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

Phase 1 Terminated 18 enrolled Rhonda Brand Intrucept Biomedicine LLC · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2019-07-10
Primary completion: 2021-02-04
Completion: 2021-02-04

Outcome

Outcome not reported

Stopped (Enrollment): “Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.”

Publications

Shrivastava-Ranjan P, Lo MK, Chatterjee P, Flint M, Nichol ST, Montgomery JM, O'Keefe BR, Spiropoulou CF. Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture. Front Cell Infect Microbiol. 2020 Nov 4;10:561502. doi: 10.3389/fcimb.2020.561502. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Q-Griffithsin	Protein / enzyme biologic	40 mg	—

Indications

No indication recorded.