CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
D/C/F/TAF +7 moredrug
Likely dose
D/C/F/TAF 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/NCT01565850
NCT01565850Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Darunavir/Cobicistat/Emtricitabine/GS-7340 Single Tablet Regimen Versus Cobicistat-boosted Darunavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in HIV-1 Infected, Antiretroviral Treatment Naive Adults

Gilead Sciences·interventional·Posted Mar 29, 2012·Updated Apr 11, 2016

In Brief

A Phase 2 clinical trial evaluating D/C/F/TAF, DRV, and 6 other interventions for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 153 participants across 44 sites in 2 countries.

Detailed Summary

This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immunodeficiency Syndrome, HIV Infections
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2012
Enrollment StartApr 1, 2012
Primary CompletionJan 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.3 years ago

Interventions

D/C/F/TAFdrug

DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily

DRVdrug

DRV 800 mg (2 × 400 mg tablets) administered orally once daily

COBIdrug

COBI 150 mg tablet administered orally once daily

FTC/TDFdrug

FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily

D/C/F/TAF Placebodrug

D/C/F/TAF placebo tablet administered orally once daily

DRV Placebodrug

DRV placebo tablet administered orally once daily

COBI Placebodrug

COBI placebo tablet administered orally once daily

FTC/TDF Placebodrug

FTC/TDF placebo tablet administered orally once daily