Protocol Title: A Open-Label, Randomized, Three-Period Crossover Trial in Healthy HIV-Negative Women to Assess the Drug-Drug Interaction Potential between Dapivirine Vaginal Ring-004, Containing 25 MG of Dapivirine, and Miconazole Nitrate, Administered as a 1200 MG Vaginal Capsule
IPM 028 was a Phase I trial designed to assess the potential drug-drug interactions as well as the safety of the co-administration of the dapivirine ring and a drug commonly used to treat vaginal yeast infections, miconazole nitrate. This study took place at one research center in Belgium and was an open-label, randomized, crossover trial in which 36 healthy, HIV-negative women were randomly assigned to one of two study sequences.
- ClinicalTrials ID: NCT01731574
Participating Research Centers
- SGS Life Science Services - Antwerp, Belgium
Publications, presentations or other scientific data
- Spence et al. Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence. Journal of Pharmaceutical and Biomedical Analysis 2016. See abstract.