Overview

PK of TAF and TDF for PrEP in Pregnant and Postpartum Women

Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, Los Angeles
Collaborators:
Desmond Tutu HIV Foundation
Gilead Sciences
University of Cape Town
Treatments:
Tenofovir