Safety of Acidform Lubricant in HIV-Uninfected Women

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

Inclusion Criteria:

• Normal menstrual history with regular cycles and with a minimum of 21 days between menses

• Low risk for HIV/STI infection. More information on this criterion can be found in the protocol.

• Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study

Exclusion Criteria:

• HIV-infected

• Menopausal

• Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry

• Menstruating at screening or enrollment visits

• Urinary tract infection at screening

• Positive chlamydia, gonorrhea, or trichomonas result at screening

• Abnormal Pap smear

• Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.

• Currently participating in a research study of other vaginal products

• History of intermenstrual bleeding within 3 months prior to study entry

• Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry

• Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry

• Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry

• Vaginal or anal intercourse during the 48 hours prior to study entry

• Oral antibiotics within 7 days of study entry

• Pregnant, less than 6 months postpartum, or breastfeeding