Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)