Overview

The Women TDF-FTC Benchmark Study

Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated with HIV protection in cisgender women. Cisgender women will be randomly assigned to receive varying frequency of weekly PrEP doses and followed for up to 16 weeks. The study will also investigate how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Washington
Collaborators:
Kenya Medical Research Institute
National Institute of Allergy and Infectious Diseases (NIAID)
University of Colorado, Denver
Treatments:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination