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The Women TAF-FTC Benchmark Study

NCT05140954 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-10-27

Study results available
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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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kenneth K Mugwanya, MBChB, MS, PhD · University of Washington

  • Peter L Anderson, PharmD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2023-12-19
Completion
2023-12-19
FDA Drug
Yes

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05140954 on ClinicalTrials.gov