NCT02121795

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

A Phase 3, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Positive Subjects Who Are Virologically Suppressed on Regimens Containing FTC/TDF

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of switching from emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) fixed dose combination (FDC) to emtricitabine/tenofovir alafenamide (F/TAF) FDC in HIV-1 positive participants who are virologically suppressed on regimens containing FTC/TDF. This study will consist of a 96 week double-blind treatment period. After Week 96, all participants will continue on blinded study drug treatment and attend visits every 12 weeks until treatment assignments are unblinded. All participants will return for an unblinding visit and will be given the option to receive open-label F/TAF and attend visits every 12 weeks until F/TAF is commercially available, or the sponsor terminates the F/TAF clinical development program.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	FTC/TDF	200/300 mg FDC tablets administered orally once daily
DRUG	F/TAF	Tablets administered orally once daily
DRUG	Allowed third antiretroviral agent	An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
DRUG	FTC/TDF Placebo	Tablets administered orally once daily
DRUG	F/TAF Placebo	Tablets administered orally once daily

Timeline

• Start date: 2014-05-06
• Primary completion: 2015-08-12
• Completion: 2019-03-01
• First posted: 2014-04-24
• Last updated: 2020-03-12
• Results posted: 2016-11-30

Locations

78 sites across 7 countries: United States, Belgium, Canada, France, Italy, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study