV DNA <20 IU/mL | Week 48, HBV DNA <69 IU/mL | Week 96, HBV DNA <20 IU/mL | Week 96, HBV DNA <69 IU/mL |
---|
Tenofovir Disoproxil Fumerate 300 mg | 46.9 | 76.5 | 61.0 | 84.0 |
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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline
Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented. (NCT02195518)
Timeframe: At Weeks 48, 96, and 144
Intervention | Percentage of Participants (Number) |
---|
| Week 48 | Week 96 | Week 144 |
---|
Tenofovir Disoproxil Fumerate 300 mg | 52.5 | 60.7 | 68.3 |
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Percentage of Participants Who Experienced Viral Breakthrough up to Week 144
Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented. (NCT02195518)
Timeframe: At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 36 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 |
---|
Tenofovir Disoproxil Fumerate 300 mg | 0.5 | 0 | 0.5 | 0 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 |
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Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144
Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA <20 IU/mL and serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 have been presented. (NCT02195518)
Timeframe: At Weeks 48, 96, and 144
Intervention | Percentage of Participants (Number) |
---|
| Week 48, HBV DNA <20 IU/mL | Week 48, HBV DNA <69 IU/mL | Week 96, HBV DNA <20 IU/mL | Week 96, HBV DNA <69 IU/mL | Week 144, HBV DNA <20 IU/mL | Week 144, HBV DNA <69 IU/mL |
---|
Tenofovir Disoproxil Fumerate 300 mg | 34.2 | 60.5 | 55.3 | 76.3 | 65.8 | 84.2 |
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Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02195518)
Timeframe: At Weeks 48, 96 and 144
Intervention | Percentage of Participants (Number) |
---|
| Week 48, HBeAg loss | Week 48, HBeAg seroconversion | Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBeAg loss | Week 96, HBeAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBeAg loss | Week 144, HBeAg seroconversion | Week 144, HBsAg loss | Week 144, HBsAg seroconversion |
---|
Tenofovir Disoproxil Fumerate 300 mg | 5.3 | 2.6 | 0.5 | 0 | 10.0 | 2.6 | 0.5 | 0.5 | 15.3 | 4.7 | 1.1 | 0.5 |
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Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144
Serological response was assessed at Weeks 48, 96 and 144 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02195518)
Timeframe: At Weeks 48,96, and 144
Intervention | Percentage of Participants (Number) |
---|
| Week 48, HBsAg loss | Week 48, HBsAg seroconversion | Week 96, HBsAg loss | Week 96, HBsAg seroconversion | Week 144, HBsAg loss | Week 144, HBsAg seroconversion |
---|
Tenofovir Disoproxil Fumerate 300 mg | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE occurred on or after the first dose date of study drug, SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment. (NCT02195518)
Timeframe: Up to Week 144
Intervention | Participants (Number) |
---|
| Any TEAEs | Serious TEAEs | Non-serious TEAEs |
---|
Tenofovir Disoproxil Fumerate 300 mg | 124 | 20 | 117 |
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Change From Baseline in Red Blood Cells (RBC)
Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144
Intervention | Trillion cells per liter (Mean) |
---|
| Week 24, n=208 | Week 48, n=208 | Week 72, n=207 | Week 96, n=207 | Week 120, n=204 | Week 144, n=204 |
---|
Tenofovir Disoproxil Fumerate 300 mg | 0.13 | 0.05 | 0.07 | 0.02 | 0.08 | 0.06 |
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Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144
Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 48,96, and 144
Intervention | Log 10 (IU/mL) (Mean) |
---|
| Category 1, Week 48, Wild type, n=57 | Category 1,Week 96, Wild type, n=57 | Category 1,Week 144, Wild type, n=56 | Category 1,Week 48, ADV-R, n=38 | Category 1, Week 96, ADV-R, n=38 | Category 1, Week 144, ADV-R, n=38 | Category 1, Week 48, ETV-R, n=32 | Category 1, Week 96, ETV-R, n=32 | Category 1, Week 144, ETV-R, n=31 | Category 1, Week 48, LAM-R, n=93 | Category 1, Week 96, LAM-R, n=92 | Category 1, Week 144,LAM-R, n=91 | Category 2, Week 48, Wild type, n=57 | Category 2,Week 96, Wild type, n=57 | Category 2 Week 144, Wild type, n=56 | Category 2, Week 48, ADV-R single mutation, n=28 | Category 2, Week 96, ADV-R, single mutation, n=28 | Category 2, Week 144, ADV-R single mutation, n=28 | Category 2, Week 48,ADV-R double mutation, n=10 | Category 2, Week 96, ADV-R double mutation, n=10 | Category 1, Week 144, ADV-R double mutation, n=10 | Category 2, Week 48, other mutation, n=113 | Category 2, Week 96, other mutation, n=112 | Category 2, Week 144, other mutation, n=110 |
---|
Tenofovir Disoproxil Fumerate 300 mg | -2.2 | -2.3 | -2.4 | -3.0 | -3.3 | -3.5 | -3.2 | -3.4 | -3.6 | -3.1 | -3.3 | -3.2 | -2.2 | -2.3 | -2.4 | -2.9 | -3.3 | -3.5 | -3.2 | -3.3 | -3.5 | -3.1 | -3.2 | -3.2 |
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Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144
Intervention | Billion cells per liter (Mean) |
---|
| Week 24, WBC, n=208 | Week 48, WBC, n=208 | Week 72, WBC, n=207 | Week 96, WBC, n=207 | Week 120, WBC, n=204 | Week 144, WBC, n=204 | Week 24, Neutrophils, n=208 | Week 48, Neutrophils, n=208 | Week 72, Neutrophils, n=207 | Week 96, Neutrophils, n=207 | Week 120, Neutrophils, n=204 | Week 144, Neutrophils, n=204 | Week 24, Lymphocytes, n=208 | Week 48, Lymphocytes, n=208 | Week 72, Lymphocytes, n=207 | Week 96, Lymphocytes, n=207 | Week 120, Lymphocytes, n=204 | Week 144, Lymphocyte, n=204 | Week 24, Monocytes, n=208 | Week 48, Monocytes, n=208 | Week 72, Monocytes, n=207 | Week 96, Monocytes, n=207 | Week 120, Monocytes, n=204 | Week 144, Monocytes, n=204 | Week 24, Eosinophils, n=208 | Week 48, Eosinophils, n=208 | Week 72, Eosinophils, n=207 | Week 96, Eosinophils, n=207 | Week 120, Eosinophils, n=204 | Week 144, Eosinophils, n=204 | Week 24, Basophils, n=208 | Week 48, Basophils, n=208 | Week 72, Basophils, n=207 | Week 96, Basophils, n=207 | Week 120, Basophils, n=203 | Week 144, Basophils, n=203 | Week 24, Platelets, n=208 | Week 48, Platelets, n=208 | Week 72, Platelets, n=207 | Week 96, Platelets, n=207 | Week 120, Platelets, n=204 | Week 144, Platelets, n=204 |
---|
Tenofovir Disoproxil Fumerate 300 mg | 0.19 | 0.15 | 0.13 | 0.07 | 0.10 | 0.12 | 0.15 | 0.09 | 0.10 | 0.05 | 0.14 | 0.12 | 0.02 | 0.05 | 0.02 | 0.02 | -0.05 | 0.00 | -0.001 | 0.004 | -0.010 | -0.009 | -0.006 | -0.008 | 0.02 | -0.00 | 0.02 | -0.00 | 0.00 | 0.00 | 0.00 | 0.00 | -0.00 | -0.00 | 0.00 | 0.00 | 3.5 | 2.5 | 1.9 | 3.9 | 7.2 | 9.3 |
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Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine
Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | Micromoles per liter (Mean) |
---|
| Week 12, total bilirubin, n=209 | Week 24, total bilirubin, n=208 | Week 36, total bilirubin, n=209 | Week 48, total bilirubin, n=207 | Week 60, total bilirubin, n=208 | Week 72, total bilirubin, n=207 | Week 84, total bilirubin, n=207 | Week 96, total bilirubin, n=207 | Week 108, total bilirubin, n=205 | Week 120, total bilirubin, n=205 | Week 132, total bilirubin, n=205 | Week 144, total bilirubin, n=204 | Week 12, direct bilirubin, n=209 | Week 24, direct bilirubin, n=208 | Week 36, direct bilirubin, n=208 | Week 48, direct bilirubin, n=207 | Week 60, direct bilirubin, n=208 | Week 72, direct bilirubin, n=207 | Week 84, direct bilirubin, n=207 | Week 96, direct bilirubin, n=207 | Week 108, direct bilirubin, n=205 | Week 120, direct bilirubin, n=205 | Week 132, direct bilirubin, n=205 | Week 144, direct bilirubin, n=204 | Week 12, serum creatinine, n=209 | Week 24, serum creatinine, n=208 | Week 36, serum creatinine, n=209 | Week 48, serum creatinine, n=208 | Week 60, serum creatinine, n=208 | Week 72, serum creatinine, n=206 | Week 84, serum creatinine, n=207 | Week 96, serum creatinine, n=207 | Week 108, serum creatinine, n=204 | Week 120, serum creatinine, n=205 | Week 132, serum creatinine, n=205 | Week 144, serum creatinine, n=203 |
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Tenofovir Disoproxil Fumerate 300 mg | -0.506 | -0.755 | -0.878 | -0.167 | -0.334 | -1.209 | -1.112 | -0.780 | -0.795 | -1.021 | -1.471 | -0.869 | -0.181 | -0.360 | -0.541 | -0.085 | -0.111 | -0.654 | -0.797 | -0.711 | -0.632 | -0.802 | -0.805 | -0.573 | 2.94 | 1.16 | 0.67 | 1.43 | 0.25 | -1.00 | -0.65 | 0.22 | -0.28 | -1.22 | -0.81 | -1.28 |
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Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | International units per liter (Mean) |
---|
| Week 12, ALT, n=209 | Week 24, ALT, n=208 | Week 36, ALT, n=209 | Week 48, ALT, n=208 | Week 60, ALT, n=208 | Week 72, ALT, n=207 | Week 84, ALT, n=207 | Week 96, ALT, n=207 | Week 108, ALT, n=205 | Week 120, ALT, n=205 | Week 132, ALT, n=205 | Week 144, ALT, n=204 | Week 12, AST, n=209 | Week 24, AST, n=208 | Week 36, AST, n=209 | Week 48, AST, n=205 | Week 60, AST, n=208 | Week 72, AST, n=207 | Week 84, AST, n=207 | Week 96, AST, n=207 | Week 108, AST, n=205 | Week 120, AST, n=205 | Week 132, AST, n=205 | Week 144, AST, n=204 | Week 12, ALP, n=208 | Week 24, ALP, n=208 | Week 36, ALP, n=209 | Week 48, ALP, n=208 | Week 60, ALP, n=208 | Week 72, ALP, n=207 | Week 84, ALP, n=207 | Week 96, ALP, n=207 | Week 108, ALP, n=205 | Week 120, ALP, n=205 | Week 132, ALP, n=205 | Week 144, ALP, n=205 | Week 12, GGT, n=208 | Week 24, GGT, n=208 | Week 36, GGT, n=209 | Week 48, GGT, n=207 | Week 60, GGT, n=208 | Week 72, GGT, n=207 | Week 84, GGT, n=207 | Week 96, GGT, n=207 | Week 108, GGT, n=205 | Week 120, GGT, n=205 | Week 132, GGT, n=205 | Week 144, GGT, n=203 | Week 12, CK, n=206 | Week 24, CK, n=198 | Week 36, CK, n=201 | Week 48 CK, n=206 | Week 60, CK, n=205 | Week 72, CK, n=206 | Week 84, CK, n=207 | Week 96, CK, n=207 | Week 108, CK, n=199 | Week 120, CK, n=203 | Week 132, CK, n=204 | Week 144, CK, n=204 | Week 12, LDH, n=209 | Week 24, LDH, n=208 | Week 36, LDH, n=209 | Week 48, LDH, n=208 | Week 60, LDH, n=208 | Week 72, LDH, n=207 | Week 84, LDH, n=207 | Week 96, LDH, n=207 | Week 108, LDH, n=205 | Week 120, LDH, n=205 | Week 132, LDH, n=205 | Week 144, LDH, n=204 |
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Tenofovir Disoproxil Fumerate 300 mg | 1.66 | -2.80 | -4.57 | -7.07 | -9.20 | -8.12 | -10.53 | -9.13 | -11.25 | -11.95 | -11.56 | -10.97 | -1.68 | -3.20 | -2.93 | -4.23 | -4.68 | -4.43 | -5.56 | -4.37 | -5.81 | -5.67 | -6.05 | -5.85 | 4.46 | 7.22 | 6.27 | 8.24 | 8.75 | 10.06 | 7.32 | 8.73 | 7.62 | 7.54 | 7.36 | 7.14 | -1.83 | -1.83 | -2.25 | -1.90 | -1.25 | -1.45 | -2.10 | -2.50 | -1.62 | -1.61 | -1.80 | -0.76 | 10.84 | -9.28 | 13.87 | -21.58 | -22.26 | -13.45 | -17.40 | 26.58 | -20.58 | 0.59 | -19.34 | -7.17 | 1.66 | -2.80 | -4.57 | -7.07 | -9.20 | -8.12 | -10.53 | -9.13 | -11.25 | -11.95 | -11.56 | -10.97 |
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Change From Baseline in Chemistry Parameters: Albumin, Total Protein
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | Grams per liter (Mean) |
---|
| Week 12, albumin, n=209 | Week 24, albumin, n=208 | Week 36, albumin, n=209 | Week 48, albumin, n=208 | Week 60, albumin, n=208 | Week 72, albumin, n=207 | Week 84, albumin, n=207 | Week 96, albumin, n=207 | Week 108, albumin, n=205 | Week 120, albumin, n=205 | Week 132, albumin, n=205 | Week 144, albumin, n=204 | Week 12, total protein, n=209 | Week 24, total protein, n=207 | Week 36, total protein, n=209 | Week 48, total protein, n=208 | Week 60, total protein, n=208 | Week 72, total protein, n=207 | Week 84, total protein, n=207 | Week 96, total protein, n=207 | Week 108, total protein, n=205 | Week 120, total protein, n=205 | Week 132, total protein, n=205 | Week 144, total protein, n=204 |
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Tenofovir Disoproxil Fumerate 300 mg | 0.22 | 0.54 | 0.04 | 0.24 | 0.38 | 0.49 | -0.03 | 0.13 | -0.56 | 0.17 | 0.51 | 0.48 | 0.31 | 0.92 | -0.30 | -0.53 | -0.32 | -0.26 | -0.57 | -0.44 | -0.21 | 0.95 | 1.00 | 0.94 |
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Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)
Blood samples were collected to analyze the chemistry parameter: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | Grams per liter (Mean) |
---|
| Week 12, n=209 | Week 24, n=209 | Week 36, n=209 | Week 48, n=208 | Week 60, n=208 | Week 72, n=208 | Week 84, n=207 | Week 96, n=207 | Week 108, n=205 | Week 120, n=205 | Week 132, n=205 | Week 144, n=204 |
---|
Tenofovir Disoproxil Fumerate 300 mg | -2.93 | -1.11 | -0.63 | -1.31 | -0.12 | 0.84 | 0.42 | -0.17 | 0.42 | 0.77 | 0.60 | 0.95 |
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Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate
Blood samples were collected to analyze the chemistry parameter: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | Milliliter per minute (Mean) |
---|
| Week 12, n=208 | Week 24, n=208 | Week 36, n=209 | Week 48, n=208 | Week 60, n=208 | Week 72, n=206 | Week 84, n=207 | Week 96, n=207 | Week 108, n=204 | Week 120, n=203 | Week 132, n=205 | Week 144, n=203 |
---|
Tenofovir Disoproxil Fumerate 300 mg | -4.564 | -2.213 | -2.311 | -3.667 | -2.053 | -0.519 | -1.065 | -2.378 | -2.512 | -0.742 | -1.499 | -0.821 |
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Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose.
Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, phosphorus, calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02195518)
Timeframe: Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144
Intervention | Millimoles per liter (Mean) |
---|
| Week 12, BUN, n=209 | Week 24, BUN, n=208 | Week 36, BUN, n=209 | Week 48, BUN, n=208 | Week 60, BUN, n=208 | Week 72, BUN, n=206 | Week 84, BUN, n=207 | Week 96, BUN, n=207 | Week 108, BUN, n=204 | Week 120, BUN, n=205 | Week 132, BUN, n=205 | Week 144, BUN, n=203 | Week 12, Potassium, n=209 | Week 24, Potassium, n=208 | Week 36, Potassium, n=209 | Week 48, Potassium, n=208 | Week 60, Potassium, n=208 | Week 72, Potassium, n=206 | Week 84, Potassium, n=206 | Week 96, Potassium, n=206 | Week 108, Potassium, n=204 | Week 120, Potassium, n=204 | Week 132, Potassium, n=204 | Week 144, Potassium, n=204 | Week 12, Sodium, n=209 | Week 24, Sodium, n=208 | Week 36, Sodium, n=209 | Week 48, Sodium, n=208 | Week 60, Sodium, n=208 | Week 72, Sodium, n=206 | Week 84, Sodium, n=207 | Week 96, Sodium, n=206 | Week 108, Sodium, n=204 | Week 120, Sodium, n=204 | Week 132, Sodium, n=204 | Week 144, Sodium, n=204 | Week 12, Chloridion n=209 | Week 24, Chloridion, n=208 | Week 36, Chloridion, n=209 | Week 48, Chloridion, n=208 | Week 60, Chloridion, n=208 | Week 72, Chloridion, n=206 | Week 84, Chloridion, n=207 | Week 96, Chloridion, n=206 | Week 108, Chloridion, n=204 | Week 120, Chloridion, n=204 | Week 132, Chloridion, n=204 | Week 144, Chloridion, n=204 | Week 12, Phosphorus, n=209 | Week 24, Phosphorus, n=208 | Week 36, Phosphorus, n=209 | Week 48, Phosphorus, n=208 | Week 60, Phosphorus, n=208 | Week 72, Phosphorus, n=207 | Week 84, Phosphorus, n=207 | Week 96, Phosphorus, n=206 | Week 108, Phosphorus, n=201 | Week 120, Phosphorus, n=203 | Week 132, Phosphorus, n=204 | Week 144, Phosphorus, n=204 | Week 12, Calcium, n=209 | Week 24, Calcium, n=208 | Week 36, Calcium, n=209 | Week 48, Calcium, n=208 | Week 60, Calcium, n=208 | Week 72, Calcium, n=207 | Week 84, Calcium, n=207 | Week 96, Calcium, n=206 | Week 108, Calcium, n=204 | Week 120, Calcium, n=204 | Week 132, Calcium, n=204 | Week 144, Calcium, n=204 | Week 12, Fasting blood glucose, n=205 | Week 24, fasting blood glucose, n=208 | Week 36, fasting blood glucose, n=208 | Week 48, fasting blood glucose, n=208 | Week 60, fasting blood glucose, n=208 | Week 72, fasting blood glucose, n=202 | Week 84, fasting blood glucose, n=207 | Week 96, fasting blood glucose, n=206 | Week 108, fasting blood glucose, n=200 | Week 120, fasting blood glucose, n=204 | Week 132, fasting blood glucose, n=204 | Week 144, fasting blood glucose, n=204 |
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Tenofovir Disoproxil Fumerate 300 mg | -0.020 | 0.069 | 0.081 | 0.075 | 0.078 | 0.119 | 0.164 | 0.100 | 0.051 | 0.110 | 0.090 | 0.193 | -0.029 | 0.028 | 0.073 | 0.016 | 0.014 | -0.032 | 0.022 | -0.019 | -0.023 | -0.002 | 0.001 | -0.000 | 0.31 | 0.52 | 0.23 | 0.40 | 0.59 | 0.47 | 0.54 | 0.44 | 0.05 | 0.03 | 0.35 | 0.13 | -0.23 | -0.32 | -0.50 | -0.31 | -0.37 | -0.30 | -0.38 | 0.04 | -0.27 | -0.17 | -0.14 | -0.28 | -0.018 | -0.001 | -0.001 | -0.008 | 0.004 | -0.011 | -0.023 | -0.019 | -0.008 | -0.015 | 0.002 | -0.016 | -0.005 | -0.027 | -0.030 | -0.041 | -0.038 | -0.061 | -0.060 | -0.051 | -0.062 | -0.051 | -0.052 | -0.050 | -0.088 | -0.087 | -0.150 | -0.234 | -0.206 | -0.187 | -0.143 | -0.132 | -0.230 | -0.180 | -0.151 | -0.070 |
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Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144
HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA <20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication. (NCT02195518)
Timeframe: At Week 144
Intervention | Percentage of Participants (Number) |
---|
Tenofovir Disoproxil Fumerate 300 mg | 77.0 |
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Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
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 |
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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
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 |
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Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
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 |
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Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
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 |
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Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
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 |
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Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
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 |
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Number of Adolescents Enrolled and Retained in the Study
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 |
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Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
Truvada | 100 |
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Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
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 |
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Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
Participants reporting multiple partners during interviewer administered questionnaires (NCT02213328)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
Truvada | 49 |
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Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
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 |
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Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). (NCT02224456)
Timeframe: Week 240
Intervention | Events per person-year (Number) |
---|
Tenofovir Disoproxil Fumarate 300 mg | 6.045 |
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Change From Baseline in Red Blood Cells (RBC)
Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Trillion cells per liter (Mean) |
---|
| Week 48, n=191 | Week 96, n=188 | Week 144, n=185 | Week 192, n=179 | Week 240, n=160 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 0.11 | 0.13 | 0.15 | 0.10 | 0.12 |
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Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Log 10 (IU/mL) (Mean) |
---|
| Week 48, n=191 | Week 96, n=188 | Week 144, n=185 | Week 192, n=174 | Week 240, n=160 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -4.2 | -4.3 | -4.3 | -4.2 | -4.3 |
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Change From Baseline in Hemoglobin (Hb)
Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Grams per liter (Mean) |
---|
| Week 48, n=191 | Week 96, n=188 | Week 144, n=185 | Week 192, n=179 | Week 240, n=160 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -0.6 | 0.2 | 0.9 | -0.3 | 1.2 |
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Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | 10^9 cells per liter (Mean) |
---|
| Week 48, WBC, n=191 | Week 96, WBC, n=188 | Week 144, WBC, n=185 | Week 192, WBC, n=179 | Week 240, WBC, n=160 | Week 48, Neutrophils, n=191 | Week 96, Neutrophils, n=188 | Week 144, Neutrophils, n=185 | Week 192, Neutrophils, n=179 | Week 240, Neutrophils, n=160 | Week 48, Lymphocytes, n=191 | Week 96, Lymphocytes, n=188 | Week 144, Lymphocytes, n=185 | Week 192, Lymphocytes, n=179 | Week 240, Lymphocytes, n=160 | Week 48, Monocytes, n=191 | Week 96, Monocytes, n=188 | Week 144, Monocytes, n=185 | Week 192, Monocytes, n=179 | Week 240, Monocytes, n=160 | Week 48, Eosinophils, n=191 | Week 96, Eosinophils, n=188 | Week 144, Eosinophils, n=185 | Week 192, Eosinophils, n=179 | Week 240, Eosinophils, n=160 | Week 48, Basophils, n=191 | Week 96, Basophils, n=188 | Week 144, Basophils, n=184 | Week 192, Basophils, n=179 | Week 240, Basophils, n=160 | Week 48, Platelets, n=191 | Week 96, Platelets, n=188 | Week 144, Platelets, n=185 | Week 192, Platelets, n=179 | Week 240, Platelets, n=160 |
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Tenofovir Disoproxil Fumarate 300 mg | 0.02 | 0.09 | -0.12 | 0.12 | 0.06 | 0.08 | 0.21 | 0.07 | 0.26 | 0.28 | 0.00 | -0.06 | -0.13 | -0.10 | -0.15 | -0.032 | -0.033 | -0.035 | -0.025 | -0.005 | -0.02 | -0.02 | -0.04 | -0.03 | -0.03 | 0.00 | 0.00 | 0.01 | 0.01 | 0.01 | 7.8 | 14.1 | 20.6 | 25.7 | 26.6 |
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Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Micromoles per liter (Mean) |
---|
| Week 48, total bilirubin, n=191 | Week 96, total bilirubin, n=188 | Week 144, total bilirubin, n=185 | Week 192, total bilirubin, n=177 | Week 240, total bilirubin, n=158 | Week 48, direct bilirubin, n=191 | Week 96, direct bilirubin, n=188 | Week 144, direct bilirubin, n=185 | Week 192, direct bilirubin, n=178 | Week 240, direct bilirubin, n=157 | Week 48, serum creatinine, n=191 | Week 96, serum creatinine, n=188 | Week 144, serum creatinine, n=184 | Week 192, serum creatinine, n=178 | Week 240, serum creatinine, n=159 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -1.485 | -1.823 | -2.665 | -2.791 | -1.772 | -0.296 | -0.462 | -0.713 | -0.780 | -0.599 | 1.03 | 1.10 | 0.76 | 1.37 | 1.35 |
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Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | mL/minute per 1.73 square meter (Mean) |
---|
| Week 48, n=191 | Week 96, n=188 | Week 144, n=185 | Week 192, n=180 | Week 240, n=161 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -0.86 | -0.87 | -0.68 | -1.06 | -1.42 |
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Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Grams per liter (Mean) |
---|
| Week 48, albumin, n=191 | Week 96, albumin, n=188 | Week 144, albumin, n=185 | Week 192, albumin, n=175 | Week 240, albumin, n=158 | Week 48, total protein, n=191 | Week 96, total protein, n=188 | Week 144, total protein, n=185 | Week 192, total protein, n=175 | Week 240, total protein, n=158 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 1.06 | 1.23 | 1.86 | 1.65 | 1.81 | -1.01 | -0.21 | 0.27 | -0.94 | -1.61 |
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Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Units per liter (Mean) |
---|
| Week 48, ALT, n=190 | Week 96, ALT, n=187 | Week 144, ALT, n=185 | Week 192, ALT, n=178 | Week 240, ALT, n=158 | Week 48, AST, n=191 | Week 96, AST, n=188 | Week 144, AST, n=184 | Week 192, AST, n=178 | Week 240, AST, n=158 | Week 48, ALP, n=190 | Week 96, ALP, n=188 | Week 144, ALP, n=185 | Week 192, ALP, n=177 | Week 240, ALP, n=158 | Week 48, GGT, n=190 | Week 96, GGT, n=188 | Week 144, GGT, n=185 | Week 192, GGT, n=175 | Week 240, GGT, n=152 | Week 48 CK, n=188 | Week 96, CK, n=185 | Week 144, CK, n=182 | Week 192, CK, n=173 | Week 240, CK, n=156 | Week 48, LDH, n=187 | Week 96, LDH, n=185 | Week 144, LDH, n=180 | Week 192, LDH, n=172 | Week 240, LDH, n=155 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -23.98 | -28.99 | -28.99 | -31.79 | -32.02 | -14.69 | -17.97 | -18.10 | -19.82 | -20.24 | 10.18 | 2.60 | -2.20 | -0.94 | -4.68 | -17.88 | -22.20 | -24.69 | -24.07 | -27.26 | 10.51 | 16.77 | 5.96 | 13.72 | 2.79 | -10.62 | -10.21 | 3.34 | -18.45 | 25.79 |
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Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Millimoles per liter (Mean) |
---|
| Week 48, BUN, n=191 | Week 96, BUN, n=188 | Week 144, BUN, n=184 | Week 192, BUN, n=178 | Week 240, BUN, n=155 | Week 48, Potassium, n=191 | Week 96, Potassium, n=186 | Week 144, Potassium, n=184 | Week 192, Potassium, n=178 | Week 240, Potassium, n=158 | Week 48, Sodium, n=191 | Week 96, Sodium, n=186 | Week 144, Sodium, n=184 | Week 192, Sodium, n=178 | Week 240, Sodium, n=158 | Week 48, Chloridion, n=191 | Week 96, Chloridion, n=186 | Week 144, Chloridion, n=183 | Week 192, Chloridion, n=178 | Week 240, Chloridion, n=158 | Week 48, Phosphorus, n=190 | Week 96, Phosphorus, n=187 | Week 144, Phosphorus, n=184 | Week 192, Phosphorus, n=175 | Week 240, Phosphorus, n=159 | Week 48, Calcium, n=190 | Week 96, Calcium, n=187 | Week 144, Calcium, n=184 | Week 192, Calcium, n=178 | Week 240, Calcium, n=158 | Week 48, Fasting Blood Glucose, n=191 | Week 96, Fasting Blood Glucose, n=188 | Week 144, Fasting Blood Glucose, n=185 | Week 192, Fasting Blood Glucose, n=177 | Week 240, Fasting Blood Glucose, n=158 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -0.046 | 0.000 | 0.037 | 0.143 | 0.131 | -0.001 | 0.002 | -0.039 | 0.015 | -0.013 | 0.21 | -0.02 | 0.35 | 0.38 | -0.13 | -0.13 | 0.40 | 0.35 | 0.77 | 0.49 | -0.044 | -0.038 | -0.037 | -0.059 | -0.042 | -0.023 | -0.006 | -0.022 | -0.004 | -0.006 | -0.162 | -0.109 | -0.094 | -0.052 | 0.052 |
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Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value (NCT02224456)
Timeframe: Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Kilopascals (Mean) |
---|
| Week 48, n=182 | Week 96, n= 176 | Week 144, n= 175 | Week 192, n=167 | Week 240, n= 131 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -3.3 | -4.7 | -5.1 | -5.1 | -6.2 |
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Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144 and Week 192
Intervention | Participants (Count of Participants) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 0 | 0 | 4 | 9 |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia. (NCT02224456)
Timeframe: Up to Week 240
Intervention | Participants (Count of Participants) |
---|
| Any TEAEs | Serious TEAE | Non-serious TEAE |
---|
Tenofovir Disoproxil Fumarate 300 mg | 139 | 34 | 129 |
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Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of Participants (Number) |
---|
| Week 48, HBsAg Loss, n=97 | Week 48, HBsAg Seroconversion, n=97 | Week 96, HBsAg , n=93 | Week 96, HBsAg Seroconversion, n=93 | Week 144, HBsAg Loss, n=93 | Week 144, HBsAg Seroconversion, n=93 | Week 192, HBsAg Loss, n=89 | Week 192, HBsAg Seroconversion, n=89 | Week 240, HBsAg Loss, n=77 | Week 240, HBsAg Seroconversion, n=77 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 1.0 | 1.0 | 0 | 0 | 3.2 | 0 | 4.5 | 2.2 | 5.2 | 1.3 |
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Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of participants (Number) |
---|
| Week 48, HBeAg Loss, n=94 | Week 48, HBeAg Seroconversion, n=94 | Week 96, HBeAg , n=94 | Week 96, HBeAg Seroconversion, n=94 | Week 144, HBeAg Loss, n=90 | Week 144, HBeAg Seroconversion, n=90 | Week 192, HBeAg Loss, n=90 | Week 192, HBeAg Seroconversion, n=90 | Week 240, HBeAg Loss, n=82 | Week 240, HBeAg Seroconversion, n=82 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 18.1 | 9.6 | 33.0 | 14.9 | 35.6 | 14.4 | 47.8 | 16.7 | 51.2 | 23.2 |
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Percentage of Participants Who Experienced Viral Breakthrough
Viral breakthrough was defined as >=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of Participants (Number) |
---|
| Week 48, n=195 | Week 96, n=195 | Week 144, n=185 | Week 192, n=180 | Week 240, n=161 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 0 | 0 | 0.5 | 1.1 | 0.6 |
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Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of participants (Number) |
---|
| Week 48, n=97 | Week 96, n= 97 | Week 144, n=96 | Week 192, n=93 | Week 240, n=87 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 63.9 | 66.0 | 70.8 | 82.8 | 82.8 |
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Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 0 | 0 | 2.1 | 4.6 | 5.6 |
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Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method. (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of participants (Number) |
---|
| Week 48, n=191 | Week 96, n=188 | Week 144, n=185 | Week 192, n=174 | Week 240, n=160 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 81.2 | 88.8 | 94.1 | 97.7 | 99.4 |
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Percentage of Participants With Histological Improvement at Week 216
The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis. (NCT02224456)
Timeframe: Week 216
Intervention | Percentage of participants (Number) |
---|
Tenofovir Disoproxil Fumarate 300 mg | 45.2 |
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Percentage of Participants With Disease Progression at Week 240
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death. (NCT02224456)
Timeframe: Week 240
Intervention | Percentage of participants (Number) |
---|
Tenofovir Disoproxil Fumarate 300 mg | 7.2 |
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Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method). (NCT02224456)
Timeframe: Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Percentage of participants (Number) |
---|
| Week 48 | Week 96 | Week 144 | Week 192 | Week 240 |
---|
Tenofovir Disoproxil Fumarate 300 mg | 2.1 | 2.6 | 4.1 | 7.2 | 7.2 |
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Percentage of Participants With Cirrhosis Reversal at Week 216
Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis. (NCT02224456)
Timeframe: Week 216
Intervention | Percentage of participants (Number) |
---|
Tenofovir Disoproxil Fumarate 300 mg | 41.9 |
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Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT02224456)
Timeframe: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
Intervention | Milliliter per minute (mL/min) (Mean) |
---|
| Week 48, n=190 | Week 96, n=188 | Week 144, n=184 | Week 192, n=177 | Week 240, n=155 |
---|
Tenofovir Disoproxil Fumarate 300 mg | -3.064 | -4.214 | -4.324 | -6.599 | -6.658 |
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Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline
(NCT02251236)
Timeframe: Baseline
Intervention | ng/mL (Median) |
---|
Stribild Arm | 4.3 |
Genvoya Arm | 2.72 |
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Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24
(NCT02251236)
Timeframe: Week 24
Intervention | ng/mL (Median) |
---|
Stribild Arm | 5.90 |
Genvoya Arm | 3.09 |
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Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
(NCT02251236)
Timeframe: Week 24
Intervention | ng/mL (Median) |
---|
Stribild Arm | 0.507 |
Genvoya Arm | 0.481 |
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Concentration of Tenofovir in Cerebrospinal Fluid at Baseline
(NCT02251236)
Timeframe: Baseline
Intervention | ng/mL (Median) |
---|
Stribild Arm | 3.03 |
Genvoya Arm | 0.49 |
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Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented. (NCT02386098)
Timeframe: Up to Week 96
Intervention | Participants (Count of Participants) |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 1 |
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 0 |
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Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF. (NCT02386098)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 73.7 |
Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 60.0 |
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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 48; n=8, 9 |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 75.0 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 66.7 |
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Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis. (NCT02386098)
Timeframe: Weeks 24, 48 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 24; n=32, 29 | Week 48; n=8, 9 |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 93.8 | 100 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 89.7 | 100 |
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Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented. (NCT02386098)
Timeframe: Up to Week 96
Intervention | Participants (Count of Participants) |
---|
| SAEs | AELD |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 4 | 2 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 3 | 1 |
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Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72
Intervention | Percentage of CD4+ cells (Mean) |
---|
| Week 4; n=37, 33 | Week 8; n=36, 30 | Week 12; n=35, 32 | Week 16; n=34, 31 | Week 24; n=31, 28 | Week 32; n=23, 22 | Week 40; n=20, 15 | Week 48; n=7, 9 | Week 60; n=4, 2 | Week 72; n=1, 1 |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 1.94 | 1.80 | 3.41 | 3.14 | 4.71 | 4.13 | 5.38 | 7.09 | 7.95 | 12.50 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 1.82 | 1.69 | 2.88 | 3.66 | 4.72 | 4.81 | 5.38 | 7.16 | 10.05 | 10.70 |
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Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72
Intervention | log10 c/mL (Mean) |
---|
| Week 2; n=10, 5 | Week 4; n=37, 33 | Week 8; n=37, 30 | Week 12; n=36, 32 | Week 16; n=34, 32 | Week 24; n=32, 29 | Week 32; n=23, 23 | Week 40; n=21, 15 | Week 48; n=8, 9 | Week 60; n=4, 3 | Week 72; n=1, 1 |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | -4.232 | -4.400 | -4.103 | -4.394 | -4.402 | -4.220 | -4.381 | -4.366 | -4.508 | -5.037 | -3.326 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | -4.050 | -3.922 | -4.145 | -4.113 | -4.074 | -4.079 | -3.364 | -4.400 | -4.680 | -4.977 | -5.713 |
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Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point. (NCT02386098)
Timeframe: Baseline and up to Week 72
Intervention | Cells per microliter (Mean) |
---|
| Week 4; n=37, 33 | Week 8; n=36, 30 | Week 12; n=35, 32 | Week 16; n=34, 31 | Week 24; n=31, 28 | Week 32; n=23, 22 | Week 40; n=20, 15 | Week 48; n=7, 9 | Week 60; n=4, 2 | Week 72; n=1, 1 |
---|
Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 57.6 | 77.6 | 90.4 | 83.2 | 127.2 | 90.0 | 139.5 | 125.0 | 127.0 | 0.0 |
,Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 26.7 | 53.7 | 115.1 | 93.8 | 109.5 | 122.1 | 137.1 | 175.1 | 158.5 | 171.0 |
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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
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. (NCT02397096)
Timeframe: Up to Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 2.5 |
Delayed Switch Group (DSG) | 0.4 |
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Percentage of Participants Experiencing ≥1 Adverse Event (AE)
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. (NCT02397096)
Timeframe: Up to week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 68.9 |
Delayed Switch Group (DSG) | 52.5 |
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Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
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. (NCT02397096)
Timeframe: Up to 24 weeks
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 2.9 |
Delayed Switch Group (DSG) | 3.6 |
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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL 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." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 89.7 |
Delayed Switch Group (DSG) | 93.3 |
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Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 92.8 |
