Clinical trial NCT01797367: Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Official title: Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
HIV
Keywords: HIV
COPD
FEV1
respiratory function
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 1026
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ \> 500 cells/mL randomized to the START trial.

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.


Eligibility 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).

Primary outcomes:
measure: Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1)
timeFrame: baseline, then at annual visits for up to 6 years
Secondary outcomes:
measure: Change from baseline in respiratory health status using the St. George's Respiratory Questionnaire for COPD (SGRQ-C)
timeFrame: baseline, then at annual visits for up to 6 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Ken M Kunisaki, MD
role: STUDY_CHAIR
affiliation: University of Minnesota
name: Dennis E Niewoehner, MD
role: STUDY_CHAIR
affiliation: University of Minnesota
name: John E Connett, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.