Protocol Title: A Double-blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring with Dapivirine in Healthy, HIV-Negative Women
IPM 015 is a Phase I/II trial designed to assess and compare the safety of a dapivirine vaginal ring against a placebo vaginal ring when inserted once every 28 days over a 12-week period among healthy, HIV-negative women. IPM 015 also assessed the acceptability of the vaginal ring and enrolled 280 healthy, HIV-negative women at multiple research centres in Kenya, Malawi, Rwanda, South Africa and Tanzania.
- ClinicalTrials ID: NCT01071174
Participating Research Centers
- Be Part Yoluntu Centre – Mbekweni, South Africa
- Desmond Tutu HIV Foundation (DTHF) – Masiphumelele and Nyanga, South Africa
- Kenya Medical Research Institute (KEMRI) – Kisumu, Kenya
- Kilimanjaro Christian Medical Centre (KCMC) – Moshi, Tanzania
- Madibeng Centre for Research (MCR) – Brits, South Africa
- Maternal, Adolescent and Child Health (MatCH) – Edendale, South Africa
- Prevention of HIV/AIDS Project (PHIVA) – Pinetown, South Africa
- Qhakaza Mbokodo – Ladysmith, South Africa
- University of North Carolina Project – Lilongwe, Malawi
Publications, presentations or other scientific data
- Nel et al. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLOS ONE 2016. 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.