At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 872 enrolled

Drug / intervention

E/C/F/TAF +3 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/NCT01797445

NCT01797445Phase 3Completed

Compare CT.gov

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

Gilead Sciences·interventional·Posted Feb 22, 2013·Updated Mar 2, 2020

In Brief

A Phase 3 clinical trial evaluating E/C/F/TAF, E/C/F/TDF, and 2 other interventions for HIV and HIV Infections. Completed, enrolled 872 participants across 117 sites in 11 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) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV, HIV Infections

CountriesCanada, Dominican Republic, France, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Sweden, United Kingdom, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedFeb 2013

Enrollment StartMar 2013

Primary CompletionSep 2014

Study CompletionOct 2018

TodayJul 2026

First PostedFeb 22, 2013

Enrollment StartMar 12, 2013

Primary CompletionSep 19, 2014

Study CompletionOct 3, 2018

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 13.4 years ago

Interventions

E/C/F/TAFdrug

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

E/C/F/TDFdrug

150/150/200/300 mg FDC tablet administered orally once daily

E/C/F/TDF Placebodrug

Tablet administered orally once daily

E/C/F/TAF Placebodrug

Tablet administered orally once daily