Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert

August 25, 2025 updated by: Eastern Virginia Medical School

A Phase I Randomized, Placebo-controlled, Double-blind Study to Assess Safety, Pharmacokinetics, and Modeled Pharmacodynamics of a Vaginal Insert Containing Tenofovir Alafenamide and Elvitegravir

MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be enrolled across three sites, in USA, Kenya, and South Africa, approximately 20 per site. Participants will be randomized (1:1) to receive either a placebo or TAF/EVG vaginal insert as well as be randomized (1:1:1) to 3 different tissue sampling time points post-treatment (24hr, 48hr and 72hr after the last dose). Participants will be asked to complete 8 study visits with clinical and behavioral evaluations, and a subset will complete an in-depth interview to assess acceptability of vaginal insert use.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Kenya
      • Thika, Kenya
        • Kenya Medical Research Institute (KEMRI)
  • South Africa
      • Durban, South Africa
        • CAPRISA eThekwini Clinical Research Site
  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School Clinical Research Clinic (EVMS CRC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 18 to 50 years (inclusive) at Screening.
  2. Assigned female sex at birth.
  3. Able and willing to provide written informed consent to be screened for and enrolled in MATRIX-001 in one of the study languages (as specified in site SOP).
  4. General good health (by volunteer history) without any evidence of clinically significant systemic disease (as determined by Investigator of Record [IoR] or designee).
  5. Has had vaginal sex and has an intact uterus and cervix.
  6. Has a regular and/or predictable bleeding pattern based on the opinion of the investigator, or is oligomenorrheic or amenorrhoeic.
  7. HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms in Appendix II).
  8. Negative urine pregnancy test at Screening and Enrollment.

  9. Protected from pregnancy by an effective contraceptive method as confirmed by site SOP; effective methods include:

    • minimum of 3 months of use of a combined hormonal contraceptive method (except vaginal rings)
    • minimum of 6 months of use of a progestin only contraceptive method or copper IUD
    • Sterilization of participant or partner
    • Correct and consistent condom use (for US site only)
    • Abstinence from penile-vaginal intercourse (for US site only)
  10. Participants over the age of 21 (inclusive) must have documentation of a Grade 0 Pap smear within the past 3 years prior to Enrollment, per the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or Grade 1 Pap smear at Screening with no treatment required.
  11. Normal cervicovaginal mucosa (as defined in MATRIX-001 Study Specific Procedures [SSP] manual).
  12. Willing and able to comply with protocol requirements, including abstaining from vaginal activity and product use at specified times.
  13. Per participant report, if in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive or to currently have an STI.

Exclusion Criteria:

  1. Per participant report, intends to do any of the following during the study participation period:

    • Become pregnant.
    • Breastfeed.
    • Relocate away from the study site.
    • Travel away from the study site for a time period that would interfere with product resupply and/or study participation.
  2. Currently breastfeeding.
  3. Positive HIV test at Screening or Enrollment.
  4. History of sensitivity/allergy to any component of the study product, topical anesthetic, cellulose based thrombogenic material, or to both silver nitrate and Monsel's solution.
  5. Positive test for Trichomonas vaginalis (TV), Neisseria gonorrhea (GC), Chlamydia trachomatis (CT), Treponema pallidum (Syphilis), or Hepatitis B surface antigen (HBsAg) at Screening or (per participant report) treated for GC, CT, TV, HBsAg or syphilis in the past 12 months.
  6. Chronic or acute vulvar, vaginal or cervical symptoms (pain, irritation, spotting/bleeding other than what would be expected from contraceptive use, discharge, etc.).
  7. Known bleeding/clotting disorder, including use of anti-coagulation.
  8. Need for continued use of any contraindicated concomitant medications (as listed in Appendix III).
  9. Participation in any other trial with use of an investigational drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study.
  10. Participants who previously received an HIV vaccine or HIV broadly neutralizing antibody (bNAb) are not eligible. Individuals may be eligible if they participated in an HIV vaccine or bNAb study but have documentation that they did not receive active product (e.g., placebo recipients).
  11. Prior use of PEP or oral PrEP (including FTC/TDF) in the past 4 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
  12. Grade 2 or higher pelvic finding or laboratory abnormality, per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1 (Female Genital Grading Tables for Use in Microbicide Studies [Dated November 2007]) or clinically significant laboratory abnormality as determined by the clinician.
  13. Use of any of the following in the past 12 months: stimulants (cocaine [including crack], methamphetamine, or non-physician prescribed pharmaceutical-grade stimulants), or inhaled nitrates, or illicit injection drug use of any kind.
  14. Has any other condition that, based on the opinion of the IoR or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active
TAF/EVG (20/16mg) vaginal insert
Drug: TAF/EVG vaginal insert
vaginal insert applied daily for 3 days then every other day for 14 days
Placebo Comparator: Placebo
Matching placebo insert
Drug: Matching Placebo vaginal insert
vaginal insert applied daily for 3 days then every other day for 14 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and Severity of Adverse Events
Time Frame: Randomization through study completion, an average of 3 months
Safety measured by reported AE's Grade 2 and higher
Randomization through study completion, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) in cervicovaginal fluid (CVF)
Time Frame: through completion of study, an average of 3 months
Concentrations of TFV, TAF and EVG
through completion of study, an average of 3 months
Pharmacokinetics (PK) in plasma
Time Frame: through completion of study, an average of 3 months
Concentrations of TFV, TAF and EVG
through completion of study, an average of 3 months
Pharmacokinetics (PK) in cervicovaginal tissue
Time Frame: through completion of study, an average of 3 months
Concentrations of TFV, TAF and EVG
through completion of study, an average of 3 months
Modeled in vitro Pharmacodynamics (PD) for HIV
Time Frame: Enrollment through study completion, an average of 3 months
Rate of anti-viral activity in CVF
Enrollment through study completion, an average of 3 months
Modeled in vitro Pharmacodynamics (PD) for Herpes simplex virus (HSV)
Time Frame: Enrollment through study completion, an average of 3 months
Rate of anti-viral activity in CVF
Enrollment through study completion, an average of 3 months
Number of participants who find using the vaginal insert acceptable.
Time Frame: Enrollment through study completion, an average of 3 months
Responses to key questions on satisfaction, comfort with insertion, willingness to use the vaginal insert
Enrollment through study completion, an average of 3 months
Number of participants with changes to vaginal microbiome
Time Frame: Enrollment through study completion, an average of 3 months
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function, including immune cells, pH, soluble markers, and immune cells.
Enrollment through study completion, an average of 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modeled Tissue PD
Time Frame: Enrollment through study completion, an average of 3 months
p24 antigen production in cervicovaginal tissue infected with HIV-1 ex vivo
Enrollment through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Virginia Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh
United States Agency for International Development (USAID)
CONRAD
Kenya Medical Research Institute
Centre for the AIDS Programme of Research in South Africa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Leila Mansoor, BPharm, PhD, Centre for the AIDS Programme of Research in South Africa
  • Study Chair: Nelly Mugo, MBChB, Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MATRIX-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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