Subclinical Atherosclerosis in HIV-infected Patients

We will obtain data using multi-slice CT technology to detect subclinical coronary disease in the HIV population. Determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this patient population.

We will investigate the prevalence of coronary plaque lesions and coronary artery calcifications in men and women with HIV disease as determined by 64-row multidetector computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control subjects without HIV infection. We hypothesize that evidence of coronary artery calcification and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis will be increased in HIV patients compared to control subjects.

We will evaluate the metabolic and inflammatory factors associated with coronary artery disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as well as metabolic and inflammatory changes associated with HIV and its treatment such as dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased insulin resistance and increased visceral fat may be associated with coronary artery disease in HIV-infected individuals.

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Key information

Conditions

HIV Infections Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Genital Diseases Heart Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Myocardial Ischemia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for HIV infected subjects arm:

Men and women age 18-60
BMI 20-35
Previously documented HIV disease for 5 years or longer either on stable highly active anti-retroviral therapy (HAART) or not on HAART.
No changes in antiretroviral regimen within the prior 3 months.

Inclusion criteria

for non-HIV infected control subjects arm:

Healthy men and women age 18-60
BMI 20-35

Exclusion criteria

for both arms:

Previously diagnosed coronary artery disease, cerebrovascular disease, or peripheral vascular disease.
Use of glucocorticoids, growth hormone, testosterone, or other anabolic agents within past 6 months
Renal disease or creatinine >1.5 mg/dL
Anti-inflammatory medications
Opportunistic infection within past 6 months in HIV infected individuals and current acute infectious illness in both HIV-infected subjects and normal controls.
Nitrates or others medications that can alter endothelial function
Contraindication to beta-blocker use
Body weight greater than 300 lbs due to DEXA scanner table limitations
Patients with previous allergic reactions to iodine-containing contrast media or to iodine will be excluded from participation
Active illicit drug use
Pregnancy or breastfeeding
Estrogen or progestin use

Treatment and study plan

Primary outcomes

Coronary Plaque

Time frame: Baseline

Secondary outcomes

Inflammatory indices, glucose homeostasis, body composition

Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Bristol-Myers Squibb

Registry information

Important dates

Study start: 2006
Primary completion: 2013
Study completion: 2013
First posted: Apr 4, 2007
Registry last updated: Dec 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed