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

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