HIVNET HIV Network for Prevention Trials

Vaginal Microbicide Study of Buffergel

(HIVNET Protocol 009)

WHAT DID WE HOPE TO LEARN FROM THIS STUDY?

The purpose of this study was 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 vagina is normally slightly acid, and HIV and other organisms that cause sexually transmitted diseases are less likely to survive in an acid environment. BufferGel is a water-based gel that can maintain the acidity of the vagina during and after sex. Besides looking at safety, this study also collected some information on the acceptability of BufferGel. The first part of this study involved 20 women in the United States. If, after analysis, the product appears to be safe, further safety studies will be performed in Africa and Asia. If BufferGel is found to be safe and acceptable for use by women, a larger test may be done to see if BufferGel works to block the spread of HIV and other acid-sensitive disease-causing organisms that cannot survive in an acid environment.

WHO IS PARTICIPATING IN THIS STUDY?

In the US, 20 women who are HIV-negative, 10 of whom are sexually active and monogamous, and 10 of whom are not sexually active, were enrolled in the study. A total of 20 HIV-negative women (5 sexually active and 15 not sexually active) will be enrolled at each of four international sites.

WHAT U.S. HIVNET SITES WERE INVOLVED IN THE STUDY?

Women and Infants Hospital and Memorial Hospital, Rhode Island

HOW WAS THIS STUDY CONDUCTED?

Participants used the gel once a day for 14 days, then twice a day for 14 days. The study looked for harmful effects of the gel on the vulva, vagina, and cervix. The participants were asked whether they liked or disliked using the gel, and why. Participants also kept a diary to record when they used the gel, to make sure that the information on the safety of BufferGel corresponded with actual use of the product.

The U.S. portion of the study has been completed, and the information from that study is being analyzed. Screening and enrollment in the international phase is ready to begin, pending regulatory approvals.