Delayed Switch Group (DSG) | 93.3 |
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Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL 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." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 90.8 |
Delayed Switch Group (DSG) | 94.6 |
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Percentage of Participants With HIV-1 RNA >=50 Copies/mL
"The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL 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." (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 1.6 |
Delayed Switch Group (DSG) | 1.8 |
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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Baseline and Week 24
Intervention | cells/mm^3 (Geometric Mean) |
---|
| Baseline | Change from Baseline |
---|
Delayed Switch Group (DSG) | 655.6 | 18.0 |
,Immediate Switch Group (ISG) | 664.5 | 5.1 |
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Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02397096)
Timeframe: Baseline and Week 24
Intervention | mg/dL (Mean) |
---|
| Baseline | Change from Baseline |
---|
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG) | 109.00 | -1.94 |
,Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG) | 108.82 | -16.54 |
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Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
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 Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy. (NCT02397096)
Timeframe: Baseline and Week 24
Intervention | mg/dL (Mean) |
---|
| Baseline | Change from Baseline |
---|
Delayed Switch (Ritonavir-boosted, PI-based) Group (DSG) | 137.99 | -1.31 |
,Immediate Switch (Ritonavir--boosted, PI-based) Group (ISG) | 139.14 | -24.74 |
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Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02397096)
Timeframe: Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24
Intervention | cells/mm^3 (Mean) |
---|
| Baseline | Change from Baseline |
---|
Delayed Switch Group (DSG) | 655.6 | 18.0 |
,Immediate Switch Group (ISG) | 660.5 | 13.9 |
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Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL 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." (NCT02397096)
Timeframe: Week 24
Intervention | Percentage of Participants (Number) |
---|
Immediate Switch Group (ISG) | 93.7 |
Delayed Switch Group (DSG) | 94.6 |
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Change From Baseline in Fasting Non-HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | -3.83 |
ATRIPLA™ | 13.26 |
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Change From Baseline in Fasting Triglycerides at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | -12.40 |
ATRIPLA™ | 22.01 |
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Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48
Intervention | Percentage of participants (Number) |
---|
MK-1439A | 3.0 |
ATRIPLA™ | 6.6 |
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Percentage of Participants Experiencing ≥1 AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT02403674)
Timeframe: Up to Week 48
Intervention | Percentage of participants (Number) |
---|
MK-1439A | 82.7 |
ATRIPLA™ | 90.7 |
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Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
MK-1439A | 84.3 |
ATRIPLA™ | 80.8 |
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Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason." (NCT02403674)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
MK-1439A | 83.8 |
ATRIPLA™ | 79.7 |
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Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed. (NCT02403674)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
MK-1439A | 59.6 |
ATRIPLA™ | 55.5 |
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Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)." (NCT02403674)
Timeframe: Up to Week 48
Intervention | Percentage of Participants (Number) |
---|
| Dizziness | Sleep disorders and disturbances | Altered sensorium |
---|
ATRIPLA™ | 37.1 | 25.5 | 8.2 |
,MK-1439A | 8.8 | 12.1 | 4.4 |
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Percentage of Participants With Tier-2 Neuropsychiatric AEs
"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders." (NCT02403674)
Timeframe: Up to Week 48
Intervention | Percentage of Participants (Number) |
---|
| Depression and suicide/self-injury | Psychosis and psychotic disorders |
---|
ATRIPLA™ | 6.6 | 1.1 |
,MK-1439A | 4.1 | 0.3 |
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Plasma Concentration of Doravirine at Week 48
Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose. (NCT02403674)
Timeframe: 0 hours post-dose and 2 hours post-dose on Week 48
Intervention | nM (Mean) |
---|
| Pre-dose | 0.5 to 2 hours post-dose |
---|
MK-1439A | 1290 | 2330 |
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Change From Baseline in CD4 Cell Counts at Week 48
The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | 198.4 |
ATRIPLA™ | 188.4 |
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Change From Baseline in Fasting Cholesterol at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | -1.97 |
ATRIPLA™ | 21.77 |
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Change From Baseline in Fasting HDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | 1.86 |
ATRIPLA™ | 8.51 |
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Change From Baseline in Fasting LDL-C at Week 48
The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy. (NCT02403674)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Percent Change from Baseline (Mean) |
---|
MK-1439A | -1.58 |
ATRIPLA™ | 8.74 |
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Change From Reference in log10 HIV-1 RNA Levels at Week 96
Change from reference in log10 HIV-1 RNA levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for Test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | log10 HIV-1 RNA copies per mL (Least Squares Mean) |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -2.72 |
Switch to D/C/F/TAF | -0.0027 |
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Change From Reference in Serum Creatinine
Change from reference in serum creatinine was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/dL (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.045 |
Switch to D/C/F/TAF | -0.034 |
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Change From Reference in UACR
Change from reference in UACR at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.70 |
Switch to D/C/F/TAF | -0.49 |
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Change From Reference in UB2MGCR
Change from reference in UB2MGCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -27.04 |
Switch to D/C/F/TAF | -40.53 |
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Change From Reference in UPCR
Change from reference in UPCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -15.46 |
Switch to D/C/F/TAF | -1.40 |
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Change From Reference in URBPCR
Change from reference in URBPCR at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 13.70 |
Switch to D/C/F/TAF | -35.53 |
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Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48
Percent change from baseline in FEPO4 at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | Percent change (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 16.00 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 22.55 |
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Percent Change From Reference in Urine FEPO4
Percent change from reference in FEPO4 at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | Percent change in urine FEPO4 (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 18.52 |
Switch to D/C/F/TAF | -7.51 |
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Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach
Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach 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. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 96
Intervention | percentage of participants (Number) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 85.1 |
Switch to D/C/F/TAF | 94.2 |
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Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach 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. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 48
Intervention | percentage of participants (Number) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 91.4 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 88.4 |
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Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide
C0-2h is defined as the plasma concentrations 2 hours after dosing. (NCT02431247)
Timeframe: 0 to 2 hours post dose
Intervention | ng/mL (Mean) |
---|
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | 11.9785 |
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Predose (Trough) Plasma Concentration (C0h) of Darunavir
C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
Intervention | nanogram per milliliter (ng/mL) (Mean) |
---|
Darunavir 800 mg [D/C/F/TAF (Test)] | 1898.9100 |
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CD4+ Cell Count Post-Week From 96 to End of Extension
The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | cells/mm^3 (Mean) |
---|
| Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months | Week 96 + 36 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 790.2 | 779.4 | 789.8 | 781.9 | 741.6 | 784.7 |
,Switch to D/C/F/TAF | 749.7 | 774.3 | 758.4 | 784.1 | 736.7 | 778.4 |
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Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48
Change from baseline in ALP at Weeks 24 and 48 was reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Units per liter (U/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -3.2 | -1.1 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 12.0 | 15.1 |
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Change From Baseline in BMD T-score of Hip and Spine
BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | BMD T-score (Mean) |
---|
| Hip region BMD T-score (Week 24) | Spine region BMD T-score (Week 24) | Hip region BMD T-score (Week 48) | Spine region BMD T-score (Week 48) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.019 | -0.121 | 0.015 | -0.061 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -0.109 | -0.322 | -0.177 | -0.225 |
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Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48
Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | nanomol per liter (nmol/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 12.7 | 16.9 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 22.1 | 28.3 |
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Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48
Change from baseline in PTH at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Picomol per liter (pmol/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.113 | -0.004 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.777 | 0.633 |
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Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48
Change from baseline in serum CTX at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | mcg/L (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.047 | 0.046 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.283 | 0.226 |
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Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48
Change from baseline in serum P1NP at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | microgram per liter (mcg/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 1.892 | 0.065 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 24.679 | 24.251 |
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Change From Reference in BMD T-score of Hip and Spine at Week 96
BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | BMD T-score (Mean) |
---|
| Hip region BMD T-score | Spine region BMD T-score |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.016 | -0.090 |
,Switch to D/C/F/TAF | 0.025 | 0.034 |
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Number of Participants With ARV Resistance
Number of participants with DRV, FTC, TDF/TAF resistance were reported. (NCT02431247)
Timeframe: Baseline to end of extension (up to 4 years)
Intervention | Participants (Count of Participants) |
---|
| DRV resistance-associated mutations (RAMs) | TFV RAMs | FTC RAMs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0 | 0 | 2 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0 | 0 | 1 |
,Switch to D/C/F/TAF | 0 | 0 | 2 |
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Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)
"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are best values and negative values are worst values of change. Percent change from baseline in hip and spine BMD was assessed." (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Percent change (Least Squares Mean) |
---|
| Hip region BMD (Week 24) | Spine region BMD (Week 24) | Hip region BMD (Week 48) | Spine region BMD (Week 48) |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.29 | -1.34 | 0.17 | -0.68 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -1.66 | -3.43 | -2.69 | -2.38 |
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Percent Change From Reference in Hip and Spine BMD
"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are best values and negative values are worst values of change. Percent change from reference in hip and spine BMD was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group." (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | Percent change in BMD (Mean) |
---|
| Hip region BMD | Spine region BMD |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.2565 | -0.9349 |
,Switch to D/C/F/TAF | 0.5467 | 0.4829 |
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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Baseline to Switch (double-blind treatment) |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 82.6 |
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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Switch to End of Extension (open-label D/C/F/TAF) |
---|
Switch to D/C/F/TAF | 88.7 |
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Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Baseline to Switch (double-blind treatment) | Switch to End of Extension (open-label D/C/F/TAF) |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 87.2 | 92.2 |
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Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Weeks 48
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 4.7 | 0.6 | 4.7 | 1.9 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 4.4 | 1.7 | 5.8 | 4.4 |
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Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Week 96
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 11.6 | 0.8 | 10.8 | 2.8 |
,Switch to D/C/F/TAF | 3.7 | 1.4 | 2.7 | 0.3 |
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Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 3.5 | 0 | 3.2 | 1.0 |
,Switch to D/C/F/TAF | 5.2 | 1.3 | 4.8 | 1.3 |
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Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension
Percentage of participants with HIV RNA <50, <20, and <200 copies/mL post Week 96 to end of extension were reported. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 + 6 months (<50 copies/mL) | Week 96 + 12 months (<50 copies/mL) | Week 96 + 18 months (<50 copies/mL) | Week 96 + 24 months (<50 copies/mL) | Week 96 + 30 months (<50 copies/mL) | Week 96 + 36 months (<50 copies/mL) | Week 96 + 6 months (<20 copies/mL) | Week 96 + 12 months (<20 copies/mL) | Week 96 + 18 months (<20 copies/mL) | Week 96 + 24 months (<20 copies/mL) | Week 96 + 30 months (<20 copies/mL) | Week 96 + 36 months (<20 copies/mL) | Week 96 + 6 months (<200 copies/mL) | Week 96 + 12 months (<200 copies/mL) | Week 96 + 18 months (<200 copies/mL) | Week 96 + 24 months (<200 copies/mL) | Week 96 + 30 months (<200 copies/mL) | Week 96 + 36 months (<200 copies/mL) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 97.7 | 99.0 | 98.1 | 97.5 | 94.7 | 100.0 | 85.8 | 89.7 | 92.4 | 90.1 | 89.5 | 94.7 | 99.7 | 100.0 | 98.7 | 97.5 | 96.5 | 100.0 |
,Switch to D/C/F/TAF | 96.3 | 96.7 | 98.2 | 95.7 | 91.4 | 68.8 | 88.2 | 91.6 | 92.8 | 87.0 | 84.5 | 62.5 | 99.3 | 99.5 | 98.2 | 97.8 | 98.3 | 87.5 |
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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 48: < 20 Copies per mL | At Week 48: <50 Copies per mL | At Week 48: <200 Copies per mL |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 79.9 | 88.7 | 91.7 |
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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 96: <20 Copies per mL | At Week 96: <50 Copies per mL | At Week 96: <200 Copies per mL |
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Switch to D/C/F/TAF | 78.4 | 93.8 | 96.9 |
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Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 48: < 20 Copies per mL | At Week 48: <50 Copies per mL | At Week 48: <200 Copies per mL | At Week 96: <20 Copies per mL | At Week 96: <50 Copies per mL | At Week 96: <200 Copies per mL |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 82.6 | 91.2 | 93.1 | 73.2 | 85.1 | 86.7 |
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Change From Reference in CD4+ Cell Count at Week 96
The immunologic change was determined by changes in cluster of differentiation (CD4+) cell count. Change from reference in CD4+ cell count at Week 96 was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | cells/mm^3 (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 228.85 |
Switch to D/C/F/TAF | 27.01 |
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Change From Reference in ALP Levels
Change from reference in ALP levels at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | U/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.9 |
Switch to D/C/F/TAF | -9.7 |
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Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48
Change from baseline in URBPCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | microgram per gram (mcg/g) (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 7.00 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 35.02 |
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Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48
Change from baseline in UPCR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | milligram per gram (mg/g) (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -15.72 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -10.53 |
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Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48
Change from baseline in UB2MGCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -30.42 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 18.36 |
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Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48
Change from baseline in UACR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.58 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -0.15 |
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Change From Baseline in Serum Creatinine at Week 48
Change from baseline in serum creatinine at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | milligram per deciliter (mg/dL) (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.05 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.09 |
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Change From Baseline in log10 HIV-1 RNA Levels at Week 48
Change from baseline in log10 HIV-1 RNA levels were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | log10 HIV-1 RNA copies per mL (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -2.95 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -2.91 |
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Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | Cells per millimeter cube (cells/mm^3) (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 190.49 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 172.01 |
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Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. (NCT02431247)
Timeframe: 0 to 24 hours post dose
Intervention | hours*nanogram per milliliter (h*ng/mL) (Mean) |
---|
Darunavir 800 mg [D/C/F/TAF] | 87909.3282 |
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Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
Intervention | h*ng/mL (Mean) |
---|
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | 132.3117 |
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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 48: <20 Copies per mL | At week 48: <200 Copies per mL |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 79.3 | 90.6 |
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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 96: <20 Copies per mL | At week 96: <200 Copies per mL |
---|
Switch to D/C/F/TAF | 83.5 | 96.9 |
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Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 48: <20 Copies per mL | At week 48: <200 Copies per mL | At week 96: <20 Copies per mL | At week 96: <200 Copies per mL |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 82.6 | 92.8 | 76.2 | 86.2 |
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Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates
Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 2 years and 6 months)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 100 | 99.6 | 99.6 | 98.6 | 97.3 | 97.3 |
,Switch to D/C/F/TAF | 100 | 99.2 | 99.2 | 97.8 | 97.8 | 92.5 |
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Percentage of Participants With PDVF Post-week 96 to End of Extension
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF | Virologic non-response | Virologic rebound | Viremic at final time point |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 1.0 | 0 | 1.0 | 0 |
,Switch to D/C/F/TAF | 2.1 | 0 | 1.4 | 0.7 |
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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Baseline - Switch) | Virologic non-response (Baseline - Switch) | Virologic rebound (Baseline - Switch) | Viremic at final time point (Baseline - Switch) |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 4.4 | 0 | 3.9 | 0.6 |
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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Baseline - Week 96) | Virologic non-response (Baseline - Week 96) | Virologic rebound (Baseline-Week 96) | Viremic at final time point (Baseline-Week 96) |
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D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 4.1 | 0.6 | 0.3 | 0.6 |
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Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Switch - Week 96) | Virologic non-response (Switch - Week 96) | Virologic rebound (Switch - Week 96) | Viremic at final time point (Switch - Week 96) |
---|
Switch to D/C/F/TAF | 1.1 | 0 | 1.1 | 0 |
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Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months |
---|
Switch to D/C/F/TAF | 100 | 97.4 | 94.1 | 89.5 | 86.4 | 79.1 |
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Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months | Week 96 + 36 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 100 | 98.9 | 95.6 | 90.6 | 87.1 | 84.8 | 84.8 |
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Change From Reference in Levels of Serum CTX
Change from reference in serum CTX levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.041 |
Switch to D/C/F/TAF | -0.162 |
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Change From Reference in Levels of PTH
Change from reference in PTH levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | pmol/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.290 |
Switch to D/C/F/TAF | -1.283 |
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Change From Reference in Levels of 25-OH Vitamin D
Change from reference in 25-OH Vitamin D were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | nmol/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 21.3 |
Switch to D/C/F/TAF | -10.3 |
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Change From Reference in Levels of Serum P1NP
Change from reference in serum P1NP levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 2.817 |
Switch to D/C/F/TAF | -11.963 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication. (NCT02452528)
Timeframe: From time of informed consent through Day 147 ± 3 days
Intervention | Participants (Count of Participants) |
---|
| TEAEs | SAEs | Deaths | Discontinuations due to AEs |
---|
ARC-520 | 0 | 0 | 0 | 0 |
,Placebo | 1 | 0 | 0 | 0 |
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Number of Participants With PrEP Adherence
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. (NCT02495779)
Timeframe: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Intervention | Participants (Count of Participants) |
---|
Intervention | 45 |
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HIV RNA Change From Baseline to Day 10
An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study. (NCT02556333)
Timeframe: 10 days
Intervention | log HIV RNA copies/mL (Number) |
---|
TAF Treatment | 0.01 |
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Spine Bone Mineral Density (BMD) at Baseline
(NCT02603120)
Timeframe: Baseline
Intervention | g/cm^2 (Mean) |
---|
B/F/TAF | 1.124 |
ABC/DTG/3TC | 1.103 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
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. (NCT02603120)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
B/F/TAF | 93.6 |
ABC/DTG/3TC | 95.0 |
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Percentage Change From Baseline in Spine BMD at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
B/F/TAF | 0.692 |
ABC/DTG/3TC | 0.416 |
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Percentage Change From Baseline in Hip BMD at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
B/F/TAF | 0.156 |
ABC/DTG/3TC | 0.299 |
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Hip Bone Mineral Density at Baseline
(NCT02603120)
Timeframe: Baseline
Intervention | g/cm^2 (Mean) |
---|
B/F/TAF | 1.006 |
ABC/DTG/3TC | 0.996 |
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Change From Baseline in CD4+ Cell Count at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | cells/µL (Mean) |
---|
B/F/TAF | -31 |
ABC/DTG/3TC | 4 |
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Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
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. (NCT02603120)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
B/F/TAF | 1.1 |
ABC/DTG/3TC | 0.4 |
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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604199)
Timeframe: Baseline, Day 113
Intervention | log IU/mL (Least Squares Mean) |
---|
Placebo | -0.070 |
ARC-520 Injection 1 mg/kg | -0.157 |
ARC-520 Injection 2 mg/kg | -0.379 |
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration. (NCT02604199)
Timeframe: Through Day 169
Intervention | Participants (Count of Participants) |
---|
| ≥ 1 AE | ≥ 1 TEAE | ≥ 1 Serious TEAE | Deaths | ≥ 1 TEAE Leading to Study Discontinuation | ≥ 1 TEAE Leading to Treatment Discontinuation |
---|
ARC-520 Injection 1 mg/kg | 6 | 6 | 2 | 0 | 0 | 0 |
,ARC-520 Injection 2 mg/kg | 12 | 12 | 1 | 0 | 0 | 0 |
,PBO High Dose | 5 | 4 | 0 | 0 | 0 | 0 |
,PBO Low Dose | 4 | 4 | 0 | 0 | 0 | 0 |
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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) Over Time
Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604199)
Timeframe: Baseline, Day 15, 29, 43, 57, 71, 85, 99
Intervention | log IU/mL (Least Squares Mean) |
---|
| Day 15 | Day 29 | Day 43 | Day 57 | Day 71 | Day 85 | Day 99 |
---|
ARC-520 Injection 1 mg/kg | 3.084 | 3.098 | 3.016 | 3.072 | 3.051 | 2.907 | 2.938 |
,ARC-520 Injection 2 mg/kg | 2.506 | 2.503 | 2.509 | 2.329 | 2.301 | 2.366 | 2.360 |
,Placebo | 3.297 | 3.291 | 3.188 | 3.291 | 3.206 | 3.309 | 3.302 |
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Change From Baseline at Day 29 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 29
Intervention | log IU/mL (Mean) |
---|
| Decrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.129 |
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Change From Baseline at Day 15 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15
Intervention | log IU/mL (Mean) |
---|
| No Decrease | Decrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | 0.032 | -0.266 | -0.666 |
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Change From Baseline at Day 15 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15
Intervention | log IU/mL (Mean) |
---|
| No Decrease | Decrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.026 | -0.035 |
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Change From Baseline at Day 15 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 15
Intervention | log IU/mL (Mean) |
---|
| Decrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.153 | -0.707 |
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Change From Baseline at Day 113 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.042 | -0.115 |
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Change From Baseline at Day 113 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | -0.359 | -0.726 |
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Change From Baseline at Day 85 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.171 |
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Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113
Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604212)
Timeframe: Baseline, Day 113
Intervention | log IU/mL (Least Squares Mean) |
---|
Placebo | -0.104 |
ARC-520 1.0 mg/kg | -0.146 |
ARC-520 2.0 mg/kg | -0.542 |
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Change From Baseline at Day 113 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 113
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.142 |
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study drug administration and started at/after the time of initiation of administration of study drug, or an AE which was present prior to initiation of study drug administration, which increased in severity after study drug administration. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. (NCT02604212)
Timeframe: Through Day 169 (± 3 days)
Intervention | participants (Number) |
---|
| ≥ 1 AE | ≥ 1 TEAE | ≥ 1 Serious TEAE | Deaths | ≥ 1 TEAE Leading to Study Discontinuation | ≥ 1 TEAE Leading to Treatment Discontinuation |
---|
ARC-520 1.0 mg/kg | 6 | 5 | 0 | 0 | 0 | 0 |
,ARC-520 2.0 mg/kg | 3 | 3 | 0 | 0 | 0 | 0 |
,Placebo High Dose Comparator | 0 | 0 | 0 | 0 | 0 | 0 |
,Placebo Low Dose Comparator | 4 | 4 | 0 | 0 | 0 | 0 |
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Change From Baseline in Log qHBsAg Over Time
Change From Baseline in log qHBsAg up to Day 99 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. (NCT02604212)
Timeframe: Baseline, Days 15, 29, 43, 57, 71, 85, 99
Intervention | log IU/mL (Mean) |
---|
| Day 15 | Day 29 | Day 43 | Day 57 | Day 71 | Day 85 | Day 99 |
---|
ARC-520 1.0 mg/kg | 3.069 | 3.148 | 3.097 | 3.148 | 3.088 | 3.198 | 3.048 |
,ARC-520 2.0 mg/kg | 3.000 | 3.027 | 2.893 | 2.882 | 2.714 | 2.698 | 2.606 |
,Placebo | 3.734 | 3.692 | 3.812 | 3.793 | 3.756 | 3.743 | 3.767 |
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Change From Baseline at Day 99 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL | Decrease > 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | -0.343 | -0.652 | -1.011 |
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Change From Baseline at Day 99 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.027 | -0.160 |
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Change From Baseline at Day 99 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 99
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.210 |
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Change From Baseline at Day 85 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.009 | -0.112 |
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Change From Baseline at Day 85 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 85
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | -0.293 | -0.684 |
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Change From Baseline at Day 71 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.011 | -0.094 |
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Change From Baseline at Day 71 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | -0.296 | -0.662 |
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Change From Baseline at Day 71 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 71
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.235 |
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Change From Baseline at Day 57 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.027 | -0.067 |
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Change From Baseline at Day 57 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | -0.276 | -0.571 |
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Change From Baseline at Day 57 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 57
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.176 |
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Change From Baseline at Day 43 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL | Decrease 0.5 to 1.0 log IU/mL |
---|
ARC-520 2.0 mg/kg | 0.017 | -0.275 | -0.633 |
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Change From Baseline at Day 43 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43
Intervention | log IU/mL (Mean) |
---|
| No Decrease | 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
Placebo | 0.022 | -0.050 |
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Change From Baseline at Day 43 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 43
Intervention | log IU/mL (Mean) |
---|
| 1 participant analyDecrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 1.0 mg/kg | -0.226 |
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Change From Baseline at Day 29 in Log qHBsAg, by Category
Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit. (NCT02604212)
Timeframe: Baseline, Day 29
Intervention | log IU/mL (Mean) |
---|
| No Decrease | Decrease > 0 to < 0.5 log IU/mL |
---|
ARC-520 2.0 mg/kg | 0.064 | -0.251 |
,Placebo | 0.048 | -0.084 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Change From Baseline in CD4 Cell Count at Week 48
The change from baseline in CD4 cell count at Week 48 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline for the Week 48 Population | Change from Baseline at Week 48 |
---|
DOR/3TC/TDF | 409 | 132 |
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Change From Baseline in CD4 Cell Count at Week 192
The change from baseline in CD4 cell count at Week 192 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 192
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline for the Week 192 Population | Change from Baseline at Week 192 |
---|
DOR/3TC/TDF | 479 | 196 |
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Time to Loss of Virologic Response
The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement. (NCT02629822)
Timeframe: Up to Week 96
Intervention | Days (Mean) |
---|
DOR/3TC/TDF | 166 |
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Change From Baseline in CD4 Cell Count at Week 96
The change from baseline in CD4 cell count at Week 96 was calculated. (NCT02629822)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline for the Week 96 Population | Change from Baseline at Week 96 |
---|
DOR/3TC/TDF | 437 | 153 |
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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 0.0 |
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Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.
