Status:
COMPLETED
Subclinical Atherosclerosis in HIV-infected Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infections
Coronary Atherosclerosis
Eligibility:
All Genders
18-60 years
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 e...
Eligibility Criteria
Inclusion
- Inclusion criteria for HIV infected subjects arm:
- Men and women age 18-60
- BMI 20-35
- Previously documented HIV disease for 5 years or longer either on stable highly active anti-retroviral therapy (HAART) or not on HAART.
- No changes in antiretroviral regimen within the prior 3 months.
- Inclusion criteria for non-HIV infected control subjects arm:
- Healthy men and women age 18-60
- BMI 20-35
- Exclusion criteria for both arms:
- Previously diagnosed coronary artery disease, cerebrovascular disease, or peripheral vascular disease.
- Use of glucocorticoids, growth hormone, testosterone, or other anabolic agents within past 6 months
- Renal disease or creatinine \>1.5 mg/dL
- Anti-inflammatory medications
- Opportunistic infection within past 6 months in HIV infected individuals and current acute infectious illness in both HIV-infected subjects and normal controls.
- Nitrates or others medications that can alter endothelial function
- Contraindication to beta-blocker use
- Body weight greater than 300 lbs due to DEXA scanner table limitations
- Patients with previous allergic reactions to iodine-containing contrast media or to iodine will be excluded from participation
- Active illicit drug use
- Pregnancy or breastfeeding
- Estrogen or progestin use
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00455793
Start Date
June 1 2006
End Date
February 1 2013
Last Update
December 2 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114