CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 881 enrolled
Drug / intervention
FTC/RPV/TAF +3 moredrug
Likely dose
FTC/RPV/TAF 25 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/NCT02345226
NCT02345226Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

Gilead Sciences·interventional·Posted Jan 26, 2015·Updated Jan 2, 2020

In Brief

A Phase 3 clinical trial evaluating FTC/RPV/TAF, EFV/FTC/TDF Placebo, and 2 other interventions for HIV-1 Infection. Completed, enrolled 881 participants across 117 sites in 9 countries.

Detailed Summary

The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBelgium, Canada, France, Germany, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartJan 26, 2015
Primary CompletionJun 29, 2016
Study CompletionJan 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.4 years ago

Interventions

FTC/RPV/TAFdrug

200/25/25 mg FDC tablets administered orally once daily

EFV/FTC/TDF Placebodrug

Tablets administered orally once daily

EFV/FTC/TDFdrug

600/200/300 mg FDC tablets administered orally once daily

FTC/RPV/TAF Placebodrug

Tablets administered orally once daily