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

NCT05813964 | Recruiting Phase 3 DMC

• 2 other identifiers: ANRS 0029s2022-502931-20
• Study Type: interventional
• Target: 524
• Locations: 2 countries
• Sites: 4

Brief 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

HIV/AIDS

Keywords

PrEP exposure prophylaxis (PrEP); On-demand; Event-driven; TAF

Outcome Measures

Primary Outcomes (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.

  All along the study

Secondary Outcomes (3)

• Efficacy of F/TDF

  All along the study

• Acceptability of F/TAF versus F/TDF

  At 1 and at 2 years of follow up.

• Safety of F/TAF versus F/TDF

  All along the study

Study Arms (2)

Event-driven PrEP with TDF/FTC

ACTIVE COMPARATOR

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.

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

Event-driven PrEP with TAF/FTC

EXPERIMENTAL

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.

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

Interventions

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

Event-driven dosing regimen

Also known as: Truvada

Event-driven PrEP with TDF/FTC

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

Event-driven dosing regimen.

Also known as: Descovy

Event-driven PrEP with TAF/FTC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Chiang Mai University, Thailand: collaborator
• Ministry of Health, Thailand: collaborator
• Assistance Publique - Hôpitaux de Paris, FRANCE: collaborator
• Gilead Sciences: collaborator

Study Sites (4)

AP-HP - Hospital Lariboisière

Paris, France

RECRUITING

AP-HP - Hôpital Saint-Louis

Paris, France

RECRUITING

MPlus Clinic

Chiang Mai, Thailand

RECRUITING

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

Chiang Mai, Thailand

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Geoffroy LIEGEON

  Infectious Diseases Department, Saint-Louis Hospital, Paris, France

  STUDY DIRECTOR

• Sumet ONGWANDEE

  Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand

  STUDY DIRECTOR

Central Study Contacts

Geoffroy LIEGEON, MD, PhD

CONTACT

+33 142494991; geoffroy.liegeon@aphp.fr

Gonzague JOURDAIN, MD, PhD

CONTACT

: +66 8 1883 0065; gonzague.jourdain@phpt.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial among cis men who have sex with men.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: April 14, 2023
• Study Start: June 5, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); TH (2)