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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome X, Body Weight Changes

In brief

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.

Key facts

Study ID

NCT00130286

Run by

Weill Medical College of Cornell University

People needed

77

Starts

2005-03-01

Expected to finish

2010-08-01

Last updated by the study team

2014-02-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• AIDS Community Research Initiative of America (ACRIA) — New York, New York, United States
• Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University — New York, New York, United States
• St. Luke's-Roosevelt Hospital Center — New York, New York, United States
• Columbia University College of Physicians and Surgeons — New York, New York, United States

Full record on ClinicalTrials.gov

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