The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 0.0 |
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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96
The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 96
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 90.0 |
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Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48
The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT02629822)
Timeframe: Up to Week 48
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 90.0 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. (NCT02629822)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. (NCT02629822)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. (NCT02629822)
Timeframe: Week 192
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 192
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48
The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. (NCT02629822)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
DOR/3TC/TDF | 100.0 |
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Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
Intervention | Percentage of participants (Number) |
---|
| < 50 copies/mL | < 40 copies/mL |
---|
Combined Treatment Groups | 95.3 | 95.3 |
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CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
Intervention | Percentage of maximum score (Mean) |
---|
Combined Treatment Groups: Time of Switch | 24.2 |
Combined Treatment Groups: Week 24 Post-Switch | 10.7 |
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Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
Intervention | mg/dL (Mean) |
---|
| LDL Cholesterol | Non-HDL Cholesterol | Cholesterol | HDL Cholesterol | Triglyceride |
---|
Combined Treatment Groups | -10.97 | -13.18 | -20.91 | -7.72 | -12.99 |
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Change From Baseline in Fasting Lipids at Week 12
Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. (NCT02652260)
Timeframe: Baseline (study Day 1) and study week 12
Intervention | mg/dL (Mean) |
---|
| LDL Cholesterol | Non-HDL Cholesterol | Cholesterol | HDL Cholesterol | Triglyceride |
---|
Deferred Switch to MK-1439A | -1.88 | -0.37 | 0.00 | 0.37 | 7.10 |
,Immediate Switch to MK-1439A | -10.78 | -14.08 | -22.14 | -8.05 | -21.19 |
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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 4
Intervention | Percentage of participants (Number) |
---|
Immediate Switch to MK-1439A | 46.5 |
Deferred Switch to MK-1439A | 65.1 |
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Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
Intervention | Percentage of participants (Number) |
---|
Combined Treatment Groups: Time of Switch | 68.6 |
Combined Treatment Groups: Week 24 Post-Switch | 30.2 |
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Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach. (NCT02652260)
Timeframe: Week 12
Intervention | Percentage of participants (Number) |
---|
Immediate Switch to MK-1439A | 41.9 |
Deferred Switch to MK-1439A | 37.2 |
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Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. (NCT02652260)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Immediate Switch to MK-1439A | 0 |
Deferred Switch to MK-1439A | 0 |
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Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
Intervention | Participants (Count of Participants) |
---|
Combined Treatment Groups | 1 |
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Change From Baseline in CNS Toxicity Score at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 12
Intervention | Percentage of maximum score (Mean) |
---|
Immediate Switch to MK-1439A | -18.1 |
Deferred Switch to MK-1439A | -21.7 |
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Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
Intervention | Participants (Count of Participants) |
---|
Combined Treatment Groups | 71 |
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Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Immediate Switch to MK-1439A | 34 |
Deferred Switch to MK-1439A | 34 |
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Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. (NCT02652260)
Timeframe: Up to Week 12
Intervention | Participants (Count of Participants) |
---|
Immediate Switch to MK-1439A | 0 |
Deferred Switch to MK-1439A | 0 |
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Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36. (NCT02652260)
Timeframe: 24 weeks post-switch
Intervention | Participants (Count of Participants) |
---|
Combined Treatment Groups | 0 |
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Change From Baseline in CNS Toxicity Score at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms. (NCT02652260)
Timeframe: Baseline and Week 4
Intervention | Percentage of maximum score (Mean) |
---|
Immediate Switch to MK-1439A | -17.6 |
Deferred Switch to MK-1439A | -15.6 |
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Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36. (NCT02652260)
Timeframe: Baseline (time of switch) and 24 weeks post-switch
Intervention | cells/mm^3 (Mean) |
---|
Combined Treatment Groups | 70.4 |
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration. (NCT02738008)
Timeframe: From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Heparc-2002: ARC-520 1.0 mg/kg | 1 | 0 |
,Heparc-2002: ARC-520 2.0 mg/kg | 4 | 0 |
,Heparc-2003: ARC-520 2.0 mg/kg | 4 | 0 |
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Number of Participants With TEAEs: CHB Participants
An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 142 (± 3 days)
Intervention | Participants (Count of Participants) |
---|
| >/= 1 TEAE | >/= 1 Serious TEAE | >/= 1 Related TEAE | >/= 1 Related Serious TEAE |
---|
CHB Participants: Cohort 3b | 2 | 0 | 0 | 0 |
,CHB Participants: Cohort 3c | 4 | 0 | 2 | 0 |
,CHB Participants: Cohort 4b | 1 | 1 | 1 | 1 |
,CHB Participants: Cohort 4c | 1 | 0 | 0 | 0 |
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 29 (± 1 day)
Intervention | Participants (Count of Participants) |
---|
| >/= 1 TEAE | >/= 1 Serious TEAE | >/= 1 Related TEAE | >/= 1 Related Serious TEAE |
---|
NHV Participants: Cohort 1 | 1 | 0 | 0 | 0 |
,NHV Participants: Cohort 2 | 2 | 0 | 0 | 0 |
,NHV Participants: Cohort 3 | 3 | 0 | 1 | 0 |
,NHV Participants: Cohort 4 | 4 | 0 | 2 | 0 |
,NHV Participants: Cohort 5 | 3 | 0 | 2 | 0 |
,NHV Participants: Cohort 6 | 2 | 0 | 1 | 0 |
,NHV Participants: Placebo | 10 | 0 | 3 | 0 |
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% Change in Bone Mineral Density From Baseline at the Femoral Neck
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks
Intervention | Percent Change (Median) |
---|
| 48 weeks | 96 weeks |
---|
Delayed Switch | 0.22 | 0.70 |
,Immediate Switch | 1.46 | 2.33 |
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Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks
Intervention | Percent Change (Median) |
---|
| 48 weeks | 96 weeks |
---|
Delayed Switch | -2.32 | 0.7 |
,Immediate Switch | 1.97 | 2.33 |
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Changes From Baseline in CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells per cubic millimeter (Mean) |
---|
DTG + 3TC - Double-blind Phase | 264.7 |
DTG + TDF/FTC-Double Blind Phase | 253.8 |
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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Ratio (Geometric Mean) |
---|
| Serum B2M, Week 24, n=338, 335 | Serum B2M, Week 48, n=324, 332 | Urine B2M, Week 24, n=121, 95 | Urine B2M, Week 48, n=119, 103 | Urine Albumin/Creatinine, Week 24, n=254, 252 | Urine Albumin/Creatinine , Week 48, n=237, 244 | Urine B2M/Urine Creatinine, Week 24, n=121, 95 | Urine B2M/Urine Creatinine, Week 48, n=114, 100 | Urine Phosphate, Week 24, n=330, 332 | Urine Phosphate, Week 48, n=316, 330 | Urine Protein/Creatinine, Week 24, n=269, 265 | Urine Protein/Creatinine, Week 48, n=252, 269 | Urine RBP 4, Week 24, n=332, 330 | Urine RBP 4, Week 48, n=318, 328 | Urine RBP 4/Urine Creatinine, Week 24, n=329, 330 | Urine RBP 4/Urine Creatinine, Week 48, n=304, 318 |
---|
DTG + 3TC-Double Blind Phase | 0.798 | 0.806 | 0.887 | 0.900 | 1.014 | 0.934 | 0.852 | 0.888 | 1.115 | 1.061 | 0.850 | 0.879 | 0.934 | 1.115 | 0.919 | 1.147 |
,DTG + TDF/FTC-Double Blind Phase | 0.872 | 0.892 | 1.351 | 1.338 | 1.050 | 1.048 | 1.331 | 1.278 | 1.012 | 1.075 | 1.016 | 1.061 | 1.073 | 1.490 | 1.110 | 1.500 |
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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 96, n=222, 243 | Urine B2M/Urine Creatinine , Week 96, n=107, 104 | Urine Phosphate, Week 96, n=292, 316 | Urine Protein/Creatinine, Week 96, n=238, 258 | Urine RBP 4/Urine Creatinine, Week 96, n=289, 311 |
---|
DTG + 3TC-Double Blind Phase | 0.924 | 0.794 | 1.113 | 0.868 | 1.310 |
,DTG + TDF/FTC-Double Blind Phase | 1.101 | 1.441 | 1.066 | 1.053 | 1.771 |
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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine , Week 144, n=207, 212 | Urine B2M/Urine Creatinine , Week 144, n=100, 102 | Urine Phosphate, Week 144, n=274, 294 | Urine Protein/Creatinine , Week 144, n=225,232 | Urine RBP 4/Urine Creatinine, Week 144, n=276, 292 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.050 | 0.751 | 1.040 | 0.988 | 1.648 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.146 | 1.518 | 0.955 | 1.210 | 2.425 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Weeks 24 and Week 48
Intervention | Percentage of participants (Number) |
---|
| Week 24, n=309, 316 | Week 48, n=318, 320 |
---|
DTG + 3TC-Double Blind Phase | 4 | 4 |
,DTG + TDF/FTC-Double Blind Phase | 2 | 3 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31,29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297, 306 | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29, 46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39, 36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
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DTG + 3TC-Double Blind Phase | 90 | 93 | 93 | 92 | 93 | 91 | 93 | 93 | 92 | 93 | 92 | 89 | 94 |
,DTG + TDF/FTC-Double Blind Phase | 86 | 94 | 96 | 92 | 95 | 93 | 85 | 95 | 87 | 95 | 81 | 93 | 94 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31, 29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297,306, | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29,46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39,36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC-Double Blind Phase | 65 | 86 | 83 | 85 | 84 | 84 | 86 | 85 | 81 | 86 | 79 | 78 | 86 |
,DTG + TDF/FTC-Double Blind Phase | 90 | 89 | 88 | 90 | 90 | 89 | 87 | 90 | 88 | 90 | 81 | 90 | 91 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31,29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297, 306 | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29, 46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39, 36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC-Double Blind Phase | 81 | 91 | 88 | 90 | 92 | 86 | 90 | 90 | 88 | 90 | 87 | 92 | 89 |
,DTG + TDF/FTC-Double Blind Phase | 90 | 93 | 94 | 92 | 93 | 94 | 87 | 93 | 91 | 94 | 81 | 98 | 94 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31, 29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297,306, | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29,46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39,36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 58 | 81 | 71 | 80 | 77 | 81 | 83 | 79 | 78 | 82 | 69 | 73 | 78 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 83 | 83 | 85 | 82 | 83 | 83 | 78 | 82 | 87 | 85 | 72 | 81 | 79 |
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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Serum or Plasma Cholesterol, Week 24, n=294, 297 | Serum or Plasma Cholesterol, Week 48, n=280, 289 | HDL Cholesterol, Direct, Week 24, n=294, 297 | HDL Cholesterol, Direct, Week 48, n=280, 289 | LDL Cholesterol, Week 24, n=294, 297 | LDL Cholesterol, Week 48, n=280, 289 | Triglycerides ,Week 24, n=294, 297 | Triglycerides , Week 48, n=280, 289 |
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DTG + 3TC-Double Blind Phase | 9.4 | 10.5 | 16.4 | 15.0 | 12.4 | 14.8 | 8.5 | 12.8 |
,DTG + TDF/FTC-Double Blind Phase | -4.7 | -2.4 | 3.4 | 5.0 | -8.1 | -4.0 | 4.3 | 4.4 |
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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Total/HDL Cholesterol Ratio, Week 24, n=294, 297 | Total/HDL Cholesterol Ratio, Week 48, n=280, 289 |
---|
DTG + 3TC-Double Blind Phase | -4.0 | -0.2 |
,DTG + TDF/FTC-Double Blind Phase | -4.6 | -4.4 |
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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI, DTG, Sensitive, n=,5,4 | INSTI, DTG, Resistant, n=5,4 | INSTI, EGV, Sensitive, n=5,4 | INSTI, EGV, Resistant, n=5,4 | INSTI, RAL, Sensitive, n=5,4 | INSTI, RAL, Resistant, n=5,4 | NRTI, 3TC, Sensitive, n=5,5 | NRTI, 3TC, Resistant, n=5,5 | NRTI, ABC, Sensitive, n=5,5 | NRTI, ABC, Resistant, n=5,5 | NRTI, AZT, Sensitive, n=5,5 | NRTI, AZT, Resistant, n=5,5 | NRTI, D4T, Sensitive, n=5,5 | NRTI, D4T, Resistant, n=5,5 | NRTI, DDI, Sensitive, n=5,5 | NRTI, DDI, Resistant, n=5,5 | NRTI, FTC, Sensitive, n=5,5 | NRTI, FTC, Resistant, n=5,5 | NRTI, TDF, Sensitive, n=5,5 | NRTI, TDF, Resistant, n=5,5 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 | 0 | 4 | 0 | 4 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI Mutations | Major mutations of NRTI |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0 | 0 |
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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=257,264 | Baseline plasma HIV-1 RNA,>100000, n=67,70 | Baseline CD4+ cell count,<=200, n=26, 27 | Baseline CD4+ cell count,>200, n=298, 307 | Age group-1, <35,n= 194, 192 | Age group-1, 35 to <50, n=104, 101 | Age group-1, >=50, n=26, 41 | Female, n=54, 49 | Male, n=270, 285 | Race, White, n=224, 231 | Race, African Am/African H., n=33, 31 | Race, Asian, n=34, 41 | Race, Other, n=33, 31 |
---|
DTG + 3TC-Double Blind Phase | 220.0 | 238.5 | 200.5 | 225.9 | 233.6 | 208.7 | 212.6 | 237.1 | 221.2 | 226.0 | 209.4 | 246.4 | 200.2 |
,DTG + TDF/FTC-Double Blind Phase | 212.4 | 235.5 | 177.9 | 220.7 | 225.2 | 211.2 | 194.8 | 226.8 | 215.6 | 219.7 | 239.9 | 197.2 | 202.7 |
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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 24
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=268,268 | Baseline plasma HIV-1 RNA,>100000, n=72,73 | Baseline CD4+ cell count,<=200, n=29,27 | Baseline CD4+ cell count,>200, n=311, 314 | Age, <35,n= 203,199 | Age, 35 to <50, n=109, 100 | Age, >=50, n=28, 42 | Female, n=57,50 | Male, n=283,291 | Race, White, n=236,235 | Race, African Am/African H., n=36,33 | Race, Asian, n=34, 41 | Race, Other, n=34,32 |
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DTG + 3TC-Double Blind Phase | 187.72 | 206.63 | 157.01 | 195.11 | 202.76 | 172.05 | 188.79 | 199.45 | 190.21 | 204.78 | 143.84 | 169.80 | 174.30 |
,DTG + TDF/FTC-Double Blind Phase | 167.93 | 205.96 | 120.17 | 180.73 | 177.62 | 179.87 | 159.34 | 181.78 | 175.05 | 182.27 | 170.51 | 165.36 | 149.34 |
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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 24, 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 24, n=340,341 | Week 48, n=324,334 |
---|
DTG + 3TC-Double Blind Phase | 192.2 | 222.2 |
,DTG + TDF/FTC-Double Blind Phase | 175.1 | 217.7 |
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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=214,223 | Baseline plasma HIV-1 RNA,>100000, n=56, 64 | Baseline CD4+ cell count,<=200, n=17, 24 | Baseline CD4+ cell count,>200, n=253, 263 | Age group, <35,n=155, 167 | Age group-1, 35 to <50, n=92, 87 | Age group-1, >=50, n=23,33 | Female, n=43, 43 | Male, n=227, 244 | Race group, White, n=190,201 | Race group, African Am/African H., n=26, 26 | Race group, Asian, n=26, 34 | Race group, Other, n=28,26 |
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DTG + 3TC - Double-blind Phase + Open-label Phase | 295.7 | 334.3 | 290.2 | 304.7 | 298.0 | 305.6 | 337.4 | 346.6 | 295.9 | 314.2 | 243.8 | 244.0 | 346.2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 296.1 | 329.6 | 272.9 | 306.2 | 316.0 | 302.1 | 242.2 | 321.7 | 300.0 | 314.0 | 295.1 | 264.1 | 279.9 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 96 | GFR creatinine adjusted, Week 96 |
---|
DTG + 3TC-Double Blind Phase | 11.3 | -15.3 |
,DTG + TDF/FTC-Double Blind Phase | 9.3 | -19.0 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 144, n=283,298 | GFR creatinine adjusted, Week 144, n=271, 289 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 13.0 | -16.7 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 12.1 | -19.3 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR-cystatin C adjusted, Week 24, n=338, 336 | GFR-cystatin C adjusted, Week 48, n=324, 332 | GFR-creatinine adjusted, Week 24, n=340, 341 | GFR-creatinine adjusted, Week 48, n=326,335 |
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DTG + 3TC-Double Blind Phase | 4.4 | 7.0 | -13.5 | -12.1 |
,DTG + TDF/FTC-Double Blind Phase | 2.2 | 4.1 | -16.7 | -15.6 |
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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
| Serum Cystatin C, Week 24, n=338, 336 | Serum Cystatin C, Week 48, n=324, 332 | Serum RBP, Week 24, n=332, 334 | Serum RBP, Week 48, n=322, 332 |
---|
DTG + 3TC-Double Blind Phase | -0.05 | -0.07 | 1.6 | 0.5 |
,DTG + TDF/FTC-Double Blind Phase | -0.03 | -0.04 | 1.9 | 0.6 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
| Serum or Plasma Creatinine, Week 24, n=340, 343 | Serum or Plasma Creatinine, Week 48, n=326, 335 |
---|
DTG + 3TC-Double Blind Phase | 11.88 | 10.39 |
,DTG + TDF/FTC-Double Blind Phase | 15.07 | 13.61 |
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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 96 | HDL Cholesterol, Direct, Week 96 | LDL Cholesterol, Week 96, | Triglycerides, Week 96, |
---|
DTG + 3TC-Double Blind Phase | 0.379 | 0.199 | 0.147 | 0.129 |
,DTG + TDF/FTC-Double Blind Phase | -0.104 | 0.090 | -0.154 | -0.112 |
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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 144, | HDL Cholesterol, Direct, Week 144 | LDL Cholesterol, Week 144, | Triglycerides, Week 144 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.367 | 0.181 | 0.170 | 0.117 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.037 | 0.098 | -0.105 | -0.104 |
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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Mean) |
---|
| Week 4, n=349, 348 | Week 24, n=352, 351 | Week 48, n=352, 351 |
---|
DTG + 3TC-Double Blind Phase | 0.0130 | 0.0131 | 0.0134 |
,DTG + TDF/FTC-Double Blind Phase | 0.0078 | 0.0168 | 0.0129 |
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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Mean) |
---|
| Week 4, n=349, 348 | Week 24, n=352, 350 | Week 48, n=352, 350 |
---|
DTG + 3TC-Double Blind Phase | 2.3 | 3.7 | 4.3 |
,DTG + TDF/FTC-Double Blind Phase | 1.2 | 3.2 | 2.8 |
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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 96, n=296, 317 | Serum Osteocalcin, Week 96, n=297, 320 | PINP, Week 96, n=297, 319 | CTX-1, Week 96, n=297, 315 |
---|
DTG + 3TC-Double Blind Phase | 0.30 | 0.40 | 15.0 | 0.1351 |
,DTG + TDF/FTC-Double Blind Phase | 2.37 | 4.57 | 28.3 | 0.2943 |
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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 144, n=281, 295 | Serum Osteocalcin, Week 144, n=281, 299 | PINP, Week 144, n=281,299 | CTX-1, Week 144, n=281, 296 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.25 | 0.29 | 4.6 | 0.0750 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.43 | 3.21 | 13.8 | 0.2164 |
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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 24, n=334, 332 | Bone-ALP, Week 48, n=321, 331 | Serum Osteocalcin, Week 24, n=335, 334 | Serum Osteocalcin, Week 48, n=322, 330 | PINP, Week 24, n=337, 336 | PINP, Week 48, n=321, 334 | CTX-1, Week 24, n=337, 334 | CTX-1, Week 48, n=323, 331 |
---|
DTG + 3TC-Double Blind Phase | 0.91 | 1.21 | 2.56 | 0.78 | 4.5 | 0.5 | 0.1192 | 0.1338 |
,DTG + TDF/FTC-Double Blind Phase | 3.13 | 3.79 | 6.74 | 6.01 | 18.3 | 13.1 | 0.2820 | 0.3352 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
| Serum Vitamin D, Week 24, n=337, 337 | Serum Vitamin D, Week 48, n=322, 333 |
---|
DTG + 3TC-Double Blind Phase | 5.9 | -3.1 |
,DTG + TDF/FTC-Double Blind Phase | 12.4 | 3.1 |
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CD4+ Cell Counts at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. (NCT02831673)
Timeframe: Weeks 24 and 48
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
| Week 24, n=340,341 | Week 48, n=324,334 |
---|
DTG + 3TC Double Blind Phase | 655.3 | 687.7 |
,DTG + TDF/FTC-Double Blind Phase | 632.8 | 675.3 |
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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Days (Median) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 29.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 29.0 |
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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 90 |
DTG + TDF/FTC-Double Blind Phase | 93 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 84 |
DTG + TDF/FTC-Double Blind Phase | 89 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 92 |
DTG + TDF/FTC-Double Blind Phase | 93 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 79 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 83 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 5 |
DTG + TDF/FTC-Double Blind Phase | 4 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 |
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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 18 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 17 |
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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 24, Week 48 and Week 96
Intervention | Participants (Count of Participants) |
---|
| Up to Week 24 | Up to Week 48 | Up to Week 96 |
---|
DTG + 3TC-Double Blind Phase | 6 | 7 | 14 |
,DTG + TDF/FTC-Double Blind Phase | 4 | 8 | 11 |
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Changes From Baseline in CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells per cubic millimeter (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 301.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 303.2 |
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Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC-Double Blind Phase | 1.535 |
DTG + TDF/FTC-Double Blind Phase | 7.704 |
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Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.760 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 8.855 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | 12.75 |
DTG + TDF/FTC-Double Blind Phase | 16.10 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 12.89 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 15.87 |
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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | -0.11 |
DTG + TDF/FTC-Double Blind Phase | -0.09 |
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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.12 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.11 |
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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Ratio (Mean) |
---|
DTG + 3TC-Double Blind Phase | -0.213 |
DTG + TDF/FTC-Double Blind Phase | -0.402 |
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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.229 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.386 |
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Change From Baseline in EQ-5D-5L Utility Score at Week 96
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC-Double Blind Phase | 0.0079 |
DTG + TDF/FTC-Double Blind Phase | 0.0091 |
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Change From Baseline in EQ-5D-5L Utility Score at Week 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.0143 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0.0135 |
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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=240,253 | Baseline plasma HIV-1 RNA,>100000, n=61,67 | Baseline CD4+ cell count,<=200, n=21,26 | Baseline CD4+ cell count,>200, n=280,294 | Age group-1, <35,n= 179,185 | Age group-1, 35 to <50, n=97,95 | Age group-1, >=50, n=25, 40 | Female, n=49,46 | Male, n=252, 274 | Race group, White, n=210,223 | Race group, African Am/African H., n=31,29 | Race group, Asian, n=29,38 | Race group, Other, n=31,30 |
---|
DTG + 3TC-Double Blind Phase | 254.8 | 300.2 | 240.5 | 265.9 | 270.2 | 259.5 | 237.6 | 277.9 | 261.4 | 275.2 | 228.5 | 212.1 | 273.4 |
,DTG + TDF/FTC-Double Blind Phase | 252.9 | 260.1 | 244.4 | 255.1 | 263.0 | 262.0 | 195.9 | 259.1 | 253.5 | 260.0 | 230.2 | 244.8 | 247.3 |
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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5.2 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 3.0 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | -2.2 |
DTG + TDF/FTC-Double Blind Phase | 0.7 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -2.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 2.9 |
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CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 96
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
DTG + 3TC Double Blind Phase | 732.8 |
DTG + TDF/FTC-Double Blind Phase | 711.5 |
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Number of Participants With AEs by Maximum Severity Grades up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Grade 1 AEs | Grade 2 AEs | Grade 3 AEs | Grade 4 AEs | Grade 5 AEs |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 33 | 229 | 37 | 7 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 35 | 242 | 34 | 5 | 0 |
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Number of Participants With Any AE and SAE up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831673)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 307 | 37 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 316 | 38 |
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Number of Participants With HIV-1 Disease Progression up to Week 144
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| No HIV-1 disease progression | From CDC Stage 1 to CDC Stage 3 Event | From CDC Stage 2 to CDC Stage 3 Event | From CDC Stage 3 to New CDC Stage 3 Event | From CDC Stage 1, 2 or 3 to Death |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 352 | 0 | 2 | 1 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 356 | 0 | 2 | 0 | 0 |
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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| ALT, Grades 1 to 4 | ALT, Grades 2 to 4 | ALT, Grades 3 to 4 | ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grades 1 to 4 | Albumin, Grades 2 to 4 | Albumin, Grades 3 to 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grades 1 to 4 | ALP, Grades 2 to 4 | ALP, Grades 3 to 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grades 1 to 4 | AST, Grades 2 to 4 | AST, Grades 3 to 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grades 1 to 4 | Bilirubin, Grades 2 to 4 | Bilirubin, Grades 3 to 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grades 1 to 4 | CO2, Grades 2 to 4 | CO2, Grades 3 to 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grades 1 to 4 | Cholesterol, Grades 2 to 4 | Cholesterol, Grades 3 to 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grades 1 to 4 | CK, Grades 2 to 4 | CK, Grades 3 to 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grades 1 to 4 | Creatinine, Grades 2 to 4 | Creatinine, Grades 3 to 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct Bilirubin, Grades 1 to 4 | Direct Bilirubin, Grades 2 to 4 | Direct Bilirubin, Grades 3 to 4 | Direct Bilirubin, Grade 1 | Direct Bilirubin, Grade 2 | Direct Bilirubin, Grade 3 | Direct Bilirubin, Grade 4 | GFR from creatinine adjusted for BSA Grades 1 to 4 | GFR from creatinine adjusted for BSA Grades 2 to 4 | GFR from creatinine adjusted for BSA Grades 3 to 4 | GFR from creatinine adjusted for BSA, Grade 1 | GFR from creatinine adjusted for BSA, Grade 2 | GFR from creatinine adjusted for BSA Grades 3 | GFR from creatinine adjusted for BSA, Grade 4 | Hypercalcaemia, Grades 1 to 4 | Hypercalcaemia, Grades 2 to 4 | Hypercalcaemia, Grades 3 to 4 | Hypercalcaemia, Grade 1 | Hypercalcaemia, Grade 2 | Hypercalcaemia, Grade 3 | Hypercalcaemia, Grade 4 | Hyperglycemia, Grades 1 to 4 | Hyperglycemia, Grades 2 to 4 | Hyperglycemia, Grades 3 to 4 | Hyperglycemia, Grade 1 | Hyperglycemia, Grade 2 | Hyperglycemia, Grade 3 | Hyperglycemia, Grade 4 | Hyperkalemia, Grades 1 to 4 | Hyperkalemia, Grades 2 to 4 | Hyperkalemia, Grades 3 to 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grades 1 to 4 | Hypernatremia, Grades 2 to 4 | Hypernatremia, Grades 3 to 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcaemia, Grades 1 to 4 | Hypocalcaemia, Grades 2 to 4 | Hypocalcaemia, Grades 3 to 4 | Hypocalcaemia, Grade 1 | Hypocalcaemia, Grade 2 | Hypocalcaemia, Grade 3 | Hypocalcaemia, Grade 4 | Hypoglycemia, Grades 1 to 4 | Hypoglycemia, Grades 2 to 4 | Hypoglycemia, Grades 3 to 4 | Hypoglycemia, Grade 1 | Hypoglycemia, Grade 2 | Hypoglycemia, Grade 3 | Hypoglycemia, Grade 4 | Hypokalemia, Grades 1 to 4 | Hypokalemia, Grades 2 to 4 | Hypokalemia, Grades 3 to 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grades 1 to 4 | Hyponatremia, Grades 2 to 4 | Hyponatremia, Grades 3 to 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL Cholesterol, Grades 1 to 4 | LDL Cholesterol, Grades 2 to 4 | LDL Cholesterol, Grades 3 to 4 | LDL Cholesterol, Grade 1 | LDL Cholesterol, Grade 2 | LDL Cholesterol, Grade 3 | LDL Cholesterol, Grade 4 | Lactate Dehydrogenase, Grades 1 to 4 | Lactate Dehydrogenase, Grades 2 to 4 | Lactate Dehydrogenase, Grades 3 to 4 | Lactate Dehydrogenase, Grade 1 | Lactate Dehydrogenase, Grade 2 | Lactate Dehydrogenase, Grade 3 | Lactate Dehydrogenase, Grade 4 | Lipase, Grades 1 to 4 | Lipase, Grades 2 to 4 | Lipase, Grades 3 to 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grades 1 to 4 | Phosphate, Grades 2 to 4 | Phosphate, Grades 3 to 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grades 1 to 4 | Triglycerides, Grades 2 to 4 | Triglycerides, Grades 3 to 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 55 | 23 | 14 | 32 | 9 | 7 | 7 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 8 | 3 | 0 | 5 | 3 | 0 | 0 | 52 | 27 | 8 | 25 | 19 | 6 | 2 | 42 | 14 | 4 | 28 | 10 | 2 | 2 | 126 | 8 | 0 | 118 | 8 | 0 | 0 | 77 | 24 | 0 | 53 | 24 | 0 | 0 | 76 | 43 | 26 | 33 | 17 | 15 | 11 | 21 | 1 | 0 | 20 | 1 | 0 | 0 | 14 | 14 | 14 | 0 | 0 | 14 | 0 | 185 | 185 | 13 | 0 | 172 | 13 | 0 | 7 | 0 | 0 | 7 | 0 | 0 | 0 | 91 | 38 | 3 | 53 | 35 | 3 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 0 | 14 | 4 | 0 | 10 | 4 | 0 | 0 | 22 | 8 | 2 | 14 | 6 | 1 | 1 | 6 | 0 | 0 | 6 | 0 | 0 | 0 | 25 | 2 | 0 | 23 | 2 | 0 | 0 | 57 | 17 | 5 | 40 | 12 | 5 | 0 | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 65 | 35 | 10 | 30 | 25 | 8 | 2 | 70 | 35 | 2 | 35 | 33 | 2 | 0 | 80 | 12 | 7 | 68 | 5 | 6 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 81 | 25 | 9 | 56 | 16 | 4 | 5 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 10 | 1 | 0 | 9 | 1 | 0 | 0 | 79 | 31 | 13 | 48 | 18 | 9 | 4 | 51 | 17 | 4 | 34 | 13 | 4 | 0 | 116 | 9 | 0 | 107 | 9 | 0 | 0 | 40 | 13 | 1 | 27 | 12 | 1 | 0 | 75 | 52 | 36 | 23 | 16 | 21 | 15 | 31 | 3 | 2 | 28 | 1 | 2 | 0 | 13 | 13 | 13 | 0 | 0 | 13 | 0 | 226 | 226 | 27 | 0 | 199 | 25 | 2 | 4 | 0 | 0 | 4 | 0 | 0 | 0 | 81 | 25 | 2 | 56 | 23 | 2 | 0 | 4 | 1 | 1 | 3 | 0 | 0 | 1 | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 13 | 3 | 1 | 10 | 2 | 1 | 0 | 17 | 3 | 1 | 14 | 2 | 0 | 1 | 7 | 1 | 0 | 6 | 1 | 0 | 0 | 28 | 0 | 0 | 28 | 0 | 0 | 0 | 35 | 14 | 4 | 21 | 10 | 4 | 0 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 80 | 49 | 18 | 31 | 31 | 10 | 8 | 68 | 47 | 6 | 21 | 41 | 6 | 0 | 62 | 14 | 3 | 48 | 11 | 2 | 1 |
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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grades 1 to 4 | Hemoglobin, Grades 2 to 4 | Hemoglobin, Grades 3 to 4 | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grades 1 to 4 | Leukocytes, Grades 2 to 4 | Leukocytes, Grades 3 to 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grades 1 to 4 | Neutrophils, Grades 2 to 4 | Neutrophils, Grades 3 to 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grades 1 to 4 | Platelets, Grades 2 to 4 | Platelets, Grades 3 to 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 9 | 1 | 0 | 8 | 1 | 0 | 0 | 16 | 4 | 0 | 12 | 4 | 0 | 0 | 25 | 19 | 7 | 6 | 12 | 5 | 2 | 14 | 8 | 1 | 6 | 7 | 0 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 7 | 1 | 0 | 6 | 1 | 0 | 0 | 3 | 2 | 0 | 1 | 2 | 0 | 0 | 18 | 11 | 6 | 7 | 5 | 5 | 1 | 11 | 4 | 1 | 7 | 3 | 1 | 0 |
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CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 144
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 767.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 758.2 |
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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC-Double Blind Phase | 4.1 |
DTG + TDF/FTC-Double Blind Phase | 2.4 |
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Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.560 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 3.813 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase | 11.71 |
DTG + TDF/FTC - Double-blind Phase | 14.75 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 12.28 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 15.14 |
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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | mg/L (Mean) |
---|
DTG + 3TC - Double-blind Phase | -0.09 |
DTG + TDF/FTC - Double-blind Phase | -0.08 |
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Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | mg/L (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.11 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.08 |
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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase | -0.113 |
DTG + TDF/FTC - Double-blind Phase | -0.395 |
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Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.245 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.359 |
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Change From Baseline in EQ-5D-5L Utility Score at Week 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.0210 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0.0131 |
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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase | 4.4 |
DTG + TDF/FTC - Double-blind Phase | 5.1 |
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Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 4.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4.5 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase | -1.7 |
DTG + TDF/FTC - Double-blind Phase | 1.3 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.1 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.4 |
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CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 96
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase | 734.9 |
DTG + TDF/FTC - Double-blind Phase | 739.9 |
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CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 144
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 763.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 770.4 |
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Change From Baseline in EQ-5D-5L Utility Score at Week 96
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase | 0.0168 |
DTG + TDF/FTC - Double-blind Phase | 0.0171 |
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Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Days (Median) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 29.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 29.0 |
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Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48
Intervention | Ratio (Geometric Mean) |
---|
| Serum B2M, Week 24, n=344,346 | Serum B2M, Week 48, n=335,336 | Urine B2M, Week 24, n=124,106 | Urine B2M, Week 48, n=109, 103 | Urine Albumin/Creatinine, Week 24, n=259, 251 | Urine Albumin/Creatinine , Week 48, n=249, 240 | Urine B2M/Urine Creatinine , Week 24, n=122, 104 | Urine B2M/Urine Creatinine , Week 48, n=108, 103 | Urine Phosphate, Week 24, n=343, 340 | Urine Phosphate, Week 48, n=335, 332 | Urine Protein/Creatinine, Week 24, n=263,279 | Urine Protein/Creatinine , Week 48, n=259, 261 | Urine RBP 4, Week 24, n=340, 338 | Urine RBP 4, Week 48, n=333, 331 | Urine RBP 4/Urine Creatinine, Week 24, n=338, 335 | Urine RBP 4/Urine Creatinine, Week 48, n=331, 328 |
---|
DTG + 3TC - Double-blind Phase | 0.809 | 0.811 | 0.844 | 0.917 | 0.907 | 0.911 | 0.880 | 0.969 | 1.041 | 1.121 | 0.818 | 0.866 | 0.656 | 0.740 | 0.670 | 0.749 |
,DTG + TDF/FTC - Double-blind Phase | 0.882 | 0.887 | 1.129 | 1.323 | 1.021 | 0.971 | 1.126 | 1.307 | 1.063 | 1.056 | 0.991 | 1.007 | 0.824 | 0.819 | 0.811 | 0.844 |
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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 96, n=239, 243 | Urine B2M/Urine Creatinine, Week 96, n=101, 96 | Urine Phosphate, Week 96, n=316, 322 | Urine Protein/Creatinine, Week 96, n=251, 261 | Urine RBP 4/Urine Creatinine, Week 96, n=314, 318 |
---|
DTG + 3TC - Double-blind Phase | 0.939 | 0.844 | 1.156 | 0.887 | 1.030 |
,DTG + TDF/FTC - Double-blind Phase | 0.997 | 1.259 | 1.069 | 1.016 | 1.287 |
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Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 144, n=230, 221 | Urine B2M/Urine Creatinine, Week 144, n=108, 93 | Urine Phosphate, Week 144, n=301, 301 | Urine Protein/Creatinine, Week 144, n=236, 246 | Urine RBP 4/Urine Creatinine, Week 144, n=294, 289 |
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DTG + 3TC - Double-blind Phase + Open-label Phase | 1.036 | 0.872 | 1.083 | 0.999 | 1.159 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.067 | 1.494 | 1.084 | 1.180 | 1.567 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Weeks 24 and 48
Intervention | Percentage of participants (Number) |
---|
| Week 24, n=313, 320 | Week 48, n=324, 332 |
---|
DTG + 3TC - Double-blind Phase | 4 | 4 |
,DTG + TDF/FTC - Double-blind Phase | 0 | 2 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count Group-1, <=200,n=32,26 | Baseline CD4+ cell count Group-1, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240, 252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
