(HIVNET Protocol 018) 

WHAT DO WE HOPE TO LEARN FROM THIS STUDY? 

The purpose of this study is to find out about the safety of a new gel that is designed for use in the vagina to prevent infection with HIV. This first step of safety testing must be completed before further studies can be done to see if it works to prevent HIV infection. The gel contains a drug, PMPA, that has been shown to kill HIV in the test tube. Besides looking at safety, this study will also collect some information on the acceptability of PMPA gel. The first part of this study will involve 70 women in the United States. If PMPA gel is found to be safe and acceptable for use by women, a larger test may be done to see if PMPA gel works to block the spread of HIV infection. 

WHO IS PARTICIPATING IN THIS STUDY? 

In the US, 40 women who are HIV-negative and are not sexually active, 10 women who are sexually active, and 20 women who are HIV-positive and sexually active will be enrolled in the study. 

WHAT U.S. HIVNET SITES WILL BE INVOLVED IN THE STUDY? 

Memorial Hospital, Providence, Rhode Island and the University of Illinois at Chicago. 

HOW WILL THIS STUDY BE CONDUCTED? 

Participants will use the gel once or twice a day for 14 days. The study will look for harmful effects of the gel on the vulva, vagina, and cervix. The participants will be asked whether they like or dislike using the gel, and why. 

WHAT IS THE TIMELINE FOR THIS STUDY? 

The study will begin enrolling participants in July 1998.