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Initiation of the First Safety Trial in Africa of an Antiretroviral-Containing Vaginal Ring Designed to Prevent HIV/AIDs Using TMC120 an NNRTI from Tibotec - press release
  Study in Southern and East Africa evaluates safety and acceptability of combining proven, long-acting women's health technology with antiretroviral drugs to prevent HIV
WASHINGTON, DC (June 8, 2010) - The nonprofit International Partnership for Microbicides (IPM) today announced the initiation of the first trial among women in Africa testing a vaginal ring containing an antiretroviral drug (ARV) that could one day be used to prevent HIV transmission during sex. The clinical trial, known as IPM 015, tests the safety and acceptability of an innovative approach that adapts a successful technology from the reproductive health field to give women around the world a tool to protect themselves from HIV infection. "Vaginal rings, commonly used in Europe and the U.S. for hormone delivery, could be well-suited to deliver HIV prevention drugs for women in developing countries," said Dr. Zeda Rosenberg, IPM's Chief Executive Officer. "This study will provide key information on the safety and acceptability of this technology for HIV prevention. It is an important step forward in our efforts to give women options they can use to safeguard their health."
Since 2001, women in developed countries have successfully used vaginal rings, such as the NuvaRing¨, ESTRING¨ and Femring¨, for birth control and hormonal therapy. These rings are appealing because they are self-administered, discreet and provide protection for a month or more. The vaginal ring being tested in IPM 015 is an ARV-based microbicide - a class of vaginal products currently being developed to prevent HIV infection in women. ARVs have revolutionized HIV treatment and have already been proven to reduce mother-to-child transmission of HIV. They are now being tested for their ability to prevent HIV infection. 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 ring is manufactured by IPM, which has a royalty-free license for dapivirine from Tibotec Pharmaceuticals, a division of Johnson & Johnson.
"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."
IPM 015 is a Phase I/II expanded safety trial that will compare the dapivirine ring with a placebo ring containing no active drug among 280 volunteers across Africa. Women in South Africa have begun volunteering for the trial, and it is hoped that other African nations will start the same study shortly. The women volunteers will be randomly assigned to use either the dapivirine or the placebo ring, which will be replaced once monthly for a three-month period.
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.
"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 Sidibe, 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.
The initiation of IPM 015 was announced at the Women Deliver conference in Washington, D.C., the largest conference focused on maternal health in more than a decade.
"Women and girls must be given the tools to protect themselves from HIV infection," said Jill Sheffield, President of Women Deliver. "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."
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An Indian-origin scientist at Weill Cornell Medical College say that a novel contraceptive may also prove effective in blocking the transmission of the HIV virus.
"HIV vaccine is the most desirable method, but that is not foreseeable in the near future....vaginally inserted ring is incorporated with multiple antiviral drugs that prevent HIV infection, and are time-released over a period up to 28 days.....He has revealed that the compounds tested were a newly developed anti-HIV agent, Boc-lysinated betulonic acid, TMC120 (dapivirine), PMPA, and 3''-azido-3''-deoxythymidine (AZT or zidovudine), which, when combined, were found to block infection in human cells exposed to the virus in a laboratory setting."
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