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

May 30, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1026

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington DC VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
baseline, then at annual visits for up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
baseline, then at annual visits for up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Study Chair: Ken M Kunisaki, MD, Minneapolis Veterans Affairs Medical Center
  • Study Chair: Dennis E Niewoehner, MD, University of Minnesota
  • Study Chair: John E Connett, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimated)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603M83587-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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