Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, HIV / AIDS, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2010 |
| End Date: | December 2016 |
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.
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.
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).
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