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HIV/AIDSPhase 3SimpPrEPNCT05813964

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

A Phase 3 study testing TDF/FTC 300mg/200mg fixed-dose combination tablets and TAF/FTC 25mg/200mg fixed-dose combination tablets in people with HIV/AIDS, run by ANRS, Emerging Infectious Diseases at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
TDF/FTC 300mg/200mg fixed-dose combination tablets and TAF/FTC 25mg/200mg fixed-dose combination tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
524 participants
Where
6 sitesin 2 countries
Study dates
5 Jun 2024to 31 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Geoffroy LIEGEON, MD, PhD contact

+33 142494991

geoffroy.liegeon@aphp.fr

Gonzague JOURDAIN, MD, PhD contact

: +66 8 1883 0065

gonzague.jourdain@cmu.ac.th

6 sites in 2 countries

Thailand4 sites, 4 recruiting

  • Thai Red Cross AIDS and Infectious Diseases Research Centre

    Bangkok, Bangkok, 10330

    Opass Opass PUTCHAROEN, MDD, MSc, +66 22516711

    Anchalee AVIHINGSANON, MD, PhD, +66 868128889, anchaleea2009@gmail.com

    Recruiting

  • MPLUS Clinic

    Chiang Mai, Chiang Mai, 50100

    Supakarn SANGTONG, BA, +6653283108, mplus.foundation@gmail.com

    Recruiting

  • STIs Clinic of the Office of Disease Prevention and Control Region 1

    Chiang Mai, Chiang Mai, 50100

    Piwanont PROMNITES, MD, +6653276364, piwanont39@gmail.com

    Recruiting

  • Lampang Hospital

    Lampang, Changwat Lampang, 52000

    Parichart SAKULKONKIJ, MD, +66 54237400, parichart1507@gmail.com

    Recruiting

Other trials in Thailand

France2 sites, 2 recruiting

  • St Louis Hospital

    Paris, 75010

    Geoffroy LIEGEON, MD, geoffroy.liegeon@aphp.fr

    Recruiting

  • AP-HP - Hospital Lariboisière

    Paris

    RAMI Agathe MD, + 33 149958037, agathe.rami@aphp.fr

    Geoffroy LIEGEON MD, +33 142494991, geoffroy.liegeon@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Read the detailed description

The study will enroll HIV-uninfected MSM at risk for acquiring HIV infection. Participants will be enrolled over 2 years and followed up until the closure of the clinical study. Therefore, the follow up duration will be up to 3 years for first enrollees and up to1 year for the last enrollee. The study will be implemented in Thailand (60% of participants) and France (40%).

Participants will be randomly assigned to one of two regimens:

  • Experimental Arm (F/TAF): one tablet of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir alafenamide (TAF) 25mg, 2 to 24 hours before sexual intercourse followed by a second tablet 24 hours after the first intake.
  • Control Arm (F/TDF): two tablets of the fixed-dose combination of emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (TDF) 300 mg, 2 to 24 hours before sexual intercourse followed by a third tablet 24 hours after the first drug intake and a fourth tablet 24 hours later.

Participants will attend up to 15 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, and swabs collection (oral and rectal). At the end of their study participation, all participants will be transitioned to locally available HIV prevention services, including PrEP.

Conditions
HIV/AIDS
Being tested
TDF/FTC 300mg/200mg fixed-dose combination tablets, TAF/FTC 25mg/200mg fixed-dose combination tablets
Keywords
PrEP exposure prophylaxis (PrEP), On-demand, Event-driven, TAF
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TDF/FTC 300mg/200mg fixed-dose combination tabletsDrug

    Also called Truvada

    Event-driven dosing regimen

  • TAF/FTC 25mg/200mg fixed-dose combination tabletsDrug

    Also called Descovy

    Event-driven dosing regimen.

Study groups in NCT05813964
Study groupRoleWhat they receive
Event-driven PrEP with TDF/FTCActive comparatorParticipants 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.
Receives: Drug: TDF/FTC 300mg/200mg fixed-dose combination tablets
Event-driven PrEP with TAF/FTCExperimentalParticipants 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.
Receives: Drug: TAF/FTC 25mg/200mg fixed-dose combination tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of F/TAF

    Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TAF arm.

    Measured: All along the study

Secondary outcomes (3)

  1. Efficacy of F/TDF

    Number of HIV infections defined by the presence of HIV ribonucleic acid (RNA) in plasma through study completion (an average of two years) in the event-driven F/TDF arm.

    Measured: All along the study

  2. Acceptability of F/TAF versus F/TDF

    Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.

    Measured: At 1 and at 2 years of follow up.

  3. Safety of F/TAF versus F/TDF

    1. Numbers of participants experiencing, through study completion (an average of 2 years):
    • at least one Grade 3 or 4 treatment-related adverse event as graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events [Corrected Version 2.1 July 2017],
    • at least one serious adverse event as graded using the same tables.
    1. Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years.
    2. Change from baseline in body weight at 1, 2, and 3 years.

    Measured: All along the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start5 Jun 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial among cis men who have sex with men.
Masking
None (open label)
Enrolment
524 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813964
Sponsor's protocol ID
ANRS 0029s
Other IDs
2022-502931-20-00
Acronym
SimpPrEP
Status last verified
Jul 2026
First submitted
2 Mar 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TDF/FTC 300mg/200mg fixed-dose combination tablets and TAF/FTC 25mg/200mg fixed-dose combination tablets in people with HIV/AIDS, run by ANRS, Emerging Infectious Diseases at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Thailand, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Geoffroy LIEGEON, MD, PhD (+33 142494991, geoffroy.liegeon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of F/TAF (time frame: All along the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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