Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women

• Status: Completed
• Trial end date: 2010-04-01
• 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-causing agents. 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 assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Anti-Infective Agents; Tenofovir

Criteria

Inclusion Criteria:

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

• Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected

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

Exclusion Criteria:

• HIV infected

• Sexually transmitted infection within 6 months of study entry

• Use of nontherapeutic intravenous drugs within 12 months of study entry

• Menopausal

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

• Menstruating at screening or enrollment visits

• Positive urine culture

• 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.

• History of toxic shock syndrome or a history of symptoms suggesting toxic shock syndrome

• History of intermenstrual bleeding within 3 months of study entry

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

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

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

• Acute or chronic hepatitis B virus infection

• Liver or kidney abnormalities

• Oral antibiotics within 7 days of study entry

• Pregnant, less than 6 months postpartum, or breastfeeding