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news.Serono's US affiliate, Serono Inc, has completed enrollment in its second multi-center, phase III trial of Serostim in the treatment of HIV-associated body shape abnormalities.
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The primary goal of the trial is to assess whether Serostim induction therapy significantly reduces the marked abnormal accumulation of visceral adipose tissue (intra-abdominal fat) and fat maldistribution which characterize HIV-associated adipose redistribution syndrome (HARS), and whether low-dose maintenance therapy prevents the abnormalities from returning during a continued course of therapy.
HARS is a subset of HIV lipodystrophy, which is characterized by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination. Patients with HARS experience abnormal, pathological accumulation of adipose tissue, which may be present with or without fat depletion and/or metabolic abnormalities.
“We are pleased to have reached this major milestone for this very important study,” said James Sapirstein, executive vice president of metabolic endocrinology at Serono Inc.