MTN 037

Status

Ongoing

Phase

Principal Investigator(s)

Craig Hendrix, MD

Objective

MTN-037 is a Phase 1, open label, sequential dose/volume escalation study designed to evaluate the safety and acceptability of PC-1005 (MIV-150/Zinc Acetate/Carrageenan gel) when administered rectally.

*Study is in follow-up*

Last updated May 8, 2021

Prevention Option(s)

Microbicides

Multipurpose Prevention Technologies

Study Design

Open label

Arms and Assigned Interventions

Description

All participants will receive 3 single escalating doses of PC-1005 gel during Visits 3, 5, and 7, with a 2-to-6-week washout period between dosing visits. Each participant will be on study for approximately 3 to 5 months.

Mode of Delivery

Gel

Products

PC-1005 gel

ARMs

Experimental

Official Code

NCT03408899

Trial Sponsors

NIAID (DAIDS-ES: 35122)

June 2018

April 2019

Enrollment

Years

Population

Men

Women

Sites

Alabama Microbicide CRS

Birmingham, Alabama

United States of America

University of Pittsburgh CRS

Pittsburgh, Pennsylvania

United States of America

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MTN 037

Alabama Microbicide CRS

University of Pittsburgh CRS