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DTG + 3TC - Double-blind Phase | 78 | 95 | 93 | 94 | 93 | 96 | 94 | 94 | 92 | 95 | 90 | 97 | 89 |
,DTG + TDF/FTC - Double-blind Phase | 92 | 94 | 89 | 95 | 94 | 94 | 91 | 95 | 90 | 95 | 89 | 90 | 93 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=32, 26 | Baseline CD4+ cell count, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240,252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
---|
DTG + 3TC - Double-blind Phase | 72 | 89 | 81 | 89 | 88 | 90 | 83 | 88 | 86 | 92 | 69 | 88 | 89 |
,DTG + TDF/FTC - Double-blind Phase | 85 | 90 | 85 | 90 | 91 | 89 | 88 | 91 | 84 | 91 | 86 | 90 | 83 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count Group-1, <=200,n=32, 26 | Baseline CD4+ cell count Group-1, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209,203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240, 252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
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DTG + 3TC - Double-blind Phase | 78 | 95 | 89 | 94 | 92 | 97 | 89 | 92 | 97 | 96 | 80 | 97 | 86 |
,DTG + TDF/FTC - Double-blind Phase | 96 | 94 | 87 | 95 | 94 | 94 | 94 | 95 | 90 | 96 | 86 | 90 | 90 |
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Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=32, 26 | Baseline CD4+ cell count, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240,252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
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DTG + 3TC - Double-blind Phase + Open-label Phase | 75 | 85 | 78 | 85 | 83 | 86 | 83 | 84 | 86 | 88 | 65 | 85 | 89 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 69 | 86 | 83 | 85 | 83 | 85 | 88 | 85 | 81 | 87 | 74 | 83 | 79 |
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Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Serum or Plasma Cholesterol, Week 24, n=298, 310 | Serum or Plasma Cholesterol, Week 48, n=298, 307 | HDL Cholesterol, Direct, Week 24, n=299, 310 | HDL Cholesterol, Direct, Week 48, n=299, 307 | LDL Cholesterol, Week 24, n=298, 309 | LDL Cholesterol, Week 48, n=297, 307 | Triglycerides,Week 24, n=299, 310 | Triglycerides, Week 48, n=299, 307 |
---|
DTG + 3TC - Double-blind Phase | 5.0 | 9.3 | 13.9 | 15.3 | 3.8 | 10.7 | 7.0 | 7.3 |
,DTG + TDF/FTC - Double-blind Phase | -4.5 | -3.3 | 7.2 | 4.0 | -7.8 | -4.1 | 0.5 | -0.3 |
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Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwarded (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Total/HDL Cholesterol Ratio, Week 24, n=298, 310 | Total/HDL Cholesterol Ratio, Week 48, n=298, 307 |
---|
DTG + 3TC - Double-blind Phase | -4.4 | -2.8 |
,DTG + TDF/FTC - Double-blind Phase | -7.5 | -4.5 |
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Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who met CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI, DTG, Sensitive, n=7,2 | INSTI, DTG, Resistant, n=7,2 | INSTI, EGV, Sensitive, n=7,2 | INSTI, EGV, Resistant, n=7,2 | INSTI, RAL, Sensitive, n=7,2 | INSTI, RAL, Resistant, n=7,2 | NRTI, 3TC, Sensitive, n=7,3 | NRTI, 3TC, Resistant, n=7,3 | NRTI, ABC, Sensitive, n=7,3 | NRTI, ABC, Resistant, n=7,3 | NRTI, AZT, Sensitive, n=7,3 | NRTI, AZT, Resistant, n=7,3 | NRTI, D4T, Sensitive, n=7,3 | NRTI, D4T, Resistant, n=7,3 | NRTI, DDI, Sensitive, n=7,3 | NRTI, DDI, Resistant, n=7,3 | NRTI, FTC, Sensitive, n=7,3 | NRTI, FTC, Resistant, n=7,3 | NRTI, TDF, Sensitive, n=7,3 | NRTI, TDF, Resistant, n=7,3 |
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DTG + 3TC - Double-blind Phase + Open-label Phase | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 2 | 0 | 2 | 0 | 2 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 |
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Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI Mutations | Major mutations of the NRTI |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0 | 0 |
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Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelet count. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grades 1 to 4 | Hemoglobin, Grades 2 to 4 | Hemoglobin, Grades 3 to 4 | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grades 1 to 4 | Leukocytes, Grades 2 to 4 | Leukocytes, Grades 3 to 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grades 1 to 4 | Neutrophils, Grades 2 to 4 | Neutrophils, Grades 3 to 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grades 1 to 4 | Platelets, Grades 2 to 4 | Platelets, Grades 3 to 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 8 | 6 | 2 | 2 | 4 | 1 | 1 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 23 | 8 | 4 | 15 | 4 | 2 | 2 | 13 | 5 | 0 | 8 | 5 | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 10 | 6 | 1 | 4 | 5 | 1 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 7 | 3 | 1 | 4 | 2 | 1 | 0 | 9 | 5 | 0 | 4 | 5 | 0 | 0 |
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Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| ALT, Grades 1 to 4 | ALT, Grades 2 to 4 | ALT, Grades 3 to 4 | ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grades 1 to 4 | Albumin, Grades 2 to 4 | Albumin, Grades 3 to 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grades 1 to 4 | ALP, Grades 2 to 4 | ALP, Grades 3 to 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grades 1 to 4 | AST, Grades 2 to 4 | AST, Grades 3 to 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grades 1 to 4 | Bilirubin, Grades 2 to 4 | Bilirubin, Grades 3 to 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grades 1 to 4 | CO2, Grades 2 to 4 | CO2, Grades 3 to 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grades 1 to 4 | Cholesterol, Grades 2 to 4 | Cholesterol, Grades 3 to 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grades 1 to 4 | CK, Grades 2 to 4 | CK, Grades 3 to 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grades 1 to 4 | Creatinine, Grades 2 to 4 | Creatinine, Grades 3 to 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct Bilirubin, Grades 1 to 4 | Direct Bilirubin, Grades 2 to 4 | Direct Bilirubin, Grades 3 to 4 | Direct Bilirubin, Grade 1 | Direct Bilirubin, Grade 2 | Direct Bilirubin, Grade 3 | Direct Bilirubin, Grade 4 | GFR, Grades 1 to 4 | GFR, Grades 2 to 4 | GFR, Grades 3 to 4 | GFR, Grade 1 | GFR, Grade 2 | GFR, Grade 3 | GFR, Grade 4 | Hypercalcaemia, Grades 1 to 4 | Hypercalcaemia, Grades 2 to 4 | Hypercalcaemia, Grades 3 to 4 | Hypercalcemia, Grade 1 | Hypercalcaemia, Grade 2 | Hypercalcaemia, Grade 3 | Hypercalcaemia, Grade 4 | Hyperglycaemia, Grades 1 to 4 | Hyperglycaemia, Grades 2 to 4 | Hyperglycaemia, Grades 3 to 4 | Hyperglycaemia, Grade 1 | Hyperglycaemia, Grade 2 | Hyperglycaemia, Grade 3 | Hyperglycaemia, Grade 4 | Hyperkalemia, Grades 1 to 4 | Hyperkalemia, Grades 2 to 4 | Hyperkalemia, Grades 3 to 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grades 1 to 4 | Hypernatremia, Grades 2 to 4 | Hypernatremia, Grades 3 to 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcaemia, Grades 1 to 4 | Hypocalcaemia, Grades 2 to 4 | Hypocalcaemia, Grades 3 to 4 | Hypocalcaemia, Grade 1 | Hypocalcaemia, Grade 2 | Hypocalcaemia, Grade 3 | Hypocalcaemia, Grade 4 | Hypoglycaemia, Grades 1 to 4 | Hypoglycaemia, Grades 2 to 4 | Hypoglycaemia, Grades 3 to 4 | Hypoglycaemia, Grade 1 | Hypoglycaemia, Grade 2 | Hypoglycaemia, Grade 3 | Hypoglycaemia, Grade 4 | Hypokalemia, Grades 1 to 4 | Hypokalemia, Grades 2 to 4 | Hypokalemia, Grades 3 to 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grades 1 to 4 | Hyponatremia, Grades 2 to 4 | Hyponatremia, Grades 3 to 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL Cholesterol, Grades 1 to 4 | LDL Cholesterol, Grades 2 to 4 | LDL Cholesterol, Grades 3 to 4 | LDL Cholesterol, Grade 1 | LDL Cholesterol, Grade 2 | LDL Cholesterol, Grade 3 | LDL Cholesterol, Grade 4 | Lactate Dehydrogenase, Grades 1 to 4 | Lactate Dehydrogenase, Grades 2 to 4 | Lactate Dehydrogenase, Grades 3 to 4 | Lactate Dehydrogenase, Grade 1 | Lactate Dehydrogenase, Grade 2 | Lactate Dehydrogenase, Grade 3 | Lactate Dehydrogenase, Grade 4 | Lipase, Grades 1 to 4 | Lipase, Grades 2 to 4 | Lipase, Grades 3 to 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grades 1 to 4 | Phosphate, Grades 2 to 4 | Phosphate, Grades 3 to 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grades 1 to 4 | Triglycerides, Grades 2 to 4 | Triglycerides, Grades 3 to 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 77 | 30 | 13 | 47 | 17 | 6 | 7 | 2 | 2 | 0 | 0 | 2 | 0 | 0 | 10 | 2 | 0 | 8 | 2 | 0 | 0 | 71 | 30 | 15 | 41 | 15 | 8 | 7 | 46 | 13 | 4 | 33 | 9 | 0 | 4 | 111 | 10 | 0 | 101 | 10 | 0 | 0 | 98 | 23 | 1 | 75 | 22 | 1 | 0 | 91 | 49 | 29 | 42 | 20 | 11 | 18 | 18 | 5 | 0 | 13 | 5 | 0 | 0 | 11 | 11 | 11 | 0 | 0 | 11 | 0 | 198 | 198 | 20 | 0 | 178 | 20 | 0 | 4 | 0 | 0 | 4 | 0 | 0 | 0 | 106 | 49 | 3 | 57 | 46 | 2 | 1 | 7 | 2 | 1 | 5 | 1 | 0 | 1 | 4 | 1 | 0 | 3 | 1 | 0 | 0 | 17 | 6 | 1 | 11 | 5 | 1 | 0 | 22 | 6 | 4 | 16 | 2 | 3 | 1 | 9 | 0 | 0 | 9 | 0 | 0 | 0 | 23 | 0 | 0 | 23 | 0 | 0 | 0 | 66 | 21 | 6 | 45 | 15 | 6 | 0 | 4 | 3 | 0 | 1 | 3 | 0 | 0 | 72 | 37 | 9 | 35 | 28 | 6 | 3 | 75 | 50 | 7 | 25 | 43 | 7 | 0 | 89 | 22 | 4 | 67 | 18 | 4 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 71 | 29 | 15 | 42 | 14 | 8 | 7 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 17 | 3 | 1 | 14 | 2 | 1 | 0 | 83 | 32 | 14 | 51 | 18 | 11 | 3 | 56 | 16 | 3 | 40 | 13 | 2 | 1 | 111 | 4 | 0 | 107 | 4 | 0 | 0 | 50 | 12 | 0 | 38 | 12 | 0 | 0 | 83 | 47 | 28 | 36 | 19 | 11 | 17 | 28 | 2 | 1 | 26 | 1 | 1 | 0 | 10 | 10 | 10 | 0 | 0 | 10 | 0 | 219 | 219 | 29 | 0 | 190 | 28 | 1 | 5 | 1 | 1 | 4 | 0 | 0 | 1 | 86 | 38 | 3 | 48 | 35 | 2 | 1 | 7 | 1 | 1 | 6 | 0 | 1 | 0 | 7 | 0 | 0 | 7 | 0 | 0 | 0 | 21 | 11 | 3 | 10 | 8 | 2 | 1 | 21 | 5 | 1 | 16 | 4 | 0 | 1 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 22 | 3 | 1 | 19 | 2 | 0 | 1 | 40 | 13 | 2 | 27 | 11 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 81 | 43 | 17 | 38 | 26 | 13 | 4 | 78 | 51 | 7 | 27 | 44 | 7 | 0 | 75 | 15 | 1 | 60 | 14 | 1 | 0 |
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Number of Participants With HIV-1 Disease Progression up to Week 144
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| No disease progression | From CDC Stage 1 to CDC Stage 3 Event | From CDC Stage 2 to CDC Stage 3 Event | From CDC Stage 3 to New CDC Stage 3 Event | From CDC Stage 1, 2 or 3 to Death |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 356 | 0 | 2 | 1 | 2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 357 | 0 | 1 | 0 | 1 |
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Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol-defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831764)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 306 | 39 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 309 | 47 |
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Number of Participants With AEs by Maximum Severity Grades up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831764)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Grade 1 AEs | Grade 2 AEs | Grade 3 AEs | Grade 4 AEs | Grade 5 AEs |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 54 | 211 | 32 | 7 | 2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 54 | 205 | 43 | 6 | 1 |
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Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Weeks 24, 48 and 96
Intervention | Participants (Count of Participants) |
---|
| Week 24 | Week 48 | Week 96 |
---|
DTG + 3TC - Double-blind Phase | 6 | 8 | 10 |
,DTG + TDF/FTC - Double-blind Phase | 4 | 8 | 12 |
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Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=259,260 | Baseline plasma HIV-1 RNA,>100000, n=59,67 | Baseline CD4+ cell count,<=200, n=25, 23 | Baseline CD4+ cell count,>200, n=293, 304 | Age group-1, <35,n= 186, 187 | Age group-1, 35 to <50, n=101, 110 | Age group-1, >=50, n=31, 30 | Female, n=44, 40 | Male, n=274, 287 | Race group, White, n=221, 234 | Race group, African Am/African H., n=35, 30 | Race group, Asian, n=31, 27 | Race group, Other, n=31, 36 |
---|
DTG + 3TC - Double-blind Phase | 257.9 | 312.1 | 229.4 | 272.3 | 266.0 | 273.6 | 265.8 | 312.7 | 261.4 | 272.1 | 246.3 | 224.0 | 312.0 |
,DTG + TDF/FTC - Double-blind Phase | 257.5 | 297.4 | 202.9 | 269.4 | 257.7 | 286.8 | 233.1 | 307.6 | 259.3 | 258.3 | 303.7 | 264.0 | 278.9 |
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Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Cells/mm^3 (Least Squares Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=273,271 | Baseline plasma HIV-1 RNA,>100000, n=64,69 | Baseline CD4+ cell count,<=200, n=28, 25 | Baseline CD4+ cell count,>200, n=309, 315 | Age group-1, <35,n= 193, 191 | Age group-1, 35 to <50, n=112, 117 | Age group-1, >=50, n=32, 32 | Age group-2, <50,n= 305, 308 | Age group-2, >=50, n= 32, 32 | Female, n=48, 41 | Male, n=289, 299 | Race group, White, n=230, 244 | Race group, African Am/African H., n=42, 31 | Race group, Asian, n=33, 27 | Race group, Other, n=32, 38 |
---|
DTG + 3TC - Double-blind Phase | 215.6 | 261.8 | 210.9 | 225.8 | 234.2 | 212.7 | 209.1 | 226.4 | 208.5 | 236.2 | 222.8 | 225.5 | 201.2 | 204.9 | 270.2 |
,DTG + TDF/FTC - Double-blind Phase | 208.7 | 248.7 | 153.2 | 221.7 | 201.7 | 244.2 | 203.9 | 217.8 | 204.1 | 263.6 | 210.0 | 214.2 | 239.0 | 189.3 | 232.6 |
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Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 24
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=283,273 | Baseline plasma HIV-1 RNA,>100000, n=66,72 | Baseline CD4+ cell count,<=200, n=29, 26 | Baseline CD4+ cell count,>200, n=320, 319 | Age group, <35,n= 201, 193 | Age group-1, 35 to <50, n=113, 119 | Age group-1, >=50, n=35, 33 | Female, n=52, 42 | Male, n=297, 303 | Race group, White, n=236, 243 | Race group, African Am/African H., n=48, 34 | Race group, Asian, n=33, 28 | Race group, Other, n=32, 40 |
---|
DTG + 3TC - Double-blind Phase | 186.01 | 193.90 | 167.95 | 189.91 | 190.12 | 180.50 | 198.74 | 213.58 | 183.41 | 186.48 | 195.18 | 154.03 | 222.21 |
,DTG + TDF/FTC - Double-blind Phase | 148.21 | 220.71 | 106.23 | 167.35 | 151.13 | 190.40 | 133.21 | 153.92 | 164.18 | 167.44 | 151.93 | 141.24 | 160.20 |
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Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48
Intervention | Cells/mm^3 (Least Squares Mean) |
---|
| Week 24, n=349, 345 | Week 48, n=337, 340 |
---|
DTG + 3TC - Double-blind Phase | 188.8 | 225.7 |
,DTG + TDF/FTC - Double-blind Phase | 163.2 | 217.2 |
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Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=241,234 | Baseline plasma HIV-1 RNA,>100000, n=55,58 | Baseline CD4+ cell count,<=200, n=25, 19 | Baseline CD4+ cell count,>200, n=271, 273 | Age group, <35,n=171, 159 | Age group-1, 35 to <50, n=95, 103 | Age group-1, >=50, n=30, 30 | Female, n=40, 37 | Male, n=256, 255 | Race group, White, n=202, 211 | Race group, African Am/African H., n=34, 24 | Race group, Asian, n=29, 25 | Race group, Other, n=31, 32 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 286.8 | 338.2 | 264.8 | 300.3 | 302.9 | 292.8 | 274.1 | 355.0 | 287.7 | 300.0 | 256.4 | 258.5 | 355.0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 277.8 | 354.7 | 208.9 | 297.9 | 277.1 | 329.2 | 250.0 | 381.8 | 279.6 | 296.5 | 377.6 | 245.4 | 240.7 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 96, n=316,326 | GFR creatinine adjusted, Week 96, n=315,325 |
---|
DTG + 3TC - Double-blind Phase | 9.1 | -14.2 |
,DTG + TDF/FTC - Double-blind Phase | 9.5 | -17.5 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 144, n=301,304 | GFR creatinine adjusted, Week 144, n=292,292 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 10.3 | -15.5 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 10.1 | -18.2 |
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Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 24, n=345,345 | GFR Cystatin C adjusted, Week 48, n=335,336 | GFR creatinine adjusted, Week 24, n=346,344 | GFR creatinine adjusted, Week 48, n=335, 337 |
---|
DTG + 3TC - Double-blind Phase | 3.8 | 5.4 | -12.0 | -12.1 |
,DTG + TDF/FTC - Double-blind Phase | 0.2 | 3.6 | -15.4 | -15.4 |
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Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Milligrams per Liter (mg/L) (Least Squares Mean) |
---|
| Serum Cystatin C, Week 24, n=345,345 | Serum Cystatin C, Week 48, n=335,336 | Serum RBP, Week 24, n=345,343 | Serum RBP, Week 48, n=334, 334 |
---|
DTG + 3TC - Double-blind Phase | -0.04 | -0.05 | 1.2 | 0.6 |
,DTG + TDF/FTC - Double-blind Phase | 0.00 | -0.04 | 1.4 | -0.1 |
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Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
| Serum or Plasma Creatinine, Week 24, n=346, 344 | Serum or Plasma Creatinine, Week 48, n=335, 337 |
---|
DTG + 3TC - Double-blind Phase | 10.51 | 10.32 |
,DTG + TDF/FTC - Double-blind Phase | 13.53 | 13.44 |
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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 96, n=270, 289 | HDL Cholesterol, Direct, Week 96, n=271, 289 | LDL Cholesterol, Week 96, n=270, 289 | Triglycerides, Week 96, n=271, 289 |
---|
DTG + 3TC - Double-blind Phase | 0.345 | 0.185 | 0.139 | 0.105 |
,DTG + TDF/FTC - Double-blind Phase | -0.132 | 0.071 | -0.160 | -0.102 |
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Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 144, n=263, 278 | HDL Cholesterol, Direct, Week 144, n=264, 278 | LDL Cholesterol, Week 144, n=263, 278 | Triglycerides, Week 144, n=264, 278 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.360 | 0.180 | 0.143 | 0.078 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.015 | 0.093 | -0.085 | -0.057 |
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Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4, n=358, 355 | Week 24, n=359, 358 | Week 48, n=359, 358 |
---|
DTG + 3TC - Double-blind Phase | 1.8 | 3.9 | 4.0 |
,DTG + TDF/FTC - Double-blind Phase | 3.1 | 4.5 | 4.6 |
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Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4, n=359, 355 | Week 24, n=360, 358 | Week 48, n=360, 358 |
---|
DTG + 3TC - Double-blind Phase | 0.0111 | 0.0207 | 0.0189 |
,DTG + TDF/FTC - Double-blind Phase | 0.0130 | 0.0203 | 0.0208 |
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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 96, n=315, 326 | Serum Osteocalcin, Week 96, n=315, 326 | PINP, Week 96, n=315, 325 | CTX-1, Week 96, n=311, 318 |
---|
DTG + 3TC - Double-blind Phase | 0.26 | 0.13 | 7.0 | 0.0604 |
,DTG + TDF/FTC - Double-blind Phase | 2.39 | 3.90 | 19.5 | 0.1787 |
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Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 144, n=302, 305 | Serum Osteocalcin, Week 144, n=300, 304 | PINP, Week 144, n=299, 300 | CTX-1, Week 144, n=291, 298 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.25 | -1.02 | -0.1 | 0.0505 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.88 | 2.87 | 9.4 | 0.1868 |
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Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 24, n=345, 346 | Bone-ALP, Week 48, n=334, 337 | Serum Osteocalcin, Week 24, n=345, 346 | Serum Osteocalcin, Week 48, n=335, 336 | PINP, Week 24, n=344, 346 | PINP, Week 48, n=335, 337 | CTX-1, Week 24, n=342, 342 | CTX-1, Week 48, n=332, 333 |
---|
DTG + 3TC - Double-blind Phase | 0.72 | 1.24 | 2.13 | 0.40 | 1.7 | 0.4 | 0.1541 | 0.1345 |
,DTG + TDF/FTC - Double-blind Phase | 3.38 | 4.33 | 6.80 | 6.30 | 15.2 | 13.3 | 0.2812 | 0.3388 |
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Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Nanomoles per Liter (nmol/L) (Least Squares Mean) |
---|
| Serum Vitamin D, Week 24, n=346, 344 | Serum Vitamin D, Week 48, n=336, 335 |
---|
DTG + 3TC - Double-blind Phase | 11.2 | 0.3 |
,DTG + TDF/FTC - Double-blind Phase | 15.4 | 0.4 |
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CD4+ Cell Counts at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Weeks 24 and 48
Intervention | Cells/mm^3 (Mean) |
---|
| Week 24, n=349,345 | Week 48, n=337,340 |
---|
DTG + 3TC - Double-blind Phase | 650.4 | 688.1 |
,DTG + TDF/FTC - Double-blind Phase | 633.0 | 689.8 |
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Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 93 |
DTG + TDF/FTC - Double-blind Phase | 94 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 88 |
DTG + TDF/FTC - Double-blind Phase | 90 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 94 |
DTG + TDF/FTC - Double-blind Phase | 94 |
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Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 84 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 84 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 6 |
DTG + TDF/FTC - Double-blind Phase | 2 |
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Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 6 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 |
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Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 13 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 16 |
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Changes From Baseline in CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase | 272.0 |
DTG + TDF/FTC - Double-blind Phase | 264.6 |
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Changes From Baseline in CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 144
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 301.7 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 296.6 |
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Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase | 0.557 |
DTG + TDF/FTC - Double-blind Phase | 2.483 |
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Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
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 |
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Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
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 |
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HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
"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 |
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HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
"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 |
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Percentage of Patients With HBsAg Negativation
Undetectable HВsAg with appearance of HbsAg antibodies or without it. (NCT02888106)
Timeframe: 48 and 72 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 48 HBsAg negativation with appearance of HbsAg antibodies | Week 72 HBsAg negativation with appearance of HbsAg antibodies | Week 48 HBsAg negativation without appearance of HbsAg antibodies | Week 72 HBsAg negativation without appearance of HbsAg antibodies |
---|
Arm A | 0 | 0 | 0 | 0 |
,Arm B | 13.3 | 23.1 | 6.7 | 7.7 |
,Arm C | 0 | 0 | 0 | 0 |
,Arm D | 0 | 0 | 0 | 0 |
,Arm E | 6.7 | 7.1 | 0 | 0 |
,Arm F | 0 | 0 | 0 | 0 |
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Percentage of Patients With HВsAg Response
HВsAg response was defined as HBsAg negativation or > 1 log10 IU/mL decline from baseline. (NCT02888106)
Timeframe: 24, 48 and 72 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 72 |
---|
Arm A | 6.7 | 0 | 0 |
,Arm B | 40.0 | 46.7 | 40.0 |
,Arm C | 13.3 | 20.0 | 13.3 |
,Arm D | 0 | 0 | 0 |
,Arm E | 6.7 | 6.7 | 13.3 |
,Arm F | 6.7 | 0 | 0 |
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Percentage of Patients With Negative HBV DNA by PCR
Percentage of patients with undetectable HBV DNA by PCR at Weeks 24, 48 and 72 (NCT02888106)
Timeframe: 24, 48 and 72 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 72 |
---|
Arm A | 33.3 | 26.7 | 33.3 |
,Arm B | 53.3 | 73.3 | 66.7 |
,Arm C | 40.0 | 40.0 | 40.0 |
,Arm D | 33.3 | 33.3 | 40.0 |
,Arm E | 53.3 | 66.7 | 26.7 |
,Arm F | 80.0 | 93.3 | 46.7 |
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Percentage of Patients With Normalized ALT
Percentage of patients with normalized ALT at Weeks 24, 48 and 72. ALT normalisation was defined as having an ALT value within the normal range (≤31 U/L for females and ≤41 U/L for males) (NCT02888106)
Timeframe: 24, 48 and 72 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 72 |
---|
Arm A | 0 | 26.7 | 10.0 |
,Arm B | 6.7 | 26.7 | 53.8 |
,Arm C | 20.0 | 46.7 | 33.3 |
,Arm D | 64.3 | 73.3 | 23.1 |
,Arm E | 20.0 | 26.7 | 35.7 |
,Arm F | 60.0 | 40.0 | 35.7 |
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The Intensity of Liver Fibrosis Based on Results of Transient Elastometry of Liver at Weeks 48 and 72.
Change in liver stiffness and intensity of liver fibrosis based on results of transient elastometry of liver at weeks 48 and 72. (NCT02888106)
Timeframe: 48 and 72 weeks
Intervention | kPa (Mean) |
---|
| Change from baseline to Week 48 | Change from baseline to Week 72 |
---|
Arm A | -0.67 | -0.67 |
,Arm B | 1.97 | 0.65 |
,Arm C | -0.27 | -2.06 |
,Arm D | -0.66 | 0.00 |
,Arm E | -2.35 | 0.21 |
,Arm F | -1.12 | -1.20 |
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Percentage of Patients With Negative HDV RNA by PCR
Negativation of HDV RNA by PCR (undetectable HDV RNA) at Week 72 (end of follow-up period) (NCT02888106)
Timeframe: 72 weeks
Intervention | Percentage of participants (Number) |
---|
Arm A | 0 |
Arm B | 53.3 |
Arm C | 26.7 |
Arm D | 6.7 |
Arm E | 6.7 |
Arm F | 33.3 |
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Number of Participants With Change (Improvement / Worsening) in Fibrosis and Histological Activity Stage From Baseline to Post-treatment
"Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results from baseline to post-treatment Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis.~Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point.~Data should be interpreted with caution due to low number of paired biopsies available." (NCT02888106)
Timeframe: 72 weeks
Intervention | Participants (Count of Participants) |
---|
| Ishak fibrosis score72521881 | Ishak fibrosis score72521882 | Ishak fibrosis score72521883 | Ishak fibrosis score72521884 | Ishak fibrosis score72521885 | Ishak fibrosis score72521886 | Knodell fibrosis score72521881 | Knodell fibrosis score72521883 | Knodell fibrosis score72521884 | Knodell fibrosis score72521885 | Knodell fibrosis score72521882 | Knodell fibrosis score72521886 | Metavir fibrosis stage72521883 | Metavir fibrosis stage72521884 | Metavir fibrosis stage72521881 | Metavir fibrosis stage72521882 | Metavir fibrosis stage72521885 | Metavir fibrosis stage72521886 | Metavir activity grade72521884 | Metavir activity grade72521885 | Metavir activity grade72521881 | Metavir activity grade72521882 | Metavir activity grade72521883 | Metavir activity grade72521886 | Histological activity index72521884 | Histological activity index72521885 | Histological activity index72521881 | Histological activity index72521882 | Histological activity index72521883 | Histological activity index72521886 |
---|
| Improvement | No change | Worsening |
---|
Arm D | 4 |
Arm D | 2 |
Arm F | 2 |
Arm D | 1 |
Arm D | 3 |
Arm B | 4 |
Arm A | 0 |
Arm B | 0 |
Arm C | 1 |
Arm F | 7 |
Arm B | 1 |
Arm C | 3 |
Arm E | 3 |
Arm F | 3 |
Arm A | 2 |
Arm E | 1 |
Arm F | 4 |
Arm F | 8 |
Arm C | 2 |
Arm F | 5 |
Arm A | 1 |
Arm B | 2 |
Arm F | 1 |
Arm D | 6 |
Arm E | 2 |
Arm F | 9 |
Arm B | 3 |
Arm C | 0 |
Arm D | 0 |
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Change in Molecular Analyses of Relative HDV RNA Expression, Relative HBV Pregenomic Expression, Relative Total HBV RNA Expression (X Region), Relative HBV RNA Expression (S Region).
"Molecular analyses of relative HDV RNA expression, relative HBV pregenomic expression, relative total HBV RNA expression (X region), relative HBV RNA expression (S region) from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks
Intervention | Relative value (Mean) |
---|
| Relative HDV RNA expression | Relative HBV pregenomic expression | Relative total HBV RNA expression (X region) | Relative HBV RNA expression (S region) |
---|
Arm A | -0.062 | -0.028 | 0.080 | -0.688 |
,Arm B | -0.068 | -0.004 | -1.088 | -2.295 |
,Arm C | 0.296 | 0.003 | -1.295 | -1.696 |
,Arm D | -1.220 | -0.001 | -0.282 | -0.451 |
,Arm E | -1.676 | -0.041 | 0.160 | 0.223 |
,Arm F | -0.975 | 0.049 | 0.403 | 0.733 |
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Change in Molecular Analyses of Total HBV DNA (X Region) Copies/Cell, HBV DNA (S Region) Copies/Cell, cccDNA Copies/Cell From Baseline to Post-treatment.
"Molecular analyses of total HBV DNA (X region) copies/cell, HBV DNA (S region) copies/cell, cccDNA copies/cell from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks
Intervention | Copies/cell (Mean) |
---|
| Total HBV DNA (X region) copies/cell | HBV DNA (S region) copies/cell | cccDNA copies/cell |
---|
Arm A | -0.041 | -0.413 | -0.045 |
,Arm B | -0.027 | -0.944 | 0.030 |
,Arm C | -0.132 | -0.747 | 0.004 |
,Arm D | 0.036 | 0.124 | -0.003 |
,Arm E | -0.297 | -1.545 | -0.117 |
,Arm F | 0.087 | 0.196 | 0.058 |
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Change in Molecular Analysis of HDAg Positive Hepatocytes (%) From Baseline to Post-treatment
"Molecular analysis of HDAg positive Hepatocytes (percentage of HDAg positive Hepatocytes) from baseline to post-treatment.~*Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: 48 and 72 weeks
Intervention | Percentage (Mean) |
---|
| Baseline | Change from baseline to post-treatment |
---|
Arm A | 0.757 | 0.099 |
,Arm B | 2.178 | -1.961 |
,Arm C | 1.209 | -1.134 |
,Arm D | 7.550 | -10.334 |
,Arm E | 12.521 | -9.028 |
,Arm F | 3.641 | -3.616 |
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Change in the Gene Expression Analyses From Baseline to Post-treatment
"Change in the gene expression analyses of CXCL10, NTCP, CYP7A1, ISG15, MX1, OAS, HLA-E, TAP1 and USP18 from baseline to post-treatment.~Biopsy post treatment performed at Week 48 for arm D:MXB 2mg and arm F:MXB 5mg bid + Tenofovir, and performed at Week 72 for arms A:PEG-IFN, B:MXB 2mg + PEG-IFN, C:MXB 5mg + PEG-IFN and arm E:MXB 10mg + PEG-IFN." (NCT02888106)
Timeframe: Weeks 48 - 72
Intervention | Relative value (Mean) |
---|
| CXCL10 relative expression | NTCP relative expression | CYP7A1 relative expression | ISG15 relative expression | MX1 relative expression | OAS relative expression | HLA-E relative expression | TAP1 relative expression | USP18 relative expression |
---|
Arm A | -0.017 | 0.001 | 0.002 | 0.207 | 0.175 | 0.067 | 0.038 | 0.000 | 0.021 |
,Arm B | -0.012 | -0.016 | 0.002 | -0.092 | -0.020 | -0.019 | -0.322 | -0.012 | -0.003 |
,Arm C | 0.010 | 0.001 | 0.000 | -0.003 | -0.013 | 0.005 | 0.015 | -0.001 | -0.003 |
,Arm D | -0.034 | 0.002 | 0.001 | -0.037 | -0.034 | -0.015 | -0.386 | -0.017 | -0.005 |
,Arm E | 0.003 | 0.011 | -0.001 | -0.163 | -0.056 | -0.025 | 0.149 | 0.007 | -0.002 |
,Arm F | -0.015 | 0.004 | 0.001 | -0.005 | -0.000 | 0.003 | -0.061 | -0.004 | 0.001 |
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Percentage of Patients With Combined Response
Combined response is defined as negative HDV RNA and ALT normalization at Weeks 24, 48, and 72. The criteria for combined response were HDV RNA value below LLoD (where LLoD=10 IU/ml) and ALT within normal range (≤31 U/L for females and ≤41 U/L for males) (NCT02888106)
Timeframe: 24, 48 and 72 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 48 | Week 72 |
---|
Arm A | 0 | 6.7 | 0 |
,Arm B | 6.7 | 20.0 | 46.7 |
,Arm C | 20.0 | 33.3 | 13.3 |
,Arm D | 13.3 | 13.3 | 6.7 |
,Arm E | 13.3 | 20.0 | 6.7 |
,Arm F | 13.3 | 13.3 | 13.3 |
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Percentage of Patients With Negative HDV RNA by PCR
Percentage of patients with negative HDV RNA by PCR (undetectable HDV RNA) at Weeks 24 and 48 (NCT02888106)
Timeframe: 24 and 48 weeks
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 48 |
---|
Arm A | 6.7 | 13.3 |
,Arm B | 60.0 | 80.0 |
,Arm C | 60.0 | 86.7 |
,Arm D | 13.3 | 13.3 |
,Arm E | 66.7 | 80 |
,Arm F | 26.7 | 46.7 |
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Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02962739)
Timeframe: Assessed weekly for 9 months
Intervention | fmol/punch (Mean) |
---|
DOT 33% | 657 |
DOT 67% | 1451 |
DOT 100% | 2381 |
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Area Under the Concentration-time Curve (AUC)
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 |
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Peak Plasma Concentration (Cmax)
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 |
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Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
"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 |
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Maternal Change in Creatinine Clearance
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 |
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Percentage of Infants Born Small for Gestational Age
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 |
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Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
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 |
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Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
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 |
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Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
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 |
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Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
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 |
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Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
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 |
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Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
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 |
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Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm
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 |
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Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
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 |
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Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
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 |
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Change in Maternal Weight Antepartum
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 |
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Change in Maternal Weight Overall
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 |
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Change in Maternal Weight Postpartum
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 |
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Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
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 |
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Infant Creatinine Clearance
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 |
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Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
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 |
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Percentage of Mother-Infant Pairs With Preterm Deliveries
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 |
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Cumulative Probability of Infant Deaths
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 |
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Cumulative Probability of Infant HIV-infection
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 |
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Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
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 |
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Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
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 |
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Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks
Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 weeks and 28 weeks
Intervention | ng*h/mL (Geometric Mean) |
---|
TDF With a Boosted PI | 3466 |
TAF With a Boosted PI | 743 |
TAF With a Boosted PI and LDV/SOF | 868 |
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Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)
Compare tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 and 28 weeks
Intervention | fmol/2x7mm punches (Geometric Mean) |
---|
TDF With a Boosted PI | 36014 |
TAF With a Boosted PI | 6735 |
TAF With a Boosted PI and LDV/SOF | 6100 |
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Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks
Compare tenofovir-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1). (NCT03126370)
Timeframe: 12 weeks, and 24 weeks and 28 weeks
Intervention | fmol/10^6 cells (Geometric Mean) |
---|
TDF With a Boosted PI | 83.0 |
TAF With a Boosted PI | 926 |
TAF With a Boosted PI and LDV/SOF | 1129 |
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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR
Change in estimated glomerular filtration rate (eGFR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | mL/min/1.73 m^2 (Geometric Mean) |
---|
TDF With a Boosted PI | 86.7 |
TAF With a Boosted PI | 91.0 |
TAF With a Boosted PI and LDV/SOF | 88.1 |
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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR
Change in estimated glomerular filtration rate (eGFR) and renal biomarkers: Urine protein to creatinine ratio (UPCR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | mg/g (Geometric Mean) |
---|
TDF With a Boosted PI | 134 |
TAF With a Boosted PI | 118 |
TAF With a Boosted PI and LDV/SOF | 97.3 |
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Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio
Change in renal biomarkers: urinary beta-2 microglobulin (B2M)/creatinine (Cr) ratio, and urinary retinol binding protein (RBP)/Cr ratio (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | ug/g (Geometric Mean) |
---|
| β2M:Cr ratio | RBP:Cr ratio |
---|
TAF With a Boosted PI | 224 | 242 |
,TAF With a Boosted PI and LDV/SOF | 178 | 146 |
,TDF With a Boosted PI | 419 | 436 |
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Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2
AEs will be summarized using MedDRA System Organ Class and preferred terms. (NCT03164564)
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) |
---|
Arm A: CAB + Placebo TDF/FTC + CAB LA | 1487 |
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1486 |
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Number of Pariicipants With Documented Incident HIV Infections
The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee. (NCT03164564)
Timeframe: HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest.
