Subclinical Atherosclerosis in HIV-infected Patients
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ClinicalTrials.gov Identifier: NCT00455793 |
Recruitment Status
:
Completed
First Posted
: April 4, 2007
Last Update Posted
: December 2, 2013
|
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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 or disease |
---|
HIV Infections Coronary Atherosclerosis |
Study Type : | Observational |
Actual Enrollment : | 263 participants |
Time Perspective: | Cross-Sectional |
Official Title: | Subclinical Atherosclerosis in HIV-infected Patients |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |
Group/Cohort |
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1
HIV
|
2
Non-HIV infected controls
|
- Coronary Plaque [ Time Frame: Baseline ]
- Inflammatory indices, glucose homeostasis, body composition [ Time Frame: Baseline ]
Biospecimen Retention: Samples With DNA

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455793
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven Grinspoon | MGH |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | April 4, 2007 Key Record Dates |
Last Update Posted: | December 2, 2013 |
Last Verified: | November 2013 |
Keywords provided by Steven K. Grinspoon, MD, 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 |