About this trial
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.
Eligibility criteria
Qualifiers
Male at birth age ≥ 18 years old
Reporting having sex with men
Negative 4th generation HIV-1 and HIV-2 test
Reporting condomless anal sex with men not more often than two days during the previous month and able to plan their sexual activity
Disqualifiers
None
Trial design
Treatments tested in this trial
- TDF/FTC 300mg/200mg fixed-dose combination tablets
- TAF/FTC 25mg/200mg fixed-dose combination tablets
Treatment groups
Sponsors and collaborators
ANRS, Emerging Infectious Diseases
Lead sponsor
Chiang Mai University, Thailand
Collaborator
Ministry of Health, Thailand
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
Gilead Sciences
Collaborator