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IPM 020

Status
Completed
Phase
II
I
Principal Investigator(s)
Dr Annalene Nel
Objective

IPM 020 is a double-blind, randomized, placebo-controlled Phase I/II expanded safety trial being conducted at 5 research centers in the United States among approximately 180 healthy, sexually active, HIV-negative women to assess the safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g as compared to the HEC-based universal placebo.

Prevention Option(s)
Microbicides
Study Design
Randomized
Arms and Assigned Interventions
Description
dapivirine gel 4789, 0.05%, 2.5g applied once daily
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
dapivirine gel 4759, 0.05%, 2.5g applied once daily
Mode of Delivery
Gel
Products
dapivirine gel
ARMs
Experimental
Description
placebo gel
Mode of Delivery
Gel
ARMs
Placebo Comparator
Trial Sponsors
IPM
June 2009
April 2011
Enrollment
180
18
Years
40
Years
Population
Women
Sites

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

Harbor-UCLA Medical Center

Torrance, California
United States of America

University of Illinois at Chicago, School of Public Health

Chicago, Illinois
United States of America

Albert Einstein College of Medicine

Bronx, New York
United States of America

SNBL Clinical Pharmacology Center

Baltimore
United States of America