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

Date Commenced:
07/2009
Project Status
Completed
Expected Date of Completion:
10/2015
Project Supporters

NHLBI, NIH

Currently recruiting
Yes
image - Start Logo 284x284 0

About the Project

Rationale

The purpose of this study is to determine if early initiation of ART is superior to deferred ART in increasing large artery elasticity (LAE) and small artery elasticity (SAE) (i.e., in reducing arterial stiffness).

Aims

• To compare the early and deferred ART groups for changes in arterial stiffness as indicated by LAE and SAE over an average follow-up period of 4.5 years.
• To compare LAE and SAE for the early and deferred treatment groups in subgroups defined by race/ethnicity, gender, age, preselected ART treatment (PI or NNRTI-based regimen) and cardiovascular risk as determined by the Framingham risk score.
• To study associations between LAE and SAE at baseline with established atherosclerotic risk factors:  age, gender, BMI, blood pressure, diabetes, smoking status, and lipoprotein levels, and with HIV viral load.
• To study the association of LAE and SAE at baseline and biomarkers that will be determined on stored specimens.
• Among patients in the early ART group, to correlate changes in LAE and SAE with lipid changes.
 

 

Design & Method

This is a sub-study of START.  It is planned to co-enroll a total of 300 patients at 12+ clinical sites. Randomization (1:1 ratio) to the early or deferred groups will be determined by the parent study.  Patients will be followed to the common closing date of the START study. Visits: baseline, mth 4, 8, 12 and annually thereafter. Arterial elasticity and changes in plasma markers of thrombosis and fibrinolysis will be measured using a non-invasive hand-held tonometer (model CR-2000 Vascular Profiler, Hypertension Diagnostics, Inc., Eagan, MN) and citrated blood draws respectively. 

Progress/Update

Global enrolment n=337

Output

The substudy results showed that there was no difference in arterial elasticity in people who started HIV drugs early when compared to those who started HIV drugs later.  That is, the timing of starting to take HIV drugs did not change how blood flows through the arteries.

Even though there was no difference in arterial function between the two groups, the results of the substudy are still very important.   We need to think carefully about diseases that might affect the heart or blood vessels (called “cardiovascular complications”) when treating HIV.  The things we learned from this substudy will help us to understand heart health in people with HIV.

Project Members
image - 1343191211 Cate Carey Replace
Senior Clinical Project Coord
Ph +61 (0)2 9385 0900
image - Megan Evans Clewett
Clinical Project Coordinator
Ph +61 (0)2 9385 0900
image - Simone Jacoby
Senior Clinical Project Coordinator
Ph +61 (0)2 9385 0900
image - 1338436367 Sean Emery.jpg
Professor Sean Emery
Professor and Program Head
image - 1342575784 Pamela Findlay Tvrp.jpg
Administrative Assistant
Ph +61 (0)2 9385 0901
Project Collaborators: External

Total of 11 sites in the Sydney region.

Australia: 2 sites: St. Vincent’s Hospital, Burwood Road General Practice; Thailand: 6 sites; Argentina: 2 sites; India: 1 site.

Project Research Area

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