Subclinical Atherosclerosis in HIV-infected Patients

HIV Infections Clinical Trial

Official title:

Subclinical Atherosclerosis in HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455793
• Other study ID #: 2006-P-000238
• Status: Completed
• Phase: N/A
• First received: April 2, 2007
• Last updated: November 27, 2013
• Start date: June 2006
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• HIV Infections
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Plaque		Baseline	No
Secondary	Inflammatory indices, glucose homeostasis, body composition		Baseline	No