Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome Clinical Trial
Official title:
Phase III, Multi-Center, Open, 12-Week, Follow-up Safety and Efficacy Study of Serostim® in Subjects With Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly
assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received
recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the
first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on
alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance"
phase). All patients in Group B initially received placebo from baseline to Week 24, and
then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007).
In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was
assigned to Group A, who fully completed all study visits without a major protocol
violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg
daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events
and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting
insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of
study termination, subjects underwent re-assessment of body composition via anthropometry
measurements and dual photon absorptiometry (DXA) scanning. In addition, at study
termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth
binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were
obtained.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment