Tests a pill taken around sex to prevent HIV in men
Tests a before-sex HIV prevention pill in HIV-negative men who have sex with men.
Plain-language title generated from the registry record
Registry title: Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Key facts
- Where
- Bangkok, Chiang Mai, and Lampang, ThailandSee the 4 sites
- Phase
- Phase 3
Where in Thailand
- Thai Red Cross AIDS and Infectious Diseases Research CentreBangkok, ThailandTaking people
- MPLUS ClinicChiang Mai, ThailandTaking people
- STIs Clinic of the Office of Disease Prevention and Control Region 1Chiang Mai, ThailandTaking people
- Lampang HospitalLampang, ThailandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ANRS, Emerging Infectious Diseases
- Trial code
- NCT05813964EU 2022-502931-20-00
- Record updated
- 2 September 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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); May be either PrEP-naïve or PrEP-experienced, but must not have used any long-acting PrEP product in the past 2 years; Non-inclusion criteria:; Symptoms and/or clinical signs consistent with an acute HIV infection; 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.