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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

Partners: Central and North West London NHS Foundation Trust

Location: Global

Funding: Gilead Sciences

Contact: mmc-research-cnwl@nhs.net

Project Summary 

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.


Research Team

Jonathan Alldis

Dr Alejandro Arenas-Pinto

Asma Ashraf

Dr Lewis Haddow

Dr Diarmuid Nugent

Dr Sarah Pett

Dr Erica Pool 

Publications

Resources

Further informationis available at https://clinicaltrials.gov/ct2/show/NCT02842086

Keywords

Randomised Controlled Trials

HIV

Prevention

Sexual Health

Sexually Transmitted Infections (STI)

Presentations
Datasets

Further research