Protocol Title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety and Acceptability of Dapivirine Gel 4759, 0.05% 2.5G, A Vaginal Microbicide, Conducted Using Daily Monitored Adherence in Healthy HIV-Negative Women
IPM 014A is a Phase I/II clinical trial designed to assess the safety and acceptability of one formulation of dapivirine gel (gel 4759, 0.05% 2.5g) as compared to a matching placebo gel in healthy, HIV-negative women in Kenya, Malawi, Rwanda and 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: NCT00917891
Participating Research Centers
- Be Part Yoluntu Centre — Mbekweni, South Africa
- College of Medicine/Johns Hopkins Research Project — Blantyre, Malawi
- Desmond Tutu HIV Foundation (DTHF) — Nyanga, South Africa
- Kenya Medical Research Institute (KEMRI) — Kisumu, Kenya
- Madibeng Centre for Research (MCR) — Brits, South Africa
- Prevention of HIV/AIDS Project (PHIVA) — Pinetown, South Africa
- Projet Ubuzima — Kigali, Rwanda
- Qhakaza Mbokodo — Ladysmith, 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.