HIV and Cardiovascular Risk

Assessment of Cardiovascular Risk in HIV Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00465426

Enrollment

129

Registered

2007-04-25

Start date

2007-04-30

Completion date

2011-11-30

Last updated

2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, HIV Infections

Keywords

HIV Infection, Cardiovascular Disease, Antiretroviral Therapy, Inflammatory Markers, Treatment Experienced

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion Criteria for Group 1 (HIV-infected group) 1. Age greater than or equal to 18 and less than or equal to 65 years of age 2. 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 3. CD4 \>350 cells/mm3 Inclusion Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects) 1. No history of HIV infection (negative HIV test) 2. Age greater than or equal to 18 and less than or equal to 65 years of age

Design outcomes

Primary

Measure	Time frame
Waist Circumference	2 years
Lipid levels	2 years
Glucose	2 years
Carotid Intima Media Thickness	2 years
Blood pressure	2 years

Secondary

Measure	Time frame
Visceral adiposity	2 years
Inflammatory markers	2 years

Countries

United States

Outcome results