Protocol Title: Double-blind, Randomized, Placebo-Controlled Trial to Study Safety, Local and Systemic Availability of TMC120 from a Vaginal Ring
IPM 008 is a Phase I trial that assessed the feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 for sevent days.
The trial population consisted of 13 healthy sexually abstinent women in Belgium. Safety and tolerability were evaluated through clinical and laboratory assessments. Feasibility of drug delivery was assessed by measuring TMC120 concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma.
IPM 008 demonstrated that ring delivery of TMC120 was safe and generally well tolerated, and release of drug in vivo could be achieved.
- ClinicalTrials ID: NCT00332995
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.