Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465426
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2007-04-24
Brief Title:
HIV and Cardiovascular Risk
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Assessment of Cardiovascular Risk in HIV Patients
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic abnormalities that may predispose them to cardiovascular disease In HIV-infected patients we will investigate progression rates of cardiovascular disease and assess whether these progression rates are predicted by increased inflammatory indices
Detailed Description:
HIV-infected patients treated with combination antiretroviral ARV therapy increasingly demonstrate metabolic abnormalities including dyslipidemia insulin resistance and body composition abnormalities that may predispose them to cardiovascular disease CVD Initial studies suggest increased carotid intima-media thickness IMT and endothelial dysfunction in this population Increased carotid IMT over time has been demonstrated in HIV-infected patients compared to control subjects However traditional risk factors such as dyslipidemia diabetes mellitus and body composition changes alone do not fully predict increased cardiovascular disease in HIV-infected patients One possible explanation is increased inflammation related directly to effects of ARV therapy or indirectly from changes in fat distribution In preliminary studies our group has shown that changes in fat distribution were highly predictive of TNF and IL-6 as well as adiponectin and that specific inflammatory cytokines were related in cross-sectional studies to increased IMT In the proposed study we will investigate using detailed methodologies the relationship between adipocytokine concentrations and subclinical atherosclerosis in both cross-sectional and longitudinal studies We will determine in HIV-infected patients on ARVs for greater than 6 months progression rates of IMT and whether progression rates are predicted by increased inflammatory indices controlling for traditional risk factors and body composition changes We will test the hypothesis that inflammation more than traditional risk factors and ARV use mediates subclinical atherosclerotic disease in HIV-infected patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK049302 | NIH | None | httpsreporternihgovquickSearchR01DK049302 |