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Hepatitis C Treatment in Underserved Populations

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C; Illicit Drug Use

Intervention: Collaborative, multidisciplinary, integrated care (Other)

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Brian Edlin

Official(s) and/or principal investigator(s):
Brian R. Edlin, MD, Principal Investigator, Affiliation: Weill Medical College, Cornell University


The purpose of this study is to examine the feasibility, safety, and effectiveness of treating persons who are actively using illicit drugs for hepatitis C using a collaborative, multidisciplinary, integrated care model. We hypothesize that by maximizing facilitators and minimizing barriers to treatment we can enable drug users to receive effective treatment for hepatitis C.

Clinical Details

Official title: Hepatitis C Treatment in Underserved Populations

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Sustained virologic response, defined as an undetectable serum HCV RNA level 24 weeks after completion of antiviral therapy.

Secondary outcome:

completion of medical and psychiatric evaluation for antiviral therapy

initiation of antiviral therapy

adherence to antiviral therapy

completion of antiviral therapy

levels of alcohol and illicit drug use

entry into treatment for substance use

entry into treatment for another unaddressed medical or psychiatric condition

neuropsychiatric side effects, including depression and hostility/irritability

treatment-limiting systemic, hematologic, or other side effects

other adverse events or adverse effects


Detailed description: This study examines the feasibility of integrated treatment for hepatitis C in active IDUs using a client-centered, multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management. The Weill Cornell Medical College Center for the Study of Hepatitis C collaborates with community-based organizations providing services to injection drug users to provide multidisciplinary, integrated care using a model that combines the resources of culturally appropriate community-based agencies with those of a state-of-the-art tertiary care center.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age 18 years or older

- Used heroin, cocaine, or injected other drugs for at least 1 year

- Have used heroin, cocaine and/or methamphetamine within the last 30 days

- Test positive for HCV antibody

- Are interested in being evaluated for HCV treatment

Exclusion Criteria:

- Persons who are obviously intoxicated, incoherent or otherwise unable to give

informed consent are excluded from participation. Such persons may participate in the study if they return at a later date and are capable of providing informed consent.

Locations and Contacts

Center for the Study of Hepatitis C, Weill Medical College, Cornell University, New York, New York 10021, United States
Additional Information

Starting date: February 2005
Last updated: October 25, 2012

Page last updated: August 20, 2015

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