drugset / Trial / NCT04937881
PK of TAF and TDF for PrEP in Pregnant and Postpartum Women
Phase 3
Completed
39 enrolled
University of California, Los Angeles
Desmond Tutu HIV Foundation · collabGilead Sciences · collabUniversity of Cape Town · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This study will establish benchmarks of TFV-DP concentrations as measures of adherence following daily dosing with Tenofovir Alafenamide (TAF) compared with Tenofovir Disoproxil Fumarate (TDF) during pregnancy and postpartum. Study Investigators will recruit from an ongoing observational cohort study in Cape Town, South Africa, PrEP-PP (recruitment ongoing through July, 2021; NIMH R01MH116771; PI Coates \& Myer). Findings form this PK sub-study will be used to inform future PrEP in pregnancy and postpartum studies and develop benchmarks of the relative PK between TDF and TAF.
Timeline
- Start
- 2022-06-13
- Primary completion
- 2023-04-17
- Completion
- 2023-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Subject | tenofovir alafenamide | Small molecule | 25 mg | — |
| Background | emtricitabine | Other / unclassified | 200 mg | — |