Safety IssuesPhase 1NCT06087913
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
A Phase 1 study testing TAF/EVG vaginal insert in people with Safety Issues, run by Eastern Virginia Medical School at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- TAF/EVG vaginal insert
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 Nov 2023to 2 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 50 years (inclusive) at Screening.
- Assigned female sex at birth.
- 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).
- General good health (by volunteer history) without any evidence of clinically significant systemic disease (as determined by Investigator of Record [IoR] or designee).
- Has had vaginal sex and has an intact uterus and cervix.
- Has a regular and/or predictable bleeding pattern based on the opinion of the investigator, or is oligomenorrheic or amenorrhoeic.
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- HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms in Appendix II).
- Negative urine pregnancy test at Screening and Enrollment.
- 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)
- 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.
- Normal cervicovaginal mucosa (as defined in MATRIX-001 Study Specific Procedures [SSP] manual).
- Willing and able to comply with protocol requirements, including abstaining from vaginal activity and product use at specified times.
- 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.
Who cannot join
- 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.
- Currently breastfeeding.
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- Positive HIV test at Screening or Enrollment.
- 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.
- 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.
- Chronic or acute vulvar, vaginal or cervical symptoms (pain, irritation, spotting/bleeding other than what would be expected from contraceptive use, discharge, etc.).
- Known bleeding/clotting disorder, including use of anti-coagulation.
- Need for continued use of any contraindicated concomitant medications (as listed in Appendix III).
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Eastern Virginia Medical School Clinical Research Clinic (EVMS CRC)
Norfolk, Virginia, 23507
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues
- Being tested
- TAF/EVG vaginal insert, Matching Placebo vaginal insert
- Keywords
- vaginal insert, HIV, pre-exposure prophylaxis (PrEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAF/EVG vaginal insertDrug
vaginal insert applied daily for 3 days then every other day for 14 days
Matching Placebo vaginal insertDrug
vaginal insert applied daily for 3 days then every other day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | TAF/EVG (20/16mg) vaginal insert Receives: Drug: TAF/EVG vaginal insert |
| Placebo | Placebo comparator | Matching placebo insert Receives: Drug: Matching Placebo vaginal insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Severity of Adverse Events
Safety measured by reported AE's Grade 2 and higher
Measured: Randomization through study completion, an average of 3 months
Secondary outcomes (7)
Pharmacokinetics (PK) in cervicovaginal fluid (CVF)
Concentrations of TFV, TAF and EVG
Measured: through completion of study, an average of 3 months
Pharmacokinetics (PK) in plasma
Concentrations of TFV, TAF and EVG
Measured: through completion of study, an average of 3 months
Pharmacokinetics (PK) in cervicovaginal tissue
Concentrations of TFV, TAF and EVG
Measured: through completion of study, an average of 3 months
Modeled in vitro Pharmacodynamics (PD) for HIV
Rate of anti-viral activity in CVF
Measured: Enrollment through study completion, an average of 3 months
Modeled in vitro Pharmacodynamics (PD) for Herpes simplex virus (HSV)
Rate of anti-viral activity in CVF
Measured: Enrollment through study completion, an average of 3 months
Number of participants who find using the vaginal insert acceptable.
Responses to key questions on satisfaction, comfort with insertion, willingness to use the vaginal insert
Measured: Enrollment through study completion, an average of 3 months
Number of participants with changes to vaginal microbiome
Evaluate mucosal factors and microbiome changes from baseline associated with mucosal function, including immune cells, pH, soluble markers, and immune cells.
