RecruitingPhase 3NCT05813964

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

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


Sponsor

ANRS, Emerging Infectious Diseases

Enrollment

524 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (conducted in Thailand and France) is testing an on-demand (event-driven) HIV prevention pill strategy using TAF/FTC — meaning you take medication around the time you expect to have sex, rather than every day — for gay and bisexual men at moderate HIV risk who have sex less frequently. **You may be eligible if...** - You were assigned male at birth and are 18 or older - You have sex with men - You test negative for HIV (4th generation test) - You have condomless anal sex, but on average no more than 2 days per month - You have had at least one higher-risk sexual behavior in the past 6 months (e.g., condomless sex with 2+ partners, or an STI) - You can anticipate your sexual activity in advance (to time the medication) **You may NOT be eligible if...** - You are HIV-positive - You have daily or very frequent sexual activity that would require daily PrEP instead - You cannot plan your sexual activity in advance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Event-driven dosing regimen

DRUGTAF/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

View Full Details on ClinicalTrials.gov

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NCT05813964


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