Actively Recruiting
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Led by ANRS, Emerging Infectious Diseases · Updated on 2025-06-20
524
Participants Needed
4
Research Sites
151 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
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.
CONDITIONS
Official 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
- Reports having sex with men
- Negative 4th generation HIV-1 and HIV-2 test
- Reports condomless anal sex with men not more than twice in the previous month and able to plan sexual activity
- At risk of HIV based on at least one behavior in the last 6 months: condomless anal sex with 2 or more partners, rectal chlamydia, gonorrhea or syphilis, exchanging sex for money or goods, binge drinking, or use of non-injectable recreational drugs
- Consents to participate and agrees to follow study visits every 3 months
- In France, affiliated with or benefiting from a social security system
You will not qualify if you...
- Symptoms or signs of acute HIV infection
- Women and trans women
- Taking feminizing hormone therapy
- Positive HIV test at screening or enrollment
- Positive hepatitis B surface antigen test
- ALT or AST levels greater than 4 times the upper limit of normal
- Estimated glomerular filtration rate less than 60 mL/min/1.73m²
- History of chronic kidney disease, osteoporosis, osteopenia, or pathological fractures unrelated to trauma
- Hypersensitivity to F/TDF or F/TAF
- Past or current participation in an HIV vaccine trial or another clinical trial without agreement
- Use of intravenous drugs within the last 12 months
- Under legal guardianship
- Unlikely to comply with trial procedures or with incompatible conditions as judged by the investigator
- Currently undergoing Post-Exposure Prophylaxis (PEP) for HIV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
G
Gonzague JOURDAIN, MD, PhD
CONTACT
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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