http://allafrica.com/stories/201006081242.html

The clinical trial, known as IPM 015 will test the safety and acceptability of the dapivirine-containing vaginal ring - which is successfully used in Europe as a delivery method for hormonal therapy and birth control.

Announcing the commencement of the trial at the Women Deliver conference in Washington DC yesterday (TUES), CEO of the International Partnership for Microbicides (IPM) Zeda Rosenberg said the vaginal ring could be well suited to deliver HIV prevention drugs for women in developing countries.

The vaginal ring used in IPM 015 is made of flexible silicone, is durable and would be easy to distribute-making it well suited for use in developing countries. Each ring slowly releases 25 mg of the ARV drug dapivirine over the course of 28 days, potentially providing sustained protection against HIV.

The vaginal rings used in this study and can be easily self-inserted. The women participating in the study will use a ring for 4 weeks at a time (plus or minus 4 days), at which point it will be replaced with a new ring, over the course of three months. Participants will be asked to complete a total of 6 visits to the research centre, including a follow-up visit 4 weeks after the last ring is removed.

The vaginal ring containing dapivirine has already been shown to be safe as tested in four prior IPM clinical trials among women in Europe, with another trial ongoing. If IPM 015 further confirms the safety and acceptability of the product among women in Africa, a Phase III program to test the ability of dapivirine rings to prevent HIV infection is scheduled to begin in Africa in 2011, with results due in 2015.

This trial is an expanded safety trial that will compare the dapivirine ring with a placebo ring containing no active drug among 280 volunteers aged 18 to 40 across Africa, including South Africa, Kenya, Rwanda, Malawi, Tanzania and Zambia.

Women in South Africa have begun volunteering for the trial and it is hoped that other African nations will start the same study shortly.

Jill Sheffield, President of Women Deliver highlighted the importance of arming women and girls with tools to
protect themselves against HIV.

"The contraceptive ring has been a formidable tool for women seeking more control over their reproductive health, and it is wonderful to see HIV researchers adapt this technology to tackle the single biggest killer of young women. The simple fact is that we will never be able to fully ensure the health of women and girls globally without halting the spread of HIV and AIDS," said Sheffield.

"Biology and gender inequality continue to place women at greater risk of disease and death, particularly in developing countries," said Elizabeth Mataka, the UN Secretary-General's Special Envoy for AIDS in Africa. "All too often, women are not in a position to control their sexual health or protect themselves from HIV infection. By empowering women with new tools to protect their health, this ring technology could bring hope where there was none before."

"The roll-out of treatment in the past few years has saved millions of lives, but the AIDS epidemic continues to spread, with women particularly vulnerable," said Michel Sidibé, the Executive Director of UNAIDS. "Preventing HIV transmission is essential if we are to protect the health and safety of future generations. If successful, innovations, like microbicides, could have an extraordinary impact."

Every day more than 3,000 women worldwide become infected with HIV. And HIV/AIDS is the leading cause of death for women aged 15-49 years in Africa. Despite this challenge, women lack a discreet method to prevent infection. Current prevention options may be impractical for women who lack the power to ensure that their male partners use condoms or remain faithful, and for those who are married, want to have children or are at risk of violence.