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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 safety, pharmacokinetics, and pharmacodynamics of the TAF/EVG insert administered vaginally (CONRAD A18-146) was completed in early 2019. A Phase 1 study to assess PK and safety after rectal administration of the TAF/EVG insert (MTN-039) was completed in April 2021; results are expected in late 2021. 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.

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:

  • National Institutes of Health (NIH)
  • U.S. Agency for International Development (USAID)

Funding Mechanism:

NIH: Microbicide Trials Network (MTN)
USAID: Cooperative Agreement,
Interagency Agreement [USAID-CDC]

Past Funding:

Bill & Melinda Gates Foundation

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