HIV InfectionsPhase 2/3NCT05140954

The Women TAF-FTC Benchmark Study

A Phase 2/3 study testing co-formulated 25mg TAF/ 200mg FTC in people with HIV Infections, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: co-formulated 25mg TAF/ 200mg FTC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteKenya
Study dates: 10 Apr 2023to 19 Dec 2023
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

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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.
At low risk for HIV. In Kenya, national guidelines define substantial risk for HIV and recommend PrEP be an option for individuals reporting: partner of HIV-infected person not on ART or on ART for <6 months, >1 partner of unknown status, transactional sex, recent STI, recurrent PEP use, inconsistent condom use, or injection drug use. So, non-pregnant cisgender women reporting any of these factors will not be eligible for the study but will be linked for PrEP at clinic of choice including at Thika Site itself.
Willing to be randomized to non-daily PrEP and come to clinic frequently for DOT PrEP
Willingness and ability to be abstinent for at least 7 days after each vaginal biopsy visit.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Kenya Medical Research Institute - Partners in Health Research and Development
Thika

Other trials in Kenya

About this study

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

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.

Read the 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:

To describe the safety of TAF-FTC-based PrEP in HIV-uninfected cisgender women.
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.
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
Being tested: co-formulated 25mg TAF/ 200mg FTC
Keywords: Pre-exposure Prophylaxis, HIV, Kenya, Descovy
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

co-formulated 25mg TAF/ 200mg FTCDrug
Also called Descovy
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

Study groups in NCT05140954
Study group	Role	What they receive
Perfect Adherence	Experimental	Cisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week). Receives: 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 Receives: 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 Receives: Drug: co-formulated 25mg TAF/ 200mg FTC

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Adverse Events
The frequency of graded adverse events by arm, including emergent HIV infection during the study period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed through 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 202319 Dec 2023

First posted2 Dec 2021
Study start10 Apr 2023
Primary completion19 Dec 2023
Study completion19 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05140954
Sponsor's protocol ID: STUDY00014075
Other IDs: CO-US-412-6203
Status last verified: May 2026
First submitted: 18 Nov 2021
Last updated: 18 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Pharmacokinetics of TAF-FTC Pre-exposure Prophylaxis in Kenyan Cisgender Women
ClinicalTrials.gov ID: NCT05140954
Acronym / sponsor ID: STUDY00014075
Conditions: HIV Infections
Keywords: Pre-exposure Prophylaxis, HIV, Kenya, Descovy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Kenya Medical Research Institute, University of Colorado, Denver, Gilead Sciences
Study start: 10 Apr 2023 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 2 Dec 2021 (actual)
Results: Posted 27 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To describe the safety of TAF-FTC-based PrEP in HIV-uninfected cisgender women.
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.
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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Perfect Adherence	Experimental	Drug: co-formulated 25mg TAF/ 200mg FTCCisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC once daily (7 doses per week).
Moderate Adherence	Experimental	Drug: co-formulated 25mg TAF/ 200mg FTCCisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC 4 times per week
Poor Adherence	Experimental	Drug: co-formulated 25mg TAF/ 200mg FTCCisgender women will receive a single tablet of coformulated 25 mg TAF/ 200mg FTC twice per week

Who may qualify

Ages: 18 to 30 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (18 listed)

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)

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
co-formulated 25mg TAF/ 200mg FTCAlso: DescovyParticipants 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	Drug	Moderate Adherence, Perfect Adherence, Poor Adherence

Primary outcome

Frequency of Adverse Events
Time frame: Assessed through the 10 week DOT dosing period
The frequency of graded adverse events by arm, including emergent HIV infection during the study period.
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Ten Weeks in Dried Blood Spots (DBS)
Time frame: Assessed at week 10
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.
Concentrations of Tenofovir Disphosphate (TFV-DP) and Emtricitabine Triphosphate (FTC-TP) Measured at Four Weeks in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Assessed at week 4
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.
Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)
Time frame: Assessed through 10 weeks
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.

Results and safety

Results posted to the registry on 27 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Poor Adherence	18	16
Moderate Adherence	18	17
Perfect Adherence	18	18

Primary outcome: Frequency of Adverse Events

Time frame: Assessed through the 10 week DOT dosing period. Number. Unit: Number of adverse events

Measure	Poor Adherence n = 18	Moderate Adherence n = 18	Perfect Adherence n = 18
Grade 1 adverse events	69	60	62
Grade 2 adverse events	1	1	0
Grade 3 or higher adverse events	0	0	0
Emergent HIV infection	0	0	0

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

Time frame: Assessed at week 10. Median (Inter-Quartile Range). Unit: fmol/punches

Measure	Poor Adherence n = 16	Moderate Adherence n = 17	Perfect Adherence n = 18
Observed TFV-DP concentrations	432 (407 to 504)	1214 (930 to 1377)	2345 (2063 to 3006)
Observed FTC-TP concentrations	261 (152 to 341)	976 (737 to 1359)	4031 (2913 to 4342)

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

Time frame: Assessed at week 4. Median (Inter-Quartile Range). Unit: fmol/10^6 cells

Measure	Poor Adherence n = 17	Moderate Adherence n = 17	Perfect Adherence n = 18
Observed TFV-DP concentrations	70 (55 to 94)	229 (159 to 278)	680 (462 to 864)
Observed FTC-TP concentrations	407 (337 to 500)	1859 (1126 to 2990)	6402 (4845 to 8010)

Primary outcome: Fitted Steady-state TFV-DP Concentrations in Dried Blood Spots (DBS)

Time frame: Assessed through 10 weeks. Median (Inter-Quartile Range). Unit: fmol/punch

Measure	Poor Adherence n = 18	Moderate Adherence n = 18	Perfect Adherence n = 18
Value	468 (423 to 531)	1010 (853 to 1231)	2355 (1923 to 2609)

Adverse events

Time frame: Adverse event data was collected over the ten weeks between randomization (i.e., administration of first dose of study product) and administration of the final dose of study product at the end of the directly observed therapy (DOT) phase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Doses Per Week (Poor Adherence)	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18
4 Doses Per Week (Moderate Adherence)	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18
7 Doses Per Week (Perfect Adherence)	0 of 18 (0%)	17 of 18 (94.4%)	0 of 18

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenneth K Mugwanya, MBChB, MS, PhD principal investigator

University of Washington

Peter L Anderson, PharmD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing co-formulated 25mg TAF/ 200mg FTC in people with HIV Infections, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Events (time frame: Assessed through the 10 week DOT dosing period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140954.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.