Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,026
- 试验地点
- 1
- 主要终点
- Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate of decrease in lung function over time compared to waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and both human immunodeficiency virus (HIV) infection and ART have been shown to case a decline in lung function as well. Decline in lung function can be an early indicator of chronic obstructive pulmonary disease (COPD), a significant cause of sickness and death in people with HIV. In this study, lung function will be measured at baseline and every year thereafter by using a spirometer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simultaneous co-enrollment in the START study
- •Signed informed consent to the Pulmonary Substudy
- •Age >= 25 years
排除标准
- •An episode of respiratory illness with 2 or more symptoms of cough, wheezing, breathlessness, or increase in sputum production within the 6 weeks before baseline spirometry.
- •Use of asthma medications (bronchodilator, inhaled corticosteroid, leukotriene inhibitor, or theophylline) for 2 or more consecutive weeks within the 6 months before baseline spirometry.
- •Relative contraindications to spirometry, such as chest or abdominal or eye surgery within the 3 months before baseline spirometry, known retinal detachment at the time of baseline spirometry.
- •Known allergy to albuterol/salbutamol
- •Relative contraindications to albuterol/salbutamol, such as resting heart rate of >110 beats per minute, or a known serious or recurrent or uncontrolled cardiac condition (such as unstable coronary artery disease, decompensated heart failure, or recurrent tachyarrhythmias).
结局指标
主要结局
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)
时间窗: baseline, then at annual visits for up to 6 years
FEV1 is measured by having the participant inhale a dose of bronchodilator (albuterol/salbutamol), wait 15 minutes, and then inhale maximally and exhale maximally and forcefully into a spirometer. Participants do at least 3 trials of spirometry for each measurement, and up to 8, to obtain 3 usable measurements.
次要结局
- Change from baseline in respiratory health status using the St. George's Respiratory Questionnaire for COPD (SGRQ-C)(baseline, then at annual visits for up to 6 years)