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OpenTrials
Completed

NCT Number: NCT03401697

Eliminating Hepatitis C Virus

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HIV Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Type2 Diabetes Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 17, 2018
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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