CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 725 enrolled
Drug / intervention
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC +5 moredrug
Likely dose
Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02431247
NCT02431247Phase 3Completed
CompareCT.gov

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/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

Janssen Sciences Ireland UC·interventional·Posted Apr 30, 2015·Updated Sep 28, 2022

In Brief

A Phase 3 clinical trial evaluating Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC, DRV/COBI FDC, and 4 other interventions for Immunodeficiency Virus Type 1, Human. Completed, enrolled 725 participants across 80 sites in 10 countries.

Detailed Summary

The purpose of this study is to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmunodeficiency Virus Type 1, Human
CountriesBelgium, Canada, France, Germany, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 30, 2015
Enrollment StartJul 6, 2015
Primary CompletionMar 2, 2017
Study CompletionSep 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.2 years ago

Interventions

Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDCdrug

A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.

DRV/COBI FDCdrug

A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.

FTC/TDF FDCdrug

A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.

D/C/F/TAF FDC - Matching Placebodrug

Matching placebo of D/C/F/TAF FDC will be administered once daily.

FTC/TDF FDC Matching Placebodrug

Matching placebo of FTC/TDF FDC will be administered once daily.

DRV/COBI FDC Matching Placebodrug

Matching placebo of DRV/COBI FDC will be administered once daily.