Trial Information

Summary: Effect of PRO 2000/5 Gel on Infectious HIV-1 and Inflammatory Mediators in Cervicovaginal Secretions

Microbicides are topical products intended to protect against the transmission of sexually transmitted infections, including HIV. The purpose of this study is to see if using a microbicide, PRO 2000/5 Gel (P), vaginally one time results in a change in the amount of HIV which is present in vaginal fluid. Participants complete two study visits within 3 days, including a pelvic exam to test for sexually transmitted infections, urine testing for pregnancy and infection, and bloodwork to check viral load. A brief telephone call is completed one week later.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

HIV-positive women between 18-45
plasma HIV-1 viral load >50,000 within 2 months prior
normal Pap smear within previous 6 months

pregnancy, lactation (breastfeeding), menopause
current hormonal contraceptive use
genital abnormality
history of intermenstrual bleeding in previous 3 months
received treatment for a sexually transmitted infection in prior 3 months
any change in antiviral therapy in prior 2 months
positive urine infection, sexually transmitted infection, or vaginal infection at the first visit

Contact:

Kathleen Hogarty, CNM
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Telephone: 212-241-9710
Fax: 212-534-3240
Email:

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Trial listings updated: June 1, 2008 at 5:43:38 AM


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