Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

University of Minnesota (UMN)

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; HIV

Study type: Observational

Funder types: Other

Identifiers

NCT01797367

0603M83587-4

Details and patient eligibility

About

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.

Enrollment: 1,026 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Simultaneous co-enrollment in the START study
• Signed informed consent to the Pulmonary Substudy
• Age >= 25 years

Exclusion criteria

• 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).