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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797367
• Other study ID #: 0603M83587-4
• Status: Completed
• Start date: March 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• HIV
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Washington DC VA Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, then at annual visits for up to 6 years

External Links

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