Protocol Title: Phase I Study of a Vaginal Ring for Delivery of TMC120 as a Vaginal Microbicide
IPM 001 is a Phase I trial that assessed the feasibility of using a silicone elastomer vaginal ring to deliver dapivirine as a microbicide.
Women enrolled in the trial experienced seven days of exposure to a placebo vaginal ring (containing no active compound) followed by seven days of exposure to a ring containing 200 mg of dapivirine. The study population consisted of 12 healthy, sexually-abstinent women.
Safety and tolerability were evaluated through clinical and laboratory assessments. Feasibility of drug delivery was assessed by measuring drug concentrations in vaginal fluids, vaginal and cervical tissue, and plasma.
The study concluded that dapivirine was safe, well tolerated and could be delivered via a vaginal ring at concentrations potentially capable of preventing male-to-female transmission of HIV.
- ClinicalTrials ID: NCT00700284
Participating Research Centers
- University of Ghent — Ghent, Belgium
Publications, presentations or other scientific data
Romano et al. Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring. AIDS Research and Human Retroviruses 2009. See abstract.