Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if the combination of recombinant human growth hormone plus rosiglitazone (an insulin-sensitizing drug) is safe and more effective than either drug alone (or no active therapy) for the treatment of fat accumulation in people with HIV infection and insulin resistance.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Hormones; Rosiglitazone

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)