TAF / Elvitegravir Topical Insert
MPT in Development
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:
Funding:
Funding Mechanism:
NIH: Microbicide Trials Network (MTN)
USAID: Cooperative Agreement, Interagency Agreement [USAID-CDC]
USAID: Cooperative Agreement, Interagency Agreement [USAID-CDC]
Past Funding:
Bill & Melinda Gates Foundation
Active Ingredient:
Elvitegravir Tenofovir Alafenamide (TAF)
Product Indications:
HIV HSV-2
Description:
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; dissemination of results is planned mid-2020. A Phase 1 study to assess rectal administration of the TAF/EVG insert (MTN-039) was initiated in late 2019 and is ongoing. 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.
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; dissemination of results is planned mid-2020. A Phase 1 study to assess rectal administration of the TAF/EVG insert (MTN-039) was initiated in late 2019 and is ongoing. 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.
