WHAT DO WE HOPE TO LEARN FROM THIS STUDY?

In this study, we want to find out if a new product called PRO 2000/5 is safe for women to use in their vaginas. This product is a gel containing PRO 2000/5, a drug that kills HIV in a test tube. Before we can study whether it could help couples prevent HIV transmission during sex, however, we need to find out how PRO 2000/5 gel affects women's bodies and whether it is safe for people to use.

Besides looking at safety, this study will also collect information on acceptability-that is, what aspects of PRO 2000/5 gel people like or don't like and if they would use it.

This study will involve women and men in the United States and in South Africa. If PRO 2000/5 gel is found to be safe and acceptable for use by women, a larger test may be done to see if PRO 2000/5 gel works to block the spread of HIV infection.

WHO IS PARTICIPATING IN THIS STUDY?

In the U.S., 24 women who are BOTH HIV-negative and sexually active and 6 women who are BOTH HIV-positive and not sexually active will be enrolled in the study. An equal number of study participants, in the same categories, will be enrolled in South Africa.

WHERE WILL THE STUDY BE DONE IN THE U.S.?

At Memorial Hospital of Rhode Island and Women and Infants Hospital, in Rhode Island, and at the University of Pennsylvania in Philadelphia, Pennsylvania.

HOW WILL THIS STUDY BE CONDUCTED?

Each woman in the study will insert the PRO 2000/5 gel in her vagina once a day or twice a day for 14 days. The researchers will check through regular physical exams throughout the study to see if the gel is having any harmful effects on the woman's vulva, vagina or cervix.

In addition, we will be asking the women whether they like or dislike using the gel and why. We will also ask the male partners of the sexually active women in the study whether they like or dislike it when their partner uses the gel and why.

AIDS resulting from HIV infection caused the deaths of over 2.3 million people in 1997. Helping test new technologies to prevent transmission of HIV is crucial for developing safe, effective, and acceptable HIV/AIDS prevention methods.