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

• Status: Not yet recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Assistance Publique - Hôpitaux de Paris, FRANCE; Chiang Mai University, Thailand; Gilead Sciences; Ministry of Health, Thailand
• Treatments: Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

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