CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 632 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/NCT02345252
NCT02345252Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

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

In Brief

A Phase 3 clinical trial evaluating FTC/RPV/TAF, FTC/RPV/TDF Placebo, and 2 other interventions for HIV-1 Infection. Completed, enrolled 632 participants across 117 sites in 12 countries.

Detailed Summary

The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 26, 2015
Enrollment StartJan 26, 2015
Primary CompletionJun 22, 2016
Study CompletionJan 9, 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

FTC/RPV/TDF Placebodrug

Tablets administered orally once daily

FTC/RPV/TDFdrug

200/25/300 mg FDC tablets administered orally once daily

FTC/RPV/TAF Placebodrug

Tablets administered orally once daily