A Study of BufferGel in Women

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Heterosexual transmission of HIV presently accounts for the vast majority of new HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen, which inactivate...

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• All participants must have:
• • HIV-negativity by licensed EIA.
• • Willingness and ability to complete a study diary.
• • A regular menstrual cycle with a minimum of 18 days between menses.
• • Ability to insert BufferGel daily as required by the protocol.
• Cohort IA participants must:
• • Agree to abstain from sexual intercourse for the duration of the study.
• Cohort IB participants must:
• • Agree to have vaginal intercourse at least 2 times per week and use non-lubricated condoms for each act of intercourse.
• • Have currently (for 3 months or longer) a single sexual partner who is at low-risk for HIV infection.
• • Exclusion Criteria
• Co-existing Condition:
• Participants with the following conditions or symptoms are excluded:
• • A Grade 3 or higher liver, renal, or hematology abnormality.
• • Menopausal.
• • Breakthrough menstrual bleeding.
• • Any STD or symptoms, as seen on pelvic exam, consistent with an STD or other genital tract infection or trauma including vaginitis, cervicitis, edema, erythema, ecchymosis, petechial hemorrhage, vulvar or cervicovaginal lesions or abrasions, subepithelial hemorrhage, or signs of genital tract infection (other than asymptomatic bacterial vaginosis) from laboratory evaluations.
• Concurrent Medication:
• Excluded:
• • Any vaginal product other than BufferGel, including lubricants and feminine hygiene products.
• • Vaginal drying agents.
• • Douche.
• • Participation in any other microbicide or contraceptive study.
• • Treatment for any STD.
• Participants with the following prior conditions are excluded:
• • IUD, abnormal PAP smear, pregnancy, abortion, or gynecologic surgery in the last 3 months.
• * Any of the following side effects related to Depo-provera use in the past 2 months:
• • headaches, dizziness, abdominal pain, fatigue, or nervousness.
• Prior Medication:
• Excluded:
• • A course of antibiotic therapy (other than treatment for malaria) in the last 14 days.
• • Any spermicide within the past month.
• • Initiation of Depo-provera for contraceptive purposes in the last 6 months.
• Risk Behavior:
• Excluded:
• • Use of intravenous drugs currently or within the past year.

Trial Officials