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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

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