drugset / Trial / NCT05140954
The Women TAF-FTC Benchmark Study
Phase 2/3
Completed
54 enrolled
University of Washington
Gilead Sciences · collabKenya Medical Research Institute · collabUniversity of Colorado, Denver · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure prophylaxis (PrEP) therapy with tenofovir alafenamide-emtricitabine (TAF-FTC). Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 18 weeks.These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.
Timeline
- Start
- 2023-04-10
- Primary completion
- 2023-12-19
- Completion
- 2023-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |