The Women TAF-FTC Benchmark Study

Status Completed

Clinical Trial Summary

The study seeks to assess the safety and define blood and tissue benchmark concentrations of Tenofovir (TFV) and Tenofovir diphosphate (TFV-DP) in Cisgender women using directly observed tenofovir alafenamide (TAF)-emtricitabine (TAF-FTC) pre-exposure prophylaxis (PrEP). These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.

Clinical Trial Description

This is an open-label, randomized, three-arm, directly observed therapy, pharmacokinetics study. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy (DOT) TAF-FTC PrEP, to help differentiate poor and modest from perfect adherence. The primary objectives of the study are: 1. To describe the safety of TAF-FTC-based PrEP in HIV-uninfected cisgender women. 2. To define the cisgender women-specific expected blood concentrations and dose-proportionality for TFV-DP in DBS and PBMCs using directly observed TAF-FTC therapy at 2, 4, 7 doses per week. 3. To establish a model to predict adherence rate to TAF-FTC by level of TFV-DP in DBS for cisgender women. The study will be the first to define TAF-FTC-based PrEP adherence-blood concentration thresholds for African cisgender women, a priority population for HIV prevention. The findings will guide accurate interpretation of safety, adherence, and efficacy of planned or ongoing HIV prevention trials in African women. ;

Study Design

Related Conditions & MeSH terms

HIV Infections

Clinical Trial Details

NCT number	NCT05140954
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	April 10, 2023
Completion date	December 19, 2023

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