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Amphora/QGriffithsin (QGRFT) fast-dissolving vaginal insert (FDI)

Phase
Pre-clinical
Principal Investigator(s)
ZYDOWSKY, THOMAS MICHAEL
Objective

Multipurpose Vaginal pH Regulator (MVP-R™) with non-ARV (anti-retroviral) microbicide for the prevention of pregnancy and HIV.

Prevention Option(s)
Microbicides
Arms and Assigned Interventions
Description
Delivery Route & Method:Topical - Fast Dissolving Insert/Capsule-Vaginal Mechanism of Action:Amphora lowers vaginal pH (pH = 3.5-4.5) in the presence of semen. The low pH inactivates sperm and bacteria. Gel coats vaginal and cervical mucosa and prevents sperm penetration. QGRFT is a potent non-ARV inhibitor of HIV. QGRFT binds to HIV envelope glycoproteins and prevents entry of HIV into target cells.
Products
Q-GRFT
Trial Sponsors
NIAID
Product Developers
Evofem Biosciences, Inc.; Population Council
May 2021
May 2021