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

March 19, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, Months 1, 4, 8, 12, annually thereafter
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.
baseline, Months 1, 4, 8, 12, annually thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, months 4, 8, 12, annually thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Study Chair: Jason V Baker, MD, University of Minnesota
  • Study Chair: Daniel Duprez, MD, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2009

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603M83587-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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