Measured: Enrollment through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start8 Nov 2023
- Primary completion2 Dec 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Placebo-Controlled, Double-Blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- CONRAD, University of Pittsburgh, Centre for the AIDS Programme of Research in South Africa, Kenya Medical Research Institute, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Leila Mansoor, BPharm, PhD, Study chair, Centre for the AIDS Programme of Research in South AfricaNelly Mugo, MBChB, Study chair, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087913
- Sponsor's protocol ID
- MATRIX-001
- Status last verified
- Aug 2025
- First submitted
- 7 Sep 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dobard CW, Peet MM, Nishiura K, Holder A, Dinh C, Mitchell J, Khalil G, Pan Y, Singh ON, McCormick TJ, Agrahari V, Gupta P, Jonnalagadda S, Heneine W, Clark MR, Garcia-Lerma JG, Doncel GF. Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques. EBioMedicine. 2022 Dec;86:104361. doi: 10.1016/j.ebiom.2022.104361. Epub 2022 Nov 21.
PubMed 36423375Thurman AR, Ouattara LA, Yousefieh N, Anderson PL, Bushman LR, Fang X, Hanif H, Clark M, Singh O, Doncel GF. A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. Front Cell Infect Microbiol. 2023 Apr 19;13:1130101. doi: 10.3389/fcimb.2023.1130101. eCollection 2023.
PubMed 37153145
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06087913
- Acronym / sponsor ID
- MATRIX-001
- Conditions
- Safety Issues
- Keywords
- vaginal insert, HIV, pre-exposure prophylaxis (PrEP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- CONRAD, University of Pittsburgh, Centre for the AIDS Programme of Research in South Africa, Kenya Medical Research Institute, United States Agency for International Development (USAID)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Placebo-Controlled, Double-Blind
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: TAF/EVG vaginal insertTAF/EVG (20/16mg) vaginal insert |
| Placebo | Placebo comparator | Drug: Matching Placebo vaginal insertMatching placebo insert |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Aged 18 to 50 years (inclusive) at Screening.
- Assigned female sex at birth.
- 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).
- General good health (by volunteer history) without any evidence of clinically significant systemic disease (as determined by Investigator of Record [IoR] or designee).
- Has had vaginal sex and has an intact uterus and cervix.
Key exclusion criteria (18 listed)
- Per participant report, intends to do any of the following during the study participation period:
- Currently breastfeeding.
- Positive HIV test at Screening or Enrollment.
- 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.
- 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.
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 |
|---|---|---|
| TAF/EVG vaginal insertvaginal insert applied daily for 3 days then every other day for 14 days | Drug | Active |
| Matching Placebo vaginal insertvaginal insert applied daily for 3 days then every other day for 14 days | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Pharmacokinetics (PK) in cervicovaginal fluid (CVF)
Time frame: through completion of study, an average of 3 months
Pharmacokinetics (PK) in plasma
Time frame: 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
Modeled in vitro Pharmacodynamics (PD) for HIV
Time frame: 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
Number of participants who find using the vaginal insert acceptable.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 36423375Dobard CW, Peet MM, Nishiura K, Holder A, Dinh C, Mitchell J, Khalil G, Pan Y, Singh ON, McCormick TJ, Agrahari V, Gupta P, Jonnalagadda S, Heneine W, Clark MR, Garcia-Lerma JG, Doncel GF. Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques. EBioMedicine. 2022 Dec;86:104361. doi: 10.1016/j.ebiom.2022.104361. Epub 2022 Nov 21.
- Background: PubMed 37153145Thurman AR, Ouattara LA, Yousefieh N, Anderson PL, Bushman LR, Fang X, Hanif H, Clark M, Singh O, Doncel GF. A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. Front Cell Infect Microbiol. 2023 Apr 19;13:1130101. doi: 10.3389/fcimb.2023.1130101. eCollection 2023.
- MTN-039 Safety and PK of TAF/EVG rectal insertLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Leila Mansoor, BPharm, PhD study chair
Centre for the AIDS Programme of Research in South Africa
Nelly Mugo, MBChB study chair
Kenya Medical Research Institute
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAF/EVG vaginal insert in people with Safety Issues, run by Eastern Virginia Medical School at 3 sites in 3 countries.
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 18 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 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Kenya, South Africa. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number and Severity of Adverse Events (time frame: Randomization through study completion, an average of 3 months). 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 NCT06087913, which also lists 2 linked publications.
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 2 Sep 2025.