Protocol Title: A Double-blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5 g and Dapivirine Gel 4789, 0.05%, 2.5 g Formulations and to Assess the Safety as Compared to the Intravaginal HEC-based Universal Placebo Gel, 2.5 g in Healthy, HIV-Negative Women
IPM 012 is a Phase I trial that assessed the pharmacokinetics and safety of two concentrations of dapivirine against a universal placebo over the course of 11 days of once daily intravaginal application of dapivirine. The trial enrolled 36 healthy HIV-negative, sexually active women at one site in Belgium.
- ClinicalTrials ID: NCT00613249
Participating Research Centers
- SGS Life Science Services – Antwerp, Belgium
Publications, presentations or other scientific data
- Nel et al. Pharmacokinetics of 2 dapivirine vaginal microbicide gels and their safety vs. Hydroxyethyl cellulose-based universal placebo gel. Journal of Acquired Immune Deficiency Syndromes 2010. See abstract.