Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4789, 0.05% 2.5g, A Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy HIV-Negative Women
IPM 014B is a Phase I/II clinical trial designed to assess the safety and acceptability of one formulation of dapivirine gel (gel 4789, 0.05% 2.5g) as compared to a matching placebo gel in 100 healthy, HIV-negative women in South Africa.
The gel was used once a day for a period of six weeks.
The trial used the Daily Monitored Adherence (DMA) design, a model used to help women establish a pattern of routine product use.
- ClinicalTrials ID: NCT00917904
Participating Research Centers
- Be Part Yoluntu Centre — Mbekweni, South Africa
- Desmond Tutu HIV Foundation (DTHF) — Masiphumelele, South Africa
- Madibeng Centre for Research (MCR) — Brits, South Africa
Publications, presentations or other scientific data
- Louw et al. Daily Monitored Adherence in a Phase I/II Dapivirine Gel Study in Madibeng, South Africa [poster presentation]. Microbicides 2010. See abstract 262.
- Nel et al. Daily Monitored Adherence as a Possible Adherence Enabler in Microbicide Trials [poster presentation]. Microbicides 2010. See abstract 88.