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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01797367
First received: January 22, 2013
Last updated: October 29, 2013
Last verified: October 2013

January 22, 2013
October 29, 2013
March 2010
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01797367 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.

  • Chronic Obstructive Pulmonary Disease
  • HIV
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
December 2015
December 2015   (final data collection date for primary outcome measure)

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).
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01797367
0603M83587 START 001E
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
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
University of Minnesota - Clinical and Translational Science Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP