NCT01423643已完成不适用
HCV/HIV Coinfection: Antiviral Therapy and Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Fibrosis stage
研究概览
简要总结
The chief purpose of this research is to understand how antiretroviral therapy (ART) affects progression of liver disease in persons co-infected with HIV and hepatitis C virus (HCV). The investigators study liver disease progression in a cohort of dually infected persons according to the success of ART.
详细描述
Enrolled subjects will complete questionnaires concerning health status, lifestyle, and alcohol/drug use. Participants will undergo liver elastography every 6-12 months.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Co-Infected Arm
- •Subject must be an HIV/HCV co-infected adult with HIV infection diagnosed by antibody testing and chronic HCV infection diagnosed by reactive HCV antibody and detectable plasma HCV RNA.
- •Subject must receive medical care at the JHU HIV clinic or through the Viral Hepatitis Center.
- •Subjects previously enrolled in the study cohort, but not currently receiving care in the Moore Clinic, may continue in the study.
- •Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- •Subject must be able to provide informed written consent.
- •Control Arm
- •Subject must have or be at risk of having medical conditions that increase the risk of liver disease. These include, but are not limited to, HIV mono-infection, HCV mono-infection, Hepatitis B infection, alcohol addiction, and/or non-alcoholic steatohepatitis.
- •Females of childbearing potential must be willing to undergo a urine or serum pregnancy test.
- •Subject must be able to provide informed written consent.
排除标准
- •To avoid risks associated with ionizing radiation, female subjects may not be pregnant or breast feeding at the time of DEXA scanning. To avoid unknown risks to the fetus, female subjects may not be pregnant at the time of liver biopsy or FibroScan.
- •To avoid interference with the DEXA scan, the subject may not have undergone a nuclear medicine exam with the past week and/or may not have undergone an x-ray procedure with contrast solution within the past 72 hours.
- •To avoid unknown risks, subjects with an implanted cardiac device such as a defibrillator or pacemaker may not undergo FibroScan.
结局指标
主要结局
Fibrosis stage
时间窗: up to 15 years
Liver histologic fibrosis stage (Ishak 0 - 6)
次要结局
- Body composition(up to 15 years)
- Serum markers(up to 15 years)
- Liver histology(up to 15 years)
- Liver stiffness(up to 15 years)
研究者
David Thomas
Chief, Infectious Diseases
Johns Hopkins University
研究点 (1)
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