Actively Recruiting
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
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-06-20
524
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
Sponsors
A
ANRS, Emerging Infectious Diseases
Lead Sponsor
C
Chiang Mai University, Thailand
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis (PrEP) using oral emtricitabine and tenofovir alafenamide (F/TAF) in HIV-uninfected cisgender men who have sex with men (MSM). The study aims to assess how well F/TAF, taken before and after sexual activity, reduces the risk of HIV infection compared to the background HIV incidence rate. This Phase 3 trial includes participants from Thailand and France and is sponsored by ANRS, Emerging Infectious Diseases. Participants will be randomly assigned to one of two groups. The experimental group will take one tablet of F/TAF 2 to 24 hours before sex followed by a second tablet 24 hours later. The control group will take two tablets of emtricitabine and tenofovir disoproxil fumarate (F/TDF) before sex followed by two additional tablets over the next 48 hours. In cases of daily sexual activity, dosing instructions differ slightly to maintain protection. The study will last up to 3 years, with up to 15 visits including physical exams and collection of blood, urine, and swabs. During the study, participants will attend regular visits every three months to monitor safety and adherence. Assessments include clinical exams and laboratory tests to check for HIV and other health markers. Researchers will measure the efficacy of both PrEP regimens, their acceptability, and safety throughout the study. After completing the trial, all participants will be connected to local HIV prevention services, including ongoing PrEP if available.
CONDITIONS
Brief Title
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male at birth aged 18 years or older
- Reporting having sex with men
- Negative 4th generation HIV-1 and HIV-2 test
- Reporting condomless anal sex with men no more than two days in the previous month and able to plan sexual activity
- At risk of HIV based on at least one behavior in the past 6 months: condomless anal sex with 2+ partners, rectal sexually transmitted infection, exchanging sex for money/goods/favors, binge drinking, or use of non-injectable recreational drugs
- Consenting to participate and agree to follow study visits every 3 months
- In France, affiliation with or benefit from a social security system
You will not qualify if you...
- Symptoms or signs of acute HIV infection
- Women and transgender women
- Taking feminizing hormone therapy
- Positive HIV test at screening or enrollment
- Positive hepatitis B surface antigen test
- ALT or AST levels over 4 times the upper limit of normal
- Estimated glomerular filtration rate below 60 mL/min/1.73 m²
- History of chronic kidney disease, osteoporosis, osteopenia, or pathological fractures unrelated to trauma
- Allergic reaction to study drugs F/TDF or F/TAF
- Past or current participation in an HIV vaccine trial or another clinical trial without approval
- Intravenous drug use within the past 12 months
- Under legal guardianship
- Unlikely to comply with study procedures or any incompatible condition per investigator judgment
- Currently using Post-Exposure Prophylaxis (PEP) for HIV
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years depending on enrollment timing
Participants take event-driven HIV pre-exposure prophylaxis (PrEP) medication with either TAF/FTC or TDF/FTC according to their assigned regimen, around times of sexual intercourse.
Up to 15 visits throughout the study
Duration - Up to 3 years depending on enrollment timing
Participants are monitored for efficacy, acceptability, and safety of the PrEP regimens during and after treatment until study closure.
Visits every 3 months
Trial Site Locations
Total: 4 locations
1
AP-HP - Hospital Lariboisière
Paris, France
Actively Recruiting
2
AP-HP - Hôpital Saint-Louis
Paris, France
Actively Recruiting
3
MPlus Clinic
Chiang Mai, Thailand
Actively Recruiting
4
STIs Clinic of the Office of Disease Prevention and Control Region 1
Chiang Mai, Thailand
Actively Recruiting
Research Team
G
Geoffroy LIEGEON, MD, PhD
G
Gonzague JOURDAIN, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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