Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05813964 | Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France. | PHASE3 | RECRUITING | 524 | — | — | Jun 5, 2024 | May 1, 2027 | Jun 20, 2025 | 4 | France, Thailand |
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.
| Arm | Type | Description |
|---|---|---|
| Event-driven PrEP with TDF/FTC | ACTIVE_COMPARATOR | Participants randomly assigned to the event-driven TDF/FTC arm will be instructed to take a loading dose of two single tablets containing coformulated TDF/FTC (300/200mg) 2 to 24 hours before sexual intercourse, followed by a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills. |
| Event-driven PrEP with TAF/FTC | EXPERIMENTAL | Participants randomly assigned to the event-driven TAF/FTC arm will be instructed to take one single tablet containing coformulated TAF/FTC (25/200mg) with or without food 2 to 24 hours before sexual intercourse followed by a second pill 24 hours after the first drug intake. In case of daily sexual intercourses, they will be instructed to take one pill per day until the last sexual intercourse and then a last pill 24 hours later. |
| Name | Type | Description |
|---|---|---|
| TDF/FTC 300mg/200mg fixed-dose combination tablets | DRUG | Event-driven dosing regimen |
| TAF/FTC 25mg/200mg fixed-dose combination tablets | DRUG | Event-driven dosing regimen. |
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 base...