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:

National Institute on Drug Abuse (NIDA)

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

History of Changes

Purpose

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:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C Liver Diseases

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 ClinicalTrials.gov identifier: NCT01448915

Contacts


Contact: Yvonne M Higgins, MS	410-614-0440	yhiggins@jhmi.edu

Locations


United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yvonne M Higgins, MS 410-614-0440 yhiggins@jhmi.edu
Principal Investigator: Mark S. Sulkowski, MD

Sponsors and Collaborators

Johns Hopkins University

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Mark S. Sulkowski, MD	Johns Hopkins University

More Information

No publications provided


Responsible Party:	Mark Sulkowski, Clinical Professor, Johns Hopkins University
ClinicalTrials.gov 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:


HIV 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 Hepatitis A Hepatitis C Digestive System Diseases Enterovirus Infections Flaviviridae Infections	Hepatitis, Viral, Human Liver Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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