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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
Event-driven dosing regimen
Event-driven dosing regimen.
AP-HP - Hospital Lariboisière
Paris, France
RECRUITINGAP-HP - Hôpital Saint-Louis
Paris, France
RECRUITINGMPlus Clinic
Chiang Mai, Thailand
RECRUITINGSTIs Clinic of the Office of Disease Prevention and Control Region 1
Chiang Mai, Thailand
RECRUITINGEfficacy of F/TAF
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.
Time frame: All along the study
Efficacy of F/TDF
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/TDF arm.
Time frame: All along the study
Acceptability of F/TAF versus F/TDF
Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.
Time frame: At 1 and at 2 years of follow up.
Safety of F/TAF versus F/TDF
1. Numbers of participants experiencing, through study completion (an average of 2 years): * at least one Grade 3 or 4 treatment-related adverse event as graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events \[Corrected Version 2.1 July 2017\], * at least one serious adverse event as graded using the same tables. 2. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years. 3. Change from baseline in body weight at 1, 2, and 3 years.
Time frame: All along the study
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