Multicenter Open-Label, Randomized, Dose-Finding, Parallel-Group, Safety and Efficacy Trial of Subcutaneous Administration of Serostim in the Maintenance of the Treatment Effect Obtained During the Study of Serostim® in Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS).
This is an open label, multi-center, randomized, parallel group, maintenance trial of Serostim® in patients who have completed a prior Serostim® HARS trial. Assign patients who encountered toxicity during the antecedent protocol to a 1 mg dose. Randomize all others in a 1:1 ratio to receive up to 2 mg or 4 mg of Serostim®, beginning Day 1 of Week 1. Adjust doses downward in persons weighing <55 kg. Continue Serostim® therapy at the assigned dose through Week 12 (Period I). Assign patients who encounter toxicity during Period I to the 1 mg group for Period II. Randomize all other patients in a 1:1 ratio to receive up to 2 mg or 1 mg of Serostim® on a weight adjusted basis. Begin Period II therapy on Day 1 of Week 13, continuing through Week 36. Study Visits are required at Screen (i.e., Final Visit of the antecedent trial), Day 1 of Week 1 (Baseline), and at Weeks 2, 6, 12, 14, 24, 30 and 36.
Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
Drug: recombinant human growth hormone (r-hGH)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment