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临床试验/NCT01448915
NCT01448915已完成不适用

Management of Hepatitis C in HIV Infected IDUs

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 828 人开始时间: 2021年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
828
试验地点
1
主要终点
Hepatitis C Treatment Uptake and HCV cure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current or prior drug use
  • Reactive HCV antibody
  • Reactive HIV antibody

排除标准

  • Women may not undergo FibroScan while pregnant
  • Persons with implanted cardiac devices may not undergo FibroScan

结局指标

主要结局

Hepatitis C Treatment Uptake and HCV cure

时间窗: 5 years

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

次要结局

  • Incidence of clinical outcomes in persons with HIV/HCV coinfection with or without HCV cure(5 years)
  • Liver stiffness measurement by elastography in persons with HIV infection(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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