View Clinical Trial (Medical Research Study)
Management of Hepatitis C in HIV Infected IDUs
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21287 |
| Conditions: |
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HIV Infection - Hepatitis C |
| Purpose: |
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The principal goal of this research project is to evaluate the extent of HCV disease and its
treatment in coinfected IDUs. Research procedures will focus on determining liver disease
prevalence and grade of disease within this population. The investigators will also
evaluate if behavioral reinforcement interventions increase the rate of treatment
participation and completion.
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| Study Summary: |
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The principal goal of this research project remains focused on hepatitis C virus (HCV)
infection in HIV-infected injection drug users (IDUs). 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. Hepatitis C Treatment Incentives: To
test the hypothesis that a contingent behavioral reinforcement intervention will effectively
increase the proportion of coinfected IDUs who initiate, attend, and complete HCV treatment.
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| Criteria: |
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Inclusion Criteria:
- History of substance abuse
- Reactive HCV antibody
- Reactive HIV antibody
Exclusion Criteria:
For the treatment arm, HCV treatment eligible defined by the absence of an absolute
contraindication to HCV treatment:
- HCV RNA not detected by PCR
- Pregnant or not willing to use birth control
- Life expectancy < 2 years
- Severe depression with suicidal ideation Allergy to interferon and/or ribavirin
Severe hematologic abnormality Renal insufficiency Women may not undergo FibroScan
while pregnant Persons with implanted cardiac devices may not undergo FibroScan
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| NCT ID: |
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NCT01448915 |
| Primary Contact: |
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Principal Investigator
Mark S. Sulkowski, MD
Johns Hopkins University
Yvonne M Higgins, MS
Phone: 410-614-0440
Email: yhiggins@jhmi.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21287
United States
Yvonne M Higgins, MS
Phone: 410-614-0440
Email: yhiggins@jhmi.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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