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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Description
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Brief Summary:

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 Design
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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

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1
HIV
2
Non-HIV infected controls


Outcome Measures
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Primary Outcome Measures :
  1. Coronary Plaque [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Inflammatory indices, glucose homeostasis, body composition [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
DNA

Eligibility Criteria
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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
Study Population
HIV infected men and women and non-HIV infected control men and women
Criteria

Inclusion criteria for HIV infected subjects arm:

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

Inclusion criteria for non-HIV infected control subjects arm:

  1. Healthy men and women age 18-60
  2. BMI 20-35

Exclusion criteria for both arms:

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

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


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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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