Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections
About this trial
This is an interventional treatment trial for HIV-Associated Lipodystrophy Syndrome focused on measuring Lipodystrophy, HIV, Growth hormone, Rosiglitazone, Visceral fat, Metabolic syndrome, Treatment Experienced, Visceral fat accumulation, fat accumulation, HIV-Associated Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria: HIV-infected On stable Food and Drug Administration (FDA)-approved antiretrovirals for at least 8 weeks Excess abdominal fat based on waist and hip measurements done at the screening visit. [waist greater than 34.7 inches (men) or 29.6 inches (women) and waist to hip ratio greater than 0.95 (men) or 0.9 (women)] Evidence of insulin resistance (based on fasting glucose and insulin levels done at screening) Triglycerides less than 750 mg/dL Exclusion Criteria: Pregnancy Active AIDS-defining infection or other acute illness, within 30 days of entry. Active cancer (except for localized Kaposi's sarcoma) or active brain tumor Any diagnosis of pancreatitis, carpal tunnel syndrome, diabetes, angina, coronary artery disease, or disorder associated with fluid retention (examples: cirrhosis, congestive heart failure) Untreated or uncontrolled high blood pressure, within 30 days of entry. Within 12 weeks of study entry, use of the following: Obesity (fat-reducing) drugs. Anti-diabetic or insulin-sensitizing drugs (examples: rosiglitazone, pioglitazone, or metformin). Systemic glucocorticoids (example: prednisone). Growth hormone or any medication for AIDS-associated wasting. Systemic chemotherapy, interferon, or radiation therapy. Androgenic agents [examples: nandrolone, oxandrolone (Oxandrin) (testosterone replacement therapy is permitted if started more than 30 days before entry)] Appetite stimulants (Marinol, Megace, Periactin). Use of cholesterol lowering drugs, unless started more than 12 weeks before entry Inability to have a magnetic resonance imaging (MRI) scan performed (examples: cardiac pacemaker, intracranial aneurysm clips)
Sites / Locations
- AIDS Community Research Initiative of America (ACRIA)
- Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
- St. Luke's-Roosevelt Hospital Center
- Columbia University College of Physicians and Surgeons
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
rhGH + rosi
rhGH placebo + rosi
rhGH + rosi placebo
Double placebo
Recombinant human growth hormone + rosiglitazone
Placebo for recombinant human growth hormone + rosiglitazone
Recombinant human growth hormone + placebo for rosiglitazone
Placebo for recombinant human growth hormone + placebo for rosiglitazone