NCT05813964 Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
| NCT ID | NCT05813964 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ANRS, Emerging Infectious Diseases |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 524 participants |
| Start Date | 2024-06-05 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 524 participants in total. It began in 2024-06-05 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Geoffroy LIEGEON
STUDY DIRECTOR
Infectious Diseases Department, Saint-Louis Hospital, Paris, France
Frequently Asked Questions
Who can join the NCT05813964 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05813964 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 524 participants.
Is NCT05813964 currently recruiting?
Yes, NCT05813964 is actively recruiting participants. Contact the research team at geoffroy.liegeon@aphp.fr for enrollment information.
Where is the NCT05813964 trial being conducted?
This trial is being conducted at Paris, France, Paris, France, Chiang Mai, Thailand, Chiang Mai, Thailand.
Who is sponsoring the NCT05813964 clinical trial?
NCT05813964 is sponsored by ANRS, Emerging Infectious Diseases. The principal investigator is Geoffroy LIEGEON at Infectious Diseases Department, Saint-Louis Hospital, Paris, France. The trial plans to enroll 524 participants.
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