WASHINGTON, D.C., July 24, 2012 A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women a vaginal ring used once a month is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).
ASPIRE A Study to Prevent Infection with a Ring for Extended Use is a Phase III trial evaluating a vaginal ring that contains dapivirine, a potent antiretroviral (ARV) drug originally developed to treat HIV. The ring slowly releases dapivirine to cells inside the vagina throughout the one-month period that it's worn, potentially giving women discreet, long-acting protection against HIV transmitted through sex.
Nearly 3,500 women in Africa will take part in ASPIRE, which is being led by the Microbicide Trials Network (MTN) and funded by the National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health, which are part of the U.S. National Institutes of Health. The Makerere University-Johns Hopkins University Research HIV Clinical Trial Unit in Kampala, Uganda this week began screening women interested in joining the study. A second site, the Emavundleni Research Center at the Desmond Tutu HIV Foundation, University of Cape Town, South Africa, should be ready to screen potential participants next week. The MTN hopes to conduct ASPIRE at a total of 17 sites in Malawi, Uganda, South Africa, Zambia and Zimbabwe.
A second trial, The Ring Study, is being conducted in parallel with ASPIRE. The Ring Study is being led by the International Partnership for Microbicides (IPM), which developed the dapivirine ring, and will involve about 1,650 women. IPM has already enrolled more nearly 400 participants at trial sites in South Africa since the study launched in April. The Ring Study will also be conducted in Rwanda and is expected to start there in August.
The two sister studies are the first effectiveness trials of
|Contact: Lisa Rossi|
Microbicide Trials Network