Eliminating Hepatitis C Virus

NCT03401697 | Completed DMC

• 1 other identifier: GCO 17-1070
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; HIV; Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in the Number of Patients with sCD163 above the upper limit of normal

  Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline

  baseline and 3 years

• Number of Type 2 Diabetes patients that initiate HCV treatment

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

  3 years

Secondary Outcomes (6)

• sCD163

  3 years

• Percentage of patients in need of repeated re-treatment

  3 years

• HOMA-IR

  3 years

• Number of resistance associated variant (RAV)

  3 years

• FIB-4 score

  3 years

Study Arms (2)

HIV/HCV Co-infected

Patients with HIV/HCV co-infection

Type 2 Diabetes

Patients with Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Andrea D. Branch, PhD

  Icahn School of Medicine at Mount Sinia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Liver Diseases

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: January 23, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)