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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01776151
First received: September 18, 2012
Last updated: January 22, 2013
Last verified: January 2013
  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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01776151     History of Changes
Other Study ID Numbers: 0603M83587 START 001D
Study First Received: September 18, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014