Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
NCT ID: NCT05813964
Last Updated: 2025-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2024-06-05
2027-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
TDF/FTC 300mg/200mg fixed-dose combination tablets
Event-driven dosing regimen
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.
TAF/FTC 25mg/200mg fixed-dose combination tablets
Event-driven dosing regimen.
Interventions
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TDF/FTC 300mg/200mg fixed-dose combination tablets
Event-driven dosing regimen
TAF/FTC 25mg/200mg fixed-dose combination tablets
Event-driven dosing regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
18 Years
MALE
Yes
Sponsors
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Chiang Mai University, Thailand
UNKNOWN
Ministry of Health, Thailand
OTHER_GOV
Assistance Publique - Hôpitaux de Paris, FRANCE
UNKNOWN
Gilead Sciences
INDUSTRY
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Geoffroy LIEGEON
Role: STUDY_DIRECTOR
Infectious Diseases Department, Saint-Louis Hospital, Paris, France
Sumet ONGWANDEE
Role: STUDY_DIRECTOR
Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand
Locations
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AP-HP - Hospital Lariboisière
Paris, , France
AP-HP - Hôpital Saint-Louis
Paris, , France
MPlus Clinic
Chiang Mai, , Thailand
STIs Clinic of the Office of Disease Prevention and Control Region 1
Chiang Mai, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-502931-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ANRS 0029s
Identifier Type: -
Identifier Source: org_study_id
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