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Eliminating Hepatitis C Virus

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT03401697
Collaborator
(none)
52
Enrollment
1
Location
37.2
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 23, 2018
    Actual Primary Completion Date :
    Mar 1, 2021
    Actual Study Completion Date :
    Mar 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    HIV/HCV Co-infected

    Patients with HIV/HCV co-infection
    Type 2 Diabetes

    Patients with Type 2 Diabetes

    Outcome Measures

    Primary Outcome Measures

    1. Change in the Number of Patients with sCD163 above the upper limit of normal [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 [3 years]

      The number of patients that initiate HCV treatment per month per patient navigator.

    Secondary Outcome Measures

    1. sCD163 [3 years]

      blood sample for sC163, a marker of systemic inflammation.

    2. Percentage of patients in need of repeated re-treatment [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 [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) [3 years]

      Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected

    5. FIB-4 score [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 [3 years]

      The HCV cure rate among patients with type 2 diabetes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Andrea D. Branch, PhD, Icahn School of Medicine at Mount Sinia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrea Branch, Professor, Liver Diseases, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT03401697
    Other Study ID Numbers:
    • GCO 17-1070
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Mar 24, 2021