Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Safety and Pharmacokinetic Study in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From Both Matrix and Reservoir Intravaginal Rings Each Containing 25mg of Dapivirine
IPM 018 is a Phase I trial that assessed the safety and tolerability of matrix and reservoir intravaginal rings containing 25mg of dapivirine when used continuously for 28 days, and compared to placebo rings.
The trial also assessed dapivirine concentrations in plasma and vaginal fluid before, during and after 28-day use of matrix and reservoir silicone elastomer intravaginal rings each containing 25mg of dapivirine.
The trial took place at one site in Belgium among 24 healthy, HIV-negative women.
- ClinicalTrials ID: NCT00469768
Participating Research Centers
- University of Ghent — Ghent, Belgium
Publications, presentations or other scientific data
- Nel et al. Safety and pharmacokinetics of dapivirine delivery from matrix and reservoir intravaginal rings to HIV-negative women. Journal of Acquired Immune Deficiency Syndromes 2009. See abstract.