Cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. Blood plasma, peripheral blood mononuclear cells (PBMC), and cervicovaginal swabs will also be collected. Drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.
Study Type
OBSERVATIONAL
Enrollment
28
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
University of Minnesota
Minneapolis, Minnesota, United States
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues
Time frame: Day 1
To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue
Time frame: Day 1
To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues
Time frame: Day 1
To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.
Time frame: Day 1
To determine relationship between local inflammation and drug disposition in the female genital tract
Time frame: Day 1
To identify potential role of the vaginal microbiome in local drug disposition,
Time frame: Day 1
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