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

Completed

• Conditions: Menopause; HIV/AIDS; Inflammation Vagina

• Registration Number: NCT03218085
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-07-13
• Study Start: 2017-07-14
• Study First Posted: 2017-07-14
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues	Day 1

Secondary Outcome Measures

Name	Time	Method
To identify potential role of the vaginal microbiome in local drug disposition,	Day 1
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 relationship between local inflammation and drug disposition in the female genital tract	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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States