NCT06087913

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-12-02
• Completion: 2024-12-02
• First posted: 2023-10-18
• Last updated: 2025-09-02

Locations

3 sites across 3 countries: United States, Kenya, South Africa

Regulatory

• FDA-regulated drug study