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Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication

NCT03823911 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2023-05-22

Study results available
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Summary

This is an interventional, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease.

Conditions

Interventions

DRUG

Elbasvir / Grazoprevir Oral Tablet [Zepatier]

All approved direct-acting antivirals for hepatitis C will be used as the intervention.

PROCEDURE

Cardiac MRI

Cardiac MRI to assess for myocardial function and fibrosis

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Poonam Mathur, DO · University of Maryland, Baltimore

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-18
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03823911 on ClinicalTrials.gov