Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine Disposition in Female Genital Tract

University of Minnesota (UMN)

Status: Completed

Conditions: Menopause; Inflammation Vagina; HIV/AIDS

Treatments: Drug: Emtricitabine; Drug: Tenofovir

Study type: Observational

Funder types: Other

Identifiers

NCT03218085

PHARM-2016-24820

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.