HIV/AIDS, Inflammation Vagina, Menopause
Conditions
Keywords
tenofovir, prevention, microbiome, cervicovaginal, biopsy, swab, cytokines, inflammation, pharmacology
Brief summary
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.
Interventions
DRUGTenofovir
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
DRUGEmtricitabine
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
Sponsors
American College of Clinical Pharmacy
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female, or transgender female with a cervix, age 18 years or older 2. HIV-positive 3. Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment. 4. Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment. 5. Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit. 6. Willing and able to give signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue | Day 1 |
| To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues | Day 1 |
| To discriminate between local and systemic effects of hormonal use on antiretroviral disposition. | Day 1 |
| To determine relationship between local inflammation and drug disposition in the female genital tract | Day 1 |
| To identify potential role of the vaginal microbiome in local drug disposition, | Day 1 |
Countries
United States
Outcome results
None listed