Evaluating on-demand HIV prevention in men who have sex with men 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
This study is testing a new on-demand HIV prevention method for men who have sex with men in Thailand and France to see if it works better than the current standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 524 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 4 sites (Paris and 3 other locations) |
| Trial ID | NCT05813964 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, acceptability, and safety of an event-driven pre-exposure prophylaxis (PrEP) regimen using a fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) in HIV-uninfected cisgender men who have sex with men (MSM). Participants will be randomly assigned to either the experimental F/TAF regimen or a control regimen using tenofovir disoproxil fumarate (F/TDF). The study will enroll participants over two years and follow them for up to three years, with regular study visits for health assessments and adherence monitoring. The goal is to determine how effectively this approach reduces the risk of HIV acquisition compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates are HIV-uninfected cisgender men aged 18 and older who engage in condomless anal sex and are at risk for HIV acquisition.
Not a fit: Patients who are women, trans women, or those not engaging in high-risk sexual behaviors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and acceptable method of HIV prevention for at-risk MSM.
How similar studies have performed: Previous studies have shown success with similar PrEP approaches, indicating potential for this method to be effective.
Eligibility criteria
Show full inclusion / exclusion 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: * 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
Where this trial is running
Paris and 3 other locations
- AP-HP - Hospital Lariboisière — Paris, France (Recruiting)
- AP-HP - Hôpital Saint-Louis — Paris, France (Recruiting)
- MPlus Clinic — Chiang Mai, Thailand (Recruiting)
- STIs Clinic of the Office of Disease Prevention and Control Region 1 — Chiang Mai, Thailand (Recruiting)
Study contacts
- Study coordinator: Geoffroy LIEGEON, MD, PhD
- Email: geoffroy.liegeon@aphp.fr
- Phone: +33 142494991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.