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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776151
First Posted: January 25, 2013
Last Update Posted: December 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
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.

Condition
Cardiovascular Diseases HIV

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
Citrated plasma is collected at each study visit and stored at a central lab for future assessment of changes in plasma markers of thrombosis and fibrinolysis.

Enrollment: 337
Study Start Date: November 2009
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776151


Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Study Chair: Jason V Baker, MD University of Minnesota - Clinical and Translational Science Institute
Study Chair: Daniel Duprez, MD, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01776151     History of Changes
Other Study ID Numbers: 0603M83587 START 001D
First Submitted: September 18, 2012
First Posted: January 25, 2013
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV
cardiovascular diseases
vascular stiffness

Additional relevant MeSH terms:
Cardiovascular Diseases