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
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease
HIV

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797367

Locations
United States, District of Columbia
Washington DC VA Medical Center
Washington, District of Columbia, United States, 20422
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01797367     History of Changes
Other Study ID Numbers: 0603M83587 START 001E
Study First Received: January 22, 2013
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV
COPD
FEV1
respiratory function

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014