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

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT01797367

Collaborator

(none)

1,026

Enrollment

Location

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease HIV

Study Design

Study Type:

Observational

Actual Enrollment :

1026 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).