Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infections and Tenofovir 1% Gel Activity

Date de début de l'étude : 1 septembre 2013

Inclusion Criteria: All volunteers In good healthsignificant systemic disease Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship for at least the last four months with a partner who is not known to be HIV positive and has no known risks for STIs OR sexually abstinent Willing and able to comply with study procedures Normal Pap smear (by written report) in the past year. Inclusion Criteria: Premenopausal volunteers 21-to-45 years of age Not at risk for pregnancy, meaning: Regular menstrual cycles (every 24 - 35 days) Luteal phase P level of greater than or equal to 3 ng/ml Inclusion Criteria: Postmenopausal volunteers 46-89 years of age OR both ovaries removed at least 30 days prior to Visit 1 No menstrual periods/vaginal bleeding in the past 12 months OR both ovaries removed at least 30 days prior to Visit 1 FSH level of greater than or equal to 20 MIU/ml Exclusion Criteria: All volunteers Clinically significant history of an abnormal Pap smear in the past year Surgery or biopsy of the vagina or cervix within 30 days Current STI or lower genital tract infection Current use of chronic immunosuppressants Current presence of vulvar, anal and/or vaginal genital warts Current tobacco use of any amount History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to silver nitrate and/or Monsel's solution Known bleeding disorder that could lead to prolonged or continuous bleeding Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, antivirals or antiretrovirals. Investigator discretion Current participation in any other drug or device study Exclusion Criteria: Premenopausal women Use of DMPA in last six months Use of any other hormonal contraceptive method without 2 subsequent, normal menses since stopping hormonal contraceptives Current use of copper IUD Currently pregnant or pregnancy within the past 3 months Currently breastfeeding/having breastfed an infant in the last 2 months Exclusion Criteria: Postmenopausal women Use of any hormonal medications in the past 30 days Contraindications to vaginal estrogen cream