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Completed

NCT Number: NCT01448915

Management of Hepatitis C in HIV Infected Injection Drug Users (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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hepatitis C Treatment Uptake and HCV cure

    Time frame: 5 years

    The proportion of persons with HIV and HCV coinfection who achieve HCV cure

Secondary outcomes

  1. 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

  2. Liver stiffness measurement by elastography in persons with HIV infection

    Time frame: 5 years

    Change in liver stiffness following HCV cure

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Management of Hepatitis C in HIV Infected IDUs

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 7, 2011
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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