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NCT01797367 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Minnesota.

Completed
Registry status
1,026
Enrollment target

NCT01797367: Completed study, sponsored by University of Minnesota.

NCT01797367 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 1,026 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01797367 has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
1,026 participants
Enrollment target

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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 1,026 participants
Start Date 2010-03
Est. Completion 2016-12-31
University of Minnesota

966 total trials

What the finished NCT01797367 record still lists

NCT01797367 is an observational study that tracks outcomes without assigning an intervention. Its 1,026 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT01797367 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01797367 about?

NCT01797367 is a clinical study titled "Pulmonary Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)". 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 ('...

What is the current status of trial NCT01797367?

This trial is currently completed. The enrollment target is 1,026 participants. The study started on 2010-03. Estimated completion is 2016-12-31.

Who is sponsoring clinical trial NCT01797367?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01797367, the US trial registry maintained by the National Library of Medicine. NCT01797367 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.