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

Study acronym: SimpPrEP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Oct 2026 → Dec 31, 2027
See other at-risk trials from ANRS, Emerging Infectious Diseases

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 2026 to Dec 31, 2027
    • Study completion pushed from May 2027 to May 31, 2028
    • Study sites: 4 to 6
    • Eligibility criteria expanded, about 20 words
    v5
  2. Study sites: 2 to 4
    • Eligibility criteria expanded, about 10 words
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Jun 5, 2024
    • Site details revised at 2 of 2 sites
    v3
  4. Start date: Jun 2023 to Sep 2023v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05813964
Lead Sponsor ANRS, Emerging Infectious Diseases
Collaborators: Chiang Mai University, Thailand, Ministry of Health, Thailand, Assistance Publique - Hôpitaux de Paris, Gilead Sciences
Conditions
(from sponsor)		 HIV/AIDS
Related terms Acquired Immunodeficiency Syndrome
Enrollment 524 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov