IPM 034

Details

Protocol Title: An Open-Label, Parallel Group Pharmacokinetic Trial in Healthy, HIV-Negative Women to Characterise the Release Profile of Dapivirine Delivered by a Silicone Matrix Ring (Ring-004), Containing 25mg of Dapivirine, over Various Ring Use Periods

Description

IPM 034 is a clinical trial designed to assess the local and systemic pharmacokinetics, as measured in plasma and vaginal fluid samples, of the dapivirine ring when used by HIV-negative women over a period of 7, 14, 28, 56 or 84 days.

Participating Research Centers

  • SGS Life Science Services — Antwerp, Belgium

Publications, presentations or other scientific data

  • Nel et al. Local and Systemic Pharmacokinetic Profile of Dapivirine Vaginal Ring-004 When Used Continuously Over Various Periods up to Twelve Weeks [poster presentation]. CROI 2015. See abstract
  • 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.