Intervention | Participants (Count of Participants) |
---|
Arm A: CAB + Placebo TDF/FTC + CAB LA | 4 |
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 36 |
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PBMC TFV-DP AUC GMR
The geometric mean ratio (GMR) of the PBMC TFV-DP area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.
Intervention | fmol*h/10^6cells (Least Squares Mean) |
---|
Treatment Phase | 7.12 |
Control Phase | 7.38 |
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Plasma TFV AUC0-INF GMR
The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.
Intervention | ng*h/mL (Least Squares Mean) |
---|
Treatment Phase | 8.75 |
Control Phase | 8.27 |
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Whole Blood Antiretroviral Concentrations
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 |
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Plasma Antiretroviral Concentrations
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 |
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Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations
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 |
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Hair Antiretroviral Imaging
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 |
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Percentage of Eosinophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: eosinophils. Mean and standard deviation values for percentage of eosinophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36 , 48, 60, 72, 84 and 96
Intervention | Percentage of eosinophils (Mean) |
---|
| Week 36, n=32 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
---|
Tenofovir Disoproxil Fumarate | 2.44 | 2.94 | 2.85 | 3.09 | 2.84 | 2.57 |
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Percentage of Basophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: basophils. Mean and standard deviation values for percentage of basophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96
Intervention | Percentage of basophils (Mean) |
---|
| Week 36, n=32 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
---|
Tenofovir Disoproxil Fumarate | 0.46 | 0.49 | 0.57 | 0.50 | 0.54 | 0.57 |
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Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. (NCT03258710)
Timeframe: Up to Week 96
Intervention | Participants (Count of Participants) |
---|
| Abnormal-not clinically significant | Abnormal-clinically significant |
---|
Tenofovir Disoproxil Fumarate | 20 | 1 |
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Number of Participants With Abnormal Urinalysis Values at Weeks 60, 72, 84 and 96
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported. (NCT03258710)
Timeframe: Weeks 60, 72, 84 and 96
Intervention | Participants (Count of Participants) |
---|
| Amorphous phosphate crystals, Week 60, 1+ | Amorphous phosphate crystals, Week 72, 1+ | Amorphous phosphate crystals, Week 84, 1+ | Amorphous urate crystals, Week 60, 1+ | Amorphous urate crystals, Week 72, 1+ | Amorphous urate crystals, Week 84, 1+ | Amorphous urate crystals, Week 96, 1+ | Bacteria, Week 60, 1+ | Bacteria, Week 72, 1+ | Bacteria, Week 72, 2+ | Bacteria, Week 84, 1+ | Bacteria, Week 84, 2+ | Bacteria, Week 96, 1+ | Bacteria, Week 96, 2+ | Calcium oxalate crystals, Week 60, 1+ | Calcium oxalate crystals, Week 72, 1+ | Calcium oxalate crystals, Week 84, 1+ | Calcium oxalate crystals, Week 96, 1+ | RTEC, Week 60, 0-0.1/Some Field | RTEC, Week 60, 0.2-0.4/Some Field | RTEC, Week 60, 1-2/Every Field | RTEC, Week 72, 0-0.1/Some Field | RTEC, Week 72, 0.2-0.4/Some Field | RTEC, Week 84, 0-0.1/Some Field | RTEC, Week 84, 0.2-0.4/Some Field | RTEC, Week 84, 1-2/Every Field | RTEC, Week 84, 3-5/Every Field | RTEC, Week 96, 0-0.1/Some Field | RTEC, Week 96, 0.2-0.4/Some Field | RTEC, Week 96, 1-2/Every Field | Urine glucose, Week 60, 3+ | Urine glucose, Week 72, 1+ | Urine glucose, Week 72, 2+ | Hyaline casts, Week 60, 0-0.1/Some Field | Hyaline casts, Week 72, 0-0.1/Some Field | Hyaline casts, Week 72, 0.2-0.4/Some Field | Hyaline casts, Week 84, 0-0.1/Some Field | Hyaline casts, Week 84, 1-2/Whole Field | Hyaline casts, Week 84, 3-5/Whole Field | Hyaline casts, Week 96, 0-0.1/Some Field | Hyaline casts, Week 96, 0.2-0.4/Some Field | Hyaline casts, Week 96, 3-5/Whole Field | Mucus threads, Week 60, 1+ | Mucus threads, Week 72, 1+ | Mucus threads, Week 84, 1+ | Mucus threads, Week 96, 1+ | Urine protein, Week 60, 1+ | Urine protein, Week 60, Trace | Urine protein, Week 72, 1+ | Urine protein, Week 72, Trace | Urine protein, Week 84, 1+ | Urine protein, Week 84, Trace | Urine protein, Week 96, 1+ | Urine protein, Week 96, Trace | RBC, Week 60, 0-0.1/Some Field | RBC, Week 60, 0.2-0.4/Some Field | RBC, Week 60, 1-2/Every Field | RBC, Week 60, 3-5/Every Field | RBC, Week 60, 6-10/Every Field | RBC, Week 60, 10-20/Every Field | RBC, Week 60, 30-50/Every Field | RBC, Week 72, 0-0.1/Some Field | RBC, Week 72, 0.2-0.4/Some Field | RBC, Week 72, 1-2/Every Field | RBC, Week 72, 3-5/Every Field | RBC, Week 72, 30-50/Every Field | RBC, Week 84, many/Every Field | RBC, Week 84, 0-0.1/Some Field | RBC, Week 84, 0.2-0.4/Some Field | RBC, Week 84, 1-2/Every Field | RBC, Week 84, 3-5/Every Field | RBC, Week 84, 6-10/Every Field | RBC, Week 84, 20-30/Every Field | RBC, Week 84, 30-50/Every Field | RBC, Week 96, many/Every Field | RBC, Week 96, 0-0.1/Some Field | RBC, Week 96, 0.2-0.4/Some Field | RBC, Week 96, 1-2/Every Field | RBC, Week 96, 3-5/Every Field | RBC, Week 96, 10-20/Every Field | Spermatozoa, Week 84, 1+ | SEC, Week 60, 0-0.1/Some Field | SEC, Week 60, 0.2-0.4/Some Field | SEC, Week 60, 1-2/Every Field | SEC, Week 60, 3-5/Every Field | SEC, Week 60, 10-20/Every Field | SEC, Week 60, 20-30/Every Field | SEC, Week 72, 0-0.1/Some Field | SEC, Week 72, 0.2-0.4/Some Field | SEC, Week 72, 1-2/Every Field | SEC, Week 72, 3-5/Every Field | SEC, Week 72, 6-10/Every Field | SEC, Week 72, 10-20/Every Field | SEC, Week 72, 20-30/Every Field | SEC, Week 84, many/Every Field | SEC, Week 84, 0-0.1/Some Field | SEC, Week 84, 0.2-0.4/Some Field | SEC, Week 84, 1-2/Every Field | SEC, Week 84, 3-5/Every Field | SEC, Week 84, 6-10/Every Field | SEC, Week 96, 0-0.1/Some Field | SEC, Week 96, 0.2-0.4/Some Field | SEC, Week 96, 1-2/Every Field | SEC, Week 96, 3-5/Every Field | SEC, Week 96, 6-10/Every Field | SEC, Week 96, 10-20/Every Field | TEC, Week 60, 0-0.1/Some Field | TEC, Week 60, 0.2-0.4/Some Field | TEC, Week 72, 0-0.1/Some Field | TEC, Week 84, 0-0.1/Some Field | TEC, Week 96, 0-0.1/Some Field | UAC, Week 60, 1+ | UAC, Week 72, 1+ | UAC, Week 96, 1+ | WBC, Week 60, 0-0.1/Some Field | WBC, Week 60, 0.2-0.4/Some Field | WBC, Week 60, 1-2/Every Field | WBC, Week 60, 3-5/Every Field | WBC, Week 60, 6-10/Every Field | WBC, Week 60, 10-20/Every Field | WBC, Week 72, 0-0.1/Some Field | WBC, Week 72, 0.2-0.4/Some Field | WBC, Week 72, 1-2/Every Field | WBC, Week 72, 3-5/Every Field | WBC, Week 72, 6-10/Every Field | WBC, Week 72, 30-50/Every Field | WBC, Week 84, many/Every Field | WBC, Week 84, 0-0.1/Some Field | WBC, Week 84, 0.2-0.4/Some Field | WBC, Week 84, 1-2/Every Field | WBC, Week 84, 10-20/Every Field | WBC, Week 84, 20-30/Every Field | WBC, Week 84, 30-50/Every Field | WBC, Week 96, 0-0.1/Some Field | WBC, Week 96, 0.2-0.4/Some Field | WBC, Week 96, 1-2/Every Field | WBC, Week 96, 6-10/Every Field | WBC, Week 96, 20-30/Every Field |
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Tenofovir Disoproxil Fumarate | 2 | 2 | 2 | 3 | 2 | 8 | 3 | 15 | 7 | 3 | 9 | 2 | 9 | 1 | 14 | 12 | 16 | 4 | 19 | 7 | 1 | 14 | 5 | 9 | 4 | 2 | 1 | 15 | 2 | 1 | 1 | 1 | 1 | 4 | 4 | 1 | 2 | 1 | 1 | 2 | 1 | 3 | 27 | 15 | 18 | 19 | 1 | 11 | 2 | 14 | 2 | 17 | 3 | 11 | 35 | 17 | 12 | 5 | 1 | 2 | 1 | 45 | 11 | 12 | 3 | 2 | 1 | 40 | 9 | 15 | 3 | 2 | 1 | 1 | 1 | 44 | 11 | 11 | 4 | 1 | 1 | 52 | 7 | 9 | 2 | 2 | 1 | 55 | 6 | 5 | 1 | 2 | 1 | 3 | 1 | 52 | 8 | 5 | 4 | 2 | 56 | 4 | 8 | 1 | 2 | 1 | 3 | 1 | 7 | 3 | 5 | 1 | 1 | 2 | 38 | 19 | 12 | 2 | 1 | 1 | 39 | 19 | 7 | 2 | 5 | 1 | 2 | 47 | 12 | 6 | 3 | 1 | 1 | 41 | 18 | 8 | 4 | 1 |
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Absolute Values for Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Grams per liter (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 148.2 | 148.9 | 148.4 | 146.3 | 144.1 | 146.5 | 147.1 | 146.4 | 144.6 | 146.4 |
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Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline (Day 1), n=75 | SBP, Week 4, n=75 | SBP, Week 12, n=74 | SBP, Week 24, n=74 | SBP, Week 36, n=73 | SBP, Week 48, n=73 | SBP, Week 60, n=73 | SBP, Week 72, n=73 | SBP, Week 84, n=72 | SBP, Week 96, n=72 | DBP, Baseline (Day 1), n=75 | DBP, Week 4, n=75 | DBP, Week 12, n=74 | DBP, Week 24, n=74 | DBP, Week 36, n=73 | DBP, Week 48, n=73 | DBP, Week 60, n=73 | DBP, Week 72, n=73 | DBP, Week 84, n=72 | DBP, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 122.5 | 122.9 | 124.9 | 121.9 | 121.5 | 122.5 | 124.7 | 124.2 | 122.1 | 120.8 | 76.0 | 75.2 | 78.1 | 75.6 | 75.3 | 77.8 | 78.0 | 77.5 | 76.3 | 76.1 |
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Absolute Values for Hematology Parameter: Prothrombin Time
Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Seconds (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 11.82 | 11.91 | 11.95 | 11.76 | 11.94 | 12.71 | 12.32 | 12.40 | 12.58 | 12.78 |
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Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Trillion cells per liter (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 4.785 | 4.841 | 4.865 | 4.820 | 4.704 | 4.780 | 4.819 | 4.793 | 4.757 | 4.777 |
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Absolute Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 0.4393 | 0.4441 | 0.4452 | 0.4367 | 0.4283 | 0.4350 | 0.4398 | 0.4391 | 0.4339 | 0.4355 |
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Absolute Values for Heart Rate
Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Beats per minute (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 74.7 | 75.8 | 76.0 | 74.8 | 74.3 | 75.3 | 75.8 | 74.9 | 75.5 | 73.1 |
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Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Micromoles per liter (Mean) |
---|
| Direct bilirubin, Baseline (Day 1), n=75 | Direct bilirubin, Week 4, n=75 | Direct bilirubin, Week 12, n=74 | Direct bilirubin, Week 24, n=74 | Direct bilirubin, Week 36, n=73 | Direct bilirubin, Week 48, n=73 | Direct bilirubin, Week 60, n=73 | Direct bilirubin, Week 72, n=73 | Direct bilirubin, Week 84, n=72 | Direct bilirubin, Week 96, n=72 | Total bilirubin, Baseline (Day 1), n=75 | Total bilirubin, Week 4, n=75 | Total bilirubin, Week 12, n=74 | Total bilirubin, Week 24, n=74 | Total bilirubin, Week 36, n=73 | Total bilirubin, Week 48, n=73 | Total bilirubin, Week 60, n=73 | Total bilirubin, Week 72, n=73 | Total bilirubin, Week 84, n=72 | Total bilirubin, Week 96, n=72 | Creatinine, Baseline (Day 1), n=75 | Creatinine, Week 4, n=75 | Creatinine, Week 12, n=74 | Creatinine, Week 24, n=74 | Creatinine, Week 36, n=73 | Creatinine, Week 48, n=73 | Creatinine, Week 60, n=73 | Creatinine, Week 72, n=73 | Creatinine, Week 84, n=72 | Creatinine, Week 96, n=72 | Uric acid, Baseline (Day 1), n=75 | Uric acid, Week 4, n=75 | Uric acid, Week 12, n=74 | Uric acid, Week 24, n=74 | Uric acid, Week 36, n=73 | Uric acid, Week 48, n=73 | Uric acid, Week 60, n=73 | Uric acid, Week 72, n=73 | Uric acid, Week 84, n=72 | Uric acid, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 3.899 | 3.944 | 3.928 | 4.021 | 3.959 | 4.029 | 3.607 | 3.959 | 3.919 | 4.418 | 10.693 | 10.009 | 9.890 | 10.584 | 10.518 | 10.635 | 9.557 | 10.237 | 10.284 | 11.329 | 62.9997 | 64.1666 | 65.8102 | 65.2965 | 65.9852 | 65.9125 | 65.3191 | 65.4887 | 66.5578 | 67.3436 | 333.0880 | 322.9367 | 323.3622 | 321.3528 | 320.9476 | 320.8661 | 309.3775 | 318.0958 | 318.0528 | 328.0487 |
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Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)
Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Millimoles per liter (Mean) |
---|
| Calcium, Baseline (Day 1), n=75 | Calcium, Week 4, n=75 | Calcium, Week 12, n=74 | Calcium, Week 24, n=74 | Calcium, Week 36, n=73 | Calcium, Week 48, n=73 | Calcium, Week 60, n=73 | Calcium, Week 72, n=73 | Calcium, Week 84, n=72 | Calcium, Week 96, n=72 | Chloride, Baseline (Day 1), n=75 | Chloride, Week 4, n=75 | Chloride, Week 12, n=74 | Chloride, Week 24, n=74 | Chloride, Week 36, n=73 | Chloride, Week 48, n=73 | Chloride, Week 60, n=73 | Chloride, Week 72, n=73 | Chloride, Week 84, n=72 | Chloride, Week 96, n=72 | Glucose, Baseline (Day 1), n=75 | Glucose, Week 4, n=75 | Glucose, Week 12, n=74 | Glucose, Week 24, n=74 | Glucose, Week 36, n=73 | Glucose, Week 48, n=73 | Glucose, Week 60, n=73 | Glucose, Week 72, n=73 | Glucose, Week 84, n=72 | Glucose, Week 96, n=72 | Potassium, Baseline (Day 1), n=75 | Potassium, Week 4, n=75 | Potassium, Week 12, n=74 | Potassium, Week 24, n=74 | Potassium, Week 36, n=73 | Potassium, Week 48, n=73 | Potassium, Week 60, n=73 | Potassium, Week 72, n=73 | Potassium, Week 84, n=72 | Potassium, Week 96, n=72 | Lactic acid, Baseline (Day 1), n=75 | Lactic acid, Week 4, n=75 | Lactic acid, Week 12, n=74 | Lactic acid, Week 24, n=74 | Lactic acid, Week 36, n=73 | Lactic acid, Week 48, n=73 | Lactic acid, Week 60, n=73 | Lactic acid, Week 72, n=73 | Lactic acid, Week 84, n=72 | Lactic acid, Week 96, n=72 | Sodium, Baseline (Day 1), n=75 | Sodium, Week 4, n=75 | Sodium, Week 12, n=74 | Sodium, Week 24, n=74 | Sodium, Week 36, n=73 | Sodium, Week 48, n=73 | Sodium, Week 60, n=73 | Sodium, Week 72, n=73 | Sodium, Week 84, n=72 | Sodium, Week 96, n=72 | Phosphorus inorganic, Baseline (Day 1), n=75 | Phosphorus inorganic, Week 4, n=75 | Phosphorus inorganic, Week 12, n=74 | Phosphorus inorganic, Week 24, n=74 | Phosphorus inorganic, Week 36, n=73 | Phosphorus inorganic, Week 48, n=73 | Phosphorus inorganic, Week 60, n=73 | Phosphorus inorganic, Week 72, n=73 | Phosphorus inorganic, Week 84, n=72 | Phosphorus inorganic, Week 96, n=72 | BUN, Baseline (Day 1), n=75 | BUN, Week 4, n=75 | BUN, Week 12, n=74 | BUN, Week 24, n=74 | BUN, Week 36, n=73 | BUN, Week 48, n=73 | BUN, Week 60, n=73 | BUN, Week 72, n=73 | BUN, Week 84, n=72 | BUN, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 2.290743 | 2.272446 | 2.265393 | 2.251232 | 2.257121 | 2.297792 | 2.316932 | 2.297451 | 2.289856 | 2.306489 | 103.5 | 103.3 | 103.5 | 103.9 | 104.0 | 103.6 | 103.6 | 104.1 | 104.9 | 104.3 | 5.832251 | 5.704208 | 5.590757 | 5.652268 | 5.582937 | 5.709165 | 5.887862 | 5.801175 | 5.938799 | 5.544061 | 4.07 | 4.07 | 4.04 | 4.03 | 4.02 | 4.05 | 4.09 | 4.10 | 4.03 | 4.05 | 1.10467 | 1.02342 | 1.07535 | 1.04970 | 1.06089 | 1.02865 | 1.15182 | 1.06332 | 1.12526 | 0.93703 | 141.6 | 141.9 | 142.3 | 142.2 | 142.0 | 142.0 | 142.2 | 142.0 | 142.0 | 141.3 | 1.072028 | 1.031558 | 1.061206 | 1.052479 | 1.061589 | 1.073090 | 1.071320 | 1.082378 | 1.070952 | 1.095169 | 4.89518 | 4.80712 | 4.86581 | 4.96519 | 4.86449 | 4.71289 | 4.84884 | 4.86889 | 4.70000 | 4.65389 |
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Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase
Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Units per liter (Mean) |
---|
| Amylase, Baseline (Day 1), n=75 | Amylase, Week 4, n=75 | Amylase, Week 12, n=74 | Amylase, Week 24, n=74 | Amylase, Week 36, n=73 | Amylase, Week 48, n=73 | Amylase, Week 60, n=73 | Amylase, Week 72, n=73 | Amylase, Week 84, n=72 | Amylase, Week 96, n=72 | Lipase, Baseline (Day 1), n=75 | Lipase, Week 4, n=75 | Lipase, Week 12, n=74 | Lipase, Week 24, n=74 | Lipase, Week 36, n=73 | Lipase, Week 48, n=73 | Lipase, Week 60, n=73 | Lipase, Week 72, n=73 | Lipase, Week 84, n=72 | Lipase, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 87.3 | 89.5 | 88.2 | 83.7 | 82.3 | 84.9 | 92.2 | 88.8 | 84.4 | 86.7 | 40.0 | 41.9 | 39.1 | 36.0 | 36.9 | 36.2 | 39.1 | 37.1 | 33.5 | 34.2 |
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Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as number of participants with HBeAg/Ab Seroconversion divided by number of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96
Intervention | Percentage of Participants (Number) |
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| Week 24 | Week 48 | Week 96 |
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Tenofovir Disoproxil Fumarate | 8 | 13 | 25 |
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Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH)
Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | International units per liter (Mean) |
---|
| ALP, Baseline (Day 1), n=75 | ALP, Week 4, n=75 | ALP, Week 12, n=74 | ALP, Week 24, n=74 | ALP, Week 36, n=73 | ALP, Week 48, n=73 | ALP, Week 60, n=73 | ALP, Week 72, n=73 | ALP, Week 84, n=72 | ALP, Week 96, n=72 | ALT, Baseline (Day 1), n=75 | ALT, Week 4, n=75 | ALT, Week 12, n=74 | ALT, Week 24, n=74 | ALT, Week 36, n=73 | ALT, Week 48, n=73 | ALT, Week 60, n=73 | ALT, Week 72, n=73 | ALT, Week 84, n=72 | ALT, Week 96, n=72 | AST, Baseline (Day 1), n=75 | AST, Week 4, n=75 | AST, Week 12, n=74 | AST, Week 24, n=74 | AST, Week 36, n=73 | AST, Week 48, n=73 | AST, Week 60, n=73 | AST, Week 72, n=73 | AST, Week 84, n=72 | AST, Week 96, n=72 | CPK, Baseline (Day 1), n=75 | CPK, Week 4, n=75 | CPK, Week 12, n=74 | CPK, Week 24, n=74 | CPK, Week 36, n=73 | CPK, Week 48, n=73 | CKP, Week 60, n=73 | CKP, Week 72, n=73 | CKP, Week 84, n=72 | CKP, Week 96, n=72 | GGT, Baseline (Day 1), n=75 | GGT, Week 4, n=75 | GGT, Week 12, n=74 | GGT, Week 24, n=74 | GGT, Week 36, n=73 | GGT, Week 48, n=73 | GGT, Week 60, n=73 | GGT, Week 72, n=73 | GGT, Week 84, n=72 | GGT, Week 96, n=72 | LDH, Baseline (Day 1), n=75 | LDH, Week 4, n=75 | LDH, Week 12, n=74 | LDH, Week 24, n=74 | LDH, Week 36, n=73 | LDH, Week 48, n=73 | LDH, Week 60, n=73 | LDH, Week 72, n=73 | LDH, Week 84, n=72 | LDH, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 210.4 | 227.6 | 243.1 | 242.1 | 245.3 | 249.4 | 253.1 | 249.2 | 237.6 | 237.7 | 23.5 | 28.3 | 27.9 | 27.5 | 25.9 | 27.0 | 26.6 | 24.2 | 26.3 | 26.4 | 22.7 | 26.1 | 25.8 | 25.5 | 24.6 | 25.7 | 25.1 | 24.1 | 25.0 | 24.9 | 138.9 | 151.0 | 144.5 | 127.9 | 131.9 | 148.7 | 134.1 | 143.3 | 127.4 | 132.3 | 30.9 | 31.6 | 31.5 | 30.4 | 27.6 | 27.8 | 28.2 | 25.6 | 27.4 | 27.8 | 165.2 | 173.9 | 171.0 | 169.4 | 170.3 | 175.3 | 174.4 | 174.6 | 172.7 | 173.2 |
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Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein
Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Grams per liter (Mean) |
---|
| Albumin, Baseline (Day 1), n=75 | Albumin, Week 4, n=75 | Albumin, Week 12, n=74 | Albumin, Week 24, n=74 | Albumin, Week 36, n=73 | Albumin, Week 48, n=73 | Albumin, Week 60, n=73 | Albumin, Week 72, n=73 | Albumin, Week 84, n=72 | Albumin, Week 96, n=72 | Total protein, Baseline (Day 1) n=75 | Total protein, Week 4, n=75 | Total protein, Week 12, n=74 | Total protein, Week 24, n=74 | Total protein, Week 36, n=73 | Total protein, Week 48, n=73 | Total protein, Week 60, n=73 | Total protein, Week 72, n=73 | Total protein, Week 84, n=72 | Total protein, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 44.7 | 44.9 | 45.2 | 44.5 | 44.2 | 44.8 | 45.1 | 44.9 | 44.6 | 45.4 | 72.4 | 72.6 | 73.1 | 72.0 | 71.7 | 72.6 | 72.8 | 72.4 | 72.4 | 73.0 |
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Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)
Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Milliliters per second per 1.73*meter^2 (Mean) |
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| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 1.46981 | 1.43825 | 1.39282 | 1.40228 | 1.37971 | 1.38564 | 1.39501 | 1.38998 | 1.36299 | 1.34355 |
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Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance
Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 114.06 | 112.50 | 108.76 | 108.86 | 105.23 | 105.50 | 107.51 | 106.73 | 104.00 | 101.47 |
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Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)
Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Micrograms per liter (Mean) |
---|
| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 3.13 | 3.39 | 3.46 | 3.50 | 3.48 | 3.55 | 3.50 | 3.27 | 3.10 | 3.18 |
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Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count
Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Giga cells per liter (Mean) |
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| Platelet count, Baseline (Day 1), n=75 | Platelet count, Week 4, n=75 | Platelet count, Week 12, n=74 | Platelet count, Week 24, n=74 | Platelet count, Week 36, n=73 | Platelet count, Week 48, n=73 | Platelet count, Week 60, n=73 | Platelet count, Week 72, n=73 | Platelet count, Week 84, n=72 | Platelet count, Week 96, n=72 | WBC count, Baseline (Day 1), n=75 | WBC count, Week 4, n=75 | WBC count, Week 12, n=74 | WBC count, Week 24, n=74 | WBC count, Week 36, n=73 | WBC count, Week 48, n=73 | WBC count, Week 60, n=73 | WBC count, Week 72, n=73 | WBC count, Week 84, n=72 | WBC count, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 226.7 | 227.1 | 228.9 | 226.1 | 231.4 | 229.9 | 231.8 | 224.9 | 224.8 | 226.6 | 5.18 | 5.21 | 5.30 | 5.06 | 4.99 | 5.16 | 4.84 | 5.00 | 5.00 | 5.08 |
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Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Weeks 24 and 96
Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Weeks 24 and 96. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responders have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 96 |
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Tenofovir Disoproxil Fumarate | 1 | 12 |
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Absolute Values for Temperature
Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | degrees Celsius (Mean) |
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| Baseline (Day 1), n=75 | Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 36.41 | 36.43 | 36.40 | 36.43 | 36.45 | 36.41 | 36.43 | 36.42 | 36.46 | 36.40 |
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Change From Baseline Log Values for HBcrAg Titer at Weeks 24, 48 and 96
Blood samples were collected to evaluate the HBcrAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96
Intervention | Log Kilounits per Liter (Mean) |
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| Week 24, n=74 | Week 48, n=73 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | -0.12 | -0.17 | -0.30 |
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Change From Baseline Log Values for HBsAg Titer at Weeks 24, 48 and 96
Blood samples were collected to evaluate the HBsAg titer at Weeks 24, 48 and 96. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 24, 48 and 96
Intervention | Log Kilo International Units per Liter (Mean) |
---|
| Week 24, n=74 | Week 48, n=73 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | -0.049 | -0.114 | -0.139 |
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Change From Baseline Values for Beta-2-microglobulin
Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Micrograms per liter (Mean) |
---|
| Week 4, n=75 | Week 12, n=74 | Week 24, n=74 | Week 36, n=73 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 206.9 | 254.6 | 392.7 | 261.1 | 206.8 | 309.4 | 235.7 | 271.3 | 196.1 |
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Change From Baseline Values for Bone Density
Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day -1) and at Weeks 24, 48, 72 and 96
Intervention | Grams per centimeter^2 (Mean) |
---|
| Femur, Week 48, n=4 | Femur, Week 96, n=22 | Lumbar vertebra, Week 24, n=1 | Lumbar vertebra, Week 48, n=6 | Lumbar vertebra, Week 72, n=1 | Lumbar vertebra, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | -0.0125 | -0.0205 | 0.0100 | -0.0100 | -0.0620 | -0.0193 |
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Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate
Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96
Intervention | Milligrams per deciliter (Mean) |
---|
| Urine Creatinine, Week 4, n=75 | Urine Creatinine, Week 12, n=74 | Urine Creatinine, Week 24, n=74 | Urine Creatinine, Week 36, n=73 | Urine Creatinine, Week 48, n=73 | Urine Creatinine, Week 60, n=73 | Urine Creatinine, Week 72, n=73 | Urine Creatinine, Week 84, n=72 | Urine Creatinine, Week 96, n=72 | Urine phosphate, Week 4, n=75 | Urine phosphate, Week 12, n=74 | Urine phosphate, Week 24, n=74 | Urine phosphate, Week 36, n=73 | Urine phosphate, Week 48, n=73 | Urine phosphate, Week 60, n=73 | Urine phosphate, Week 72, n=73 | Urine phosphate, Week 84, n=72 | Urine phosphate, Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | -5.353 | 2.047 | 11.715 | 15.849 | 4.674 | 5.567 | -1.378 | 19.337 | 10.346 | -3.87 | -2.08 | 2.46 | 0.85 | 0.68 | -0.09 | 0.85 | 5.21 | -0.72 |
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Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment. (NCT03258710)
Timeframe: Up to Week 96
Intervention | Participants (Count of Participants) |
---|
| Any SAE | Any non-SAE |
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Tenofovir Disoproxil Fumarate | 2 | 36 |
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Number of Participants With Abnormal Urinalysis Values at Weeks 4, 12, 24, 36 and 48
Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample. Results for RTEC, hyaline casts, RBC, SEC, TEC and WBC can be read as counts per field (some/ every/ whole field). Only abnormal parameters and participants with abnormal data has been reported. (NCT03258710)
Timeframe: Weeks 4, 12, 24, 36 and 48
Intervention | Participants (Count of Participants) |
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| Amorphous phosphate crystals, Week 4, 1+ | Amorphous phosphate crystals, Week 12, 1+ | Amorphous phosphate crystals, Week 24, 1+ | Amorphous phosphate crystals, Week 36, 1+ | Amorphous phosphate crystals, Week 48, 1+ | Amorphous urate crystals, Week 4, 1+ | Amorphous urate crystals, Week 12, 1+ | Amorphous urate crystals, Week 24, 1+ | Amorphous urate crystals, Week 36, 1+ | Amorphous urate crystals, Week 48, 1+ | Bacteria, Week 4, 1+ | Bacteria, Week 12, 1+ | Bacteria, Week 24, 1+ | Bacteria, Week 24, 2+ | Bacteria, Week 36, 1+ | Bacteria, Week 48, 1+ | Bacteria, Week 48, 2+ | Calcium oxalate crystals, Week 4, 1+ | Calcium oxalate crystals, Week 12, 1+ | Calcium oxalate crystals, Week 24, 1+ | Calcium oxalate crystals, Week 36, 1+ | Calcium oxalate crystals, Week 48, 1+ | RTEC, Week 4, 0-0.1/Some Field | RTEC, Week 4, 0.2-0.4/Some Field | RTEC, Week 4, 1-2/Every Field | RTEC, Week 12, 0-0.1/Some Field | RTEC, Week 12, 0.2-0.4/Some Field | RTEC, Week 24, 0-0.1/Some Field | RTEC, Week 24, 0.2-0.4/Some Field | RTEC, Week 24, 1-2/Every Field | RTEC, Week 36, 0-0.1/Some Field | RTEC, Week 36, 0.2-0.4/Some Field | RTEC, Week 36, 1-2/Every Field | RTEC, Week 48, 0-0.1/Some Field | RTEC, Week 48, 0.2-0.4/Some Field | RTEC, Week 48, 1-2/Every Field | Fungi, Week 4, 1+ | Fungi, Week 12, 1+ | Fungi, Week 24, 1+ | Fungi, Week 36, 1+ | Fungi, Week 48, 1+ | Urine glucose, Week 4, 1+ | Urine glucose, Week 4, Trace | Urine glucose, Week 12, 2+ | Urine glucose, Week 12, Trace | Urine glucose, Week 24, 3+ | Urine glucose, Week 36, Trace | Urine glucose, Week 48, 1+ | Urine glucose, Week 48, 3+ | Urine glucose, Week 48, Trace | Hyaline casts, Week 4, 0-0.1/Some Field | Hyaline casts, Week 12, 0-0.1/Some Field | Hyaline casts, Week 12, 3-5/Whole Field | Hyaline casts, Week 24, 0-0.1/Some Field | Hyaline casts, Week 24, 1-2/Whole Field | Hyaline casts, Week 24, 3-5/Whole Field | Hyaline casts, Week 36, 0-0.1/Some Field | Hyaline casts, Week 36, 0.2-0.4/Some Field | Hyaline casts, Week 36, 1-2/Every Field | Hyaline casts, Week 36, 1-2/Whole Field | Hyaline casts, Week 48, 0-0.1/Some Field | Hyaline casts, Week 48, 0.2-0.4/Some Field | Mucus threads, Week 4, 1+ | Mucus threads, Week 12, 1+ | Mucus threads, Week 24, 1+ | Mucus threads, Week 36, 1+ | Mucus threads, Week 48, 1+ | Urine protein, Week 4, 1+ | Urine protein, Week 4, 2+ | Urine protein, Week 4, Trace | Urine protein, Week 12, 1+ | Urine protein, Week 12, Trace | Urine protein, Week 24, 1+ | Urine protein, Week 24, 2+ | Urine protein, Week 24, Trace | Urine protein, Week 36, 1+ | Urine protein, Week 36, 2+ | Urine protein, Week 36, Trace | Urine protein, Week 48, Trace | RBC, Week 4, 0-0.1/Some Field | RBC, Week 4, 0.2-0.4/Some Field | RBC, Week 4, 1-2/Every Field | RBC, Week 4, 3-5/Every Field | RBC, Week 4, 6-10/Every Field | RBC, Week 12, numerous/Every Field | RBC, Week 12, 0-0.1/Some Field | RBC, Week 12, 0.2-0.4/Some Field | RBC, Week 12, 1-2/Every Field | RBC, Week 12, 3-5/Every Field | RBC, Week 12, 6-10/Every Field | RBC, Week 12, 10-20/Every Field | RBC, Week 24, 0-0.1/Some Field | RBC, Week 24, 0.2-0.4/Some Field | RBC, Week 24, 1-2/Every Field | RBC, Week 24, 3-5/Every Field | RBC, Week 24, 6-10/Every Field | RBC, Week 24, 10-20/Every Field | RBC, Week 24, 20-30/Every Field | RBC, Week 36, 0-0.1/Some Field | RBC, Week 36, 0.2-0.4/Some Field | RBC, Week 36, 1-2/Every Field | RBC, Week 36, 3-5/Every Field | RBC, Week 36, 6-10/Every Field | RBC, Week 36, 10-20/Every Field | RBC, Week 48, 0-0.1/Some Field | RBC, Week 48, 0.2-0.4/Some Field | RBC, Week 48, 1-2/Every Field | RBC, Week 48, 3-5/Every Field | RBC, Week 48, 6-10/Every Field | RBC, Week 48, 10-20/Every Field | Spermatozoa, Week 4, 1+ | Spermatozoa, Week 12, 1+ | Spermatozoa, Week 24, 1+ | Spermatozoa, Week 36, 1+ | Spermatozoa, Week 48, 1+ | SEC, Week 4, 0-0.1/Some Field | SEC, Week 4, 0.2-0.4/Some Field | SEC, Week 4, 1-2/Every Field | SEC, Week 4, 3-5/Every Field | SEC, Week 4, 10-20/Every Field | SEC, Week 12, 0-0.1/Some Field | SEC, Week 12, 0.2-0.4/Some Field | SEC, Week 12, 1-2/Every Field | SEC, Week 12, 3-5/Every Field | SEC, Week 12, 6-10/Every Field | SEC, Week 12, 10-20/Every Field | SEC, Week 12, 30-50/Every Field | SEC, Week 24, 0-0.1/Some Field | SEC, Week 24, 0.2-0.4/Some Field | SEC, Week 24, 1-2/Every Field | SEC, Week 24, 3-5/Every Field | SEC, Week 24, 6-10/Every Field | SEC, Week 24, 10-20/Every Field | SEC, Week 24, 20-30/Every Field | SEC, Week 36, 0-0.1/Some Field | SEC, Week 36, 0.2-0.4/Some Field | SEC, Week 36, 1-2/Every Field | SEC, Week 36, 3-5/Every Field | SEC, Week 48, 0-0.1/Some Field | SEC, Week 48, 0.2-0.4/Some Field | SEC, Week 48, 1-2/Every Field | SEC, Week 48, 3-5/Every Field | SEC, Week 48, 6-10/Every Field | TEC, Week 4, 0-0.1/Some Field | TEC, Week 12, 0-0.1/Some Field | TEC, Week 24, 0-0.1/Some Field | TEC, Week 24, 0.2-0.4/Some Field | TEC, Week 36, 0-0.1/Some Field | TEC, Week 36, 0.2-0.4/Some Field | TEC, Week 36, 1-2/Every Field | TEC, Week 48, 0-0.1/Some Field | UAC, Week 4, 1+ | UAC, Week 12, 1+ | UAC, Week 24, 1+ | UAC, Week 36, 1+ | UAC, Week 48, 1+ | WBC, Week 4, 0-0.1/Some Field | WBC, Week 4, 0.2-0.4/Some Field | WBC, Week 4, 1-2/Every Field | WBC, Week 4, 3-5/Every Field | WBC, Week 4, 10-20/Every Field | WBC, Week 12, 0-0.1/Some Field | WBC, Week 12, 0.2-0.4/Some Field | WBC, Week 12, 1-2/Every Field | WBC, Week 12, 3-5/Every Field | WBC, Week 12, 6-10/Every Field | WBC, Week 24, 0-0.1/Some Field | WBC, Week 24, 0.2-0.4/Some Field | WBC, Week 24, 1-2/Every Field | WBC, Week 24, 3-5/Every Field | WBC, Week 24, 6-10/Every Field | WBC, Week 24, 10-20/Every Field | WBC, Week 24, 30-50/Every Field | WBC, Week 36, 0-0.1/Some Field | WBC, Week 36, 0.2-0.4/Some Field | WBC, Week 36, 1-2/Every Field | WBC, Week 36, 3-5/Every Field | WBC, Week 36, 6-10/Every Field | WBC, Week 36, 30-50/Every Field | WBC, Week 48, 0-0.1/Some Field | WBC, Week 48, 0.2-0.4/Some Field | WBC, Week 48, 1-2/Every Field | WBC, Week 48, 3-5/Every Field | WBC, Week 48, 6-10/Every Field |
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Tenofovir Disoproxil Fumarate | 2 | 2 | 3 | 2 | 2 | 3 | 6 | 8 | 5 | 5 | 5 | 11 | 6 | 2 | 8 | 11 | 1 | 11 | 9 | 14 | 15 | 10 | 23 | 5 | 1 | 25 | 4 | 19 | 2 | 1 | 19 | 2 | 1 | 21 | 5 | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 6 | 3 | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 17 | 21 | 23 | 25 | 22 | 1 | 1 | 15 | 2 | 24 | 4 | 1 | 28 | 3 | 1 | 27 | 15 | 35 | 20 | 13 | 4 | 3 | 1 | 33 | 23 | 11 | 4 | 1 | 1 | 40 | 14 | 14 | 1 | 2 | 1 | 2 | 42 | 20 | 7 | 1 | 2 | 1 | 39 | 14 | 14 | 3 | 2 | 1 | 1 | 0 | 2 | 3 | 0 | 58 | 7 | 7 | 2 | 1 | 54 | 9 | 6 | 2 | 1 | 1 | 1 | 55 | 6 | 8 | 1 | 1 | 2 | 1 | 59 | 4 | 9 | 1 | 58 | 4 | 5 | 5 | 1 | 4 | 4 | 5 | 2 | 3 | 1 | 1 | 5 | 0 | 0 | 0 | 2 | 1 | 35 | 27 | 10 | 1 | 2 | 37 | 22 | 8 | 6 | 1 | 42 | 20 | 5 | 3 | 1 | 2 | 1 | 45 | 20 | 1 | 4 | 2 | 1 | 43 | 14 | 11 | 2 | 2 |
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Percentage of Total Neutrophils at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: total neutrophils. Mean and standard deviation values for percentage of neutrophils reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96
Intervention | Percentage of neutrophils (Mean) |
