Eliminating Hepatitis C Virus

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401697
• Other study ID #: GCO 17-1070
• Status: Completed
• Start date: January 23, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV
• Type2 Diabetes

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	sCD163	blood sample for sC163, a marker of systemic inflammation.	3 years
Secondary	Percentage of patients in need of repeated re-treatment	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 years
Secondary	HOMA-IR	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.	3 years
Secondary	Number of resistance associated variant (RAV)	Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected	3 years
Secondary	FIB-4 score	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 )	3 years
Secondary	HCV cure rate	The HCV cure rate among patients with type 2 diabetes	3 years