NCT05140954

The Women TAF-FTC Benchmark Study

Safety and Pharmacokinetics of TAF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The study seeks to assess the safety of and define blood and tissue benchmark concentrations of tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP) in cisgender women using directly observed oral pre-exposure prophylaxis (PrEP) therapy with tenofovir alafenamide-emtricitabine (TAF-FTC). Cisgender women will be randomly assigned to receive varying frequencies of weekly PrEP doses and followed for up to 18 weeks.These data will help accurate interpretation of efficacy results obtained in HIV prevention trials and programs in cisgender women.

Detailed description

This is an open-label, randomized, three-arm, directly observed therapy (DOT), pharmacokinetics study. HIV-uninfected non-pregnant cisgender women at low risk for HIV acquisition will be randomly assigned to 1 of 3 dosing frequencies of DOT with tenofovir alafenamide-emtricitabine (TAF-FTC) oral PrEP, to help differentiate poor and moderate 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 expected blood concentrations and dose-proportionality specific to cisgender women for tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) and peripheral blood mononuclear cells (PBMCs) using directly observed therapy of TAF-FTC at 2, 4, and 7 doses per week, representing poor, moderate, and perfect adherence, respectively. 3. To establish a model to predict adherence rate to TAF-FTC by level of TFV-DP in DBS for cisgender women. HIV-uninfected non-pregnant cisgender women will be randomly assigned to 1 of 3 dosing frequencies of directly observed therapy of TAF-FTC oral PrEP: 2, 4, or 7 doses/week to differentiate poor and moderate from perfect adherence. 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	co-formulated 25mg TAF/ 200mg FTC	Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet of co-formulated 25 mg TAF/ 200mg FTC

Timeline

• Start date: 2023-03-28
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2021-12-02
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

1 site across 1 country: Kenya

Regulatory

• FDA-regulated drug study