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Completed

NCT Number: NCT01776151

Arterial Elasticity: 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') is better at reducing the stiffness of arteries than waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Artery stiffness has been associated with an increased risk of cardiovascular (heart) disease, and could be useful as an earlier indicator of heart disease. In this study, the stiffness of arteries will be measured at study entry, months 4, 8, 12, and annually thereafter, using a tonometer on the participant's forearm.

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Key information

Conditions

Cardiovascular Diseases HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Simultaneous co-enrollment in the START study
  • Signed informed consent

Exclusion criteria

  • Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation

Treatment and study plan

Primary outcomes

  1. Change from baseline in large artery elasticity (LAE

    Time frame: baseline, Months 1, 4, 8, 12, annually thereafter

    Large artery elasticity is measured using a tonometer placed on the forearm.

  2. Change from baseline in small artery elasticity (SAE)

    Time frame: baseline, Months 1, 4, 8, 12, annually thereafter

    Small artery elasticity is measured using a tonometer placed on the forearm.

Secondary outcomes

  1. Changes in plasma markers of thrombosis and fibrinolysis

    Time frame: baseline, months 4, 8, 12, annually thereafter

    Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2013
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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