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About
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.
Full 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 produce this extra insulin to help keep their blood sugar normal. This is called "insulin resistance."
Studies have shown that growth hormone (also called "Serostim") can decrease abdominal fat, but it can also worsen the insulin resistance. Rosiglitazone (also called "Avandia") is used to treat insulin resistance in people who have diabetes, so we want to see if taking growth hormone and rosiglitazone together will be better for treating the fat accumulation part of lipodystrophy than either drug alone or no active therapy.
The study is 24 weeks long, divided into two 12-week parts.
The first part of the study is double-blind, meaning that neither participants nor the study staff will know which drugs participants are on. Participants will be assigned randomly (like flipping a coin) to one of four groups:
Everyone in the study will need to be hospitalized overnight for special tests at the beginning of the study and at week 12.
The second part of the study is open-label, meaning that participants and the study staff will know which drugs participants are receiving. All volunteers will receive both active drugs:
Enrollment
Sex
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Inclusion criteria
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:
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)
Primary purpose
Allocation
Interventional model
Masking
77 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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