drugset / Trial / NCT05813964
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Phase 3
Recruiting
524 enrolled
ANRS, Emerging Infectious Diseases
Assistance Publique - Hôpitaux de Paris · collabChiang Mai University, Thailand · collabGilead Sciences · collabMinistry of Health, Thailand · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-06-05
- Primary completion
- 2026-10
- Completion
- 2027-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |