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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 the TAF/EVG insert dosed either vaginally (single dose) or rectally (double dose) provides strong protection against vaginal or rectal SHIV exposure. A Phase I study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) 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; both studies demonstrated the TAF/EVG insert was well tolerated and provided promising PK and modeled PD results for event-driven HIV (and possibly HSV-2) prophylaxis. 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. Currently, the TAF/EVG insert is being studied in several expanded Phase I safety and PK clinical studies: MATRIX-001 initiated in November 2023 in the US, Kenya, and South Africa to evaluate multiple dosings of the insert used vaginally; RITE-PrEP initiated in January 2024 at one site in the US to evaluate multiple dosings of the insert used rectally in both men and women; and MATRIX-004 is expected to start late 2024 to evaluate the impact of vaginal sexual activity on PK and PD. An additional drug-drug interaction (DDI) study is also under consideration (MATRIX) to further evaluate the TAF/EVG insert when dosed with other commonly used vaginal products, in preparation for Phase II clinical testing. A new insert generation with additional antibacterial properties is also under preclinical characterization.

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

For more information, contact: Meredith Clark at clarkmr@evms.edu / conradinnovations@evms.edu

Development Stage:

Clinical – Phase 1 Trial (C1)

Hormonal/Non-Hormonal:

Non-Contraceptive

Delivery Route & Method:

Topical - Fast Dissolving Insert – Vaginal, Rectal

Mechanism of Action:

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

Developer:

  • CONRAD

Funding:

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

Funding Mechanism:

MATRIX

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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