Q-Griffithsin (Q-GRFT) Enema
This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse. GRFT is one of the most powerful, broad-spectrum antivirals ever tested and its activity is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, human papillomavirus (HPV), and hepatitis C. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT
Development Stage:
Clinical – Phase 1 Trial (C1)
Hormonal/Non-Hormonal:
Non-Contraceptive
Delivery Route & Method:
Topical - Enema - Rectal
Mechanism of Action:
Cell-viral fusionblocking agent
Developer:
- University of Louisville
- University of Pittsburgh
Funding:
- Nat. Institute Allergy & Infect. Diseases (NIAID)
Funding Mechanism:
NIAID: U19
Active Ingredient(s):
- QGRFT
Product Indication(s):
- Hepatitis
- HIV
- HPV
- HSV-2