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NCT01776151 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01776151
Other study ID # 0603M83587-3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 15, 2009
Est. completion date September 2015

Study information
Verified date March 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 337
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Changes in plasma markers of thrombosis and fibrinolysis 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
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