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

NCT06087913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

DRUG

TAF/EVG vaginal insert

vaginal insert applied daily for 3 days then every other day for 14 days

DRUG

Matching Placebo vaginal insert

vaginal insert applied daily for 3 days then every other day for 14 days

Sponsors & Collaborators

  • CONRAD

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Centre for the AIDS Programme of Research in South Africa

    collaborator NETWORK

  • Kenya Medical Research Institute

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Leila Mansoor, BPharm, PhD · Centre for the AIDS Programme of Research in South Africa

  • Nelly Mugo, MBChB · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2024-12-02
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States
  • Kenya
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087913 on ClinicalTrials.gov