Clinical trial NCT01448915: Management of Hepatitis C in HIV Infected Injection Drug Users (IDUs)
Official title: Management of Hepatitis C in HIV Infected IDUs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Hepatitis C
Keywords: HIV
Human immunodeficiency virus
Acquired Immune Deficiency Syndrome Virus
AIDS virus
Immunodeficiency Virus, Human
Virus, Human Immunodeficiency
Hepatitis C
Hepatitis C, chronic
Hepatitis C virus
Hepatitis C antibodies
Hepatitis C antigens
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-10-07
Enrollment: 828
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Hepatitis C Treatment Uptake and HCV cure
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure
timeFrame: 5 years
measure: Liver stiffness measurement by elastography in persons with HIV infection
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mark S. Sulkowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 center. Hepatology. 2017 Nov;66(5):1402-1412. doi: 10.1002/hep.29308. Epub 2017 Oct 11.
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 Infect Dis. 2017 Feb 11;4(1):ofx024. doi: 10.1093/ofid/ofx024. eCollection 2017 Winter.