CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Elbasvir / Grazoprevir Oral Tablet [Zepatier] +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03823911
NCT03823911Phase 4Completed
CompareCT.gov

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

University of Maryland, Baltimore·interventional·Posted Jan 31, 2019·Updated May 22, 2023

In Brief

A Phase 4 clinical trial evaluating Elbasvir / Grazoprevir Oral Tablet [Zepatier] and Cardiac MRI for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 87 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Diseases, Hepatitis C, Hiv
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Merck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 31, 2019
Enrollment StartNov 18, 2018
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.4 years ago

Interventions

Elbasvir / Grazoprevir Oral Tablet [Zepatier]drug

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

Cardiac MRIprocedure

Cardiac MRI to assess for myocardial function and fibrosis