Conditions: HIV-1 Infection
Keywords: HIV HIV-1 Positive Virologically-suppressed
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 668
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen. arm 2: Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks.

Interventions: intervention 1: FTC/TDF intervention 2: F/TAF intervention 3: Allowed third antiretroviral agent intervention 4: FTC/TDF Placebo intervention 5: F/TAF Placebo
Intervention descriptions: intervention 1: 200/300 mg FDC tablets administered orally once daily intervention 2: Tablets administered orally once daily intervention 3: 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®). intervention 4: Tablets administered orally once daily intervention 5: Tablets administered orally once daily

Protocol document: