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

NCT05813964 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2025-06-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TDF/FTC 300mg/200mg fixed-dose combination tablets

Event-driven dosing regimen

DRUG

TAF/FTC 25mg/200mg fixed-dose combination tablets

Event-driven dosing regimen.

Sponsors & Collaborators

  • Chiang Mai University, Thailand

    collaborator UNKNOWN

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris, FRANCE

    collaborator UNKNOWN

  • Gilead Sciences

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Geoffroy LIEGEON · Infectious Diseases Department, Saint-Louis Hospital, Paris, France

  • Sumet ONGWANDEE · Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2026-10-31
Completion
2027-05-31

Countries

  • France
  • Thailand

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813964 on ClinicalTrials.gov