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Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Sponsor: ANRS, Emerging Infectious Diseases
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.
Official title: A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
524
Start Date
2024-06-05
Completion Date
2027-05
Last Updated
2025-06-20
Healthy Volunteers
Yes
Conditions
Interventions
TDF/FTC 300mg/200mg fixed-dose combination tablets
Event-driven dosing regimen
TAF/FTC 25mg/200mg fixed-dose combination tablets
Event-driven dosing regimen.
Locations (4)
AP-HP - Hospital Lariboisière
Paris, France
AP-HP - Hôpital Saint-Louis
Paris, France
MPlus Clinic
Chiang Mai, Thailand
STIs Clinic of the Office of Disease Prevention and Control Region 1
Chiang Mai, Thailand