drugset / Trial / NCT06435026
Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
Phase 2
Completed
54 enrolled
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupOpen-labelOther
Summary
This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.
Timeline
- Start
- 2024-06-18
- Primary completion
- 2026-02-11
- Completion
- 2026-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 450 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 600 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 300 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 400 mg | Oral |