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The Women TAF-FTC Benchmark Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

The Women TAF-FTC Benchmark Study

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

NCT05140954•University of Washington

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.

Eligibility

Age

18 - 30 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Age ≥18 and ≤30 years old
•Willing to undergo urine pregnancy tests
•Has understood the information provided and has provided written informed consent before any study-related procedures are performed.
•HIV uninfected based on negative HIV rapid tests, according to Kenyan national algorithm
•Normal renal function (estimated glomerular filtration rate \>60 mL/min)
•Hepatitis B surface Ag negative
•No active clinically significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with study participation
•Lack of severe anemia (Hemoglobin \>10 g/dL)
•Willing to use DOT and come to clinic frequently for DOT PrEP for at least 10 weeks
•Willing to have home visits for follow up
+8 more criteria

Exclusion Criteria

•Inability to give informed consent
•Positive screening HIV+ as determined by standard rapid serologic assays or suspected acute HIV infection in the opinion of the clinician. (example signs and symptoms of acute HIV infection include combinations of fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy cervical or inguinal)
•Positive HBV surface antigen test at screening
•Calculated creatinine clearance \<60 ml/min.
•Any laboratory value or uncontrolled medical conditions that, in the opinion of the investigators, would interfere with the study conditions such as, heart disease and/or cancer.
•Prohibited concomitant medications are: investigational agents (within 30 days of enrollment), aminoglycosides, ganciclovir/valganciclovir, chronic high-dose acyclovir/valacyclovir (\>800mg acyclovir or \>500mg valacyclovir for \>7 days), cyclosporine, amphotericin B, foscarnet, and cidofovir, and products with same or similar active ingredients as the study medications including TAF®, TRUVADA®, ATRIPLA®, COMPLERA®, EMTRIVA®, VIREAD®; or drugs containing lamivudine or adefovir, which are close analogs of FTC and tenofovir, respectively.
•Current or past use of PrEP (pre-exposure prophylaxis)
•Not willing to have home visits
•Pregnancy or plan to become pregnant in the next 6 months or unwillingness to use birth control
•Current breastfeeding
+1 more criteria

Locations (1)

Kenya Medical Research Institute - Partners in Health Research and Development

Thika, Kenya

Key Dates

Start Date

March 28, 2023

Primary Completion Date

December 19, 2023

Completion Date

December 19, 2023

Last Updated

October 27, 2025

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

co-formulated 25mg TAF/ 200mg FTC

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Women TAF-FTC Benchmark Study

Inclusion Criteria

Exclusion Criteria

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