Prevalence and Pathogenesis of Lung Disease in a Large HIV Cohort-Pitt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.
研究概览
简要总结
HIV-infected patients have an increased incidence of emphysema compared to non-HIV-infected patients, and it has been hypothesized that this accelerated disease progression is the result of one or more latent infections that amplifies the pulmonary inflammatory response. The investigators will examine the prevalence and progression of emphysema in subjects with and without HIV and determine risk factors for emphysema in this population.
详细描述
Specific Aim 1: To test the hypothesis that emphysema is more prevalent and progresses more quickly in HIV+ subjects compared to HIV- controls: The investigators will characterize the prevalence, nature, and progression of HIV-associated emphysema. Emphysema will be determined in HIV+ and HIV- subjects by spirometry, diffusing capacity, and quantitative computed tomography and/or EBCT. These studies will be repeated at 18 and 36 months after baseline to assess differences in progression between HIV+ and HIV- subjects. Multifactorial regression analyses will determine the contribution of various risk factors to presence and progression of emphysema.
The investigators will perform pulmonary function testing at baseline and compare degree of obstruction according to HIV status while adjusting for other clinical variables that influence lung function. Assessment of degree of emphysema and its distribution can be accomplished using quantitative CT morphometry density analysis. This technique measures lung density by pixel analysis expressed in Hounsfield units (HU) or its inverse (ml of gas/gram of tissue) which increases proportionately with the magnitude of emphysema. These measurements have been histologically-verified and give quantitative, reproducible measurements of percentage and distribution of lung considered normal, mildly emphysematous, and severely emphysematous. The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.
Specific Aim 2: To establish a bank of saliva, sputum, serum, plasma, DNA, RNA, proteins and cells from the biological samples of these subjects with a purpose of performing future proteomic and genomic analyses of gene expression, genetic associations, disease pathogenesis and markers of disease progression in subjects with HIV infection and lung diseases:
2a) To test the role of low level infections with physiologic obstruction in HIV-infected patients. The investigators will examine the role of co-infection with Pneumocystis and other microbes in the pathogenesis of HIV-associated emphysema and the mechanism by which they cause emphysema progression by examining induced sputum specimens at baseline, 18 months, and 36 months.
Specific Aim 3. To test the hypothesis that persistent, sub-clinical infection in HIV+ subjects augments the pulmonary inflammatory response and leads to emphysema.
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 72 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or older
- •By participant's report, s/he is:
- •HIV positive OR
- •HIV negative and at high risk
- •Recruited via:
- •Pitt Men's Study/MAC
- •Women's Interagency Health Study
- •Attendee of UPMC HIV/AIDS Program
排除标准
- •Acute onset of shortness of breath, cough, fever or heart condition such as tachycardia, angina or arrhythmias
- •Pregnancy
- •MI, CVA or cardiovascular event within last 3 months
- •Eye or abdominal surgery with last 3 months
- •Active TB by documentation or self-report
- •Weight > 500 lbs.
- •Exposure to > 10 rads in the previous 12 months (i.e., 2 CT or 4 cardiac cath…or other fluoroscopic exams For bronchoscopy subjects only
- •Subjects with an upper or lower respiratory tract infection
- •Individuals with a Primary diagnosis of vocal cord dysfunction, or those with significant or uncontrolled systemic diseases will be excluded
- •75 years of age or older
结局指标
主要结局
The investigators will compare emphysema in the HIV+ and HIV- subjects and compare progression over time.
时间窗: 36 months
The investigators will perform pulmonary function testing at baseline and compare degree of obstruction according to HIV status while adjusting for other clinical variables that influence lung function. Assessment of degree of emphysema and its distribution can be accomplished using quantitative CT morphometry density analysis. PFT, sputum, CT will be done at baseline, 18mo and 36 mo.
次要结局
未报告次要终点