HIV Prevention Clinical Trial
Official title:
Influence of Female Reproductive Cycle and Menopause on Cervicovaginal Tissue Susceptibility to HIV-1 Infections and Tenofovir 1% Gel Activity
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.
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).
;
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
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