August 16, 2006

BIRMINGHAM, Ala. - Researchers at the University of Alabama at Birmingham (UAB) are beginning a clinical trial to assess the safety of a vaginal gel containing the HIV drug tenofovir, designed to protect against HIV and sexually transmitted infections. They are seeking healthy woman between the ages of 19-50 to participate in the clinical trial. Those interested in participating should call 205-996-6126 for more information.

Tenofovir is an anti-AIDS drug that stops HIV from invading cells that have not yet been infected with the virus. It already has been tested in thousands of HIV-infected persons and it is being used in an oral form for HIV treatment. Animal studies have shown that tenofovir gel can prevent transmission of a virus similar to HIV, but it is not yet known whether it has the same effect in humans.

This study will assess the safety of tenofovir gel in women, monitoring of absorption of the drug into the blood, conducting regular physical examinations and interviewing participants to identify any side effects and to learn more about women’s use of the gel. Results of a smaller, earlier safety study, showed no major safety concerns. They showed no serious side effects and little, if any, absorption of the drug into the blood stream.

The study is sponsored by the National Institute of Allergy and Infectious Diseases Division of AIDS, National Institute of Health and Human development, National Institute on Drug Abuse, National Institute of Mental Health, National Institutes of Health, and co-sponsored by Gilead Sciences Inc., the gel’s manufacturer.