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RECRUITING
NCT05813964
PHASE3

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

Sponsor: ANRS, Emerging Infectious Diseases

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.

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

DRUG

TDF/FTC 300mg/200mg fixed-dose combination tablets

Event-driven dosing regimen

DRUG

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