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Antiviral

Elbasvir / Grazoprevir Oral Tablet [Zepatier] for Cardiovascular Disease (CHROME Trial)

Phase 4
Waitlist Available
Led By Poonam Mathur, DO
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 48 weeks after functional cure of hcv
Awards & highlights

CHROME Trial Summary

This trial will compare the effects of treating HCV in people who are also infected with HIV, to people with HIV who do not have HCV. They will compare the rates of myocardial injury and cardiovascular disease.

Eligible Conditions
  • Cardiovascular Disease
  • Hepatitis C
  • HIV (Human Immunodeficiency Virus)

CHROME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 48 weeks after functional cure of hcv
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 48 weeks after functional cure of hcv for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
Secondary outcome measures
Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C

CHROME Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Hepatitis C Mono-InfectedExperimental Treatment2 Interventions
Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection
Group II: HIV and Hepatitis C Co-InfectedExperimental Treatment2 Interventions
Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection.
Group III: HIV Mono-InfectedActive Control1 Intervention
Patients infected with HIV only, and not currently or previously infected with hepatitis C.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pibrentasvir
FDA approved
Cardiac MRI
2017
Completed Phase 4
~3280

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,569 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,412 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,996 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research trial accommodating participants who have exceeded the age of eighty-five?

"This medical trial is looking for patients aged 18 or over, but younger than 70 years old."

Answered by AI

What primary purpose does Elbasvir / Grazoprevir Oral Tablet [Zepatier] serve?

"Elbasvir / Grazoprevir Oral Tablet [Zepatier] is often prescribed to patients with chronic hepatitis c genotype 1a. Additionally, this drug has been demonstrated to be efficacious for the management of other diseases related to hepatitis c, such as those previously treated with an HCV regimen containing an NS5A inhibitor or chronic hepatitis C genotypes 4 and 2."

Answered by AI

What is the current population size involved in this research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this research is currently enrolling participants, having first been posted on November 18th 2018 and most recently revised October 31st 2022. 90 volunteers across two medical centres are sought after for the experiment."

Answered by AI

Am I eligible to be a volunteer for this research trial?

"This clinical trial has recruited 90 individuals with cardiac ailments that meet the following criteria: Age 18 or above, HIV+ but on a regulated antiretroviral regimen for 8 weeks before HCV treatment commences, Females of childbearing potential must agree to employ two forms of birth control during their treatment and 6 months after ribavirin therapy is halted. Male patients who are sexually active with women must also utilize contraceptives throughout their course of treatment and half a year post-therapy."

Answered by AI

Are there currently opportunities for individuals to join this clinical experiment?

"Yes, the trial is actively enrolling patients, as indicated by its posting date of November 18th 2018 and most recent update on October 31st 2022."

Answered by AI

Are there any preceding studies or research involving Elbasvir / Grazoprevir Oral Tablet [Zepatier]?

"Elbasvir/Grazoprevir Oral Tablet [Zepatier] was initially studied in 2016 at the AOU Città della Salute e della Scienza di Torino. Since then, 339 trials have been completed and 36 studies are currently recruiting patients; a large amount of these taking place in Baltimore, Maryland."

Answered by AI

Has the Elbasvir / Grazoprevir Oral Tablet [Zepatier] been accepted by the FDA?

"Elbasvir / Grazoprevir Oral Tablet [Zepatier] has been approved, and thus is rated a 3 on our scale of safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
Poonam Mathur 2018. "Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03823911.
~14 spots leftby Apr 2025
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