Chronic Obstructive Pulmonary DiseaseNCT01797367
Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
An observational study of Chronic Obstructive Pulmonary Disease and HIV, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, HIV
- How many people
- 1,026 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
Who may be able to join
- Simultaneous co-enrollment in the START study
- Signed informed consent to the Pulmonary Substudy
- Age >= 25 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: baseline, then at annual visits for up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2010
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken M Kunisaki, MD, Study chair, Minneapolis Veterans Affairs Medical CenterDennis E Niewoehner, MD, Study chair, University of MinnesotaJohn E Connett, PhD, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797367
- Sponsor's protocol ID
- 0603M83587-4
- Status last verified
- May 2023
- First submitted
- 22 Jan 2013
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36959289Hodgson 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.
PubMed 28409005Kunisaki 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.
PubMed 27773665Kunisaki 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.
PubMed 25711330
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
- ClinicalTrials.gov ID
- NCT01797367
- Acronym / sponsor ID
- 0603M83587-4
- Conditions
- Chronic Obstructive Pulmonary Disease, HIV
- Keywords
- HIV, COPD, FEV1, respiratory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
Key inclusion criteria (3 listed)
- Simultaneous co-enrollment in the START study
- Signed informed consent to the Pulmonary Substudy
- Age >= 25 years
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 36959289MacDonald 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.
- Derived from this study: PubMed 28409005Hodgson 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.
- Derived from this study: PubMed 27773665Kunisaki 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.
- Derived from this study: PubMed 25711330Kunisaki 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.
- INSIGHT network website, including information on the START Pulmonary SubstudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken M Kunisaki, MD study chair
Minneapolis Veterans Affairs Medical Center
Dennis E Niewoehner, MD study chair
University of Minnesota
John E Connett, PhD study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and HIV, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797367, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.