drugset / Trial / NCT06274398
Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study
Phase 1
Completed
21 enrolled
Eastern Virginia Medical School
CONRAD · collabCenters for Disease Control and Prevention · collabEmory University · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.
Timeline
- Start
- 2024-01-16
- Primary completion
- 2025-03-31
- Completion
- 2025-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | elvitegravir | Small molecule | 16 mg | Rectal |
| Subject | tenofovir alafenamide | Small molecule | 20 mg | Rectal |
Indications
No indication recorded.