The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
Study Type
OBSERVATIONAL
Enrollment
87
UCLA CARE Center
Los Angeles, California, United States
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Time frame: Baseline
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Serum hsCRP
Time frame: Baseline
Reactive Hyperemia Index (RHI)
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Time frame: Week 52
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Serum hsCRP
Time frame: Week 52
Insulin Resistance by HOMA-IR
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Time frame: Baseline
Insulin Resistance by HOMA-IR
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Time frame: Week 52
Framingham Risk Score (FRS), 10-year Risk (%)
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is \<1 to \>/= 30% Higher risk % is worse predicted outcome.
Time frame: Baseline
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Framingham Risk Score (FRS), 10-year Risk (%)
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is \<1 to \>/= 30% Higher risk % is worse predicted outcome.
Time frame: Week 52
Change in RHI
Time frame: Baseline to Week 52
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Change in serum hsCRP level
Time frame: Baseline to Week 52
Change in HOMA-IR
Time frame: Baseline to Week 52
Change in Framingham Risk Score (10-year Risk, %)
Change in estimated 10-year risk (% risk) for developing coronary heart disease (CHD). Positive value indicates increase in estimated 10-year risk for CHD from baseline to Week 52. Negative value indicates decrease in estimated 10-year risk for CHD from baseline to Week 52.
Time frame: Baseline to Week 52