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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
September 18, 2012
January 25, 2013
December 2, 2015
November 2009
September 2015   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01776151 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
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.
Non-Probability Sample
Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
  • Cardiovascular Diseases
  • HIV
Not Provided
Not Provided
Baker JV, Engen NW, Huppler Hullsiek K, Stephan C, Jain MK, Munderi P, Pett S, Duprez D; International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group. Assessment of arterial elasticity among HIV-positive participants with high CD4 cell counts: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial. HIV Med. 2015 Apr;16 Suppl 1:109-18. doi: 10.1111/hiv.12239.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
September 2015
September 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01776151
0603M83587 START 001D
No
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
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
University of Minnesota - Clinical and Translational Science Institute
November 2015