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Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.

NCT05813964

RecruitingPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV/AIDS

Interventions: TDF/FTC 300mg/200mg fixed-dose combination tablets, TAF/FTC 25mg/200mg fixed-dose combination tablets

Countries: France, Thailand

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)
* May be either PrEP-naïve or PrEP-experienced, but must not have used any long-acting PrEP product in the past 2 years.

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
Locations (6)
  • Paris, France
  • Paris, France
  • Bangkok, Bangkok, Thailand
  • Lampang, Changwat Lampang, Thailand
  • Chiang Mai, Chiang Mai, Thailand
  • Chiang Mai, Chiang Mai, Thailand