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

NCT01776151 | Completed

• 1 other identifier: 0603M83587-3
• Study Type: observational
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; HIV

Keywords

HIV; cardiovascular diseases; vascular stiffness

Outcome Measures

Primary Outcomes (2)

• Change from baseline in large artery elasticity (LAE

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

  baseline, Months 1, 4, 8, 12, annually thereafter

• Change from baseline in small artery elasticity (SAE)

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

  baseline, Months 1, 4, 8, 12, annually thereafter

Secondary Outcomes (1)

• Changes in plasma markers of thrombosis and fibrinolysis

  baseline, months 4, 8, 12, annually thereafter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ \> 500 cells/mL randomized to the START trial.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• 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(0 1):109-18. doi: 10.1111/hiv.12239.

  PMID: 25711329 DERIVED

Related Links

• INSIGHT network website, including information on the START Arterial Elasticity Substudy

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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Jason V Baker, MD

  University of Minnesota

  STUDY CHAIR

• Daniel Duprez, MD, PhD

  University of Minnesota

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: January 25, 2013
• Study Start: April 15, 2009
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

US (1)