Translation Evaluation of Aging, Inflammation and HIV in Lung Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Measurement of the inflammome in HIV-associated lung disease.
研究概览
简要总结
Hypothesis;Aging modifies the risk of pulmonary dysfunction in HIV+ individuals.
The study is a multicenter, prospective observational study of aging and pulmonary function in HIV. The investigator will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in both younger (<50 years) and older (≥50 years) HIV+ and HIV-uninfected controls. The investigator will build on existing cohorts and enrich enrollment for individuals over the age of 50 while adjusting for important co-variates such as ART, smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. Study visits will consist of blood draw, questionnaires, and pulmonary function testing.
详细描述
All clinical procedures will be performed by a registered nurse. Bronchoscopy procedures will be performed by physician.
Subjects will be instructed to avoid smoking, alcoholic beverages and caffeine or medications containing caffeine for eight hours, prior to the visit. In addition, the subject will be asked to hold all medications that are bronchodilators prior to the test being administered and to eat a light meal 2-4 hours prior to testing.
Part I
Respiratory questionnaires:
Translation Evaluation of Aging, Inflammation and HIV in Lung Function questionnaire, MMRC and the ST. George's Questionnaire will be administered. These are paper and pencil questionnaires that inquire about respiratory symptoms, quality of life, smoking history and other health issures. This will take approximately 30 minutes to complete.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnancy or breast-feeding.
- •Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
- •Increasing respiratory symptoms or febrile (temperature >100.40F [380C]) within 4 weeks of study entry.
- •Hospitalization within 4 weeks prior to study entry.
- •Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
- •Active cancer requiring systemic chemotherapy or radiation.
- •Active infection of lungs, brain, or abdomen.
- •Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.
排除标准
- •HIV+ young:
- •HIV-1 infection, documented in medical record at any time prior to study entry.
- •Men and women age 45 years and below.
- •Ability and willingness to complete all tests.
- •Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- •HIV-1 infection, documented in medical record at any time prior to study entry.
- •Men and women age 50 years and above.
- •Ability and willingness to complete all tests.
- •Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- •HIV- young:
- •HIV-uninfected, documented at most recent MACS or WIHS visit.
- •Men and women age 45 years and below.
- •Ability and willingness to complete all tests.
- •Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
- •HIV-uninfected, documented at most recent MACS or WIHS visit.
- •Men and women age 50 years and above.
- •Ability and willingness to complete all tests.
- •Participant in MACS, Women's Interagency Health Study and secondarily clinics and the community
结局指标
主要结局
Measurement of the inflammome in HIV-associated lung disease.
时间窗: 4 years
We will use this cohort to evaluate biomarkers of inflammation such as IL-6, IL-8, TNF-alpha, and hsCRP to determine if we can identify specific HIV COPD phenotypes using novel decision tree analyses. We will examine relationship of the inflammatory signature associated with COPD to aging markers in Aim 2, as well as ART effects, co-infections, degree of immunosuppression, and other co-variates.
Number of HIV+ individuals with increased lung dysfunction disproportionate to age.
时间窗: 2 years
determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in both younger (\<50 years) and older (≥50 years) HIV+ and HIV-uninfected controls. We will build on existing cohorts and enrich enrollment for individuals over the age of 50 while adjusting for important co-variates such as ART, smoking history, co-infections, and illicit drug use.
Number of HIV COPD patients with increased immune cell and lung cellular aging.
时间窗: 3 yrs
We will attempt to proved the hypothesis that immune cell and lung cellular aging are increased in HIV COPD.We will examine telomere length and senescence markers in peripheral immune cells, lung immune cells and in lung epithelial cells and will test the hypothesis that HIV+ individuals with worse lung function and faster pulmonary decline manifest a greater degree of immune activation and cellular senescence.
次要结局
- Measurement of Pulmonary immune cell senescence in HIV+ individuals with poor lung function.(4 years)
- The number of lung epithelial cell senescence in HIV+ individuals.(4 years)
研究者
Alison Morris
Professor
University of Pittsburgh