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

February 17, 2022 updated by: Johns Hopkins University

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

828

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Persons with HIV and HCV coinfection
Persons with HIV and HCV coinfection who receive medical care for HIV infection at Johns Hopkins Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatitis C Treatment Uptake and HCV cure
Time Frame: 5 years
The proportion of persons with HIV and HCV coinfection who achieve HCV cure
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
Liver stiffness measurement by elastography in persons with HIV infection
Time Frame: 5 years
Change in liver stiffness following HCV cure
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00029706
  • R01DA016065 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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