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PREVENT study

Phase
I
Principal Investigator(s)
Ken Ho, MD
Objective

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.

 

Recruitment prematurely terminated due to COVID-19 (as of May 2021)

Prevention Option(s)
Microbicides
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Experimental: Open-label Q-GRFT enema Open-label Q-GRFT enema administered rectally once as a single dose (Arm 1) Drug: Q-Griffithsin (Q-GRFT) enema Investigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT Other Name: Study product enema
Products
Q-GRFT
ARMs
Experimental
Description
Experimental: Randomized, blinded Q-GRFT enema Blinded Q-GRFT enema administered rectally once as a single dose (Arm 2) Drug: Q-Griffithsin (Q-GRFT) enema Investigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT Other Name: Study product enema
Products
Q-GRFT
ARMs
Experimental
Description
Placebo Comparator: Randomized, blinded placebo enema Blinded placebo enema administered once as a single dose (Arm 3) Other: Placebo enema Approximately 125mL of 0.9% sodium chloride solution
ARMs
Placebo Comparator
Official Code
NCT04032717
Related Publications
Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture
Trial Sponsors
Rhonda Brand; NIAID; Intrucept Biomedicine LLC
July 2019
February 2021
18
Years
45
Years
Population
Men
Women