View Clinical Trial (Medical Research Study)
Subclinical Atherosclerosis in HIV-infected Patients
| City: |
|
Boston |
| State: |
|
Massachusetts |
| Zip Code: |
|
02114 |
| Conditions: |
|
HIV Infections - Coronary Atherosclerosis |
| 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.
|
| Study Summary: |
|
|
| 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
|
| NCT ID: |
|
NCT00455793 |
| Primary Contact: |
|
Principal Investigator
Steven Grinspoon
MGH
Janet Lo, MD
Phone: (617)724-3425
Email: jlo@partners.org
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 18, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|