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

Completed

• Conditions: HIV; Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01797367
• Lead Sponsor: University of Minnesota

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1026

Inclusion Criteria

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)	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.

Secondary Outcome Measures

Name	Time	Method
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	The SGRQ-C is a standardized, validated, self-administered questionnaire that measures respiratory health status and includes domains of respiratory symptoms, activity limitations, and psychosocial impact. It will be given to participants to complete in their native language. It contains 40 items and takes approximately 10-15 minutes to complete.

Trial Locations

Locations (1)

Washington DC VA Medical Center; 🇺🇸 Washington, District of Columbia, United States