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

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