PREVENT study

Status:
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:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 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
Mode of Delivery
ARMsExperimental
DescriptionExperimental: 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
Mode of Delivery
ARMsExperimental
Official Code: NCT04032717
Trial Sponsors: Intrucept Biomedicine LLC, NIAID, Rhonda Brand
Start Date
End Date
July 10, 2019
February 4, 2021
Enrollment:0
Age range: 18 Years ↔ 45 Years
Population:Cisgender Men, Cisgender Women