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

HIV/AIDS Clinical Trial

Official title:

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218085
• Other study ID #: PHARM-2016-24820
• Status: Completed
• Start date: July 14, 2017
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS
• Inflammation
• Inflammation Vagina
• Menopause
• Vaginitis

Intervention

Drug:
• Tenofovir
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
• Emtricitabine
Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	American College of Clinical Pharmacy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the influence of exogenous and endogenous sex hormones on tenofovir and emtricitabine concentrations in cervical tissues		Day 1
Secondary	To assess the influence of endogenous and exogenous sex hormones on the expression of drug metabolizing enzymes and transporters in cervical tissue		Day 1
Secondary	To determine the influence of endogenous and exogenous sex hormones on the endogenous nucleotide pool in cervical tissues		Day 1
Secondary	To discriminate between local and systemic effects of hormonal use on antiretroviral disposition.		Day 1
Secondary	To determine relationship between local inflammation and drug disposition in the female genital tract		Day 1
Secondary	To identify potential role of the vaginal microbiome in local drug disposition,		Day 1