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临床试验/NCT01519141
NCT01519141已完成不适用

Immunologic and Inflammatory Factors and Cardiovascular Risk in Patients With HIV Infection or Autoimmune Diseases

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 579 人开始时间: 2003年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
579
试验地点
1
主要终点
carotid intima-media thickness

研究概览

简要总结

This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients that is being conducted to learn more about immunologic factors, inflammation, and cardiovascular risk in patients with HIV infection or in patients with autoimmune disease. The investigators plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. The investigators will also measure lipid and lipoprotein levels, inflammatory markers, markers of Cytomegalovirus (CMV) infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T-cells, T-cell turnover, proportions of T-cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviors. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years.

Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry.

To demonstrate the feasibility of a larger scale investigation of cardiac arrhythmia in HIV positive and negative patients with cardiac disease, the investigators will use 48-hour Holter monitor surveillance to monitor HIV-infected and uninfected patients with a history of myocardial infarction, systolic left ventricular dysfunction, and/or pulmonary artery hypertension for the presence of cardiac arrhythmia.

The FDG PET scan (18F-fluorodeoxyglucose positron emission tomography-computed tomography) will be used to detect and quantify inflammation in the body.

详细描述

This proposal is currently approved by CHR (#H9577-18534-03C, exp date 3/26/04); the purpose of this new application is to split the currently approved protocol into a separate protocol with a separate PI. Data collected and patients seen under the previously approved protocol will be carried over into this new separate protocol. This is a longitudinal observational study of HIV-infected patients and HIV-negative control patients, and individuals with autoimmune diseases. We plan to obtain measurement of carotid artery intima media thickness (IMT) using high resolution ultrasound as a noninvasive means for tracking atherosclerotic progression. In addition, patients will undergo ct scan for coronary calcium and single slice abdominal ct scan to assess visceral fat. We will also measure lipid and lipoprotein levels, inflammatory markers, markers of CMV infection, thrombotic markers, atherogenic lipoproteins, and markers of immune function. Immunophenotyping will be performed on freshly collected blood and analyzed by flow cytometry to identify activated T cells,T cell turnover, proportions of T cells, and CMV function. HIV-infected patients will have CD4 count and HIV viral load measured in addition. Patients will undergo detailed clinical history including HIV disease, specific HIV medications, comorbid conditions, and health related behaviours. Physical exam and measurements will be obtained to assess for the presence of lipodystrophy. Patients will undergo study visits for ultrasound, blood draw, and interview at 4-12 month intervals for the next 3 years. Patients will also go assessment of endothelial function, endothelial progenitor cells, arterial stiffness as measured using pulse wave tonometry. In patients with detectable calcium on CT scan, they will be given the option of obtaining CT angiography. Patients will also undergo testing for peripheral arterial disease using ankle brachial index testing and exercise treadmill testing.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stable antiretroviral therapy for at least 12 months, and have no immediate plans to alter therapy.
  • All plasma HIV RNA levels within the past year must be below conventional levels of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 1000 copies will be allowed if they were preceded and followed by undetectable viral load determinations.
  • Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment

排除标准

  • 未提供

结局指标

主要结局

carotid intima-media thickness

时间窗: 2 years

Increased carotid intima-media thickness (mm)

brachial artery flow-mediated dilatation

时间窗: 2 years

decreased brachial artery flow-mediated dilatation (%)

D-dimer

时间窗: 2 years

Increased D-dimer levels (mcg/mL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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