Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Cardiovascular Diseases HIV |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START) |
- Change from baseline in large artery elasticity (LAE [ Time Frame: baseline, Months 1, 4, 8, 12, annually thereafter ] [ Designated as safety issue: No ]Large artery elasticity is measured using a tonometer placed on the forearm.
- Change from baseline in small artery elasticity (SAE) [ Time Frame: baseline, Months 1, 4, 8, 12, annually thereafter ] [ Designated as safety issue: No ]Small artery elasticity is measured using a tonometer placed on the forearm.
- Changes in plasma markers of thrombosis and fibrinolysis [ Time Frame: baseline, months 4, 8, 12, annually thereafter ] [ Designated as safety issue: No ]Citrated plasma will be collected and stored for central measurement of plasma markers of thrombosis and fibrinolysis in the future.
Biospecimen Retention: Samples Without DNA
Citrated plasma is collected at each study visit and stored at a central lab for future assessment of changes in plasma markers of thrombosis and fibrinolysis.
| Enrollment: | 337 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Enrollees are HIV-positive, antiretroviral-naive individuals with CD4+ > 500 cells/mL randomized to the START trial.
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
Contacts and Locations| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| Study Chair: | Jason V Baker, MD | University of Minnesota - Clinical and Translational Science Institute |
| Study Chair: | Daniel Duprez, MD, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01776151 History of Changes |
| Other Study ID Numbers: | 0603M83587 START 001D |
| Study First Received: | September 18, 2012 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
HIV cardiovascular diseases vascular stiffness |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013