Clinical trial NCT03401697: Eliminating Hepatitis C Virus
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
HIV
Type2 Diabetes
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Number of Patients with sCD163 above the upper limit of normal
timeFrame: baseline and 3 years
measure: Number of Type 2 Diabetes patients that initiate HCV treatment
timeFrame: 3 years
Secondary outcomes:
measure: sCD163
timeFrame: 3 years
measure: Percentage of patients in need of repeated re-treatment
timeFrame: 3 years
measure: HOMA-IR
timeFrame: 3 years
measure: Number of resistance associated variant (RAV)
timeFrame: 3 years
measure: FIB-4 score
timeFrame: 3 years
measure: HCV cure rate
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinia
name: Andrea D. Branch, PhD
role: PRINCIPAL_INVESTIGATOR
References: