The Study is a Multicenter, Prospective Observational Study of Pathogenesis of HIV Pulmonary Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- differences in the trajectory of FEV1 in clinical COPD phenotypes,
研究概览
简要总结
The overall hypotheses of this proposal are that discrete phenotypes of HIV Chronic Obstructive Pulmonary disease (COPD) differ in their trajectories, biomarkers, and risk factors and that persistent viral infection including residual HIV is linked to HIV COPD.
详细描述
The study is a multicenter, prospective observational study of pathogenesis of HIV pulmonary disease. We will determine the prevalence and risk factors for lung dysfunction as quantified by pulmonary function testing in HIV+ subjects. We will build on our existing longitudinal cohorts while adjusting for important co-variates such as antiretroviral therapy (ART), smoking history, co-infections, and illicit drug use. Evaluations will be scheduled at baseline, 18 months, and 36 months. (6, 12, 18 and 36 months for ART initiators at the UCSF). Study visits will consist of blood draw, questionnaires, pulmonary function testing, 6-minute walk test, CT of the chest at visit two. Oral specimen collection and glycocalyx and echocardiogram (visit two) at the Pittsburgh site only.
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
- •HIV-1 infection, documented in medical record at any time prior to study entry.
- •Men and women age 18 to
- •Ability and willingness to complete all tests.
- •Participant in HLRC studies, MACS, Women's Interagency Health Study, and local HIV clinics.
- •For UCSF only, new ART initiators from Women's Interagency Health Study or the HIV clinic
排除标准
- •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 (excluding mental health).
- •Uncontrolled hypertension at screening visit (systolic > 180 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
结局指标
主要结局
differences in the trajectory of FEV1 in clinical COPD phenotypes,
时间窗: 36 months
PFT's at baseline, 18 months and 36months to determine modifying risk factors and relationship of phenotypes to mortality, and delineate the association of ART and lung dysfunction.
次要结局
- will measure biomarkers of these phenotypes and ability to predict HIV COPD(36 months)
研究者
Alison Morris
Professor
University of Pittsburgh