Status:
COMPLETED
HIV and Cardiovascular Risk
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV Infections
Cardiovascular Disease
Eligibility:
All Genders
18-65 years
Brief Summary
HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we will investiga...
Detailed Description
HIV-infected patients treated with combination antiretroviral (ARV) therapy increasingly demonstrate metabolic abnormalities, including dyslipidemia, insulin resistance and body composition abnormalit...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Group 1 (HIV-infected group)
- Age greater than or equal to 18 and less than or equal to 65 years of age
- HIV positive, on the same combination ARV regimen for \> than 6 months, including but not limited to either 2 NRTIs and an NNRTI or PI, or a triple NRTI regimen
- CD4 \>350 cells/mm3
- Inclusion Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)
- No history of HIV infection (negative HIV test)
- Age greater than or equal to 18 and less than or equal to 65 years of age
Exclusion
- Exclusion Criteria for Group 1 (HIV-infected group)
- Hgb \< 10.0 g/dL, creatinine \> 1.5 mg/dL, SGPT \> 2.5x ULN
- Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months
- New antiretroviral regimen within 6 months of study initiation
- Active substance abuse
- Medications known to affect glucose or body composition
- Positive pregnancy test or recently pregnant within the past year or lactating
- Presence of active cancers
- Acute viral, bacterial or other infections (excluding HIV)
- Weight loss in the past 3 months of greater than 10 pounds
- Criteria for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects)
- Hgb \< 10.0 g/dL, creatinine \> 1.5 mg/dL, SGPT \> 2.5x ULN
- Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months.
- Active substance abuse
- Medications known to affect glucose or body composition
- Positive pregnancy test or recently pregnant within the past year or lactating
- Acute viral, bacterial or other infections
- Weight loss in the past 3 months of greater than 10 pounds
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00465426
Start Date
April 1 2007
End Date
November 1 2011
Last Update
October 31 2012
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114