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Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)

NCT04032717 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-07-06

No results posted yet for this study

Summary

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.

Conditions

  • HIV Prevention

Interventions

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

Placebo enema

Approximately 125mL of 0.9% sodium chloride solution

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Intrucept Biomedicine LLC

    collaborator UNKNOWN

  • Rhonda Brand

    lead OTHER

Principal Investigators

  • Ken Ho, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2021-02-04
Completion
2021-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032717 on ClinicalTrials.gov