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Effect of HDL-raising therapies on Endothelial Function, Lipoproteins, and Inflammation in HIV-infected Subjects with low HDL Cholesterol: A Phase II Randomized Trial of Extended Release Niacin vs. Fenofibrate (ACTG 5293)
Purpose of This Trial:
To see if high-density lipoprotein (HDL or “good”) cholesterol is increased in HIV-infected people treated with extended-release niacin or fenofibrate, and to see if the reaction of an artery in the arm improves with these medications

You may be eligible if you are:
  • HIV positive man or woman, age 18 or older
  • Taking anti-HIV medications for more than 2 years
  • CD4 (T-cell) count ≥ 100 with an undetectable HIV viral load
  • Fasting HDL (“good”) cholesterol ≤ 40mg/dL for men and ≤ 50 mg/dL for women
  • Fasting triglycerides between 200 and 800 mg/dL
  • Fasting LDL (“bad”) cholesterol below 160 mg/dL
  • Do not have diabetes or heart disease
  • Are not being treated for or starting treatment for Hepatitis C
  • Are not pregnant, breastfeeding or planning pregnancy
  • Are not taking certain medications to lower cholesterol
Medications While On Study:
Extended-release niacin and aspirin or fenofibrate will be provided at no cost
Length of Study:
About 24 weeks (6 months)
Schedule of Study Appointments:
Screening, entry and at weeks 4, 8, 12, 16 and 24
Clinical exams and lab tests are provided at no cost. You will receive $20 per visit starting at entry and $15 for each ultrasound test of the artery in your arm.
The ACTU Screening Nurse at 206-744-3184.
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© University of Washington AIDS Clinical Trial Unit, updated 01/23/2012.