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Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006493
First received: November 14, 2000
Last updated: June 23, 2005
Last verified: January 2004

November 14, 2000
June 23, 2005
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Complete list of historical versions of study NCT00006493 on ClinicalTrials.gov Archive Site
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Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
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The purpose of this research is to study the effects of rosiglitazone, a drug usually taken for Type II diabetes, on HIV-associated hyperlipidemia. HIV-associated lipodystrophy is a medical condition characterized by gradual changes in the distribution of body fat. The body fat located in the extremities and face disappears while body fat around the abdomen and upper back increases. Certain biochemical changes occur in association with these changes in fat distribution. Lipid levels particularly serum triglycerides are increased. HDL, the "good cholesterol" is decreased. Higher than normal level of insulin or insulin resistance is also found in this condition. This latter condition is one of the hallmarks of Type II diabetes. The protease inhibitors, a class of HIV medications, are associated with the occurrence of HIV-associated lipodystrophy. It has been suggested that a biochemical pathway known as the peripheral peroxisomal activating receptor (PPAR) gamma system is blocked leading to the onset of this condition.

Rosiglitazone is a new drug approved by the FDA in 1999 for the treatment of type II diabetes. It lowers blood sugar by improving insulin resistance, which as mentioned before, is the hallmark of Type II diabetes. It has also been noted to improve blood lipid levels. Rosiglitazone works by stimulating the PPAR gamma system. It is hoped that this drug can turn on the PPAR system and reverse the HIV-associated lipodystrophy syndrome.

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Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hyperlipidemia
Drug: Rosiglitazone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  • HIV-positive with CD4 count > 500 and undetectable viral load
  • Treated with protease inhibitors for more than three months
  • Serum triglycerides > 400mg/dl
  • Clinical diagnosis of HIV-associated lipodystrophy
  • No history of type II diabetes
  • Fasting blood sugar < 126 mg/dl
  • No history of liver disease
  • Negative Hepatitis B antigen and Hepatitis C antibody
  • Not on the following medications: warfarin, digoxin, nifedipine, erythromycin, cyclosporine or HMG coA-reductase inhibitors
  • Hemoglobin > 11g/dl
  • Women of childbearing age must consent to barrier contraception
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006493
NCRR-M01RR00096-1006, M01RR00096
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National Center for Research Resources (NCRR)
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National Center for Research Resources (NCRR)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP