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

NCT00025753 | Completed

• 1 other identifier: NCRR-M01RR00036-0823
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Insulin Resistance

Interventions

rosiglitazone (Avandia) DRUG

Aerobic and weight lifting exercise training BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• The Campbell Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

HIV Infections; Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 19, 2001
• First Posted: October 22, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)