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

Launched by ANRS, EMERGING INFECTIOUS DISEASES · Apr 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to help prevent HIV infection in men who have sex with men (MSM) in Thailand and France. Specifically, it looks at a treatment called event-driven pre-exposure prophylaxis (PrEP) using two medications, emtricitabine and tenofovir alafenamide (TAF/FTC). Participants will take these medications before and after sexual intercourse to see how well they can reduce the risk of getting HIV.

To be eligible for the study, participants must be men aged 18 or older who have had sex with other men and have tested negative for HIV. They should also be able to plan their sexual activities and have engaged in some higher-risk behaviors in the past six months, like having condomless sex with different partners. Throughout the trial, participants will need to visit the clinic every three months to monitor their health and adherence to the medication. This study aims to ensure that the treatment is safe and acceptable, making it a potential option for those at risk of HIV.

Gender

MALE

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:
• • 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