Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia - Tabular View

Tracking Information
First Received Date ^ICMJE	November 14, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Rosiglitazone in the Treatment of HIV-Associated Hyperlipidemia
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label
Condition ^ICMJE	HIV Infections Hyperlipidemia
Intervention ^ICMJE	Drug: Rosiglitazone
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00006493
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR00096-1006, M01RR00096
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	January 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP