CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 439 enrolled
Drug / intervention
NNRTI +2 moredrug
Likely dose
FTC/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/NCT01495702
NCT01495702Phase 3Completed
CompareCT.gov

A Phase 3b Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Plus Emtricitabine (FTC) and Tenofovir DF (TDF) to the Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically Suppressed, HIV 1 Infected Patients

Gilead Sciences·interventional·Posted Dec 20, 2011·Updated Jan 7, 2016

In Brief

A Phase 3 clinical trial evaluating NNRTI, FTC/TDF, and 1 other intervention for Acquired Immunodeficiency Syndrome and HIV Infections. Completed, enrolled 439 participants across 80 sites in 12 countries.

Detailed Summary

This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcquired Immunodeficiency Syndrome, HIV Infections
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Portugal, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionNov 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.5 years ago

Interventions

NNRTIdrug

NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.

FTC/TDFdrug

FTC/TDF (200/300 mg) administered according to prescribing information

Stribilddrug

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food