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.
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: 1. Growth hormone (one injection, daily) PLUS rosiglitazone (one tablet, twice daily). 2. Growth hormone PLUS rosiglitazone placebo ("sugar pill"). 3. Growth hormone placebo (plain water injection) PLUS rosiglitazone. 4. Growth hormone placebo PLUS rosiglitazone placebo. 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: * Growth hormone (one 2 mg injection, every other day) PLUS rosiglitazone (one 4 mg tablet, twice daily).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
77
4 mg tablet twice a day x 12 weeks (double-blind phase)
Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)
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
Change in Insulin Sensitivity
Change in insulin sensitivity value from baseline to week 12 by frequently sampled intravenous glucose tolerance test This assessment was only conducted at baseline and week 12; therefore the change reflects the difference between these two time points.
Time frame: 12 weeks
Change in Visceral Adipose Tissue Volume
Change in visceral adipose tissue volume from baseline to week 12 measured by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Time frame: 12 weeks
Change in Subcutaneous Adipose Tissue Volume
Change in subcutaneous adipose tissue volume from baseline to week 12 by whole body MRI Data are presented only for subjects who had MRI scans done at both time points.
Time frame: 12 weeks
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