Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Status:
Not yet recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy, acceptability, and safety of a
simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in
HIV-uninfected cisgender men who have sex with men (MSM).
Primary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25
mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours
after the first intake, in reducing the risk of HIV acquisition in MSM relative to the
background HIV incidence rate.
Phase:
Phase 3
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborators:
Assistance Publique - Hôpitaux de Paris, FRANCE Chiang Mai University, Thailand Gilead Sciences Ministry of Health, Thailand
Treatments:
Emtricitabine tenofovir alafenamide Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination