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
  Purpose

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 Intervention Phase
HIV Infections
Hyperlipidemia
Drug: Rosiglitazone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006493

Locations
United States, New York
Division of Endocrinology
New York, New York, United States, 10016
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006493     History of Changes
Other Study ID Numbers: NCRR-M01RR00096-1006, M01RR00096
Study First Received: November 14, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hyperlipidemias
Dyslipidemias
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014