HIV and Cardiovascular Risk

Completed

Conditions studied: HIV Infections, Cardiovascular Disease

In brief

HIV-infected patients treated with combination antiretroviral therapy demonstrate metabolic abnormalities that may predispose them to cardiovascular disease. In HIV-infected patients we will investigate progression rates of cardiovascular disease and assess whether these progression rates are predicted by increased inflammatory indices.

Key facts

Study ID

NCT00465426

Run by

Massachusetts General Hospital

People needed

129

Starts

2007-04-01

Expected to finish

2011-11-01

Last updated by the study team

2012-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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