To participate in the study, women must be between 18 and 24 years old, sexually active, healthy and free of any sexually transmitted disease. They cannot be pregnant or breast feeding. They must either have regular menstrual periods or not have them at all.
Moscicki said that the safety trial is important because earlier spermicidal microbicides like nonoxynol 9, which was an ingredient in a variety of contraceptive products from condoms to contraceptive creams and gels, was eventually found to increase rather than decrease HIV infection rates.
"Nonoxynol 9 was used commonly and was thought to be an extremely safe type of anti-microbial spermicide. But researchers found that it actually increased the rate of HIV infection in women. So now we realize that we must approach new microbicides a little more carefully," Moscicki said.
According to the U.S. Centers for Disease Control and Prevention, women account for more than one quarter of all new HIV/AIDS diagnoses. Women of color are especially affected by HIV infection and AIDS. In 2002, the most recent year for which data are available, HIV infection was the leading cause of death for African American women aged 25 to 34 years. It was the third leading cause of death for African American women aged 35 to 44 years and the fourth leading cause of death for African American women aged 45?4 years and for Hispanic women aged 35 to 44.
In the same year, HIV infection was the fifth leading cause of death among all women aged 35 to 44 and the sixth leading cause of death among all women aged 25 to 34. The only diseases causing more deaths of women were a variety of different types of cancer and heart disease.
Moscicki said that if the gel is approved by the FDA, women would use it about an hour before having intercourse.
Source:University of California - San Francisco