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Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Completed
Conditions
HIV
Cardiovascular Diseases
Registration Number
NCT01776151
Lead Sponsor
University of Minnesota
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') 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
337
Inclusion Criteria
  • Simultaneous co-enrollment in the START study
  • Signed informed consent
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Exclusion Criteria
  • Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change from baseline in small artery elasticity (SAE)baseline, Months 1, 4, 8, 12, annually thereafter

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

Change from baseline in large artery elasticity (LAEbaseline, Months 1, 4, 8, 12, annually thereafter

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

Secondary Outcome Measures
NameTimeMethod
Changes in plasma markers of thrombosis and fibrinolysisbaseline, 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.

Trial Locations

Locations (1)

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

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