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Subclinical Atherosclerosis in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455793
First received: April 2, 2007
Last updated: November 27, 2013
Last verified: November 2013
History of Changes
  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:

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
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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Massachusetts General Hospital

Additional 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
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:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015