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

Status:
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
Study Design:
Arms and Assigned Interventions
DescriptionDelivery 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.
Mode of Delivery
ARMs
Official Code: Amphora/QGriffithsin (QGRFT) fast-dissolving vaginal insert (FDI) (http://www.mpts101.org/mpt-database/product-page/38-mpts/mpts-topical-tablets/149-amphora-fast-dissolving-vaginal-insert-fdi-2)
Related Publications:
1R01AI150324-01
Trial Sponsors: NIAID
Start Date
End Date
May 24, 2021
May 24, 2021
Enrollment:0
Age range: ↔ any
Population: