Problem being addressed
Despite extremely high rates of HIV infection in women, there is currently no discrete method to prevent infection.
Detailed description of the solution
The Microbicide Ring is a flexible, silicon vaginal ring that releases dapivirine slowly over the course of a month. Using matrix technology, the drug is evenly dispersed throughout the ring. After insertion, no further action is required by the user until a new ring must be inserted one month later. Similar rings are used in the United States for contraception to great effect, and studies have shown this method to be acceptable to both men and women in Kenya.
Designed by
- Design: International Partnership for Microbiodes (IPM)
- Manufacturing: USA and Sweden. For Clinical Phase 1&2 trials, microbiode rings were manufactured at IPM's CTM facility in Pennsylvania, USA. IPM has contracted QPharma in Sweden to manufacture the vaginal rings for Phase 3 trials, which are expected to last several years.
When and where it was tested/implemented
This device is in the middle of extensive clinical trials in Eastern and Southern Africa. In 2010, 280 HIV-negative women in these regions were randomly assigned to a drug delivery group or placebo group and were required to return to the clinic to replace the ring every month three months. This study primarily tested safety and documented the acceptability of the device to women and their capacity to use it correctly. Results are due in 2015 for a Phase 3 study to test the device's effectiveness at preventing HIV infection, pending the results of the current trials.
Funding Source
Private and public funding through non-profit partnerships.
References
Peer-reviewed publication
Malcolm, R. K., Edwards, K. L., Kiser, P., Romano, J., & Smith, T. J. (2010). Advances in microbicide vaginal rings. Antiviral Research, 88 Suppl 1, S30-9.
Nel A, Smythe S, Young K, et al. (2009.) Safety and pharmacokinetics of dapivirine delivery from matrix and reservoir intravaginal rings to HIV-negative women. Journal of Acquired Immune Deficiency Syndrome 51(4):417-423.
Romano J, Variano B, Coplan P et al. (2009.) Safety and availability of dapivirine (TMC120) delivered from an intravaginal ring. AIDS Research and Human Retroviruses 25(5):483-8.
Other internally generated reports
International Partnership for Microbicides. (2011.) First combination ARV vaginal ring for HIV prevention being tested in Phase I safety trial. Link available here.
International Partnership for Microbicides. (2011.) Microbicide overview. PDF available here.
Externally generated reports
AIDSMeds. (2011.) Two-drug vaginal HIV microbicide ring enters U.S. safety study. Link available here.