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

NCT01797367 | Completed

• 1 other identifier: 0603M83587-4
• Study Type: observational
• Target: 1,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; HIV

Keywords

HIV; COPD; FEV1; respiratory function

Outcome Measures

Primary Outcomes (1)

• Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)

  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 Outcomes (1)

• 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

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Related Publications (4)

• MacDonald DM, Samorodnitsky S, Wendt CH, Baker JV, Collins G, Kruk M, Lock EF, Paredes R, Poongulali S, Weise DO, Winston A, Wood R, Kunisaki KM; INSIGHT START Pulmonary Substudy Group. Pneumoproteins and biomarkers of inflammation and coagulation do not predict rapid lung function decline in people living with HIV. Sci Rep. 2023 Mar 23;13(1):4749. doi: 10.1038/s41598-023-29739-x.

  PMID: 36959289 DERIVED

• Hodgson S, Griffin TJ, Reilly C, Harvey S, Witthuhn BA, Sandri BJ, Kunisaki KM, Wendt CH. Plasma sphingolipids in HIV-associated chronic obstructive pulmonary disease. BMJ Open Respir Res. 2017 Apr 3;4(1):e000180. doi: 10.1136/bmjresp-2017-000180. eCollection 2017.

  PMID: 28409005 DERIVED

• Kunisaki KM, Niewoehner DE, Collins G, Aagaard B, Atako NB, Bakowska E, Clarke A, Corbelli GM, Ekong E, Emery S, Finley EB, Florence E, Infante RM, Kityo CM, Madero JS, Nixon DE, Tedaldi E, Vestbo J, Wood R, Connett JE; INSIGHT START Pulmonary Substudy Group. Pulmonary effects of immediate versus deferred antiretroviral therapy in HIV-positive individuals: a nested substudy within the multicentre, international, randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial. Lancet Respir Med. 2016 Dec;4(12):980-989. doi: 10.1016/S2213-2600(16)30319-8. Epub 2016 Oct 20.

  PMID: 27773665 DERIVED

• Kunisaki KM, Niewoehner DE, Collins G, Nixon DE, Tedaldi E, Akolo C, Kityo C, Klinker H, La Rosa A, Connett JE; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Pulmonary function in an international sample of HIV-positive, treatment-naive adults with CD4 counts > 500 cells/muL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1(0 0):119-28. doi: 10.1111/hiv.12240.

  PMID: 25711330 DERIVED

Related Links

• INSIGHT network website, including information on the START Pulmonary Substudy

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2010
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

US (1)