Subclinical Atherosclerosis in HIV-infected Patients - Full Text View

Purpose

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.

Condition
HIV Infections Coronary Atherosclerosis


Study Type:	Observational
Study Design:	Time Perspective: Cross-Sectional
Official Title:	Subclinical Atherosclerosis in HIV-infected Patients

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease HIV/AIDS

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Coronary Plaque [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Inflammatory indices, glucose homeostasis, body composition [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

DNA


Enrollment:	263
Study Start Date:	June 2006
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 HIV
2 Non-HIV infected controls

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

HIV infected men and women and non-HIV infected control men and women

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00455793

Locations


United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Bristol-Myers Squibb

Investigators


Principal Investigator:	Steven Grinspoon	MGH

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Looby SE, Fitch KV, Srinivasa S, Lo J, Rafferty D, Martin A, Currier JC, Grinspoon S, Zanni MV. Reduced ovarian reserve relates to monocyte activation and subclinical coronary atherosclerotic plaque in women with HIV. AIDS. 2016 Jan 28;30(3):383-93. doi: 10.1097/QAD.0000000000000902.

Zanni MV, Kelesidis T, Fitzgerald ML, Lo J, Abbara S, Wai B, Marmarelis E, Hernandez NJ, Yang OO, Currier JS, Grinspoon SK. HDL redox activity is increased in HIV-infected men in association with macrophage activation and non-calcified coronary atherosclerotic plaque. Antivir Ther. 2014;19(8):805-11. doi: 10.3851/IMP2756. Epub 2014 Feb 17.

Fitch KV, Srinivasa S, Abbara S, Burdo TH, Williams KC, Eneh P, Lo J, Grinspoon SK. Noncalcified coronary atherosclerotic plaque and immune activation in HIV-infected women. J Infect Dis. 2013 Dec 1;208(11):1737-46. doi: 10.1093/infdis/jit508. Epub 2013 Sep 16.

Hwang JJ, Wei J, Abbara S, Grinspoon SK, Lo J. Receptor activator of nuclear factor-κB ligand (RANKL) and its relationship to coronary atherosclerosis in HIV patients. J Acquir Immune Defic Syndr. 2012 Nov 1;61(3):359-63. doi: 10.1097/QAI.0b013e31826a6c16.

Burdo TH, Lo J, Abbara S, Wei J, DeLelys ME, Preffer F, Rosenberg ES, Williams KC, Grinspoon S. Soluble CD163, a novel marker of activated macrophages, is elevated and associated with noncalcified coronary plaque in HIV-infected patients. J Infect Dis. 2011 Oct 15;204(8):1227-36. doi: 10.1093/infdis/jir520.

Lo J, Abbara S, Rocha-Filho JA, Shturman L, Wei J, Grinspoon SK. Increased epicardial adipose tissue volume in HIV-infected men and relationships to body composition and metabolic parameters. AIDS. 2010 Aug 24;24(13):2127-30. doi: 10.1097/QAD.0b013e32833c055a.


Responsible Party:	Steven K. Grinspoon, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00455793 History of Changes
Other Study ID Numbers:	2006-P-000238
Study First Received:	April 2, 2007
Last Updated:	November 27, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:


HIV atherosclerosis

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 30, 2016