Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Recruiting · NCT05813964 · Interventional (participants receive a specific treatment) · Lead sponsor: ANRS, Emerging Infectious Diseases
View the official record on ClinicalTrials.gov →Interventions studied
TAF/FTC 25mg/200mg fixed-dose combination tabletsTDF/FTC 300mg/200mg fixed-dose combination tablets
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
4 locations listed.
- MPlus Clinic - Chiang Mai, Thailand
- STIs Clinic of the Office of Disease Prevention and Control Region 1 - Chiang Mai, Thailand
- AP-HP - Hospital Lariboisière - Paris, France
- AP-HP - Hôpital Saint-Louis - Paris, France