Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006493
• Other study ID #: NCRR-M01RR00096-1006
• Secondary ID: M01RR000096
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2000
• Last updated: June 23, 2005

Study information

• Verified date: January 2004
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Rosiglitazone

Locations

Country	Name	City	State
United States	Division of Endocrinology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,