Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Trial to Evaluate the Safety of Dapivirine Gel 4759, 0.05% 2.5g and Dapivirine Gel 4789, 0.05% 2.5g Formulations as Compared to the Vaginal HEC-based Universal Placebo Gel, 2.5g in Healthy HIV-negative Women
IPM 020 is a Phase I/II expanded safety trial designed to assess and compare the safety of once-daily application of two formulations of dapivirine gel (gels 4859 and 4789) as compared to a universal placebo gel.
The trial was conducted at five research centers in the United States among 128 healthy, sexually active, HIV-negative women.
Secondary objectives of this trial looked at pharmacokinetics, adherence and acceptability of the two formulations of dapivirine gel.
- ClinicalTrials ID: NCT00799058
Participating Research Centers
- Albert Einstein College of Medicine & Montefiore Medical Center — Bronx, NY, USA
- Harbor-UCLA Medical Center — Los Angeles, CA, USA
- Project WISH, University of Illinois at Chicago — Chicago, IL, USA
- SNBL Clinical Pharmacology Center — Baltimore, MD, USA
- University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site — Birmingham, AL, USA
Publications, presentations or other scientific data
- van der Straten et al. Daily use of two dapivirine vaginal gels in the United States (IPM 020): adherence and acceptability [oral presentation]. Microbicides 2012.