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

NCT03218085 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2024-04-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-14
Primary Completion
2024-02-15
Completion
2024-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03218085 on ClinicalTrials.gov