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

April 2, 2007
November 27, 2013
June 2006
February 2013   (final data collection date for primary outcome measure)
Coronary Plaque [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00455793 on ClinicalTrials.gov Archive Site
Inflammatory indices, glucose homeostasis, body composition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Subclinical Atherosclerosis in HIV-infected Patients
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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

DNA

Non-Probability Sample

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

  • HIV Infections
  • Coronary Atherosclerosis
Not Provided
  • 1
    HIV
  • 2
    Non-HIV infected controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00455793
2006-P-000238
No
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
Bristol-Myers Squibb
Principal Investigator: Steven Grinspoon MGH
Massachusetts General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP