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NCT04032717 · ClinicalTrials.gov registry record · Phase 1
Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)
A Phase 1 study, sponsored by Rhonda Brand.
- Terminated
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04032717: Clinical Trial Phase 1 study, sponsored by Rhonda Brand.
NCT04032717 is a Phase 1 study that was terminated before completion, run by Rhonda Brand. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032717, a Phase 1 study, was terminated before completion, sponsored by Rhonda Brand.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
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.
Primary Outcome
Safety analysis will be conducted on all participants who have receive study product. The number and the frequency of ≥ Grade 2 adverse events (AEs) and ≥ Grade 1 Genitourinary AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Version 2.1 (March 2017), Addendum 1 Female Genital Grading Table for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this ta
Interventions
- DRUG Q-Griffithsin (Q-GRFT) enema
- OTHER Placebo enema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-07-10 |
| Est. Completion | 2021-02-04 |
| Phase | Phase 1 |
Why NCT04032717 stopped before completion
NCT04032717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Q-Griffithsin (Q-GRFT) enema is the first listed.
NCT04032717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04032717 about?
NCT04032717 is a clinical study titled "Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)". 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.
What is the current status of trial NCT04032717?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-07-10. Estimated completion is 2021-02-04.
What interventions are being tested in trial NCT04032717?
The interventions under investigation include: Q-Griffithsin (Q-GRFT) enema (DRUG), Placebo enema (OTHER).
Who is sponsoring clinical trial NCT04032717?
This trial is sponsored by Rhonda Brand, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04032717's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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