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Eliminating Hepatitis C Virus

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ClinicalTrials.gov Identifier: NCT03401697
Recruitment Status : Suspended (COVID-19)
First Posted : January 17, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.

Condition or disease
Hepatitis C HIV Type2 Diabetes

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort
HIV/HCV Co-infected
Patients with HIV/HCV co-infection
Type 2 Diabetes
Patients with Type 2 Diabetes



Primary Outcome Measures :
  1. Change in the Number of Patients with sCD163 above the upper limit of normal [ Time Frame: baseline and 3 years ]
    Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline

  2. Number of Type 2 Diabetes patients that initiate HCV treatment [ Time Frame: 3 years ]
    The number of patients that initiate HCV treatment per month per patient navigator.


Secondary Outcome Measures :
  1. sCD163 [ Time Frame: 3 years ]
    blood sample for sC163, a marker of systemic inflammation.

  2. Percentage of patients in need of repeated re-treatment [ Time Frame: 3 years ]
    The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia. If such patients are identified, they will be referred for risk reduction counseling.

  3. HOMA-IR [ Time Frame: 3 years ]
    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.

  4. Number of resistance associated variant (RAV) [ Time Frame: 3 years ]
    Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected

  5. FIB-4 score [ Time Frame: 3 years ]
    The FIB-4 score of HCV positive patients with type 2 diabetes. The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests that help to estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and NASH. Formula : ( Age x AST ) / ( Platelets x ( sqr ( ALT )

  6. HCV cure rate [ Time Frame: 3 years ]
    The HCV cure rate among patients with type 2 diabetes


Biospecimen Retention:   Samples Without DNA
Blood (10 mL) will be collected from 100 HIV/HCV coinfected patients before and after HCV cure. sCD163 will be measured using the human CD163 Quantkine ELISA kit from R and D systems. Blood (10 mL) will also be collected from up to 50 patients who fail therapy or become reinfected with HCV. The HCV RNA quasispecies will be analyzed using the deep sequencing methods. Serum will be saved for HIV/HCV Co-infected.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.
Criteria

Inclusion Criteria:

Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection

  • 18 years of age or older
  • HCV RNA positive
  • Any HCV genotype
  • Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
  • Expected life expectancy sufficient to receive a benefit from HCV cure
  • No conditions that are contraindications for the use of HCV medications

Inclusion criteria for HCV treatment in patients with type 2 diabetes

  • 18 years of age or older
  • HCV RNA positive
  • Any HCV genotype
  • Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
  • Expected life expectancy sufficient to receive a benefit from HCV cure

Exclusion Criteria:

  • No conditions that are contraindications for the use of HCV medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401697


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Andrea D. Branch, PhD Icahn School of Medicine at Mount Sinia
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03401697    
Other Study ID Numbers: GCO 17-1070
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Direct outreach to providers (giving them the names of their patients who are candidates for treatment)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections