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临床试验/NCT01524562
NCT01524562已完成不适用

HIV-Accelerated Liver Disease in Uganda

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 786 人开始时间: 2011年12月20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
786
试验地点
1
主要终点
Defining the eriology of liver disease

研究概览

简要总结

Background:

  • Liver disease is a leading cause of death in people who have the human immunodeficiency virus (HIV). It especially affects those who have both HIV and hepatitis B or C viruses. Most research on HIV-related liver disease has been conducted in North America and Europe. However, HIV-related liver disease in Uganda and other African nations may involve other diseases that are not common in the West, and may not involve hepatitis B or C. Researchers want to study HIV-related liver disease in Uganda to learn more about the differences between Western and African trends of this disease.

Objectives:

  • To study HIV-related liver disease in rural Uganda.

Eligibility:

  • Individuals at least 18 years of age who were tested for possible liver disease. Some participants will have HIV infection; others will be uninfected.
  • All participants will be from rural areas of Uganda.

Design:

  • Participants will have at least two study visits.
  • Participants will have a physical exam and medical history. They will complete a questionnaire about health and quality of life. Blood, urine, and stool samples will be collected. Participants will also have a liver scan to check for liver scarring, and an ultrasound to take images of the liver.
  • Participants who may have liver disease will visit a local hospital for more tests. A liver biopsy will be performed to collect liver tissue samples.

详细描述

With improved survival following the introduction of highly active antiretroviral therapy (HAART), liver disease has become a leading cause of death among HIV-infected persons in Western cohorts, primarily affecting those co-infected with hepatitis B or C viruses (HBV, HCV). However, data are sparse on liver disease in HIV-infected populations from Uganda and other African nations, where the etiologies of liver disease are broader and include aflatoxin, schistosomiasis and other infectious and environmental agents. Our previous noninvasive study in rural, Rakai, Uganda indicates that the prevalence of significant liver fibrosis is high among HIV-infected individuals (17%) and is 50% higher than in HIV-uninfected persons, although the prevalence of viral hepatitis B co-infection is low (5%). The study presented here is a biopsy-based study that follows up on these results with the objectives of defining the etiology of liver disease and describing the mechanisms of HIV-accelerated liver fibrosis in this setting.

研究设计

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

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Defining the eriology of liver disease

时间窗: 2 years

Describe the etiologiges and compare the pathogenesis of liver fibrosis in HIV-infected and HIV-uninfected persons wirh evidence of liver disease in rural, Rakai Uganda.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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