CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 enrolled
Drug / intervention
F/TAF +4 moredrug
Likely dose
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/NCT02469246
NCT02469246Phase 3Completed
CompareCT.gov

A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

Gilead Sciences·interventional·Posted Jun 11, 2015·Updated Oct 25, 2019

In Brief

A Phase 3 clinical trial evaluating F/TAF, ABC/3TC, and 3 other interventions for HIV-1 Infection. Completed, enrolled 567 participants across 80 sites in 12 countries.

Detailed Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC tablets versus maintaining ABC/3TC in human immunodeficiency virus type 1 (HIV-1) infected adults who are virologically suppressed on regimens containing ABC/3TC.

Study Details

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

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 11, 2015
Enrollment StartJun 29, 2015
Primary CompletionDec 11, 2017
Study CompletionMar 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.1 years ago

Interventions

F/TAFdrug

200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily

ABC/3TCdrug

600/300 mg FDC tablets administered orally once daily

ABC/3TC Placebodrug

Tablets administered orally once daily

F/TAF Placebodrug

Tablets administered orally once daily

3rd ARV agentdrug

An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).