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Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution

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ClinicalTrials.gov Identifier: NCT00025753
Recruitment Status : Completed
First Posted : October 22, 2001
Last Update Posted : June 24, 2005
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Study Description
Brief Summary:
Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.

Condition or disease Intervention/treatment
HIV Infections Insulin Resistance Drug: rosiglitazone (Avandia) Behavioral: Aerobic and weight lifting exercise training

Detailed Description:
We propose a 12wk controlled, randomized trial that compares the effects of rosiglitazone therapy, exercise training and combined rosiglitazone and exercise training. We hypothesize that rosiglitazone will lower blood sugar, insulin, blood fats, muscle and liver lipid content and composition in HIV-infected people. Exercise training will induce the same benefits, but will also reduce abdominal fat mass. We hypothesize that combining exercise training with rosiglitazone therapy will be most effective at reducing blood sugar, insulin, lipids, muscle and liver lipid contents, and restoring body fat distribution than either intervention alone. At baseline and after 12 wk of treatment we will measure: the ability of insulin to promote the clearance of sugar from the blood, the clearance rate of blood sugar, the rate of glucose production by the liver, blood fat and cholesterol concentrations, body fat content and fat distribution in the arms, legs, trunk regions, muscle and liver lipid content and composition.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution

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Arms and Interventions

Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

The research volunteers will consist of HIV-infected men and women treated with PI-based HAART who have developed insulin resistance of impaired glucose homeostasis:

  • fasting (8h) plasma glucose 110-126 mg/dL (6.1-7.1 mM) OR
  • plasma glucose >140 (7.8 mM) 2 hours after a 75g-oral glucose load.

Although not required for enrollment, many of these volunteers will also have developed trunk adipose tissue redistribution (defined as): trunk/appendicular adipose ratio using whole-body DEXA >1.1 (men), >0.9 (women), or visceral adipose/total abdominal adipose tissue (VAT/TAT) >0.40 using 1H-MRI imaging at the level of the umbilicus (~L3-L4 inter-vertebral space). Many will also have developed fasting hypertriglyceridemia (>300mg/dL, >3.4 mM).

  • Plasma viremia (Roche Amplicor assay) <5000 copies/ml OR a CD4 T-cell county >= 200 cells/ul for at least 3 months prior to enrollment.
  • Stable on a PI-containing HAART regimen for at least 3 months prior to enrollment.
  • 18-65 years of age
  • Body mass index <= 34kg/m*2, total body fat <=35% of weight
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00025753

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Center for Research Resources (NCRR)
The Campbell Foundation
More Information

ClinicalTrials.gov Identifier: NCT00025753     History of Changes
Other Study ID Numbers: NCRR-M01RR00036-0823
First Posted: October 22, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

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