Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Ring Containing 25mg of Dapivirine
IPM 024 is a safety and pharmacokinetic trial that evaluated how a platinum-catalyzed matrix dapivirine vaginal ring delivers drug for 28 consecutive days. Specifically, it assessed the safety and tolerability of the vaginal ring containing dapivirine as compared to the placebo ring.
It also assessed dapivirine concentrations in plasma and vaginal fluids before, during, and after 28 day use of a silicone elastomer matrix vaginal ring containing dapivirine.
The trial took place at one research centre in Belgium among 16 healthy, HIV-negative women.
- ClinicalTrials ID: NCT02920827
Participating Research Centers
- SGS Life Science Services – Antwerp, Belgium
Publications, presentations or other scientific data
- Nel et al. Safety and pharmacokinetics trial of dapivirine matrix vaginal ring [poster presentation]. AIDS 2010.
- Nel et al. A safety and pharmacokinetic trial assessing delivery of dapivirine from a vaginal ring in healthy women. AIDS 2014. See abstract.