Status:
COMPLETED
Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Lead Sponsor:
University of Minnesota
Conditions:
Chronic Obstructive Pulmonary Disease
HIV
Eligibility:
All Genders
25+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Simultaneous co-enrollment in the START study
- Signed informed consent to the Pulmonary Substudy
- Age \>= 25 years
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
1026 Patients enrolled
Trial Details
Trial ID
NCT01797367
Start Date
March 1 2010
End Date
December 31 2016
Last Update
May 31 2023
Active Locations (1)
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1
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20422