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
|Condition or disease|
|Hepatitis C HIV Type2 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|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|
Patients with HIV/HCV co-infection
Type 2 Diabetes
Patients with Type 2 Diabetes
- 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
- 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.
- sCD163 [ Time Frame: 3 years ]blood sample for sC163, a marker of systemic inflammation.
- 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.
- 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.
- 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
- 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 )
- HCV cure rate [ Time Frame: 3 years ]The HCV cure rate among patients with type 2 diabetes
Biospecimen Retention: Samples Without DNA
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
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Andrea D. Branch, PhD||Icahn School of Medicine at Mount Sinia|