HIV Prevention
Conditions
Brief summary
Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women.
Detailed description
Premenopausal women: Baseline blood and genital samples will be taken in the follicular and luteal phase (visits 2 and 3). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visits 4/4a and 5/5a). Postmenopausal women: Premenopausal women: Baseline blood and genital samples will be taken (visit 2). The participant will be given TFV gel and instructed to insert two doses, separated by 2 hours, and return to the clinic 3 hours after the second insertion for blood and genital samples (visit 3/3a). Estradiol cream will be distributed at visit 4. Post estradiol blood and genital samples will be taken at Visit 5. The participant will given TFV gel and instructed to insert 2 doses as before, while continuing to use the estradiol cream. Post TFV gel and estradiol cream blood and genital samples will be taken (visit 6/6a).
Interventions
Sponsors
CONRAD
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue | 3 hours after dosing |
| Concentrations of TFV-DP in genital tissue | 3 hours after dosing |
Countries
United States
Outcome results
None listed