COMPLETED

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

Conditions

Safety Issues vaginal insert HIV pre-exposure prophylaxis (PrEP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-08

Study Completion:2024-12-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06087913

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Eastern Virginia Medical School Clinical Research Clinic (EVMS CRC)

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Eastern Virginia Medical School

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

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 Registration Dates

Study Start Date2023-11-08

Study Completion Date2024-12-02

Study Record Updates

Study Start Date2023-11-08

Study Completion Date2024-12-02

Terms related to this study

Keywords Provided by Researchers

vaginal insert
HIV
pre-exposure prophylaxis (PrEP)

Additional Relevant MeSH Terms

Safety Issues