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

ANRS 0029s

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.

2024-06-05

2026-10-01

2027-05-01

Recruiting

Early phase I

524

Inclusion Criteria: * 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 * Risk of HIV acquisition based on self-report of at least one of the following behaviors during the 6 months before enrollment: condomless anal sex with at least 2 different sexual partners, sexually transmitted infection (rectal chlamydia and/or rectal gonorrhea and/or syphilis), provided or received money goods or favor in exchange of sex, binge drinking or use of non-injectable recreational drugs. * Consenting to participate and agreeing to follow the clinical trial procedures, including adherence to study visits every 3 months * In France: Person affiliated with or benefiting from a social security system (article L1121-11of the public health code in France) Non-inclusion criteria: * Women and trans women * Taking feminizing hormone therapy * Positive HIV test result at screening or enrollment even if HIV infection is not confirmed * Positive hepatitis B surface antigen test * ALT or AST \> 4 ULN * Estimated glomerular filtration rate \< 60mL/min/1.73m² * History of chronic kidney disease, osteoporosis, osteopenia or pathological fracture not related to trauma * Hypersensitivity to the study products F/TDF or F/TAF * Past or concurrent participation in a HIV vaccine trial or concurrent participation in another clinical trial without the agreement of the principal investigators of the two trials * Use of intravenous drugs within the last 12 months * Person under legal guardianship * Not likely to comply with the clinical trial procedures or with any condition incompatible with study participation, upon the investigator's judgement. * Ongoing Post-Exposure Prophylaxis (PEP) for HIV

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial among cis men who have sex with men.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 524, 'type': 'ESTIMATED'}}

2024-06-06