Arterial Elasticity: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)
- Conditions
- HIVCardiovascular Diseases
- Registration Number
- NCT01776151
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
- Simultaneous co-enrollment in the START study
- Signed informed consent
- Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Henry Ford Health System
🇺🇸Detroit, Michigan, United States