Status:
COMPLETED
Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV-Associated Lipodystrophy Syndrome
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 n...
Detailed Description
A number of people with HIV infection who gain weight in the abdomen (sometimes called lipodystrophy) also have a high level of the sugar-controlling hormone called insulin. These people need to produ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00130286
Start Date
March 1 2005
End Date
August 1 2010
Last Update
February 13 2014
Active Locations (4)
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1
AIDS Community Research Initiative of America (ACRIA)
New York, New York, United States, 10018
2
Cornell HIV Clinical Trials Unit, Weill Medical College of Cornell University
New York, New York, United States, 10021
3
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
4
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032