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
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Sulkowski, Johns Hopkins University Identifier:
First received: September 27, 2011
Last updated: October 6, 2011
Last verified: October 2011
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.

Condition Intervention Phase
HIV Infection
Hepatitis C
Behavioral: Contigent voucher incentive (CVI)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Hepatitis C in HIV Infected IDUs

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 800
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Contigent voucher incentive (CVI)
Subjects receive vouchers based on adherence to clinical visits and HCV medication.

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01448915

Contact: Yvonne M Higgins, MS 410-614-0440

United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yvonne M Higgins, MS    410-614-0440   
Principal Investigator: Mark S. Sulkowski, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark S. Sulkowski, MD Johns Hopkins University
  More Information

Responsible Party: Mark Sulkowski, Clinical Professor, Johns Hopkins University Identifier: NCT01448915     History of Changes
Other Study ID Numbers: NA00029706  R01DA016065 
Study First Received: September 27, 2011
Last Updated: October 6, 2011
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Human immunodeficiency virus
Acquired Immune Deficiency Syndrome Virus
AIDS virus
Immunodeficiency Virus, Human
Virus, Human Immunodeficiency
Hepatitis C
Hepatitis C, chronic
Hepatitis C virus
Hepatitis C antibodies
Hepatitis C antigens

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
HIV Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on July 24, 2016