Cardiovascular DiseasesPhase 4CHROMENCT03823911
Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
A Phase 4 study testing Elbasvir / Grazoprevir Oral Tablet [Zepatier] and Cardiac MRI in people with Cardiovascular Diseases and Hepatitis C, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Hepatitis C, Hiv
- What is being tested?
- Elbasvir / Grazoprevir Oral Tablet [Zepatier] and Cardiac MRI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2018to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or equal to 18 years old
- Able and willing to sign informed consent
- Chronically infected with any HCV genotype (1a, 1b, 2, 3, 4, 5, or 6), defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)
- If HIV+, suppressed on a stable, protocol-approved, ARV regimen for ≥ 8 weeks prior to starting HCV treatment
- HIV RNA < 50 copies/mL (or < LLOQ if the local laboratory assay's LLOQ is ≥50 copies/mL) prior to Screening. Subjects with an isolated or unconfirmed HIV RNA > 50 copies/mL (or > LLOQ if the local laboratory assay's LLOQ is ≥50 copies/mL) are not excluded.
- CD4 count >100 cells/mm3
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- Willing to have samples stored for future use
- If tested positive for NS5A resistance-associated polymorphisms or PEG-IFN and ribavirin experienced, able to tolerate ribavirin-containing regimen for 16 weeks. Ribavirin will be administered at the discretion of the PI.
- Women of childbearing potential who receive ribavirin will have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin. Men receiving ribavirin who are sexually active with women will also have to be willing to commit to abstinence from sexual activity, or use of two forms of contraceptive during treatment and for the 6 months after completion of ribavirin.
Who cannot join
- Decompensated liver disease (Childs Pugh B or C)
- Unable to comply with research study visits
- Poor venous access not allowing screening laboratory collection
- Have any condition that the investigator considers a contraindication to study participation
- Pregnant or breastfeeding woman
- Prior HCV treatment with Direct-Acting Antivirals. Note: Patients who are treatment-experienced with PEG-IFN/RBV will not be excluded; their inclusion in the study will be considered by the PI.
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- HIV+ patients with prior HCV treatment who achieved sustained virologic response (SVR)/ functional cure
- Use of a concomitant medication that is contraindicated with the use of the DAA for HCV treatment (per package insert)
- Coinfection with HCV and HBV, in partcular HBsAg + patients.
- Patients with HBcAb+ will not be excluded, but will have HBV DNA levels checked and will be monitored while on DAA therapy and medically managed as considered appropriate by the PI.
- Have any condition that the investigator considers a contraindication to study participation or not eligible per standard of care for HCV treatment
- Patients with the following devices are excluded from participating in the cardiovascular MRI study:
- Central nervous system aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted insulin pump
- Metal shrapnel or bullet
- The following groups of people are also excluded from participating in the cardiovascular MRI study:
- Patients with stable renal disease (estimated glomerular filtration rate (eGFR)<30ml/min/1.73m2 body surface area. The eGFR must be within two weeks of the the MRI exam.
- Patients with acute renal disease.
- Patients who choose to have the cardiac MRI and are over 60 years of age, have a history of renal failure, or have type I or II diabetes mellitus must have laboratory tests the same day as the MRI exam.
- Positive urine drug screen at screening. Not all patients with positive drug screen will be excluded; decision will be made by the PI.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Human Virology, CRU
Baltimore, Maryland, 21201
Unity Parkside Health Center
Washington D.C., District of Columbia, 20019
About this study
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
- Cardiovascular Diseases, Hepatitis C, Hiv
- Being tested
- Elbasvir / Grazoprevir Oral Tablet [Zepatier], Cardiac MRI
- Keywords
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases, Hepatitis C, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir / Grazoprevir Oral Tablet [Zepatier]Drug
Also called Sofosbuvir/Ledipasvir, Sofosbuvir/Velpatasvir, Glecaprevir/Pibrentasvir, Sofosbuvir/Velpatasvir/Voxilaprevir
All approved direct-acting antivirals for hepatitis C will be used as the intervention.
Cardiac MRIProcedure or surgery
Cardiac MRI to assess for myocardial function and fibrosis
| Study group | Role | What they receive |
|---|---|---|
| HIV Mono-Infected | Active comparator | Patients infected with HIV only, and not currently or previously infected with hepatitis C. Receives: Procedure: Cardiac MRI |
| Hepatitis C Mono-Infected | Experimental | Patients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection Receives: Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier]; Procedure: Cardiac MRI |
| HIV and Hepatitis C Co-Infected | Experimental | Patients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection. Receives: Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier]; Procedure: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
Change in high-sensitivity C-reactive protein
Measured: Baseline to 72 weeks after functional cure of HCV
Secondary outcomes (1)
Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C
Change in the cardiac biomarkers Troponin I and Troponin T
Measured: Baseline to 48 weeks after functional cure of HCV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start18 Nov 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Poonam Mathur, University of Maryland, Baltimore
- Investigators
- Poonam Mathur, DO, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823911
- Sponsor's protocol ID
- HP-00081300
- Acronym
- CHROME
- Status last verified
- May 2023
- First submitted
- 28 Jan 2019
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Stored samples will be sent to the Institute of Human Virology at the University of Maryland and to BHF Centre for Cardiovascular Sciences: Individuals with new seroconversion to HIV will have samples sent for viral sequencing and phylogenetic analysis. Individuals with detectable HCV RNA after completion of HCV treatment or new infection during the follow up period will have current sample, and baseline stored sample sent for viral sequencing and phylogenetic analysis. In addition, we will study the viral and host immunity to HCV and HIV in all patients. The results will be used to characterize each individual with regards to immune status and chronicity of disease.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication
- ClinicalTrials.gov ID
- NCT03823911
- Acronym / sponsor ID
- CHROME / HP-00081300
- Conditions
- Cardiovascular Diseases, Hepatitis C, Hiv
- Keywords
- Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Merck Sharp & Dohme LLC
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 22 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV Mono-Infected | Active comparator | Procedure: Cardiac MRIPatients infected with HIV only, and not currently or previously infected with hepatitis C. |
| Hepatitis C Mono-Infected | Experimental | Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier], Procedure: Cardiac MRIPatients infected with Hepatitis C and have no evidence of active HIV or hepatitis B infection |
| HIV and Hepatitis C Co-Infected | Experimental | Drug: Elbasvir / Grazoprevir Oral Tablet [Zepatier], Procedure: Cardiac MRIPatients co-infected with HIV and hepatitis C, and have no evidence of active hepatitis B infection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > or equal to 18 years old
- Able and willing to sign informed consent
- Chronically infected with any HCV genotype (1a, 1b, 2, 3, 4, 5, or 6), defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater)
- If HIV+, suppressed on a stable, protocol-approved, ARV regimen for ≥ 8 weeks prior to starting HCV treatment
- Willing to have samples stored for future use
Key exclusion criteria (24 listed)
- Decompensated liver disease (Childs Pugh B or C)
- Unable to comply with research study visits
- Poor venous access not allowing screening laboratory collection
- Have any condition that the investigator considers a contraindication to study participation
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbasvir / Grazoprevir Oral Tablet [Zepatier]Also: Sofosbuvir/Ledipasvir, Sofosbuvir/Velpatasvir, Glecaprevir/Pibrentasvir, Sofosbuvir/Velpatasvir/VoxilaprevirAll approved direct-acting antivirals for hepatitis C will be used as the intervention. | Drug | HIV and Hepatitis C Co-Infected, Hepatitis C Mono-Infected |
| Cardiac MRICardiac MRI to assess for myocardial function and fibrosis | Procedure or surgery | HIV Mono-Infected, HIV and Hepatitis C Co-Infected, Hepatitis C Mono-Infected |
Primary outcome
Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein
Time frame: Baseline to 72 weeks after functional cure of HCV
Change in high-sensitivity C-reactive protein
1 secondary outcome
Change in Troponin I and Troponin T From Baseline to After Functional Cure of Hepatitis C
Time frame: Baseline to 48 weeks after functional cure of HCV
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Stored samples will be sent to the Institute of Human Virology at the University of Maryland and to BHF Centre for Cardiovascular Sciences: Individuals with new seroconversion to HIV will have samples sent for viral sequencing and phylogenetic analysis. Individuals with detectable HCV RNA after completion of HCV treatment or new infection during the follow up period will have current sample, and baseline stored sample sent for viral sequencing and phylogenetic analysis. In addition, we will study the viral and host immunity to HCV and HIV in all patients. The results will be used to characterize each individual with regards to immune status and chronicity of disease.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poonam Mathur, DO principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elbasvir / Grazoprevir Oral Tablet [Zepatier] and Cardiac MRI in people with Cardiovascular Diseases and Hepatitis C, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiovascular Disease Risk From Baseline to After Functional Cure of Hepatitis C, as Measured by High-sensitivity C-reactive Protein (time frame: Baseline to 72 weeks after functional cure of HCV). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.