Clinical trial NCT05813964: Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HIV/AIDS
Keywords: PrEP exposure prophylaxis (PrEP)
On-demand
Event-driven
TAF
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chiang Mai University, Thailand
name: Ministry of Health, Thailand
name: Assistance Publique - Hôpitaux de Paris, FRANCE
name: Gilead Sciences
First posted: 2023-04-14
Enrollment: 524
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase III, international, multicenter, open-label, parallel-group, randomized, controlled trial among cis men who have sex with men.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Non-inclusion criteria:

* 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

Primary outcomes:
measure: Efficacy of F/TAF
timeFrame: All along the study
Secondary outcomes:
measure: Efficacy of F/TDF
timeFrame: All along the study
measure: Acceptability of F/TAF versus F/TDF
timeFrame: At 1 and at 2 years of follow up.
measure: Safety of F/TAF versus F/TDF
timeFrame: All along the study
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP - Hôpital Saint-Louis
city: Chiang Mai
country: Thailand
facility: STIs Clinic of the Office of Disease Prevention and Control Region 1
Study officials:
affiliation: Infectious Diseases Department, Saint-Louis Hospital, Paris, France
name: Geoffroy LIEGEON
role: STUDY_DIRECTOR
affiliation: Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health, Nonthaburi, Thailand
name: Sumet ONGWANDEE
role: STUDY_DIRECTOR
References: