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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01776151

Enrollment

337

Registered

2013-01-25

Start date

2009-04-15

Completion date

2015-09-30

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, HIV

Keywords

HIV, cardiovascular diseases, vascular stiffness

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in large artery elasticity (LAE	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)	baseline, Months 1, 4, 8, 12, annually thereafter	Small artery elasticity is measured using a tonometer placed on the forearm.

Secondary

Measure	Time frame	Description
Changes in plasma markers of thrombosis and fibrinolysis	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.

Countries

United States

Outcome results