NCT05813964RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 524 (estimated)
- First submitted
- 2 Mar 2023
- Start date
- 5 Jun 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- HIV
- NCT number
- NCT05813964
- EU CT number
- 2022-502931-20-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 524
- From 5 Jun 2024 to the primary completion date, 31 Dec 2027
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Thai Red Cross AIDS and Infectious Diseases Research Centre Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| STIs Clinic of the Office of Disease Prevention and Control Region 1 Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Recruiting |
| MPLUS Clinic Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Recruiting |
| Lampang Hospital Coordinator of this site? Confirm its status | Lampang | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.