---|
| Week 36, n=32 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
---|
Tenofovir Disoproxil Fumarate | 58.46 | 58.72 | 58.20 | 58.45 | 58.97 | 58.43 |
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Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24, 48 and 96. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as number of participants with HBsAg/Ab Seroconversion divided by number of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Tenofovir Disoproxil Fumarate | 0 | 0 | 0 |
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Percentage of Participants Who Achieved HBsAg Loss at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24, 48 and 96. A 'Loss' of HBsAg means antigen is negative. HBsAg loss percentage is defined as number of participants with HBsAg loss divided by number of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Tenofovir Disoproxil Fumarate | 0 | 0 | 0 |
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Percentage of Participants Who Achieved HBeAg Loss at Weeks 24, 48 and 96
Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24, 48 and 96. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as number of participants with HBeAg loss divided by number of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03258710)
Timeframe: At Weeks 24, 48 and 96
Intervention | Percentage of Participants (Number) |
---|
| Week 24 | Week 48 | Week 96 |
---|
Tenofovir Disoproxil Fumarate | 12 | 12 | 25 |
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Percentage of Participants Who Achieved 0.25 Logarithm to the Base 10 (Log10) Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48
Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were<=-0.25 log10 and non-responder values were >-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen [HBcrAg], HBeAg, hepatitis B surface antibody [HBsAb],Hepatitis B envelope antibody [HBeAb], alanine aminotransferase [ALT]) from at least 15 days after the start of study treatment. Data for HBsAg responders have been presented. (NCT03258710)
Timeframe: Baseline (Day 1, Pre-dose) and at Week 48
Intervention | Percentage of Participants (Number) |
---|
| <= -0.25 log10 | > -0.25 log10 |
---|
Tenofovir Disoproxil Fumarate | 4 | 96 |
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Percentage of Monocytes at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: monocytes. Mean and standard deviation values for percentage of monocytes reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96
Intervention | Percentage of monocytes (Mean) |
---|
| Week 36, n=32 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
---|
Tenofovir Disoproxil Fumarate | 5.30 | 5.46 | 5.65 | 5.67 | 5.71 | 5.45 |
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Percentage of Lymphocytes at Indicated Time Points
Blood samples were collected for the analysis of hematology parameter: lymphocytes. Mean and standard deviation values for percentage of lymphocytes reported was presented. (NCT03258710)
Timeframe: At Weeks 36, 48, 60, 72, 84 and 96
Intervention | Percentage of lymphocytes (Mean) |
---|
| Week 36, n=32 | Week 48, n=73 | Week 60, n=73 | Week 72, n=73 | Week 84, n=72 | Week 96, n=72 |
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Tenofovir Disoproxil Fumarate | 33.34 | 32.39 | 32.73 | 32.29 | 31.94 | 32.98 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Islatravir 0.25 mg | 89.7 |
Islatravir 0.75 mg | 90.0 |
Islatravir 2.25 mg | 77.4 |
DOR/3TC/TDF | 83.9 |
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Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24
Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 24
Intervention | cells/mm^3 (Mean) |
---|
Islatravir 0.25 mg | 220.5 |
Islatravir 0.75 mg | 192.8 |
Islatravir 2.25 mg | 142.9 |
DOR/3TC/TDF | 142.1 |
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Change From Baseline in CD4+ T-cell Count at Week 96
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 96
Intervention | cells/mm^3 (Mean) |
---|
Islatravir 0.25 mg | 243.4 |
Islatravir 0.75 mg | 161.3 |
Islatravir 2.25 mg | 136.5 |
DOR/3TC/TDF | 268.9 |
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Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported. (NCT03272347)
Timeframe: Baseline and Week 192
Intervention | cells/mm^3 (Mean) |
---|
DOR/ISL Continued (Part 4) | 3.8 |
DOR/ISL Switch (Part 4) | -3.4 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA <50 copies in Part 4 are reported. (NCT03272347)
Timeframe: Up to Week 192
Intervention | Percentage of participants (Number) |
---|
DOR/ISL Continued (Part 4) | 85.1 |
DOR/ISL Switch (Part 4) | 95.5 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 48 weeks
Intervention | Percentage of participants (Number) |
---|
Islatravir 0.25 mg | 62.1 |
Islatravir 0.75 mg | 56.7 |
Islatravir 2.25 mg | 59.3 |
DOR/3TC/TDF | 60.7 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)
Intervention | Percentage of participants (Number) |
---|
Islatravir 0.25 mg | 86.2 |
Islatravir 0.75 mg | 90.0 |
Islatravir 2.25 mg | 88.9 |
DOR/3TC/TDF | 96.4 |
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Number of Participants Discontinuing Study Drug Due to AEs up to Week 144
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 1 |
Islatravir 0.75 mg | 0 |
Islatravir 2.25 mg | 2 |
DOR/3TC/TDF | 1 |
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Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24
Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. (NCT03272347)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
Islatravir 0.25 mg | 93.1 |
Islatravir 0.75 mg | 100.0 |
Islatravir 2.25 mg | 90.3 |
DOR/3TC/TDF | 90.3 |
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Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 18 |
Islatravir 0.75 mg | 20 |
Islatravir 2.25 mg | 14 |
DOR/3TC/TDF | 16 |
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Number of Participants Experiencing AEs From Week 96 Through Study Duration
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 12 |
Islatravir 0.75 mg | 19 |
Islatravir 2.25 mg | 11 |
DOR/3TC/TDF | 12 |
DOR/ISL Continued | 36 |
DOR/ISL Switch | 14 |
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Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experienced AEs during Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192
Intervention | Participants (Count of Participants) |
---|
DOR/ISL Continued (Part 4) | 36 |
DOR/ISL Switch (Part 4) | 14 |
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Change From Baseline in CD4+ T-cell Count at Week 144
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 144
Intervention | cells/mm^3 (Mean) |
---|
Islatravir 0.25 mg | 204.4 |
Islatravir 0.75 mg | 209.0 |
Islatravir 2.25 mg | 162.9 |
DOR/3TC/TDF | 270.0 |
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Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who discontinued the study drug due to AEs in Part 4 are reported. (NCT03272347)
Timeframe: Week 144 up to Week 192
Intervention | Participants (Count of Participants) |
---|
DOR/ISL Continued (Part 4) | 0 |
DOR/ISL Switch (Part 4) | 0 |
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Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Week 96 up to Week 192
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 1 |
Islatravir 0.75 mg | 0 |
Islatravir 2.25 mg | 0 |
DOR/3TC/TDF | 0 |
DOR/ISL Continued | 0 |
DOR/ISL Switch | 0 |
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Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52. (NCT03272347)
Timeframe: Up to 24 weeks
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 0 |
Islatravir 0.75 mg | 0 |
Islatravir 2.25 mg | 2 |
DOR/3TC/TDF | 1 |
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Number of Participants Experiencing Adverse Events (AEs) up to Week 144
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. (NCT03272347)
Timeframe: Up to 144 weeks
Intervention | Participants (Count of Participants) |
---|
Islatravir 0.25 mg | 26 |
Islatravir 0.75 mg | 27 |
Islatravir 2.25 mg | 24 |
DOR/3TC/TDF | 27 |
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Change From Baseline in CD4+ T-cell Count at Week 48
Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication. (NCT03272347)
Timeframe: Baseline and Week 48
Intervention | cells/mm^3 (Mean) |
---|
Islatravir 0.25 mg | 182.0 |
Islatravir 0.75 mg | 183.0 |
Islatravir 2.25 mg | 100.7 |
DOR/3TC/TDF | 181.4 |
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Summary of Changes in CD4 Count From Baseline to Week 96 (Cohort 2)
The mean difference is calculated as CD4 count at Week 96 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.
Intervention | cells/mm^3 (Mean) |
---|
Cohort 2: DOR/3TC/TDF | 42.5 |
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Summary of Changes in CD4 Count From Baseline to Week 48 (Cohort 2)
The mean differences is calculated as CD4 count at Week 48 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.
Intervention | cells/mm^3 (Mean) |
---|
Cohort 2: DOR/3TC/TDF | 80.1 |
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Summary of Changes in CD4 Count From Baseline to Week 24 (Cohort 2)
The mean difference is calculated as CD4 count at Week 24 minus CD4 count at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.
Intervention | cells/mm^3 (Mean) |
---|
Cohort 2: DOR/3TC/TDF | 84.8 |
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PK Parameter: Single-dose Maximum Concentration (Cmax) of DOR (Cohort 1)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
Intervention | µM (Geometric Mean) |
---|
Cohort 1: DOR | 2.14 |
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PK Parameter: Single-dose 24 Hour-concentration (C24hr) of DOR (Cohort 1)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
Intervention | nM (Geometric Mean) |
---|
Cohort 1: DOR | 514 |
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PK Parameter: Cmax of Tenofovir (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 293 |
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PK Parameter: Cmax of DOR (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.
Intervention | µM (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 2.13 |
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PK Parameter: Cmax of 3TC (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Cmax was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 2100 |
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PK Parameter: C24hr of DOR (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.
Intervention | nM (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 282 |
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PK Parameter: C24hr of 3TC (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 66.3 |
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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug (Cohort 2) Through End of Study
Percentage and Clopper-Pearson 95% CI of participants with Grade 5 adverse events (death). (NCT03332095)
Timeframe: Measured from Day 0 through Week 96.
Intervention | percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 0 |
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Summary of log10 Drop From Baseline to Week 48 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
The differences between log10 HIV RNA at Week 48 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.
Intervention | Log10 plasma HIV-1 RNA (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -2.1 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 24 (Cohort 2)
Virologic responses were assessed at week 24 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.7 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 48 (Cohort 2)
Virologic responses were assessed at week 48 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.6 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 50 Copies/mL at Week 96 (Cohort 2)
Virologic responses were assessed at week 96 as percentage of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >50 copies/mL. Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 92.5 |
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Pharmacokinetic (PK) Parameter: Single-dose Area-under-the-curve (AUC0-∞) of Doravirine (DOR) (Cohort 1)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to infinity. Steady state AUC0-24 is equivalent to single dose AUC0-∞. (NCT03332095)
Timeframe: Measured during the entry (day 0) visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12, 24, 48 and 72 hours post-dose.
Intervention | µM*hr (Geometric Mean) |
---|
Cohort 1: DOR | 34.8 |
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PK Parameter: AUC0-24hr of 3TC (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | h.ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 11300 |
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PK Parameter: AUC0-24hr of DOR (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 2, 4, 12 and 24 hours post-dose.
Intervention | µM*hr (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 22.9 |
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PK Parameter: AUC0-24hr of Tenofovir (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). Area under the curve (AUC) was determined using non-compartmental analyses and estimated by the linear up/log down trapezoidal rule, from time zero to 24 hours. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | h.ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 2550 |
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Percentage of Participants With Grade 5 Adverse Events (Death) Regardless of Relationship to Study Drug
Percentage and Clopper-Pearson 95% CI of participants with Grade 5 AEs (death) regardless of relationship to study drug. (NCT03332095)
Timeframe: Cohort 1: Measured from Day 0 through Week 2; Cohort 2: Measured from Day 0 through Week 24.
Intervention | percentage of participants (Number) |
---|
Cohort 1: DOR | 0 |
Cohort 2: DOR/3TC/TDF | 0 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 48 (Cohort 2)
Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.6 |
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PK Parameter: C24hr of Tenofovir (Cohort 2)
Pharmacokinetic parameters were determined from plasma concentration-time profiles using non-compartmental methods (WinNonlin, version 6.3, Pharsight Corp., Mountain View, CA). C24hr was projected from individual plasma concentration-time profiles using the non-parametric superposition function in WinNonLin v6.3. Intensive PK samples were collected for the first ten participants enrolled in Cohort 2. (NCT03332095)
Timeframe: Measured at Week 1 visit. Blood samples were drawn at pre-dose, and at 1, 2, 4, 8, 12 and 24 hours post-dose.
Intervention | ng/mL (Geometric Mean) |
---|
Cohort 2: DOR/3TC/TDF | 50.2 |
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Summary of log10 Drop From Baseline to Week 96 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
The differences between log10 HIV RNA at Week 96 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.
Intervention | Log10 plasma HIV-1 RNA (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -4.3 |
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Summary of log10 Drop From Baseline to Week 24 in Plasma HIV-1 RNA (ART-naive Participants) (Cohort 2)
The differences between log10 HIV RNA at Week 24 minus at Day 0 are summarized. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.
Intervention | Log10 plasma HIV-1 RNA (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -2.6 |
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Summary of Changes in CD4% From Baseline to Week 96 (Cohort 2)
The mean difference is calculated as CD4% at Week 96 minus CD4% at the Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 96.
Intervention | Percent of total lymphocytes (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -0.5 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 96 (Cohort 2)
Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 92.5 |
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Summary of Changes in CD4% From Baseline to Week 48 (Cohort 2)
The mean difference is calculated as CD4% at Week 48 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 48.
Intervention | Percent of total lymphocytes (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -0.4 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 40 Copies/mL at Week 24 (Cohort 2)
Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >40 copies/mL; Otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.7 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 96 (Cohort 2)
Virologic responses were assessed at week 96 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 96.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 92.9 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 48 (Cohort 2)
Virologic responses were assessed at week 48 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 48.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.7 |
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Percentage of Participants With Plasma HIV-1 RNA Less Than 200 Copies/mL at Week 24 (Cohort 2)
Virologic responses were assessed at week 24 as percentage (%) of participants and Clopper-Pearson 95% CI. Missing values were considered as failures for participants with missing data due to discontinuation of study drug as a result of virologic failure or for non-treatment related reasons with last available RNA >200 copies/mL; otherwise participants with missing values were excluded. (NCT03332095)
Timeframe: Measured at week 24.
Intervention | Percentage of participants (Number) |
---|
Cohort 2: DOR/3TC/TDF | 97.7 |
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Summary of Changes in CD4% From Baseline to Week 24 (Cohort 2)
The mean difference is calculated as CD4% at Week 24 minus CD4% at Day 0 with associated 95% Clopper-Pearson CI. (NCT03332095)
Timeframe: Measured at Day 0 and week 24.
Intervention | Percent of total lymphocytes (Mean) |
---|
Cohort 2: DOR/3TC/TDF | -1.5 |
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DOT Diary Mobile App Ease of Use
5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP. (NCT03387462)
Timeframe: 8 weeks
Intervention | Score on a scale (Likert) (Median) |
---|
DOT Diary Optimization Intervention | 4 |
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Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion (NCT03387462)
Timeframe: 8 weeks
Intervention | Percentage of doses taken (Number) |
---|
DOT Diary Optimization Intervention | 93 |
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Assessment of Situations and Reasons for Sub-optimal Use of the App
Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization (NCT03387462)
Timeframe: 8 weeks
Intervention | Count of participants for each reason (Number) |
---|
| Technical problems | Away from home |
---|
DOT Diary Optimization Intervention | 8 | 6 |
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DOT Diary Mobile App Acceptability
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. (NCT03387462)
Timeframe: 8 weeks
Intervention | Score on scale (Mean) |
---|
DOT Diary Optimization Intervention | 79.8 |
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The Mean Bone Mass Density (T-score) Change
To describe trends in bone mass density from baseline to end of study. Bone Mass Density(BMD) was evaluated using T-score of Lumber-spine. The T-score is a comparison of the results to a average peak bone mass of healthy young adult. 0 indicates healthy young adult's mean with a SD of 1. Normal BMD was defined with T-score of -1.0 or above; osteopenia with T-score between -1.1 and -2.4, and osteoporosis with T-score of -2.5 or below (ref). Worsened BMD was defined by upstaging of BMD class from normal to osteopenia or worse or from osteopenia to osteoporosis. Improved BMD was defined by downstaging of BMD class from osteopenia to normal or osteoporosis to osteopenia or normal. (NCT03471624)
Timeframe: Baseline, month 24
Intervention | T-score (Mean) |
---|
| Baseline | 24 month |
---|
Tenofovir Alafenamide for 24 Months | -1.43 | -1.17 |
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Number of Participants With Normal Alanine Aminotransferase (ALT).
Alanine aminotransferase (ALT) normalization is defined if ALT was less than 35 U/L for men or 25 U/L for women (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months
Intervention | Participants (Count of Participants) |
---|
| Baseline | month 6 | month 12 | month 18 | month 24 |
---|
Tenofovir Alafenamide for 24 Months | 203 | 212 | 197 | 203 | 203 |
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Calculated eGFR
To describe trends in calculated eGFR as available by local labs. Estimated glomerular filtration rates (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equation (eGFR [mL∕min∕1.73m2] =141 × [minimum Scr∕K, 1]α × [maximum Scr/K, 1]1.209 × 0.993age × 1.018 [if female] × 1.159 [if black]) where Scr is serum creatinine in µmol/L, K is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months
Intervention | mL/min/1.73m^2 (Median) |
---|
| Baseline | month 6 | month 12 | month 18 | month 24 |
---|
Tenofovir Alafenamide for 24 Months | 90.2 | 90.8 | 91.2 | 91.8 | 92.1 |
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Number of Participants With HBV DNA <20 IU Per mL
To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment. (NCT03471624)
Timeframe: Baseline, 6, 12, 18, 24 months
Intervention | Participants (Count of Participants) |
---|
| Baseline | month 6 | month 12 | month 18 | month 24 |
---|
Tenofovir Alafenamide for 24 Months | 257 | 261 | 257 | 256 | 255 |
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Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TFV was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ® (NCT03510468)
Timeframe: 0-24 hours post dosing on days 14, 22, and 31
Intervention | hr*ng/ml (Geometric Mean) |
---|
| Day 14 | Day 22 | Day 31 |
---|
Pharmacokinetic Study in Healthy Volunteers | 262.2 | 265.3 | 230.8 |
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Number of Patients Who Accepted Rapid HIV Treatment Initiation
(NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
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Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day
Number of patients who respond yes to starting ART same day versus those who respond no in the survey. (NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
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Number of Patients Who Receive Rapid HIV Treatment Initiation
Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered. (NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
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Number of Patients Offered Rapid HIV Treatment Initiation
(NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
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AUCtau of Raltegravir
Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)
Intervention | ng*h/ml (Geometric Mean) |
---|
Treatment B (Part 2) | 2912.45 |
Treatment C (Part 2) | 2653.65 |
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AUCtau of Narlaprevir
Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)
Intervention | ng*h/ml (Geometric Mean) |
---|
Treatment A (Part 1) | 20504.31 |
Treatment C (Part 1) | 21366.2 |
Treatment A (Part 2) | 26199.19 |
Treatment C (Part 2) | 24458.48 |
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AUCtau of Tenofovir
Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)
Intervention | ng*h/ml (Geometric Mean) |
---|
Treatment B (Part 1) | 2599.95 |
Treatment C (Part 1) | 2799.72 |
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Number of Patients With Abnormal ECG Changes
There were no subjects with abnormal ECG changes during the study (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Intervention | Participants (Count of Participants) |
---|
| Part 1 | Part 2 |
---|
Treatment A (Part 1/Part 2) | 0 | 0 |
,Treatment B (Part 1/Part 2) | 0 | 0 |
,Treatment C (Part 1/Part 2) | 0 | 0 |
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Number of Patients With Changes in Vital Signs
There were no subjects with abnormal changes in vital signs (NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Intervention | Participants (Count of Participants) |
---|
Treatment A (Part 1) | 0 |
Treatment B (Part 1) | 0 |
Treatment C (Part 1) | 0 |
Treatment A (Part 2) | 0 |
Treatment B (Part 2) | 0 |
Treatment C (Part 2) | 0 |
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Number of Patients With Adverse Events
(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Intervention | Participants (Count of Participants) |
---|
Treatment A (Part 1) | 1 |
Treatment B (Part 1) | 0 |
Treatment C (Part 1) | 4 |
Treatment A (Part 2) | 0 |
Treatment B (Part 2) | 0 |
Treatment C (Part 2) | 1 |
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Cmax of Tenofovir
Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)
Intervention | ng/ml (Geometric Mean) |
---|
Treatment B (Part 1) | 263.037 |
Treatment C (Part 1) | 344.796 |
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Cmax of Raltegravir
Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)
Intervention | ng/ml (Geometric Mean) |
---|
Treatment B (Part 2) | 830.204 |
Treatment C (Part 2) | 715.726 |
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Cmax of Narlaprevir
Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study (NCT03537404)
Timeframe: Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)
Intervention | ng/ml (Geometric Mean) |
---|
Treatment A (Part 1) | 2130.2742 |
Treatment C (Part 1) | 2172.233 |
Treatment A (Part 2) | 2946.131 |
Treatment C (Part 2) | 2880.612 |
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Number of Patients With Abnormal Laboratory Values
(NCT03537404)
Timeframe: Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study
Intervention | Participants (Count of Participants) |
---|
| Part 1 | Part 2 |
---|
Treatment A (Part 1) | 0 | 0 |
,Treatment B (Part 1) | 0 | 0 |
,Treatment C (Part 1) | 2 | 1 |
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Number of Participants With Improvement of Histological Findings According to the Liver Biopsy Results
"Change (improvement/ worsening) in fibrosis and histological activity stage according to the liver biopsy study results at week 24 compared to baseline.~Liver fibrosis was evaluated by histological staging systems with stage 0 corresponding to absence of fibrosis and with the highest score (the last stage in all systems) corresponding to cirrhosis.~Improvement is defined as a decrease of at least 1 point in histological staging systems; worsening is defined as an increase of at least 1 point.~Data should be interpreted with caution due to low number of paired biopsies available." (NCT03546621)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Ishak fibrosis score72506758 | Ishak fibrosis score72506760 | Ishak fibrosis score72506761 | Ishak fibrosis score72506759 | Knodell fibrosis score72506759 | Knodell fibrosis score72506760 | Knodell fibrosis score72506761 | Knodell fibrosis score72506758 | Metavir fibrosis stage72506760 | Metavir fibrosis stage72506761 | Metavir fibrosis stage72506758 | Metavir fibrosis stage72506759 | Metavir activity grade72506758 | Metavir activity grade72506759 | Metavir activity grade72506760 | Metavir activity grade72506761 | Histological activity index72506758 | Histological activity index72506760 | Histological activity index72506761 | Histological activity index72506759 |
---|
| No change | Worsening | Improvement |
---|
Arm B | 1 |
Arm C | 2 |
Arm B | 3 |
Arm D | 2 |
Arm A | 2 |
Arm B | 2 |
Arm A | 4 |
Arm A | 1 |
Arm C | 4 |
Arm C | 0 |
Arm C | 3 |
Arm D | 3 |
Arm A | 0 |
Arm C | 1 |
Arm D | 0 |
Arm A | 3 |
Arm D | 1 |
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Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24
Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24 (NCT03546621)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
| Week 2472506758 | Week 2472506759 | Week 2472506760 | Week 2472506761 | Week 4872506758 | Week 4872506759 | Week 4872506760 | Week 4872506761 |
---|
| Responder | Non-Responder |
---|
Arm A | 6 |
Arm B | 9 |
Arm C | 11 |
Arm A | 22 |
Arm B | 23 |
Arm C | 19 |
Arm A | 2 |
Arm B | 1 |
Arm C | 1 |
Arm D | 0 |
Arm A | 26 |
Arm B | 31 |
Arm C | 29 |
Arm D | 28 |
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Durability of HDV RNA Response
Durability of HDV RNA response to 24 weeks post treatment (NCT03546621)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Response at Week 24 only | Response at Week 24 and 48 |
---|
Arm A | 15 | 2 |
,Arm B | 16 | 1 |
,Arm C | 23 | 3 |
,Arm D | 1 | 0 |
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Changes in ALT Values
Changes in ALT values at Week 24 and Week 48 compared to baseline. (NCT03546621)
Timeframe: 24 and 48 weeks
Intervention | U/L (Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Arm A | -49.6 | -1.6 |
,Arm B | -79.4 | -18.2 |
,Arm C | -78.9 | 1.4 |
,Arm D | -29.2 | -26.3 |
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Change in Hepatitis B Surface Antigen
Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline (NCT03546621)
Timeframe: 24 and 48 weeks
Intervention | IU/mL (Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Arm A | -0.048 | -0.138 |
,Arm B | 0.003 | -0.162 |
,Arm C | 0.034 | -0.134 |
,Arm D | 0.025 | -0.070 |
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Change (Absence of Increase) in Fibrosis Marker
Change (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline (NCT03546621)
Timeframe: 24 and 48 weeks
Intervention | g/L (Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Arm A | -0.076 | -0.056 |
,Arm B | 0.020 | 0.075 |
,Arm C | 0.024 | -0.008 |
,Arm D | -0.141 | -0.031 |
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Absence of a Fibrosis Progression According to the Findings of Transient Elastometry
Decrease in liver stiffness and absence of a fibrosis progression according to the findings of transient elastometry (fibroscan) at week 24 compared to baseline (NCT03546621)
Timeframe: 24 weeks
Intervention | kPa (Mean) |
---|
| Baseline | Change from Baseline to Week 24 |
---|
Arm A | 14.45 | -2.85 |
,Arm B | 17.18 | -2.52 |
,Arm C | 16.00 | -3.38 |
,Arm D | 16.20 | -0.78 |
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Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline
Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline. (NCT03546621)
Timeframe: 24 and 48 weeks
Intervention | IU/mL (Mean) |
---|
| Change from Baseline to Week 24 | Change from Baseline to Week 48 |
---|
Arm A | -0.314 | -0.244 |
,Arm B | -0.484 | -0.194 |
,Arm C | -0.173 | -0.267 |
,Arm D | -0.343 | -0.257 |
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Number of Infants Receiving Timely Birth Dose Vaccination
Timeliness of infant HBV vaccination is defined as >90% of infants receiving birth dose vaccine within 24 hours of life (NCT03567382)
Timeframe: Within 24 hours after birth
Intervention | Participants (Count of Participants) |
---|
Infants Born to High-risk Mothers | 8 |
Infants Born to Low-risk Mothers | 38 |
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Number of Participants With Lab Testing Acceptability Survey Scores >80%
"The acceptability of laboratory testing approach to participants will be defined as >80% acceptability on a two questions each measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for participant responses will include: Very unacceptable (1), Somewhat unacceptable (2), No opinion (3), Somewhat acceptable (4), Very acceptable (5) and Did not allow study personnel to take my blood. Scores equal to or greater than 4 considered 80%." (NCT03567382)
Timeframe: Upon completion of the exit survey, or up to 12 months
Intervention | Participants (Count of Participants) |
---|
| Testing for Mothers | Testing for Infants |
---|
High-risk Mothers | 7 | 7 |
,Low-risk Mothers | 41 | 40 |
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Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%
"The acceptability of the intervention approach to participants will be defined as >80% acceptability on a single question measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for responses will include: Very unacceptable (1), Somewhat unacceptable (2), No opinion (3), Somewhat acceptable (4), Very acceptable (5) and Did not allow study personnel to vaccinate my infant. Scores equal to or greater than 4 considered 80%." (NCT03567382)
Timeframe: Upon completion of the exit survey, or up to 12 months
Intervention | Participants (Count of Participants) |
---|
High-risk Mothers | 7 |
Low-risk Mothers | 42 |
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Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy
Adherence to tenofovir therapy is defined as <20% of pills remaining on monthly pill counts for high-risk mothers with HBV receiving tenofovir (NCT03567382)
Timeframe: Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period.
