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First received: September 07, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Safety Issues

Study Type: INTERVENTIONAL


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

Brief 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.

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