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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:
• 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)
Locations
Other Locations
France
AP-HP - Hôpital Saint-Louis
RECRUITING
Paris
AP-HP - Hospital Lariboisière
RECRUITING
Paris
Thailand
MPlus Clinic
RECRUITING
Chiang Mai
STIs Clinic of the Office of Disease Prevention and Control Region 1
RECRUITING
Chiang Mai
Contact Information
Primary
Geoffroy LIEGEON, MD, PhD
geoffroy.liegeon@aphp.fr
+33 142494991
Backup
Gonzague JOURDAIN, MD, PhD
gonzague.jourdain@phpt.org
: +66 8 1883 0065
Time Frame
Start Date:2024-06-05
Estimated Completion Date:2027-05
Participants
Target number of participants:524
Treatments
Active_comparator: Event-driven PrEP with TDF/FTC
Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.
Experimental: Event-driven PrEP with TAF/FTC
Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.