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

NCT01797367 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1026

Last updated 2023-05-31

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Ken M Kunisaki, MD · Minneapolis Veterans Affairs Medical Center

  • Dennis E Niewoehner, MD · University of Minnesota

  • John E Connett, PhD · University of Minnesota

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01797367 on ClinicalTrials.gov