Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Pharmacokinetic and Safety Trial in HIV-Negative Women to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring and to Evaluate the Safety of a Matrix Vaginal Ring Containing 25mg of Dapivirine
IPM 013 is a Phase I trial designed to assess the safety of the platinum-catalyzed matrix vaginal ring containing dapivirine as compared to placebo ring when used for 56 days (group A) or 57 days (group B ) by healthy, sexually active HIV-negative women. The trial is also designed to examine local and systemic pharmacokinetics of dapivirine vaginal ring as measured in plasma, vaginal fluids, and cervical tissue during the trial period. The trial was conducted over three months at one research center in Belgium among 48 women.
- ClinicalTrialsID: NCT01144676
Participating Research Centers
- SGS Life Science Services — Antwerp, Belgium
Publications, presentations or other scientific data
- Nel et al. Pharmacokinetics and Safety Assessment of Anti-HIV Dapivirine Vaginal Microbicide Rings with Multiple Dosing. Journal of AIDS & Clinical Research 2014. See abstract.