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Taking people in FrancePhase 3

Tests a pill taken around sex to prevent HIV in men

Tests a before-sex HIV prevention pill in HIV-negative men who have sex with men.

Key facts

Who runs it
ANRS, Emerging Infectious Diseases
Where
Paris, FranceSee the siteAlso in 1 other country, 4 sites
Registry title
Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
Status
Recruiting
Phase
Phase 3
People taking part
524 people, planned
Started
5 Jun 2024
Expected to end
31 May 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • TDF/FTC 300mg/200mg fixed-dose combination tablets
  • TAF/FTC 25mg/200mg fixed-dose combination tablets
Record updated
2 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men who have sex with men, aged 18 or older, who do not have HIV and may be at risk of getting it. It tests taking PrEP pills around sex.

Age
18 years or older
Sex
Male at birth; women and trans women cannot join
Disease stage
No HIV infection (negative HIV test); at risk of getting HIV
Earlier treatment
Can be new to PrEP or have used PrEP before, but must not have used any long-acting PrEP product in the past 2 years
Biomarker or test result
Negative 4th generation HIV-1 and HIV-2 test

Main reasons for not taking part

  • Signs or symptoms of a recent HIV infection
  • Positive HIV test, or positive hepatitis B surface antigen test
  • Kidney problems (eGFR below 60) or history of chronic kidney disease, osteoporosis or osteopenia
  • Use of intravenous drugs in the last 12 months
  • Taking feminizing hormone therapy, or ongoing post-exposure prophylaxis (PEP) for HIV

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Where in France

Also in 1 other country, 4 sites

  • Assistance Publique Hopitaux de ParisParis, FranceTaking people

About the trial

What the trial wants to find out

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).

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Event-driven PrEP with TDF/FTCExisting treatment, for comparison

    Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills.

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

  • Event-driven PrEP with TAF/FTCTreatment being tested

    Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later.

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Randomized Controlled Trial to Evaluate the Efficacy, Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAF/FTC in Men Who Have Sex With Men in Thailand and France
Plain-language title
Tests a pill taken around sex to prevent HIV in menGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 September 2026