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

NCT ID: NCT01448915

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 828 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-03-31

Brief Summary

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.

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.

Conditions

HIV Infection; Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Persons with HIV and HCV coinfection

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark S. Sulkowski, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Bilal U, Lau B, Lazo M, McCaul ME, Hutton HE, Sulkowski MS, Moore RD, Chander G. Interaction Between Alcohol Consumption Patterns, Antiretroviral Therapy Type, and Liver Fibrosis in Persons Living with HIV. AIDS Patient Care STDS. 2016 May;30(5):200-7. doi: 10.1089/apc.2016.0010.

Reference Type: BACKGROUND

PMID: 27158847 (View on PubMed)

Falade-Nwulia O, Sutcliffe C, Moon J, Chander G, Wansom T, Keruly J, Katzianer J, Nathanson A, Marks J, Mehta S, Thomas D, Moore R, Sulkowski M. High hepatitis C cure rates among black and nonblack human immunodeficiency virus-infected adults in an urban center. Hepatology. 2017 Nov;66(5):1402-1412. doi: 10.1002/hep.29308. Epub 2017 Oct 11.

Reference Type: RESULT

PMID: 28608973 (View on PubMed)

Wansom T, Falade-Nwulia O, Sutcliffe CG, Mehta SH, Moore RD, Thomas DL, Sulkowski MS. Barriers to Hepatitis C Virus (HCV) Treatment Initiation in Patients With Human Immunodeficiency Virus/HCV Coinfection: Lessons From the Interferon Era. Open Forum Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.

Reference Type: RESULT

PMID: 28480293 (View on PubMed)

Other Identifiers

R01DA016065

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00029706

Identifier Type: -

Identifier Source: org_study_id

NCT00496912

Identifier Type: -

Identifier Source: nct_alias