Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006493
Recruitment Status : Completed
First Posted : November 15, 2000
Last Update Posted : June 24, 2005
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Hyperlipidemia Drug: Rosiglitazone Phase 2

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment

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MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006493

United States, New York
Division of Endocrinology
New York, New York, United States, 10016
Sponsors and Collaborators
National Center for Research Resources (NCRR) Identifier: NCT00006493     History of Changes
Other Study ID Numbers: NCRR-M01RR00096-1006
M01RR000096 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2004

Keywords provided by National Center for Research Resources (NCRR):
HIV-associated hyperlipidemia

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs