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

ConditionHIV/AIDS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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 criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • TDF/FTC 300mg/200mg fixed-dose combination tablets
  • TAF/FTC 25mg/200mg fixed-dose combination tablets

Treatment groups

524 Participants
are divided into 2 treatment groups

Sponsors and collaborators

ANRS, Emerging Infectious Diseases

Lead sponsor

Chiang Mai University, Thailand

Collaborator

Ministry of Health, Thailand

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

Gilead Sciences

Collaborator