BridgeMD
Tests treatment safety and results for HIV/AIDS
Official title Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.
ClinicalTrials.gov ID: NCT05813964
What this study is testing
What is TDF/FTC 300mg/200mg fixed-dose combination tablets?
TDF/FTC 300mg/200mg fixed-dose combination tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hiv/aids.
Also referred to as Truvada.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only. Healthy volunteers may be eligible.
You may be able to join 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...
See the full eligibility 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...
- 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-
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Chiang Mai, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Chiang Mai, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.