Informations générales (source: ClinicalTrials.gov)
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 (SimpPrEP)
Interventional
Phase 3
ANRS, Emerging Infectious Diseases (Voir sur ClinicalTrials)
juin 2024
mai 2027
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint-Louis - Paris - France | Jean Michel MOLINA, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
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
- 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