HIV and Cardiovascular Risk

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00465426

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

129

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cardiovascular Disease

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 Design

Study Type:

Observational

Actual Enrollment :

129 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessment of Cardiovascular Risk in HIV Patients

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 HIV Positive men and women 18-65 years of age
2 HIV negative men and women 18-65 years of age

Outcome Measures

Primary Outcome Measures

Carotid Intima Media Thickness [2 years]
Waist Circumference [2 years]
Blood pressure [2 years]
Lipid levels [2 years]
Glucose [2 years]

Secondary Outcome Measures

Inflammatory markers [2 years]
Visceral adiposity [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Inclusion Criteria for Group 1 (HIV-infected group)

Age greater than or equal to 18 and less than or equal to 65 years of age
HIV positive, on the same combination ARV regimen for > than 6 months, including but not limited to either 2 NRTIs and an NNRTI or PI, or a triple NRTI regimen
CD4 >350 cells/mm3

Inclusion Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)

No history of HIV infection (negative HIV test)
Age greater than or equal to 18 and less than or equal to 65 years of age

Exclusion Criteria:

Exclusion Criteria for Group 1 (HIV-infected group)

Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN
Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months
New antiretroviral regimen within 6 months of study initiation
Active substance abuse
Medications known to affect glucose or body composition
Positive pregnancy test or recently pregnant within the past year or lactating
Presence of active cancers
Acute viral, bacterial or other infections (excluding HIV)
Weight loss in the past 3 months of greater than 10 pounds

Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)

Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN
Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months.
Active substance abuse
Medications known to affect glucose or body composition
Positive pregnancy test or recently pregnant within the past year or lactating
Acute viral, bacterial or other infections
Weight loss in the past 3 months of greater than 10 pounds