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

HIV/AIDS Clinical Trial

— SimpPrEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813964
• Other study ID #: ANRS 0029s
• Secondary ID: 2022-502931-20
• Status: Recruiting
• Phase: Phase 3
• Start date: June 5, 2024
• Est. completion date: May 2027

Study information

• Verified date: June 2024
• Source: ANRS, Emerging Infectious Diseases
• Contact: Geoffroy LIEGEON, MD, PhD
• Phone: +33 142494991
• Email: geoffroy.liegeon[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: May 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Drug:
• TDF/FTC 300mg/200mg fixed-dose combination tablets
Event-driven dosing regimen
• TAF/FTC 25mg/200mg fixed-dose combination tablets
Event-driven dosing regimen.

Locations

Country	Name	City	State
France	AP-HP - Hôpital Saint-Louis	Paris
Thailand	STIs Clinic of the Office of Disease Prevention and Control Region 1	Chiang Mai

Sponsors (5)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Assistance Publique - Hôpitaux de Paris, FRANCE, Chiang Mai University, Thailand, Gilead Sciences, Ministry of Health, Thailand

Countries where clinical trial is conducted

France,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	All along the study
Secondary	Acceptability of F/TAF versus F/TDF	Satisfaction score assessed by a self-administrated study medication satisfaction questionnaire.	At 1 and at 2 years of follow up.
Secondary	Safety of F/TAF versus F/TDF	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.; Change from baseline in estimated glomerular filtration rate at 1, 2, and 3 years.; Change from baseline in body weight at 1, 2, and 3 years.	All along the study