CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
E/C/F/TAF +2 moredrug
Likely dose
E/C/F/TAF 10 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/NCT01968551
NCT01968551Phase 3Completed
CompareCT.gov

A Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults

Gilead Sciences·interventional·Posted Oct 24, 2013·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF, DRV, and 1 other intervention for HIV-1 and 2 related conditions. Completed, enrolled 158 participants across 62 sites in 2 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1, HIV Infections, Acquired Immunodeficiency Syndrome
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 24, 2013
Enrollment StartSep 3, 2013
Primary CompletionJul 21, 2015
Study CompletionJul 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.7 years ago

Interventions

E/C/F/TAFdrug

150/150/200/10 mg FDC tablet administered orally once daily

DRVdrug

800 mg tablet administered orally once daily

Baseline DRV- containing ARV regimendrug

Participants will take their baseline DRV- containing ARV regimen as prescribed.