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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Sulkowski, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01448915
First received: September 27, 2011
Last updated: October 6, 2011
Last verified: October 2011

September 27, 2011
October 6, 2011
September 2009
July 2013   (final data collection date for primary outcome measure)
  • Hepatitis C Treatment Eligibility [ Time Frame: one year ] [ Designated as safety issue: No ]
    The proportion of IDUs who have clear medical contraindications to HCV treatment (i.e., HCV treatment eligibility).
  • Liver Disease Staging [ Time Frame: one year ] [ Designated as safety issue: No ]
    The prevalence of significant hepatic fibrosis (≥ modified HAI stage 2) among treatment eligible IDUs randomly selected from clinical settings (i.e., the histopathologic disease stage ).
  • Hepatitis C Treatment Incentives [ Time Frame: one year ] [ Designated as safety issue: No ]
    The proportion of treatment-eligible IDUs who initiate PEG/RBV therapy after enrolling into the Standard of Care (SOC) or Contingent Voucher Incentive (CVI) treatment arms.
Same as current
Complete list of historical versions of study NCT01448915 on ClinicalTrials.gov Archive Site
  • Liver stiffness [ Time Frame: one year ] [ Designated as safety issue: No ]
    Liver stiffness, derived from liver elastography
  • Body mass index [ Time Frame: one year ] [ Designated as safety issue: No ]
    Body mass index, derived from height and weight
  • Serum markers [ Time Frame: one year ] [ Designated as safety issue: No ]
    Serum levels of various chemical markers
Same as current
Not Provided
Not Provided
 
Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
Management of Hepatitis C in HIV Infected IDUs

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infection
  • Hepatitis C
Behavioral: Contigent voucher incentive (CVI)
Subjects receive vouchers based on adherence to clinical visits and HCV medication.
  • No Intervention: Standard of Care
    HCV treatment in a standard-of-care setting (without voucher intervention)
  • Experimental: Contingent Voucher Incentive
    Contingent voucher incentive: At timed intervals during HCV treatment, subjects receive vouchers based on behavioral objectives.
    Intervention: Behavioral: Contigent voucher incentive (CVI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Yvonne M Higgins, MS 410-614-0440 yhiggins@jhmi.edu
United States
 
NCT01448915
NA00029706, R01DA016065
Yes
Mark Sulkowski, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark S. Sulkowski, MD Johns Hopkins University
Johns Hopkins University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP