A Phase 3, Randomized, 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)
Dates: 12th January 2017 - (ongoing)
UCL lead/Principal Investigator: Dr Richard Gilson
Funding: Gilead Sciences
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.
Dr Alejandro Arenas-Pinto
Dr Lewis Haddow
Dr Diarmuid Nugent
Dr Sarah Pett
Dr Erica Pool
Further informationis available at https://clinicaltrials.gov/ct2/show/NCT02842086