Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India
PRO 2000 Gel is designed to be inserted into the vagina to protect women from getting HIV during sex. So far, PRO 2000 Gel has been tested for safety in 136 women from Europe and the United States. This study will evaluate the safety and acceptability of PRO 2000 Gel when used by women in Pune, India. The study will also examine what Indian women and men think about using PRO 2000 Gel.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Safety and Acceptability Study of the Investigational Vaginal Microbicide PRO 2000/5 Gel (P)|
Topical microbicides are designed to prevent the sexual transmission of HIV and other disease pathogens. PRO 2000/5 Gel (P), or PRO 2000, is a vaginal microbicide that has been evaluated in Phase I safety trials in Europe and the U.S. PRO 2000 Gel is easily manufactured, highly stable, and highly water-soluble. The aqueous gel formulation contains a synthetic carbomer, a lactic acid/lactate buffer, and preservatives. In vitro, PRO 2000 Gel has been shown to suppress infection by herpes viruses, Chlamydia trachomatis, Neisseria gonorrhoeae, and a wide range of HIV-1 isolates. This study will evaluate the safety and acceptability of PRO 2000 Gel in HIV uninfected women in Pune, India. The study is a precursor to a larger Phase II/III study of PRO 2000 Gel.
Participants in this study will be sexually active HIV uninfected women at either low or high risk for HIV infection. Male partners of these women will also be enrolled in the study. Participants will be asked to apply PRO 2000 Gel twice a day for 14 consecutive days between menses and to have vaginal intercourse with a single male partner, using study-provided male condoms, at least twice per week during the two weeks of PRO 2000 Gel use. Participants will have a screening visit, an enrollment visit, and 3 study visits during the two weeks of PRO 2000 Gel use; each visit will last about 1 hour. Study visits will include a medical history, gynecologic exam, blood and urine tests, and product acceptability questionnaires. Colposcopy will be performed three times during the study. Participants will also be asked to complete a Daily Study Record about product use and sexual activity and questionnaires about their willingness to use the product and their perceptions of the product.
Four weeks after using PRO 2000 Gel, participants will be asked to participate in a focus group to discuss product acceptability. Participants' male partners will also be asked to participate in focus groups about product use.
|Study Chair:||Smita N. Joshi, MBBS||National AIDS Research Institute, Pune, India|
|Study Chair:||Steven J. Reynolds, MD, FRCP(C)||Johns Hopkins University Department of Medicine|