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TAF / Elvitegravir Topical Insert

Solid, tablet-like dosage form for dual-compartment (vaginal or rectal) on-demand use. Studies in non-human primates demonstrate proof-of-concept that a single TAF/EVG insert dosed vaginally several hours either before or after SHIV exposure provides strong protection. A Phase I study to assess the safety, pharmacokinetics, and pharmacodynamics of a single TAF/EVG insert administered vaginally (CONRAD A18-146) was completed in 2019, and a Phase 1 study to assess PK and safety after rectal administration of the TAF/EVG insert (MTN-039) was completed in April 2021 with results presented in February 2023 at CROI.  A placebo form of this insert was also evaluated in two international, multi-site acceptability studies, including the Quatro study, comparing four vaginal dosage forms in African women, and the MTN-035 (DESIRE) study, comparing three different rectal dosage forms. Under the USAID-funded MATRIX award, the TAF/EVG insert will be advanced into a multi-dose safety and PK clinical study.

*Also referred to as a dual-prevention product by MATRIX

Development Stage:

Clinical – Phase 1 Trial (C1)



Delivery Route & Method:

Topical - Fast Dissolving Insert – Vaginal, Rectal

Mechanism of Action:

Nucleoside analogue reverse transcriptase inhibitor (NRTI); Integrase strand-transfer inhibitor




  • Centers for Disease Control and Prevention (CDC)
  • Eastern Virginia Medical School
  • PEPFAR through USAID
  • U.S. Agency for International Development (USAID)

Funding Mechanism:


Past Funding:

U.S. Agency for International Development (USAID)/PEPFAR
Bill & Melinda Gates Foundation (support of QUATRO)
National Institutes of Health (NIH) (MTN 035 and 039 studies)
Interagency Agreement (USAID-CDC)

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