A first-of-its-kind clinical research trial at the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit will look at two different methods of female-controlled HIV prevention: Microbicides and pre-exposure prophylaxis. The ground-breaking trial offers women living in the Greater Cleveland area a unique opportunity to help alter the course of the worldwide AIDS epidemic. The clinical trial is the first to be offered through the newly established National Institute of Health-funded Microbicide Trials Network.
The development of female-controlled HIV prevention methods are a research priority around the world, as the number of HIV-infected women continues to increase dramatically. Of the estimated 33.2 million people infected with HIV globally, 15.4 million are women. This trial will investigate the use of microbicides as a new method focused on the women's control of their own preventative medicine. Microbicides are topical treatments in the form of a gel, foam, cream, or depot device that could decrease or prevent the sexual transmission of HIV. Pre-exposure prophylaxis (PrEP) refers to taking oral medicine prior to sexual activity.
The most effective method currently available for the prevention of HIV infection is the consistent use of condoms. However, research has shown that many women do not have the power to require their husbands or male partners to wear a condom. This is especially true in the developing world, but is also true in economically developed countries such as the United States. Effective microbicides and/or PrEP will allow a woman to take control over her own protection from HIV, rather than having to rely on her male partner to wear a condom. There are no commercially available HIV microbicides or PrEP medicines available at this time.
This study is enrolling healthy, sexually active, HIV-negative women ages 18-45.
"Because MTN001 is an earlier phase trial, we are not seeking women who are at high risk for HIV infection," said Robert Salata, chief of Division of Infectious Diseases and HIV Medicine at University Hospitals, and co-principal investigator of the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit. "The trial is looking at the acceptability of the microbicide and PrEP drug to the participants and their adherence in using them over a period of time. We are seeking women who are motivated by their wish to empower women to protect themselves from HIV, and who are able to meet the time and effort requirements of the clinical trial."
The MTN001 trial encourages all those interested in this landmark research to contact the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit. The trial will last approximately 21 weeks, with 12 clinic visits during that period of time. Compensation is provided to participants. All clinic visits will be at the Clinical Trials Unit site at University Hospitals.
To call to enroll or for more information on HIV microbicide trials in Cleveland, call 216.844.AIDS (2437) or go online.
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