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

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT03218085

Collaborator

American College of Clinical Pharmacy (Other)

Enrollment

Location

66.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS Menopause Inflammation Vagina	Drug: Tenofovir Drug: Emtricitabine

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine

Actual Study Start Date :

Jul 14, 2017

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2023

Outcome Measures

Primary Outcome Measures

Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues [Day 1]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female, or transgender female with a cervix, age 18 years or older
HIV-positive
Stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment.
Virally suppressed (HIV-RNA copies <50 copies/mL) for at least 6 months at time of enrollment.
Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
Willing and able to give signed informed consent.