Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)



Status:Active, not recruiting
Conditions:HIV / AIDS, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 90
Updated:2/14/2019
Start Date:September 2009
End Date:March 2019

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Management of Hepatitis C in HIV Infected IDUs

The principal goal of this research project is to evaluate the natural history of HCV and
liver disease and its treatment in HIV-infected persons who use drugs. Research procedures
will focus on determining liver disease prevalence and severity within this population. This
is an observational study without study specific interventions.

The principal goal of this research project is to evaluate the natural history of HCV and
liver disease and its treatment in HIV-infected persons who use drugs. The recent
availability of a novel, non-invasive method of measuring HCV disease stage makes it possible
to test the relationship of HCV disease stage and the management of coinfected IDUs with
adequate precision. The investigators will apply the innovative technology, elastography
(FibroScan®) to ask whether the marked differences in the final disease outcome, end-stage
liver disease (ESLD), can be explained by a measure of liver stiffness as assessed by
elastography (FibroScan®). While advances in non-invasive disease assessment are critical to
HCV management, the greatest challenge to improving HCV treatment effectiveness in coinfected
persons remains low rates of treatment uptake and adherence, even when freely accessible. In
response to this glaring disparity, the investigators will test potent behavioral
reinforcement interventions to improve the management of HCV disease by adapting a rigorously
studied contingent behavioral incentives program to the treatment to coinfected IDUs.
Hepatitis C Treatment Eligibility: To determine the population prevalence of significant
liver disease in coinfected IDUs using an innovative, non-invasive methodology (transient
elastography, FibroScan®) to measure liver stiffness. Liver Disease Staging: To test the
hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive
of the development of ESLD, defined as hepatic decompensation, hepatocellular cancer, and
liver-related death, in coinfected IDUs.

Inclusion Criteria:

- Current or prior drug use

- Reactive HCV antibody

- Reactive HIV antibody

Exclusion Criteria:

- Women may not undergo FibroScan while pregnant

- Persons with implanted cardiac devices may not undergo FibroScan
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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