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
Overview
- Phase
- Phase 3
- Intervention
- TDF/FTC 300mg/200mg fixed-dose combination tablets
- Conditions
- HIV/AIDS
- Sponsor
- ANRS, Emerging Infectious Diseases
- Enrollment
- 524
- Locations
- 4
- Primary Endpoint
- Efficacy of F/TAF
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Detailed Description
The study will enroll HIV-uninfected MSM at risk for acquiring HIV infection. Participants will be enrolled over 2 years and followed up until the closure of the clinical study. Therefore, the follow up duration will be up to 3 years for first enrollees and up to1 year for the last enrollee. The study will be implemented in Thailand (60% of participants) and France (40%). Participants will be randomly assigned to one of two regimens: * Experimental Arm (F/TAF): one tablet of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir alafenamide (TAF) 25mg, 2 to 24 hours before sexual intercourse followed by a second tablet 24 hours after the first intake. * Control Arm (F/TDF): two tablets of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg, 2 to 24 hours before sexual intercourse followed by a third tablet 24 hours after the first drug intake and a fourth tablet 24 hours later. Participants will attend up to 15 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, and swabs collection (oral and rectal). At the end of their study participation, all participants will be transitioned to locally available HIV prevention services, including PrEP.
Investigators
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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: TDF/FTC 300mg/200mg fixed-dose combination tablets
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.
Intervention: TAF/FTC 25mg/200mg fixed-dose combination tablets
Outcomes
Primary Outcomes
Efficacy of F/TAF
Time Frame: All along the study
Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.
Secondary Outcomes
- Efficacy of F/TDF(All along the study)
- Safety of F/TAF versus F/TDF(All along the study)
- Acceptability of F/TAF versus F/TDF(At 1 and at 2 years of follow up.)