Intervention | Participants (Count of Participants) |
---|
High-risk Mothers | 9 |
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Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life. (NCT03567382)
Timeframe: Measured at 6 months after birth
Intervention | Participants (Count of Participants) |
---|
Infants Born to High-risk Mothers | 0 |
Infants Born to Low-risk Mothers | 0 |
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Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Intervention | ng/mL (Mean) |
---|
| Baseline (Day 1) | Week 2 | Week 4 | Week 12 | Week 24 |
---|
ABI-H0731 + SOC NUC | 77.5 | 85.5 | 86.8 | 79.3 | 79.3 |
,Placebo + SOC NUC | 89.1 | 76.2 | 84.1 | 86.7 | 78.3 |
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Number of Participants With a Clinically-significant Change in Vital Signs
Vital signs assessed were body temperature, respiratory rate, and pulse rate (NCT03576066)
Timeframe: Baseline and up to Week 24
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 0 |
Placebo + SOC NUC | 0 |
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Number of Participants With a Clinically-significant Electrocardiogram Abnormality
(NCT03576066)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 0 |
Placebo + SOC NUC | 0 |
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Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy
Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants). (NCT03576066)
Timeframe: Baseline to Week 24
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 1 |
Placebo + SOC NUC | 0 |
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Number of Participants With One or More Abnormal Safety Laboratory Result
(NCT03576066)
Timeframe: Up to Week 36
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 27 |
Placebo + SOC NUC | 20 |
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Number of Participants With One or More Adverse Events
(NCT03576066)
Timeframe: Up to Follow-up (maximum up to Week 36)
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 24 |
Placebo + SOC NUC | 8 |
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Number of Participants With Premature Study Discontinuation
(NCT03576066)
Timeframe: Up to Follow-up (maximum up to Week 36)
Intervention | Participants (Count of Participants) |
---|
ABI-H0731 + SOC NUC | 0 |
Placebo + SOC NUC | 1 |
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Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
(NCT03576066)
Timeframe: Baseline to Week 24
Intervention | Log10 International Units (IU)/mL (Mean) |
---|
| Baseline | Change from baseline |
---|
HBeAg-positive Participants: ABI-H0731 + SOC NUC | 0.55 | -0.05 |
,HBeAg-positive Participants: Placebo + SOC NUC | 0.43 | -0.10 |
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Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC
(NCT03576066)
Timeframe: Baseline to Week 24
Intervention | Log10 International Units (IU)/mL (Mean) |
---|
| Baseline | Change from baseline |
---|
HBeAg-negative Participants: ABI-H0731 + SOC NUC | 2.99 | 0.09 |
,HBeAg-negative Participants: Placebo + SOC NUC | 3.35 | -0.00 |
,HBeAg-positive Participants: ABI-H0731 + SOC NUC | 3.48 | 0.03 |
,HBeAg-positive Participants: Placebo + SOC NUC | 3.57 | 0.03 |
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Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy
(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Intervention | ng/mL (Mean) |
---|
| Baseline (Day 1) | Week 2 | Week 4 | Week 12 | Week 24 |
---|
ABI-H0731 + SOC NUC | 0.436 | 1390 | 1390 | 1330 | 1330 |
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Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Intervention | ng/mL (Mean) |
---|
| Baseline (Day 1) | Week 2 | Week 4 | Week 12 | Week 24 |
---|
ABI-H0731 + SOC NUC | 1.10 | 0.554 | 0.872 | 0.583 | 1.04 |
,Placebo + SOC NUC | 1.78 | 0.346 | 0.621 | 0.704 | 0.739 |
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Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy
(NCT03576066)
Timeframe: Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
Intervention | ng/mL (Mean) |
---|
| Baseline (Day 1) | Week 2 | Week 4 | Week 12 | Week 24 |
---|
ABI-H0731 + SOC NUC | 9.67 | 13.1 | 21.3 | 18.4 | 18.9 |
,Placebo + SOC NUC | 12.2 | 14.1 | 11.8 | 11.7 | 13.3 |
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Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
"Participants were asked would you prefer to use the ring or the tablets for HIV prevention? at their enrollment, Month 12, and product use end visit (Month 18) visits." (NCT03593655)
Timeframe: All three study periods (enrollment, month 12, and month 18 study visits)
Intervention | Participants (Count of Participants) |
---|
| Enrollment71925906 | Enrollment71925905 | Month 1271925905 | Month 1271925906 | Month 1871925905 | Month 1871925906 |
---|
| Neither product | Skipped question | Preferred ring | Preferred tablets | Either product equally |
---|
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 51 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 43 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 43 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 57 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 29 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 18 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 0 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 1 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 74 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 76 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 37 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 30 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 5 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 2 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 1 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 67 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 66 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 35 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 33 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 13 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 5 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 4 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 0 |
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Number of Participant-Visits Reporting Acceptability of Study Product
"During the study period where participants were randomized to use FTC/TDF they were asked to rate how much they liked using the tablets for HIV prevention (3 and 6 months after initiating the product).~During the study period where participants were randomized to use the dapivirine vaginal ring they were asked to rate how much they liked using the ring for HIV prevention (3 and 6 months after initiating the product)." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Visits (Count of Units) |
---|
| Week 1271925903 | Week 1271925904 | Week 2471925903 | Week 2471925904 | Week 3671925903 | Week 3671925904 | Week 4871925904 | Week 4871925903 |
---|
| Neither like nor dislike, dislike, or dislike very | Like, or like very much |
---|
FTC/TDF | 72 |
Dapivirine Vaginal Ring | 5 |
FTC/TDF | 35 |
Dapivirine Vaginal Ring | 105 |
FTC/TDF | 73 |
Dapivirine Vaginal Ring | 6 |
FTC/TDF | 32 |
Dapivirine Vaginal Ring | 91 |
FTC/TDF | 93 |
Dapivirine Vaginal Ring | 14 |
FTC/TDF | 18 |
Dapivirine Vaginal Ring | 90 |
FTC/TDF | 68 |
Dapivirine Vaginal Ring | 21 |
FTC/TDF | 47 |
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Number of Participants With Grade 2 or Higher Adverse Events (AEs)
"During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., moderate or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods.~This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods)." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Participants (Count of Participants) |
---|
| Study Period 1 (Weeks 1-24)71925903 | Study Period 1 (Weeks 1-24)71925904 | Study Period 2 (Weeks 25-48)71925903 | Study Period 2 (Weeks 25-48)71925904 |
---|
| No grade 2+ AE | At least one grade 2+ AE |
---|
Dapivirine Vaginal Ring | 36 |
FTC/TDF | 36 |
Dapivirine Vaginal Ring | 88 |
FTC/TDF | 87 |
Dapivirine Vaginal Ring | 22 |
FTC/TDF | 28 |
Dapivirine Vaginal Ring | 95 |
FTC/TDF | 94 |
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Number of Participant-Visits With No Product Use
"During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use.~During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Visits (Count of Units) |
---|
| Study Period 171925903 | Study Period 171925904 | Study Period 271925904 | Study Period 271925903 |
---|
| No use | At least some use |
---|
Dapivirine Vaginal Ring | 19 |
FTC/TDF | 11 |
Dapivirine Vaginal Ring | 705 |
FTC/TDF | 660 |
Dapivirine Vaginal Ring | 41 |
FTC/TDF | 10 |
Dapivirine Vaginal Ring | 642 |
FTC/TDF | 635 |
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Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))
"Change in serum biomarkers of inflammation (hs-CRP (in mg/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of inflammation (high sensitivity C-reactive protein) were measured. hs-CRP > 1 mg/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | mg/L (Mean) |
---|
HIV Patients on Stable Therapy | -0.40 |
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Change in Myocyte Injury and Strain (hs Troponin (in ng/L))
"Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (high sensitivity troponin) were measured. hs-troponin >14 ng/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | ng/L (Mean) |
---|
HIV Patients on Stable Therapy | -0.04 |
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Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))
"Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (NT-pro-BNP) were measured. NT-proBNP > 100 pg/mL are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | pg/mL (Mean) |
---|
HIV Patients on Stable Therapy | -14.2 |
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Change in Peak Stress Global MBF
"Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of B/F/TAF.~Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired stress MBF is defined as <1.8 mL/min/g and is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and 24 weeks
Intervention | mL/min/g (Mean) |
---|
HIV Patients on Stable Therapy | 0.09 |
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Change in Global CFR
"Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy.~Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of <2.0, which is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and week 24
Intervention | ratio (Mean) |
---|
HIV Patients on Stable Therapy | -.05 |
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EVG Cmax
Maximum Plasma Concentration (Cmax) for Elvitegravir (ng/mL) (NCT03717129)
Timeframe: 72 Hr
Intervention | ng/mL (Mean) |
---|
Genvoya Oral Dose | 1650 |
Genvoya Crushed Dose | 1946 |
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AUC0-∞ for FTC
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 |
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Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG
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 |
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TFV Half-life
Terminal elimination half-life for TFV (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 42.5 |
Genvoya Crushed Dose | 40.7 |
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TFV Cmax
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 |
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FTC Half-life
Terminal elimination half-life for FTC (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 15.2 |
Genvoya Crushed Dose | 16.1 |
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EVG Half-life
Terminal elimination half-life for EVG (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 5 |
Genvoya Crushed Dose | 5.1 |
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FTC Cmax
Maximum Plasma Concentration (Cmax) for Emtricitabine (ng/mL) (NCT03717129)
Timeframe: 72 hr
Intervention | ng/mL (Mean) |
---|
Genvoya Oral Dose | 2095 |
Genvoya Crushed Dose | 1968 |
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AUC0-∞ for Tenofovir (TFV)
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 |
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Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
"Incidence of subjects with suppression/loss of viral Hepatitis B e antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy" (NCT03780543)
Timeframe: upto Week 148
Intervention | Participants (Count of Participants) |
---|
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201 | 4 |
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201 | 4 |
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Sustained Viral Response (SVR) at 24 Weeks Off Treatment
"To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.~SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24." (NCT03780543)
Timeframe: Completing from week 52 until week 76
Intervention | Participants (Count of Participants) |
---|
Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201 | 0 |
Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201 | 0 |
Treatment-naïve Subjects With HBeAg Positive cHBV | 0 |
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Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
"To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)~To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS" (NCT03780543)
Timeframe: EOT: up to Week 52 or 148; EOS: up to 3 years off treatment
Intervention | Participants (Count of Participants) |
---|
| Numbers with normal ALT levels at EOT | Number with normal ALT levels at EOS |
---|
Treatment-naïve Subjects With HBeAg Positive cHBV | 5 | 5 |
,Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201 | 2 | 1 |
,Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201 | 0 | 0 |
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Number of Subjects With Adverse Events
Incidence of treatment emergent adverse events (AEs) (NCT03780543)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Number of subjects with AEs | Number of subjects with discontinuation due to an AE | Number of subjects with significant abnormal ECGs |
---|
Treatment-naïve Subjects With HBeAg Positive cHBV | 12 | 2 | 0 |
,Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201 | 16 | 1 | 0 |
,Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201 | 26 | 0 | 1 |
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ALT Normalization at Week 24
Proportion of participants with normal ALT at Week 24 (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 4 |
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HBeAg Loss at Week 48
Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 0 |
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CD4 Cell Count Change at Week 24
Change from baseline in CD4 cell count at Week 24 (NCT03797014)
Timeframe: Baseline; Week 24
Intervention | cells/microliter (Mean) |
---|
B/F/TAF | 32.8 |
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CD4 Cell Count Change at Week 48
Change from baseline in CD4 cell count at Week 48 (NCT03797014)
Timeframe: Baseline; Week 48
Intervention | cells/microliter (Mean) |
---|
B/F/TAF | 76.6 |
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HBsAg Loss at Week 48
Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 0 |
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HBV DNA at Week 24
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 24 |
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HBV DNA at Week 48
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 22 |
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HIV-1 RNA at Week 24
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 25 |
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HIV-1 RNA at Week 48
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 22 |
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ALT Normalization at Week 48
Proportion of participants with normal ALT at Week 48 (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 4 |
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Period 2: Change From Baseline in Hematology Parameter of MCV
Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Femtoliters (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -1.02 | -0.17 | -0.82 |
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Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 5.000 |
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Period 2: Tmax of FTC
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 1.500 |
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Period 2: Tmax of TAF
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 1.000 |
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Period 2: Tmax of TFV
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 3.000 |
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Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before (NCT03836729)
Timeframe: Up to Day 24
Intervention | Participants (Number) |
---|
| Non-SAEs | SAEs |
---|
TAF/FTC | 9 | 0 |
,TAF/FTC+GSK3640254 | 3 | 0 |
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Period 1: Absolute Values of Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline | SBP, Day 2 | SBP, Day 3 | SBP, Day 4 | SBP, Day 5 | SBP, Day 7 | DBP, Baseline | DBP, Day 2 | DBP, Day 3 | DBP, Day 4 | DBP, Day 5 | DBP, Day 7 |
---|
TAF/FTC | 123.3 | 124.7 | 121.5 | 120.6 | 121.0 | 124.1 | 75.3 | 75.4 | 73.8 | 75.4 | 73.9 | 78.2 |
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Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Units per Liter (Mean) |
---|
| Amylase, Baseline | Amylase, Day 7 | Amylase, Day 14 | Lipase, Baseline | Lipase, Day 7 | Lipase, Day 14 |
---|
TAF/FTC | 56.4 | 54.1 | 53.6 | 22.2 | 18.2 | 16.9 |
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Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Baseline | Alkaline phosphatase, Day 7 | Alkaline phosphatase, Day 14 | AST, Baseline | AST, Day 7 | AST, Day 14 | ALT, Baseline | ALT, Day 7 | ALT, Day 14 | GGT Baseline | GGT Day 7 | GGT Day 14 | LDH, Baseline | LDH, Day 7 | LDH, Day 9 | CK, Baseline | CK, Day 7 | CK, Day 14 |
---|
TAF/FTC | 60.9 | 58.3 | 63.4 | 24.6 | 18.4 | 17.6 | 26.6 | 24.4 | 20.4 | 1.76 | 1.91 | 2.40 | 138.0 | 123.4 | 126.0 | 219.6 | 116.6 | 120.4 |
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Period 1: Absolute Values of Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Ratio (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 1.0136 | 1.0143 | 1.0147 |
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Period 1: Absolute Values of Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Breaths per minute (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 14.0 | 12.5 | 13.5 | 13.5 | 15.3 | 14.6 |
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Period 1: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Beats per minute (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 73.9 | 72.8 | 70.1 | 69.9 | 72.3 | 66.3 |
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Period 1: Absolute Values of pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | pH (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 6.22 | 5.88 | 6.03 |
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Period 2: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Beats per minute (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
---|
TAF/FTC+GSK3640254 | 70.5 | 71.9 | 71.4 | 69.2 | 79.0 |
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Period 1: Absolute Values of Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Beats per minute (Mean) |
---|
| Baseline | Day 1, 2 hours post-dose | Day 1, 4 hours post-dose |
---|
TAF/FTC | 67.6 | 69.1 | 64.4 |
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Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Baseline | PR Interval, Day 1, 2 hours post-dose | PR Interval, Day 1, 4 hours post-dose | QRS Duration, Baseline | QRS Duration, Day 1, 2 hours post-dose | QRS Duration, Day 1, 4 hours post-dose | QT Interval, Baseline | QT Interval, Day 1, 2 hours post-dose | QT Interval, Day 1, 4 hours post-dose | QTcF Interval, Baseline | QTcF Interval, Day 1, 2 hours post-dose | QTcF Interval, Day 1, 4 hours post-dose | QTcB Interval, Baseline | QTcB Interval, Day 1, 2 hours post-dose | QTcB Interval, Day 1, 4 hours post-dose |
---|
TAF/FTC | 161.3 | 162.8 | 159.4 | 91.0 | 89.9 | 91.3 | 377.8 | 370.3 | 383.6 | 391.6 | 386.7 | 390.3 | 398.8 | 394.6 | 393.3 |
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Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Baseline | Total Protein, Day 7 | Total Protein, Day 14 | Globulin, Baseline | Globulin, Day 7 | Globulin, Day 14 | Albumin, Baseline | Albumin, Day 7 | Albumin, Day 14 |
---|
TAF/FTC | 69.8 | 72.4 | 72.6 | 25.9 | 28.4 | 28.7 | 43.9 | 44.0 | 43.9 |
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Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 250.4 |
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Period 1: AUC (0-tau) of FTC
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 9787.5 |
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Period 1: AUC (0-tau) of Tenofovir (TFV)
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 221.9 |
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Period 1: Cmax of TFV
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 13.14 |
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Period 1: Ctau of TFV
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 7.688 |
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Period 1: Maximum Observed Concentration (Cmax) of TAF
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 203.4 |
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Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 71.81 |
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Period 1: Tmax of FTC
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 1.500 |
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Period 1: Tmax of TAF
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 1.00 |
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Period 1: Tmax of TFV
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 3.000 |
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Period 1:Cmax of FTC
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 1811 |
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Period 2: AUC (0-tau) of FTC
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 9421.0 |
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Period 2: AUC (0-tau) of GSK3640254
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 24.53 |
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Period 2: AUC (0-tau) of TAF
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 215.4 |
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Period 2: AUC (0-tau) of TFV
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 229.1 |
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Period 2: Cmax of GSK3640254
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 1.411 |
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Period 2: Cmax of TAF
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 175.1 |
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Period 2: Cmax of TFV
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 13.30 |
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Period 2: Ctau of FTC
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 82.92 |
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Period 1: Change From Baseline in Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Day 2 | SBP, Day 3 | SBP, Day 4 | SBP, Day 5 | SBP, Day 7 | DBP, Day 2 | DBP, Day 3 | DBP, Day 4 | DBP, Day 5 | DBP, Day 7 |
---|
TAF/FTC | 1.4 | -1.8 | -2.7 | -2.3 | 0.8 | 0.1 | -1.6 | 0.1 | -1.4 | 2.9 |
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Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Day 7 | Alkaline phosphatase, Day 14 | AST, Day 7 | AST, Day 14 | ALT, Day 7 | ALT, Day 14 | GGT Day 7 | GGT Day 14 | LDH, Day 7 | LDH, Day 14 | CK, Day 7 | CK, Day 14 |
---|
TAF/FTC | -2.6 | 2.4 | -6.2 | -6.9 | -2.1 | -6.2 | 0.2 | -1.7 | -14.6 | -12.0 | -103.0 | -99.2 |
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Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Day 7 | Glucose, Day 14 | Cholesterol, Day 7 | Cholesterol, Day 14 | Anion gap, Day 7 | Anion gap, Day 14 | Calcium, Day 7 | Calcium, Day 14 | CO2, Day 7 | CO2, Day 14 | Chloride, Day 7 | Chloride, Day 14 | Phosphate, Day 7 | Phosphate, Day 14 | Potassium, Day 7 | Potassium, Day 14 | Sodium, Day 7 | Sodium, Day 14 | Triglycerides, Day 7 | Triglycerides, Day 14 | BUN, Day 7 | BUN, Day 14 |
---|
TAF/FTC | -0.160 | -0.320 | -0.004 | -0.389 | 1.9 | 2.2 | 0.028 | 0.028 | -1.6 | -0.9 | -1.1 | -2.0 | 0.017 | 0.026 | 0.03 | -0.03 | -0.6 | -0.6 | 0.092 | -0.044 | -0.018 | -0.195 |
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Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Units per Liter (Mean) |
---|
| Amylase, Day 7 | Amylase, Day 14 | Lipase, Day 7 | Lipase, Day 14 |
---|
TAF/FTC | -2.3 | -2.8 | -4.0 | -5.3 |
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Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Day 7 | Creatinine, Day 14 | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Direct bilirubin, Day 7 | Direct bilirubin, Day 14 |
---|
TAF/FTC | 5.69 | 7.36 | 2.25 | 2.10 | 0.15 | 0.64 |
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Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Day 7 | Total Protein, Day 14 | Globulin, Day 7 | Globulin, Day 14 | Albumin, Day 7 | Albumin, Day 14 |
---|
TAF/FTC | 2.6 | 2.9 | 2.5 | 2.8 | 0.1 | 0.1 |
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Period 1: Change From Baseline in Heart Rate
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Beats per minute (Mean) |
---|
| Day 1, 2 hours post-dose | Day 1, 4 hours post-dose |
---|
TAF/FTC | 1.5 | -3.3 |
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Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Trillion cells per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.189 | 0.226 |
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Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.0121 | 0.0189 |
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Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 6.1 | 8.4 |
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Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Picograms (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.13 | 0.36 |
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Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 1 Day 7 | Basophils, Period 1 Day 14 | Eosinophils, Period 1 Day 7 | Eosinophils, Period 1 Day 14 | Monocytes, Period 1 Day 7 | Monocytes, Period 1 Day 14 | Leukocytes, Period 1 Day 7 | Leukocytes, Period 1 Day 14 | Lymphocytes, Period 1 Day 7 | Lymphocytes, Period 1 Day 14 | Neutrophils, Period 1 Day 7 | Neutrophils, Period 1 Day 14 | Platelets, Period 1 Day 7 | Platelets, Period 1 Day 14 |
---|
TAF/FTC | -0.005 | -0.006 | -0.021 | -0.020 | 0.014 | 0.049 | -0.08 | 0.27 | -0.246 | -0.262 | 0.188 | 0.513 | 3.3 | 21.8 |
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Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | pH (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -0.34 | -0.19 |
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Period 1: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Beats per minute (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -1.2 | -3.8 | -4.0 | -1.6 | -7.6 |
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Period 1: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Breaths per minute (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -1.5 | -0.5 | -0.5 | 1.3 | 0.6 |
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Period 1: Change From Baseline in Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Ratio (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.0007 | 0.0011 |
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Period 1: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Degree Celsius (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -0.16 | -0.15 | -0.09 | -0.15 | -0.24 |
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Period 1: Change From Baseline in Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -2.5395 | -2.5395 |
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Period 2: Absolute Values of Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline, n= 16 | SBP, Day 4, n=15 | SBP, Day 7, n=15 | SBP, Day 9, n=15 | SBP, Day 10, n=15 | DBP, Baseline, n= 16 | DBP, Day 4, n= 15 | DBP, Day 7, n= 15 | DBP, Day 9, n= 15 | DBP, Day 10, n= 15 |
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TAF/FTC+GSK3640254 | 120.4 | 119.3 | 120.8 | 117.9 | 123.7 | 74.4 | 74.3 | 77.9 | 70.3 | 72.1 |
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Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Units per Liter (Mean) |
---|
| Amylase, Baseline, n= 16 | Amylase, Day 3, n= 16 | Amylase, Day 7, n= 15 | Amylase, Day 9, n= 15 | Lipase, Baseline, n= 16 | Lipase, Day 3, n= 16 | Lipase, Day 7, n= 15 | Lipase, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 53.6 | 56.8 | 52.7 | 55.7 | 16.9 | 24.6 | 17.5 | 21.0 |
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Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Baseline Day 3, n= 16 | Alkaline phosphatase, Day 3, n= 16 | Alkaline phosphatase, Day 7, n= 15 | Alkaline phosphatase, Day 9, n= 15 | AST, Baseline, n= 16 | AST, Day 3, n= 16 | AST, Day 7, n= 15 | AST, Day 9, n= 15 | ALT, Baseline, n= 16 | ALT, Day 3, n= 16 | ALT, Day 7, n= 15 | ALT, Day 9, n= 15 | GGT, Baseline, n= 16 | GGT, Day 3, n= 16 | GGT, Day 7, n= 15 | GGT, Day 9, n= 15 | LDH, Baseline, n= 16 | LDH, Day 3, n= 16 | LDH, Day 7, n= 15 | LDH, Day 9, n= 15 | CK, Baseline, n= 16 | CK, Day 3, n= 16 | CK, Day 7, n= 15 | CK, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 63.4 | 67.1 | 65.4 | 61.8 | 17.6 | 16.2 | 17.2 | 17.6 | 20.4 | 18.4 | 18.5 | 19.7 | 2.40 | 2.14 | 2.41 | 1.95 | 126.0 | 119.0 | 118.0 | 119.2 | 120.4 | 123.8 | 135.8 | 122.2 |
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Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Baseline, n= 16 | Glucose, Day 3, n= 15 | Glucose, Day 7, n= 15 | Glucose, Day 9, n= 15 | Cholesterol, Baseline, n= 16 | Cholesterol, Day 3, n=15 | Cholesterol, Day 7, n= 15 | Cholesterol, Day 9, n= 16 | Anion gap, Baseline, n= 16 | Anion gap, Day 3, n= 16 | Anion gap, Day 7, n= 15 | Anion gap, Day 9, n= 15 | Calcium, Baseline, n= 16 | Calcium, Day 3, n= 16 | Calcium, Day 7, n= 15 | Calcium, Day 9, n= 15 | CO2, Baseline, n= 16 | CO2, Day 3, n= 16 | CO2, Day 7, n= 15 | CO2, Day 9, n= 15 | Chloride, Baseline, n= 16 | Chloride, Day 3, n= 16 | Chloride, Day 7, n= 15 | Chloride, Day 9, n= 15 | Phosphate, Baseline, n= 16 | Phosphate, Day 3, n= 16 | Phosphate, Day 7, n= 15 | Phosphate, Day 9, n= 15 | Potassium, Baseline, n= 16 | Potassium, Day 3, n= 16 | Potassium, Day 7, n= 15 | Potassium, Day 9, n= 15 | Sodium, Baseline, n= 16 | Sodium, Day 3, n= 16 | Sodium, Day 7, n= 15 | Sodium, Day 9, n=15 | Triglycerides, Baseline, n= 16 | Triglycerides, Day 3, n= 16 | Triglycerides, Day 7, n= 15 | Triglycerides, Day 9, n= 15 | BUN, Baseline, n= 16 | BUN, Day 3, n= 16 | BUN, Day 7, n= 15 | BUN Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 4.791 | 5.027 | 5.129 | 4.950 | 3.864 | 3.875 | 3.894 | 3.822 | 10.9 | 10.5 | 10.3 | 10.5 | 2.387 | 2.399 | 2.424 | 2.421 | 30.8 | 30.3 | 30.7 | 30.5 | 101.3 | 103.6 | 101.9 | 102.7 | 1.103 | 1.165 | 1.112 | 1.117 | 4.22 | 4.23 | 4.21 | 4.35 | 138.8 | 140.2 | 138.8 | 139.3 | 1.033 | 1.029 | 1.120 | 0.961 | 4.246 | 4.558 | 4.260 | 4.263 |
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Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Baseline, n= 16 | Creatinine, Day 3, n= 16 | Creatinine, Day 7, n= 15 | Creatinine, Day 9, n= 15 | Total bilirubin, Baseline, n= 16 | Total bilirubin, Day 3, n= 16 | Total bilirubin, Day 7, n= 15 | Total bilirubin, Day 9, n= 15 | Direct bilirubin, Baseline, n= 16 | Direct bilirubin, Day 3, n= 16 | Direct bilirubin, Day 7, n= 15 | Direct bilirubin, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 87.52 | 85.18 | 91.53 | 88.27 | 11.44 | 10.62 | 11.33 | 9.68 | 2.40 | 2.14 | 2.41 | 1.95 |
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Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Baseline, n= 16 | Total Protein, Day 3, n= 16 | Total Protein, Day 7, n= 15 | Total Protein, Day 9, n= 15 | Globulin, Baseline, n= 16 | Globulin, Day 3, n= 16 | Globulin, Day 7, n= 15 | Globulin, Day 9, n= 15 | Albumin, Baseline, n= 16 | Albumin, Day 3, n= 16 | Albumin, Day 7, n= 15 | Albumin, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 72.6 | 72.8 | 75.7 | 73.3 | 28.7 | 28.9 | 30.9 | 28.8 | 43.9 | 43.9 | 44.8 | 44.5 |
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Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Baseline, n= 16 | PR Interval, Day 1, 2 hours post-dose, n= 16 | PR Interval, Day 1, 4 hours post-dose, n= 16 | PR Interval, Day 4, Pre-dose, n= 15 | PR Interval, Day 4, 2 hours post-dose, n= 15 | PR Interval, Day 4, 4 hours post-dose, n= 15 | PR Interval, Day 7, Pre-dose, n= 15 | PR Interval, Day 7, 2 hours post-dose, n= 15 | PR Interval, Day 7, 4 hours post-dose, n= 15 | PR Interval, Day 9 post-dose, n= 15 | QRS Duration, Baseline, n= 16 | QRS Duration, Day 1, 2 hours post-dose, n= 16 | QRS Duration, Day 1, 4 hours post-dose, n= 16 | QRS Duration, Day 4, Pre-dose, n= 15 | QRS Duration, Day 4, 2 hours post-dose, n= 15 | QRS Duration, Day 4, 4 hours post-dose, n= 15 | QRS Duration, Day 7, Pre-dose, n= 15 | QRS Duration, Day 7, 2 hours post-dose, n= 15 | QRS Duration, Day 7, 4 hours post-dose, n= 15 | QRS Duration, Day 9 post-dose, n= 15 | QT Interval, Baseline, n= 16 | QT Interval, Day 1, 2 hours post-dose, n= 16 | QT Interval, Day 1, 4 hours post-dose, n= 16 | QT Interval, Day 4, Pre-dose, n= 15 | QT Interval, Day 4, 2 hours post-dose, n= 15 | QT Interval, Day 4, 4 hours post-dose, n= 15 | QT Interval, Day 7, Pre-dose, n= 15 | QT Interval, Day 7, 2 hours post-dose, n= 15 | QT Interval, Day 7, 4 hours post-dose, n= 15 | QT Interval, Day 9 post-dose, n= 15 | QTcF Interval, Baseline, n= 16 | QTcF Interval, Day 1, 2 hours, n= 16 | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | QTcF Interval, Day 4, Pre-dose, n= 15 | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | QTcF Interval, Day 7, Pre-dose, n= 15 | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | QTcF Interval, Day 9 post-dose, n= 15 | QTcB Interval, Baseline, n= 16 | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | QTcB Interval, Day 4, Pre-dose, n= 15 | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | QTcB Interval, Day 7, Pre-dose, n= 15 | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | QTcB Interval, Day 9 post-dose, n= 15 |
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TAF/FTC+GSK3640254 | 167.3 | 160.4 | 163.6 | 167.1 | 160.7 | 163.7 | 164.9 | 164.3 | 163.9 | 168.8 | 91.4 | 88.9 | 90.1 | 91.8 | 91.8 | 91.1 | 94.5 | 92.7 | 91.6 | 94.3 | 377.7 | 365.1 | 375.9 | 385.6 | 371.5 | 383.9 | 381.7 | 369.9 | 384.1 | 382.4 | 390.0 | 385.6 | 392.4 | 395.0 | 388.3 | 393.4 | 393.0 | 383.8 | 389.5 | 396.8 | 395.7 | 396.4 | 400.4 | 399.2 | 396.2 | 398.0 | 398.3 | 390.5 | 391.9 | 404.0 |
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Period 2: Absolute Values of Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Beats per minute (Mean) |
---|
| Baseline, n= 16 | Day 1, 2 hours post-dose, n= 16 | Day 1, 4 hours post-dose, n= 16 | Day 4, Pre-dose, n= 15 | Day 4, 2 hours post-dose, n= 15 | Day 4, 4 hours post-dose, n= 15 | Day 7, Pre-dose, n= 15 | Day 7, 2 hours post-dose, n= 15 | Day 7, 4 hours post-dose, n= 15 | Day 9 post-dose, n= 15 |
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TAF/FTC+GSK3640254 | 66.5 | 71.5 | 69.3 | 65.1 | 68.9 | 65.3 | 65.9 | 67.4 | 63.3 | 67.7 |
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Period 2: Absolute Values of pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | pH (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 6.03 | 6.22 | 6.07 | 6.07 |
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Period 2: Absolute Values of Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Breaths per minute (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
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TAF/FTC+GSK3640254 | 15.6 | 12.5 | 13.3 | 14.9 | 14.3 |
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Period 2: Absolute Values of Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Ratio (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 1.0147 | 1.0178 | 1.0170 | 1.0151 |
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Period 2: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Degree Celsius (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
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TAF/FTC+GSK3640254 | 36.49 | 36.37 | 36.40 | 36.46 | 36.53 |
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Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 2 Baseline, n= 16 | Basophils, Period 2 Day 3, n= 15 | Basophils, Period 2 Day 7, n= 15 | Basophils, Period 2 Day 9, n= 15 | Eosinophils, Period 2 Baseline, n= 16 | Eosinophils, Period 2 Day 3, n= 15 | Eosinophils, Period 2 Day 7, n= 15 | Eosinophils, Period 2 Day 9, n= 16 | Monocytes, Period 2 Baseline, n= 16 | Monocytes, Period 2 Day 3, n= 16 | Monocytes, Period 2 Day 7, n= 15 | Monocytes, Period 2 Day 9, n= 15 | Leukocytes, Period 2 Baseline, n= 16 | Leukocytes, Period 2 Day 3, n= 16 | Leukocytes, Period 2 Day 7, n= 15 | Leukocytes, Period 2 Day 9, n= 15 | Lymphocytes, Period 2 Baseline, n= 16 | Lymphocytes, Period 2 Day 3, n= 16 | Lymphocytes, Period 2 Day 7, n= 15 | Lymphocytes, Period 2 Day 9, n= 15 | Neutrophils, Period 2 Baseline, n= 16 | Neutrophils, Period 2 Day 3, n= 16 | Neutrophils, Period 2 Day 7, n= 15 | Neutrophils, Period 2 Day 9, n= 15 | Platelets, Period 2 Baseline, n= 16 | Platelets, Period 2 Day 3, n= 16 | Platelets, Period 2 Day 7, n= 15 | Platelets, Period 2 Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 0.040 | 0.036 | 0.038 | 0.043 | 0.208 | 0.185 | 0.157 | 0.153 | 0.545 | 0.492 | 0.448 | 0.421 | 6.20 | 5.14 | 5.39 | 5.51 | 1.718 | 1.560 | 1.570 | 1.563 | 3.724 | 2.857 | 3.189 | 3.324 | 274.3 | 283.4 | 294.0 | 290.4 |
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Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Trillion cells per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 5.203 | 5.090 | 5.190 | 5.001 |
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Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.4453 | 0.4306 | 0.4444 | 0.4247 |
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Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 150.4 | 146.4 | 149.1 | 143.9 |
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Period 2: Absolute Values of the Hematology Parameter: MCH
Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Picograms (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 28.98 | 28.88 | 28.83 | 28.87 |
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Period 2: Absolute Values of the Hematology Parameter: MCV
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Femtoliters (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 85.85 | 84.83 | 85.85 | 85.20 |
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Period 2: Absolute Values of Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 3.3860 | 3.3860 | 3.3860 | 3.3860 |
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Period 2: Change From Baseline in Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Day 4 | SBP, Day 7 | SBP, Day 9 | SBP, Day 10 | DBP, Day 4 | DBP, Day 7 | DBP, Day 9 | DBP, Day 10 |
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TAF/FTC+GSK3640254 | -0.3 | 1.1 | -1.7 | 4.1 | 0.1 | 3.7 | -4.0 | -2.1 |
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Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Day 3, n= 16 | Alkaline phosphatase, Day 7, n= 15 | Alkaline phosphatase, Day 9, n= 15 | AST, Day 3, n= 16 | AST, Day 7, n= 15 | AST, Day 9, n= 15 | ALT, Day 3, n= 16 | ALT, Day 7, n= 15 | ALT, Day 9, n= 15 | GGT, Day 3, n= 16 | GGT, Day 7, n= 15 | GGT, Day 9, n= 15 | LDH, Day 3, n= 16 | LDH, Day 7, n= 15 | LDH, Day 9, n= 15 | CK, Day 3, n= 16 | CK, Day 7, n= 15 | CK, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 3.7 | 2.6 | -1.0 | -1.4 | -0.5 | -0.1 | -2.0 | -1.9 | -0.7 | -0.9 | -1.4 | -1.9 | -7.0 | -8.2 | -7.0 | 3.4 | 11.3 | -2.3 |
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Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Day 3, n= 15 | Glucose, Day 7, n= 15 | Glucose, Day 9, n= 15 | Cholesterol, Day 3, n=15 | Cholesterol, Day 7, n= 15 | Cholesterol, Day 9, n= 16 | Anion gap, Day 3, n= 16 | Anion gap, Day 7, n= 15 | Anion gap, Day 9, n= 15 | Calcium, Day 3, n= 16 | Calcium, Day 7, n= 15 | Calcium, Day 9, n= 15 | CO2, Day 3, n= 16 | CO2, Day 7, n= 15 | CO2, Day 9, n= 15 | Chloride, Day 3, n= 16 | Chloride, Day 7, n= 15 | Chloride, Day 9, n= 15 | Phosphate, Day 3, n= 16 | Phosphate, Day 7, n= 15 | Phosphate, Day 9, n= 15 | Potassium, Day 3, n= 16 | Potassium, Day 7, n= 15 | Potassium, Day 9, n= 15 | Sodium, Day 3, n= 16 | Sodium, Day 7, n= 15 | Sodium, Day 9, n= 15 | Triglycerides, Day 3, n= 16 | Triglycerides, Day 7, n= 15 | Triglycerides, Day 9, n= 15 | BUN, Day 3, n= 16 | BUN, Day 7, n= 15 | BUN, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 0.236 | 0.315 | 0.136 | 0.011 | 0.102 | 0.030 | -0.4 | -0.5 | -0.3 | 0.013 | 0.037 | 0.033 | -0.5 | -0.1 | -0.4 | 2.3 | 0.6 | 1.3 | 0.062 | 0.002 | 0.007 | 0.01 | -0.03 | 0.10 | 1.4 | 0.1 | 0.6 | -0.003 | 0.111 | -0.049 | 0.312 | -0.031 | -0.028 |
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Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Units per Liter (Mean) |
---|
| Amylase, Day 3, n= 16 | Amylase, Day 7, n= 15 | Amylase, Day 9, n= 15 | Lipase, Day 3, n= 16 | Lipase, Day 7, n= 15 | Lipase, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 3.3 | -1.9 | 1.1 | 7.7 | 0.0 | 3.5 |
