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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448915
First Posted: October 7, 2011
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
September 27, 2011
October 7, 2011
August 21, 2017
September 2009
March 2019   (Final data collection date for primary outcome measure)
Hepatitis C Treatment Uptake and HCV cure [ Time Frame: 5 years ]
The proportion of persons with HIV and HCV coinfection who achieve HCV cure
  • Hepatitis C Treatment Eligibility [ Time Frame: one year ]
    The proportion of IDUs who have clear medical contraindications to HCV treatment (i.e., HCV treatment eligibility).
  • Liver Disease Staging [ Time Frame: one year ]
    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 ]
    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.
Complete list of historical versions of study NCT01448915 on ClinicalTrials.gov Archive Site
  • Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure [ Time Frame: 5 years ]
    Clinical events including liver failure and liver cancer
  • Liver stiffness measurement by elastography in persons with HIV infection [ Time Frame: 5 years ]
    Change in liver stiffness following HCV cure
  • Liver stiffness [ Time Frame: one year ]
    Liver stiffness, derived from liver elastography
  • Body mass index [ Time Frame: one year ]
    Body mass index, derived from height and weight
  • Serum markers [ Time Frame: one year ]
    Serum levels of various chemical markers
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 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum and plasma specimens are collected at regular intervals
Non-Probability Sample
This is a prospective observational cohort of HIV-infected persons receiving medical care at the Johns Hopkins Hospital. Participants are eligible if they are HCV antibody positive and use or have used drugs.
  • HIV Infection
  • Hepatitis C
Not Provided
Persons with HIV and HCV coinfection
Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
March 2019
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01448915
NA00029706
R01DA016065 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark S. Sulkowski, MD Johns Hopkins University
Johns Hopkins University
August 2017