A Phase 3, Randomised, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection (GS-US-412-2055)
The primary objective of this study is to assess the efficacy of emtricitabine/tenofovir alafenamide (F/TAF; Descovy) in the prevention of HIV infection in men at risk. The outcome measure is the rate of HIV-1 seroconversion in men (MSM) and transgender women (TGW) who have sex with men and who are administered F/TAF daily, or emtricitabine/tenofovir (Truvada; F/TDF) over a period of 96 weeks of follow-up. Secondary objectives include an assessment of bone and renal safety.
The study is being conducted in up to 100 sites in Europe and North America, and has recruited over 5,000 participants.