Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert (NCT06087913) | Clinical Trial Compass
CompletedPhase 1
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
United States, Kenya, South Africa68 participantsStarted 2023-11-08
Plain-language 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. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.
Who can participate
Age range18 Years ā 50 Years
SexFEMALE
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Inclusion criteria
ā. Aged 18 to 50 years (inclusive) at Screening.
ā. Assigned female sex at birth.
ā. 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).
ā. General good health (by volunteer history) without any evidence of clinically significant systemic disease (as determined by Investigator of Record \[IoR\] or designee).
ā. Has had vaginal sex and has an intact uterus and cervix.
ā. Has a regular and/or predictable bleeding pattern based on the opinion of the investigator, or is oligomenorrheic or amenorrhoeic.
ā. HIV-uninfected based on testing performed at Screening and Enrollment (per protocol algorithms in Appendix II).
ā. Negative urine pregnancy test at Screening and Enrollment.
Exclusion criteria
ā. Per participant report, intends to do any of the following during the study participation period:
ā. Currently breastfeeding.
ā. Positive HIV test at Screening or Enrollment.
ā. 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.
What they're measuring
1
Number and Severity of Adverse Events
Timeframe: Randomization through study completion, an average of 3 months
ā. 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.
ā. Chronic or acute vulvar, vaginal or cervical symptoms (pain, irritation, spotting/bleeding other than what would be expected from contraceptive use, discharge, etc.).
ā. Known bleeding/clotting disorder, including use of anti-coagulation.
ā. Need for continued use of any contraindicated concomitant medications (as listed in Appendix III).