The Women TAF-FTC Benchmark Study

NCT05140954 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: STUDY00014075CO-US-412-6203
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pre-exposure Prophylaxis; HIV; Kenya; Descovy

Outcome Measures

Primary Outcomes (4)

• Frequency of Adverse Events

  The frequency of graded adverse events by arm, including emergent HIV infection during the study period.

  Assessed through the 10 week DOT dosing period

• Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS)

  TFV-DP and FTC-TP concentrations observed in dried blood spots (DBS) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

  Assessed at week 10

• Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs)

  Steady-state TFV-DP and FTC-TP concentrations observed in peripheral blood mononuclear cells (PBMCs) after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

  Assessed at week 4

• Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)

  Fitted steady-state TFV-DP concentrations after ten weeks of directly observed therapy with TAF-FTC oral PrEP, in women randomized to receive 2, 4, or 7 doses per week, representing poor, moderate, or perfect adherence, respectively.

  Assessed through 10 weeks

Study Arms (3)

Perfect Adherence

EXPERIMENTAL

Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).

Drug: co-formulated 25mg TAF/ 200mg FTC

Moderate Adherence

EXPERIMENTAL

Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week

Drug: co-formulated 25mg TAF/ 200mg FTC

Poor Adherence

EXPERIMENTAL

Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week

Drug: co-formulated 25mg TAF/ 200mg FTC

Interventions

co-formulated 25mg TAF/ 200mg FTC DRUG

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

Also known as: Descovy

Moderate Adherence; Perfect Adherence; Poor Adherence

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Has access to an active smartphone to allow off-site observation of dosing if unable to come to the clinic or as determined by the study staff, the participant resides in close location to clinic to permit home visit if unable to come to the clinic. i.e., potential participants without a smartphone may be enrolled in the study if investigator determines that the participant resides within reasonable distance from the clinic that would permit home visit id the participant misses their visit.
• Intention to stay within the study site's catchment area for at least 10 weeks.
• Resides or works in catchment area with high speed internet coverage to permit video streaming
• Not pregnant or breast feeding
• Willing to use effective contraception during the study period.

You may not qualify if:

• 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
• High risk of HIV infection (for example: sexually active with an HIV infected partner; engages in condomless intercourse with HIV-infected partners or partner of unknown status during the study; females who exchange sex for money, shelter, or gifts; active injection drug use or during the last 12 months; newly diagnosed sexually transmitted infections in last 6 months.

Sponsors & Collaborators

• University of Washington: lead
• Kenya Medical Research Institute: collaborator
• University of Colorado, Denver: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Kenya Medical Research Institute - Partners in Health Research and Development

Thika, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Racivir; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

1. Dosing of TAF/FTC was up to only ten weeks. 2. Assessment of drug concentrations in PBMCs is highly dependent on cell processing and count protocols, meaning that it is difficult to compare PBMCs results across laboratories and studies. 3. The study did not explicitly evaluate the concentration-efficacy relationship.

Results Point of Contact

• Title: Kenneth K. Mugwanya, MBChB, MS, PhD
• Organization: Departments of Global Health and Epidemiology, University of Washington

mugwanya@uw.edu

+1 206 520-3800

Study Officials

• Kenneth K Mugwanya, MBChB, MS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Peter L Anderson, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 2, 2021
• Study Start: March 28, 2023
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-09

Locations

KE (1)