Clinical Trial

Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.

Study acronym: SimpPrEP
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-04-03; most recent amendment 2025-06-17.
Status change: Not Yet Recruiting → Recruiting 2024-06-05
Trial Details
NCT Number NCT05813964
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Chiang Mai University, Thailand, Ministry of Health, Thailand, Assistance Publique - Hôpitaux de Paris, Gilead Sciences
Conditions HIV/AIDS
Enrollment 524 participants
Start Date 2024-06-05
Primary Completion 2026-10 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2025-06-20