CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 279 enrolled
Drug / intervention
E/C/F/TDF +3 moredrug
Likely dose
E/C/F/TDF 300 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/NCT01497899
NCT01497899Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences·interventional·Posted Dec 23, 2011·Updated Nov 19, 2018

In Brief

A Phase 2 clinical trial evaluating E/C/F/TDF, E/C/F/TAF Placebo, and 2 other interventions for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 279 participants across 41 sites in 2 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2011
Enrollment StartDec 28, 2011
Primary CompletionOct 17, 2012
Study CompletionAug 22, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.5 years ago

Interventions

E/C/F/TDFdrug

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

E/C/F/TAF Placebodrug

Tablet administered orally once daily

E/C/F/TAFdrug

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

E/C/F/TDF Placebodrug

Tablet administered orally once daily