NCT03218085

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

Role of Exogenous and Endogenous Sex Hormones on Tenofovir and Emtricitabine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS
• Menopause
• Inflammation Vagina

Interventions

Type	Name	Description
DRUG	Tenofovir	Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
DRUG	Emtricitabine	Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit

Timeline

• Start date: 2017-07-14
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2017-07-14
• Last updated: 2024-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study