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

NCT ID: NCT01776151

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-15

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases HIV

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason V Baker, MD

Role: STUDY_CHAIR

University of Minnesota

Daniel Duprez, MD, PhD

Role: STUDY_CHAIR

University of Minnesota

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25711329 (View on PubMed)

Related Links

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http://www.insight-trials.org

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

Other Identifiers

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0603M83587-3

Identifier Type: -

Identifier Source: org_study_id

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