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Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Day 3, n= 16 | Creatinine, Day 7, n= 15 | Creatinine, Day 9, n= 15 | Total bilirubin, Day 3, n= 16 | Total bilirubin, Day 7, n= 15 | Total bilirubin, Day 9, n= 15 | Direct bilirubin, Day 3, n= 16 | Direct bilirubin, Day 7, n= 15 | Direct bilirubin, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | -2.34 | 3.53 | 0.28 | -0.82 | -0.26 | -1.91 | -0.26 | -0.03 | -0.49 |
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Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Day 3, n= 16 | Total Protein, Day 7, n= 15 | Total Protein, Day 9, n= 15 | Globulin, Day 3, n= 16 | Globulin, Day 7, n= 15 | Globulin, Day 9, n= 15 | Albumin, Day 3, n= 16 | Albumin, Day 7, n= 15 | Albumin, Day 9, n= 15 |
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TAF/FTC+GSK3640254 | 0.1 | 3.1 | 0.8 | 0.2 | 2.3 | 0.2 | -0.1 | 0.9 | 0.6 |
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Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Day 1, 2 hours post-dose, n= 16 | PR Interval, Day 1, 4 hours post-dose, n= 16 | PR Interval, Day 4, Pre-dose, n= 15 | PR Interval, Day 4, 2 hours post-dose, n= 15 | PR Interval, Day 4, 4 hours post-dose, n= 15 | PR Interval, Day 7, Pre-dose, n= 15 | PR Interval, Day 7, 2 hours post-dose, n= 15 | PR Interval, Day 7, 4 hours post-dose, n= 15 | PR Interval, Day 9 post-dose, n= 15 | QRS Duration, Day 1, 2 hours post-dose, n= 16 | QRS Duration, Day 1, 4 hours post-dose, n= 16 | QRS Duration, Day 4, Pre-dose, n= 15 | QRS Duration, Day 4, 2 hours post-dose, n= 15 | QRS Duration, Day 4, 4 hours post-dose, n= 15 | QRS Duration, Day 7, Pre-dose, n= 15 | QRS Duration, Day 7, 2 hours post-dose, n= 15 | QRS Duration, Day 7, 4 hours post-dose, n= 15 | QRS Duration, Day 9 post-dose, n= 15 | QT Interval, Day 1, 2 hours post-dose, n= 16 | QT Interval, Day 1, 4 hours post-dose, n= 16 | QT Interval, Day 4, Pre-dose, n= 15 | QT Interval, Day 4, 2 hours post-dose, n= 15 | QT Interval, Day 4, 4 hours post-dose, n= 15 | QT Interval, Day 7, Pre-dose, n= 15 | QT Interval, Day 7, 2 hours post-dose, n= 15 | QT Interval, Day 7, 4 hours post-dose, n= 15 | QT Interval, Day 9 post-dose, n= 15 | QTcF Interval, Day 1, 2 hours post-dose, n= 16 | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | QTcF Interval, Day 4, Pre-dose, n= 15 | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | QTcF Interval, Day 7, Pre-dose, n= 15 | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | QTcF Interval, Day 9 post-dose, n= 15 | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | QTcB Interval, Day 4, Pre-dose, n= 15 | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | QTcB Interval, Day 7, Pre-dose, n= 15 | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | QTcB Interval, Day 9 post-dose, n= 15 |
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TAF/FTC+GSK3640254 | -6.8 | -3.7 | -0.5 | -6.9 | -3.9 | -2.7 | -3.3 | -3.7 | 1.2 | -2.5 | -1.4 | 0.5 | 0.5 | -0.2 | 3.3 | 1.5 | 0.3 | 3.0 | -12.6 | -1.8 | 7.3 | -6.8 | 5.6 | 3.5 | -8.4 | 5.8 | 4.1 | -4.4 | 2.4 | 6.1 | -0.6 | 4.5 | 4.1 | -5.1 | 0.6 | 7.9 | 0.7 | 4.7 | 5.5 | 2.5 | 4.3 | 4.6 | -3.2 | -1.7 | 10.3 |
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Period 2: Change From Baseline in Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Beats per minute (Mean) |
---|
| Day 1, 2 hours post-dose, n= 16 | Day 1, 4 hours post-dose, n= 16 | Day 4, Pre-dose, n= 15 | Day 4, 2 hours post-dose, n= 15 | Day 4, 4 hours post-dose, n= 15 | Day 7, Pre-dose, n= 15 | Day 7, 2 hours post-dose, n= 15 | Day 7, 4 hours post-dose, n= 15 | Day 9 post-dose, n= 15 |
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TAF/FTC+GSK3640254 | 5.0 | 2.8 | -0.5 | 3.3 | -0.3 | 0.3 | 1.8 | -2.3 | 2.1 |
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Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Trillion cells per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.113 | 0.000 | -0.189 |
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Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.0147 | -0.0007 | -0.0204 |
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Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -3.9 | -1.1 | -6.4 |
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Period 2: Change From Baseline in Hematology Parameter of MCH
Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Picograms (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.11 | -0.21 | -0.17 |
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Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 2 Day 3, n= 15 | Basophils, Period 2 Day 7, n= 15 | Basophils, Period 2 Day 9, n= 15 | Eosinophils, Period 2 Day 3, n=15 | Eosinophils, Period 2 Day 7, n=15 | Eosinophils, Period 2 Day 9, n=16 | Monocytes, Period 2 Day 3, n= 16 | Monocytes, Period 2 Day 7, n= 15 | Monocytes, Period 2 Day 9, n= 15 | Leukocytes, Period 2 Day 3, n= 16 | Leukocytes, Period 2 Day 7, n= 15 | Leukocytes, Period 2 Day 9, n= 15 | Lymphocytes, Period 2 Day 3, n= 16 | Lymphocytes, Period 2 Day 7, n= 15 | Lymphocytes, Period 2 Day 9, n= 15 | Neutrophils, Period 2 Day 3, n= 16 | Neutrophils, Period 2 Day 7, n= 15 | Neutrophils, Period 2 Day 9, n= 15 | Platelets, Period 2 Day 3, n= 16 | Platelets, Period 2 Day 7, n= 15 | Platelets, Period 2 Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.004 | -0.002 | 0.003 | -0.023 | -0.039 | -0.043 | -0.053 | -0.077 | -0.104 | -1.06 | -0.61 | -0.49 | -0.158 | -0.105 | -0.111 | -0.868 | -0.417 | -0.282 | 9.2 | 19.8 | 16.2 |
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Period 2: Change From Baseline in pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | pH (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.19 | 0.10 | 0.10 |
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Period 2: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Beats per minute (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | 2.4 | 1.9 | -0.3 | 9.5 |
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Period 2: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Breaths per minute (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | -3.2 | -2.4 | -0.8 | -1.5 |
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Period 2: Change From Baseline in Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Ratio (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.0031 | 0.0024 | 0.0005 |
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Period 2: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Degree Celsius (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | -0.10 | -0.07 | -0.01 | 0.07 |
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Period 2: Change From Baseline in Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.0000 | 0.0000 | 0.0000 |
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Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Baseline | Glucose, Day 7 | Glucose, Day 14 | Cholesterol, Baseline | Cholesterol, Day 7 | Cholesterol, Day 14 | Anion gap, Baseline | Anion gap, Day 7 | Anion gap, Day 14 | Calcium, Baseline | Calcium, Day 7 | Calcium, Day 14 | CO2, Baseline | CO2, Day 7 | CO2, Day 14 | Chloride, Baseline | Chloride, Day 7 | Chloride, Day 14 | Phosphate, Baseline | Phosphate, Day 7 | Phosphate, Day 14 | Potassium, Baseline | Potassium, Day 7 | Potassium, Day 14 | Sodium, Baseline | Sodium, Day 7 | Sodium, Day 14 | Triglycerides, Baseline | Triglycerides, Day 7 | Triglycerides, Day 14 | BUN, Baseline | BUN, Day 7 | BUN, Day 14 |
---|
TAF/FTC | 5.111 | 4.951 | 4.791 | 4.253 | 4.249 | 3.864 | 8.7 | 10.6 | 10.9 | 2.359 | 2.387 | 2.387 | 31.7 | 30.1 | 30.8 | 103.3 | 102.2 | 101.3 | 1.078 | 1.094 | 1.103 | 4.25 | 4.28 | 4.22 | 139.4 | 138.8 | 138.8 | 1.076 | 1.168 | 1.033 | 4.441 | 4.423 | 4.246 |
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Period 1: Absolute Values of Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 5.9255 | 3.3860 | 3.3860 |
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Period 1: Absolute Values of the Hematology Parameter: MCV
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Femtoliters (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 85.92 | 85.09 | 85.85 |
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Period 1: Absolute Values of the Hematology Parameter: MCH
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Picograms (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 28.63 | 28.75 | 28.98 |
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Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 142.0 | 148.1 | 150.4 |
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Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 0.4264 | 0.4384 | 0.4453 |
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Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Trillion cells per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 4.977 | 5.166 | 5.203 |
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Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 1 Baseline | Basophils, Period 1 Day 7 | Basophils, Period 1 Day 14 | Eosinophils, Period 1 Baseline | Eosinophils, Period 1 Day 7 | Eosinophils, Period 1 Day 14 | Monocytes, Period 1 Baseline | Monocytes, Period 1 Day 7 | Monocytes, Period 1 Day 14 | Leukocytes, Period 1 Baseline | Leukocytes, Period 1 Day 7 | Leukocytes, Period 1 Day 14 | Lymphocytes, Period 1 Baseline | Lymphocytes, Period 1 Day 7 | Lymphocytes, Period 1 Day 14 | Neutrophils, Period 1 Baseline | Neutrophils, Period 1 Day 7 | Neutrophils, Period 1 Day 14 | Platelets, Period 1 Baseline | Platelets, Period 1 Day 7 | Platelets, Period 1 Day 14 |
---|
TAF/FTC | 0.046 | 0.041 | 0.040 | 0.225 | 0.204 | 0.205 | 0.522 | 0.536 | 0.571 | 6.18 | 6.10 | 6.45 | 1.945 | 1.699 | 1.683 | 3.441 | 3.628 | 3.954 | 253.3 | 256.6 | 275.1 |
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Period 1: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Degree Celsius (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 36.49 | 36.33 | 36.34 | 36.41 | 36.34 | 36.25 |
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Period 2: Ctau of GSK3640254
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 0.7883 |
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Period 2: Ctau of TFV
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 8.244 |
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Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Baseline | Creatinine, Day 7 | Creatinine, Day 14 | Total bilirubin, Baseline | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Direct bilirubin, Baseline | Direct bilirubin, Day 7 | Direct bilirubin, Day 14 |
---|
TAF/FTC | 80.16 | 85.85 | 87.52 | 9.64 | 11.89 | 11.74 | 1.76 | 1.91 | 2.40 |
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Period 2:Cmax of FTC
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 1701 |
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Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Femtoliters (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -0.83 | -0.07 |
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Average Tenofovir Concentrations in Plasma.
Average tenofovir concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 61.02 |
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Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
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 |
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Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.
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 |
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Average Emtricitabine Concentrations in Plasma.
Average emtricitabine concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 78.07 |
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Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
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 |
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Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
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 |
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Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.
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 |
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Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
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 |
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Average Progesterone Concentrations in Serum.
Average progesterone concentrations in serum measured in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 2.46 |
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Average Estradiol Concentrations in Serum.
Average estradiol concentrations in serum reported in pg/mL (NCT03917420)
Timeframe: Day 5
Intervention | pg/ml (Mean) |
---|
Tenofovir/Emtricitabine | 101.06 |
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Average Testosterone Concentrations in Serum.
Average testosterone concentrations in serum measured in ng/mL (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 55.45 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 7705 | 2120 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 6855 |
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Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 51.23 | 1.03 |
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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 45.9 | 11.9 |
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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 20.2 | 14.7 |
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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 39.1 | 18.2 |
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Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 23.7 |
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Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 0.30 | 0 |
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Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0.03 | 0 |
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Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 0 | 0 |
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Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.01 |
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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 198.2 | 15.1 |
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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 104.3 | 12.5 |
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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 187.5 | 56.3 |
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Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 116.5 |
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Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 9.25 | 0 |
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Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 1.23 | 0.02 |
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Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 9.54 | 0.02 |
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Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.17 |
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Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 41.47 | 0 |
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Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0.60 | 0.02 |
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Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.31 |
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Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 0 | 0 |
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Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0 | 0 |
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Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 0 | 0 |
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Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0 |
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Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 1725 | 0 |
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Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 113 | 0 |
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Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 2710 | 0 |
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Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 300 |
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Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 1818 | 0 |
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Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 232 | 0 |
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Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 2243 | 0 |
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Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 283 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 621 | 158 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 429 | 117 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 569 | 291 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 375 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 4 hour | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 7800 | 955 |
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Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 5140 | 714 |
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Percentage of Participants With Grade 3 or Greater Adverse Events
The percentage of participants experiencing grade 3 or greater adverse events at Week 24 (NCT03998176)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 12 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 analyzed by the snapshot algorithm, which defines a participants 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. (NCT03998176)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 21 |
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 analyzed by the snapshot algorithm, which defines a participants 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. (NCT03998176)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 32 |
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Percentage of Participants With Grade 3 or Greater Adverse Events
The percentage of participants experiencing grade 3 or greater adverse events at Week 48 (NCT03998176)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 15 |
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Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)
Tenofovir diphosphate concentration in dried blood spots at week 4 (NCT04050371)
Timeframe: After 4 weeks of daily observed dosing of FTC/TDF
Intervention | fmol/punch (Median) |
---|
Transgender Women | 973.5 |
Transgender Men | 1078 |
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Estradiol Concentration
Estradiol concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF
Intervention | pg/mL (Median) |
---|
| Week 0 | Week 4 |
---|
Transgender Men | 24.2 | 23.1 |
,Transgender Women | 141.5 | 116 |
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Total Testosterone
Total testosterone concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF
Intervention | ng/dL (Median) |
---|
| Week 0 | Week 4 |
---|
Transgender Men | 559 | 595 |
,Transgender Women | 56.5 | 56.7 |
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Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms
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 |
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Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)
"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 |
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Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods
"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 |
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Geometric Mean of Infant DPV Concentrations From Plasma by Visit
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 |
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Geometric Mean of Infant FTC-TP Concentration by Visit
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 |
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Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit
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 |
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Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations
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 |
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Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations
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 |
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Geometric Mean of Maternal TFV-DP Concentrations by Visit
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 |
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Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit
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 |
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Geometric Mean of Maternal FTC-TP Concentrations by Visit
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 |
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Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit
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 |
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Geometric Mean of Maternal DPV Concentrations From Plasma by Visit
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 |
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Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations
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 |
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Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations
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 |
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Geometric Mean of Infant TFV-DP Concentrations by Visit
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 |
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Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms
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 |
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Number and Proportion of Infants With Detectable TFV-DP Concentrations
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 |
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Number and Proportion of Infants With Detectable Plasma DPV Concentrations
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 |
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Number and Proportion of Infants With Detectable FTC-TP Concentrations
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 |
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Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations
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 |
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The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product
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 |
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Residual Drug Levels in Returned VRs
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 |
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Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations
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 |
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Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms
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 |
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Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms
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 |
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Change From Baseline in Body Weight at Week 48
Body weight was measured at baseline and at Week 48. Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48
Intervention | kilogram (Mean) |
---|
Group 1: DOR/ISL | 3.45 |
Group 2: BIC/FTC/TAF | 3.32 |
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Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 48 weeks by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48
Intervention | cells/mm^3 (Mean) |
---|
Group 1: DOR/ISL | 182.4 |
Group 2: BIC/FTC/TAF | 233.5 |
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Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. (NCT04233879)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
Group 1: DOR/ISL | 1 |
Group 2: BIC/FTC/TAF | 0 |
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Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE were reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 7.4 |
Group 2: BIC/FTC/TAF | 3.3 |
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Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <40 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 88.6 |
Group 2: BIC/FTC/TAF | 86.3 |
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Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott Real Time polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 88.9 |
Group 2: BIC/FTC/TAF | 88.3 |
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Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <200 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 89.6 |
Group 2: BIC/FTC/TAF | 88.6 |
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Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experience an AE was reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 90.6 |
Group 2: BIC/FTC/TAF | 86.3 |
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Number of Sex Acts by Condom Usage
"Number of sex acts by condom usage was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of sex acts with up to 3 partners.~In the past 30 days, how many times did you have sex with ['this partner']? When I ask about the number of times you had sex, please count each sexual act. For example, if you had 2 rounds of sexual intercourse with your partner on a single evening, count that as two times you had sex. Please remember that this only refers to vaginal and anal sex. It does not refer to oral sex.~To assess condom use by sex act, the following question was asked to assess the number of sex acts with condoms and without condoms with up to 3 partners:~Of the ___ sex acts, how many times did you not use condoms the entire time?" (NCT04318210)
Timeframe: Up to 12 months
Intervention | sex acts (Mean) |
---|
| Number of sex acts among women | Number of sex acts among men | Number of condomless sex acts among women | Number of condomless sex acts among men | Number of sex acts involving a condom among women | Number of sex acts involving a condom among men |
---|
TDF-FTC as PrEP | 4.01 | 5.95 | 1.28 | 1.70 | 2.72 | 4.24 |
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Self-reported Drug Adherence Over the Past 3 Days
"A 30-day supply of TDF/FTC was dispensed at each monthly visit, for up to 12 months.~Participants were asked monthly about their drug adherence and were asked to recall their time of dosing over the past 3 days.~Question: Please think back to [yesterday, 2 days ago, 3 days ago]. What time did you take Truvada? Was it in the morning, afternoon, evening, or you weren't able to take the pill that day?" (NCT04318210)
Timeframe: Up to 12 Months
Intervention | Participants (Count of Participants) |
---|
| Took daily dosage in past 3 days | Took 2 doses in past 3 days | Took 1 doses in past 3 days | No doses taken in past 3 days |
---|
TDF-FTC as PrEP | 199 | 9 | 2 | 19 |
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Serious Adverse Events
Study visits were scheduled every month until study completion. Participants were instructed to return to the clinic for evaluation in event of illness. Participants reported any adverse effects (AEs) at monthly or interim visits and were determined as serious adverse events (SAE) when at least possibly related to study drug. DAIDS Table for Grading Severity of Adult Adverse Experiences for Vaccine & Prevention Research Programs was used for grading. Definitions: Grade 3-'probably related'-strong temporal relationship to study product that cannot be explained by participant's clinical state or other factors and a causal relationship is biologically plausible. Grade 4-'definitely related'-distinct temporal relationship to administration of the study product that cannot be explained by the participant's clinical state or other factors or AE occurs on re-challenge or the AE is a known reaction to the product or chemical group or can be predicted by the product's pharmacology. (NCT04318210)
Timeframe: Up to 12 Months
Intervention | participants (Number) |
---|
| Hyperamylasemia, Grade 3 | Hypophosphatemia, Grade 3 | Hypercreatininemia, Grade 1 |
---|
TDF-FTC as PrEP | 2 | 5 | 1 |
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Number of Sex Partners
"Number of sex partners was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of partners reported in the past 30 days:~In the past 30 days, with how many partners have you had sexual intercourse?" (NCT04318210)
Timeframe: Up to 12 months
Intervention | sexual partners (Mean) |
---|
| Number of sex partners among women, overall | Number of sex partners among men, overall |
---|
TDF-FTC as PrEP | 0.87 | 1.03 |
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HIV Seroconversion
Study visits were scheduled every month until completion of the study and during monthly study visits, HIV testing was performed, for up to 12 months. During monthly visits, routine HIV testing was performed with two HIV rapid tests. If HIV-infection was suspected, HIV antigen-antibody (Ag/Ab) combination enzyme immunoassay (EIA) (Bio-Rad, GS HIV Combo Ag/Ab EIA) testing was performed, and RNA viral load was measured. (NCT04318210)
Timeframe: Up to 12 Months
Intervention | Participants (Count of Participants) |
---|
TDF-FTC as PrEP | 0 |
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Extracellular Tenofovir (TFV) for Recent Drug Exposure
"Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring extracellular tenofovir (TFV) for recent drug exposure (~24 hours). Of 229 participants, 196 participants had monthly DBSs available for analysis. A sampling algorithm was designed to make inference to TFV and TFV-DP levels at all 12 months. For the TFV extracellular analysis, participants were randomly assigned to one of three sampling schedules, with equal probability: (a) months 1, 2, 5, 8, and 11; (b) months 1, 3, 6, 9, and 12; and (c) months 1, 4, 7, 10, and 12. These 196 participants contributed a total of 777 monthly DBSs for the TFV extracellular analysis.~Extracellular TFV detectability was defined as having a mean TFV level (of up to four measurements) equal to or greater than 5 ng/mL." (NCT04318210)
Timeframe: Up to 12 months
Intervention | number of DBS samples (Number) |
---|
| Detectable TFV | No detectable TFV |
---|
TDF-FTC as PrEP | 713 | 64 |
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Intracellular Tenofovir-diphosphate (TFV-DP)
Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring intracellular tenofovir-diphosphate (TFV-DP) for long-term drug exposure (~7 days). The 196 participants who had monthly DBSs available were stratified by site, gender, and the 3 patterns previously assigned for the TFV extracellular analysis (2×2×3 = 12 strata). Then 60 participants were selected, 5 from each of the 12 strata, to balance by site, gender, and the above 3 patterns were maintained. In turn, the monthly DBSs indicated by the assigned pattern were analyzed. These 60 participants contributed a total of 237 monthly DBSs for the TFV-DP intracellular analysis. The observed TFV-DP levels in our study population were categorized as follows (units of drug in fmol/mL): 0 doses per week (<912); 1 dose taken per week (≥912 and <1824); 2 doses taken per week (≥1824 and <2688); 3 doses taken per week (≥2688 and <3600); 4 doses taken per week (≥3600 and <4464); 5 to 7 doses taken (NCT04318210)
Timeframe: Up to 12 months
Intervention | number of DBS samples (Number) |
---|
| 7 doses per week | 6 doses per week | 5 doses per week | 4 doses per week | 3 doses per week | 2 doses per week | 1 dose per week | 0 doses per week |
---|
TDF-FTC as PrEP | 141 | 29 | 20 | 6 | 12 | 4 | 5 | 19 |
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HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment (NCT04465916)
Timeframe: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
Intervention | log10 IU/mL (Least Squares Mean) |
---|
Experimental Arm | -0.029 |
Control Arm | -0.066 |
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Virologic Failure Rate
Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period (NCT04465916)
Timeframe: 40 weeks
Intervention | participants (Number) |
---|
| Week 16 | Week 20 | Week 28 | Week 40 |
---|
Control Arm | 0 | 0 | 0 | 0 |
,Experimental Arm | 0 | 0 | 0 | 0 |
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Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire
"Using a 4-point scale (1=Completely Unacceptable; 2=Somewhat Unacceptable; 3=Somewhat Acceptable; 4=Highly Acceptable), participants were asked to answer the following question about their experience with the product: If a rectal douche like the one you were administered today at the clinic could protect you against HIV, would you consider using this douche?. The endpoint was operationalized as binary, with scores 1 to 2 grouped as low acceptability and scores 3 to 4 as high acceptability." (NCT04686279)
Timeframe: Following administration of study product, up to 1 hour
Intervention | Participants (Count of Participants) |
---|
| Low Acceptability | High Acceptability |
---|
TFV Medicated Douche | 0 | 8 |
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Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
The safety of a single dose of a TFV douche when applied rectally is measured by the number of ≥Grade 2 adverse events (AEs) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, and whether AEs are attributed to the study product. (NCT04686279)
Timeframe: Following administration of study product, up to 7 days
Intervention | events (Number) |
---|
| Number of Grade 2 Adverse Events | Number of Grade 2 AEs attributed to study product |
---|
TFV Medicated Douche | 3 | 0 |
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Tenofovir Diphosphate (TFV-DP) Concentration
Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured the study douche administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour post dose), Day 2 (24 hours post dose), or Day 4 (72 hours post dose). (NCT04686279)
Timeframe: At 1 hour, 24 hours, or 72 hours after the TFV douche administration
Intervention | femtomole/million cells (Median) |
---|
| 1 hour post-dose | 24 hours post-dose | 72 Hours post-dose |
---|
TFV Medicated Douche | 2441 | 3472 | 406 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 IU/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 | Off-Treatment Week 44 | Off-Treatment Week 48 |
---|
VBR + AB-720 + SOC NrtI (Continued NrtI Only) | -1.6 | -1.4 | -1.4 | -1.5 | -1.7 | -2.0 | -2.0 | -1.9 | -1.8 | -1.7 | -1.6 | -2.2 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 IU/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 |
---|
VBR + AB-729 + SOC NrtI (Discontinued All) | -1.9 | -1.9 | -1.8 | -1.7 | -1.8 | -1.7 | -1.8 | -1.7 | -1.6 |
,VBR + SOC Nrtl (Continued NrtI Only) | 0 | 0 | -0.1 | -0.1 | 0 | 0 | 0 | 0.0 | 0 |
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Change From Baseline in Mean log10 HBV RNA Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 U/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 |
---|
AB-729 + SOC NrtI (Discontinued All) | -1.1 | -0.8 | -0.8 | -0.8 | -0.6 | -0.5 | -0.6 | -0.1 | .5 | -0.4 |
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Number of Participants With One or More Adverse Events (AEs)
(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Intervention | Participants (Count of Participants) |
---|
VBR + AB-729 + SOC NrtI | 26 |
VBR + SOC NrtI | 12 |
AB-729 + SOC NrtI | 12 |
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Number of Participants With One or More Abnormal Laboratory Result
(NCT04820686)
Timeframe: Laboratory results were collected from the time of signing the informed consent until the study was early terminated, up to 96 weeks.
Intervention | Participants (Count of Participants) |
---|
VBR + AB-729 + SOC NrtI | 30 |
VBR + SOC NrtI | 16 |
AB-729 + SOC NrtI | 16 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
Intervention | log10 IU/mL (Mean) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 |
---|
AB-729 + SOC NrtI | -0.2 | -0.3 | -0.6 | -1.1 | -1.3 | -1.6 | -1.6 | -1.7 | -1.7 | -1.9 | -1.8 | -1.9 | -1.9 |
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Change From Baseline in Mean log10 HBV RNA On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.
Intervention | log10 U/mL (Mean) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | Week 56 |
---|
VBR + AB-729 + SOC NrtI | -.6 | -.7 | -.7 | -.6 | -0.6 | -0.7 | -0.5 | -0.9 | -0.7 | -0.7 | -0.6 | -0.6 | -0.7 | -0.7 | -1.0 |
,VBR + SOC NrtI | -.2 | 0.2 | 0 | 0 | 0 | .1 | .2 | .2 | .1 | .1 | .1 | 0 | -0.1 | -0.1 | .2 |
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Number of Participants With Premature Treatment Discontinuation Due to AEs
(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Intervention | Participants (Count of Participants) |
---|
| AB-729 discontinuation due to AE |
---|
AB-729 + SOC NrtI | 0 |
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Number of Participants With Premature Treatment Discontinuation Due to AEs
(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Intervention | Participants (Count of Participants) |
---|
| VBR discontinuation due to AE |
---|
VBR + SOC NrtI | 1 |
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Change From Baseline in Mean log10 HBV RNA On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and 56.
Intervention | log10 U/mL (Mean) |
---|
| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 |
---|
AB-729 + SOC NrtI | -.4 | -.6 | -0.5 | -0.7 | -0.8 | -0.8 | -0.7 | -0.8 | -0.7 | -0.7 | -0.6 | -0.8 | -0.7 |
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Change From Baseline in Mean log10 HBV RNA Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 U/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 |
---|
VBR + AB-729 + SOC NrtI (Discontinued All) | -0.6 | -0.5 | -0.7 | 0 | .7 | .5 | 0 | .2 | 0 |
,VBR + SOC Nrtl (Continued NrtI Only) | -0.1 | 0 | -0.2 | 0.3 | -0.2 | -0.4 | -0.7 | -0.2 | 0 |
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Change From Baseline in Mean log10 HBV RNA Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 U/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 | Off-Treatment Week 44 | Off-Treatment Week 48 |
---|
VBR + AB-720 + SOC NrtI (Continued NrtI Only) | -0.8 | -0.5 | -0.6 | -0.5 | -0.3 | -0.4 | -0.8 | -1.0 | -1.0 | -0.9 | -1.0 | -1.2 |
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Number of Participants With Premature Treatment Discontinuation Due to AEs
(NCT04820686)
Timeframe: AEs were collected from the time of signing the informed consent until the final follow-up visit, up to 96 weeks.
Intervention | Participants (Count of Participants) |
---|
| VBR discontinuation due to AE | AB-729 discontinuation due to AE |
---|
VBR + AB-729 + SOC NrtI | 3 | 1 |
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Change From Baseline in Mean log10 HBV RNA Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 U/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 | Off-Treatment Week 44 |
---|
AB-729 + SOC NrtI (Continued NrtI Only) | -0.9 | -0.9 | -1.0 | -0.9 | -0.7 | 0.7 | -0.6 | -0.3 | -0.1 | -0.6 | .1 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 IU/mL (Mean) |
---|
| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 |
---|
AB-729 + SOC NrtI (Discontinued All) | -1.8 | -1.8 | -1.7 | -1.4 | -1.2 | -1.3 | -1.6 | -1.5 | -1.2 | -1.2 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) Off-Treatment
(NCT04820686)
Timeframe: Weeks 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96.
Intervention | log10 IU/mL (Mean) |
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| Off-Treatment Week 4 | Off-Treatment Week 8 | Off-Treatment Week 12 | Off-Treatment Week 16 | Off-Treatment Week 20 | Off-Treatment Week 24 | Off-Treatment Week 28 | Off-Treatment Week 32 | Off-Treatment Week 36 | Off-Treatment Week 40 | Off-Treatment Week 44 |
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AB-729 + SOC NrtI (Continued NrtI Only) | -1.8 | -1.8 | -2.0 | -1.6 | -2.1 | -2.9 | -3.0 | -3.2 | -3.0 | -2.9 | -2.8 |
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Change From Baseline in Mean log10 Serum Hepatitis B Surface Antigen (HBsAg) On-Treatment
Subjects remained on their assigned oral agents (ie, VBR+NrtI for Groups 1 and 2; NrtI for Group 3) until Week 48 laboratory results required for Treatment Stopping Criteria assessment were available so there are some results past Week 48. (NCT04820686)
Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56.
Intervention | log10 IU/mL (Mean) |
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| Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | Week 56 |
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VBR + AB-729 + SOC NrtI | -0.3 | -.3 | -0.7 | -1.2 | -1.5 | -1.7 | -1.7 | -1.7 | -1.8 | -1.9 | -1.8 | -1.9 | -1.9 | -1.8 | -1.5 |
,VBR + SOC Nrtl | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0.1 |
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Participant Partners Who Tested for HIV
The secondary outcome was number of partners who tested for HIV (as reported by the female partner and confirmed with photo or used HIVST in intervention arm) by study arm. (NCT04897737)
Timeframe: 1 month after intervention
Intervention | male partners (Number) |
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Intervention | 35 |
Control | 9 |
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Recent PrEP Adherence
The primary study outcome is recent PrEP adherence according to urine tenofovir test by study arm. (NCT04897737)
Timeframe: 1 month after intervention
Intervention | Participants (Count of Participants) |
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Intervention | 33 |
Control | 18 |
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