HIV-1 Infection Clinical Trial
Official title:
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
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.
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