Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813964
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-03-02
Brief Title:
Efficacy Acceptability and Safety of Event-driven HIV PrEP Using TAFFTC in MSM in Thailand and France
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
A Randomized Controlled Trial to Evaluate the Efficacy Acceptability and Safety of Event-driven Pre-exposure Prophylaxis for HIV Using TAFFTC in Men Who Have Sex With Men in Thailand and France
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SimpPrEP
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 TAFFTC 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 FTAF 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
Primary objective To assess the efficacy of emtricitabine 200 mg tenofovir alafenamide 25 mg FTAF 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 FTAF 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 FTDF 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
Participants will be randomly assigned to one of two regimens
Experimental Arm FTAF 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 FTDF 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502931-20 | EUDRACT_NUMBER | None | None |