CI

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/NCT01780506
NCT01780506Phase 3Completed
CompareCT.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 Jan 31, 2013·Updated Nov 19, 2018

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 12 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) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesAustralia, Austria, Belgium, Canada, Italy, Japan, Puerto Rico, Spain, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2013
Enrollment StartDec 26, 2012
Primary CompletionAug 26, 2014
Study CompletionSep 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 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