Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
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.
Chronic Obstructive Pulmonary Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)|
- Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: baseline, then at annual visits for up to 6 years ] [ Designated as safety issue: No ]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.
- Change from baseline in respiratory health status using the St. George's Respiratory Questionnaire for COPD (SGRQ-C) [ Time Frame: baseline, then at annual visits for up to 6 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01797367
|United States, District of Columbia|
|Washington DC VA Medical Center|
|Washington, District of Columbia, United States, 20422|
|Study Chair:||Ken M Kunisaki, MD||Minneapolis Veterans Affairs Medical Center|
|Study Chair:||Dennis E Niewoehner, MD||University of Minnesota - Clinical and Translational Science Institute|
|Study Chair:||John E Connett, PhD||University of Minnesota - Clinical and Translational Science Institute|