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

Hepatitis C Clinical Trial

Official title:

Management of Hepatitis C in HIV Infected IDUs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448915
• Other study ID #: NA_00029706
• Secondary ID: R01DA016065
• Status: Completed
• Start date: March 31, 2021
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00496912

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV Infection

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 — View Citation

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 Infec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis C Treatment Uptake and HCV cure	The proportion of persons with HIV and HCV coinfection who achieve HCV cure	5 years
Secondary	Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure	Clinical events including liver failure and liver cancer	5 years
Secondary	Liver stiffness measurement by elastography in persons with HIV infection	Change in liver stiffness following HCV cure	5 years