Serono Completes Enrollment for Phase III Trial of Serostim for HIV-associated Fat Redistribution

One of the least understood aspects of HIV-related lipodystrophy is fat redistribution. One of the few interventions that appears to affect the abnormal accumulation of intra-abdominal fat is recombinant growth hormone (Serostim).

Serono announced that the company has completed enrollment in its second multi-center Phase III trial of Serostim in the treatment of HIV-associated adipose redistribution syndrome (HARS). Following is an edited version of the Serono announcement:

“The primary goal of this randomized, double-blind, placebo-controlled trial is to assess whether Serostim(r) induction therapy significantly reduces the marked abnormal accumulation of visceral adipose tissue (intra-abdominal fat) and fat maldistribution which characterize HARS, and whether low-dose maintenance therapy prevents the abnormalities from returning during a continued course of therapy.

"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.  "An unmet need clearly exists in this patient population. Serono is committed to ensuring rapid completion of the trial and a US registration submission for Serostim as a treatment for this orphan indication."

"More than 300 patients were enrolled in the study in only six months. The dedication of the clinical investigators, all study site personnel and our in-house study team coupled with the need and enthusiasm for this project in the HIV community led to speedy enrollment of this study," said Paul Lammers, Chief Medical Officer at Serono, Inc. "The results of this pivotal Phase III clinical trial are eagerly awaited."

What is HARS?

”HIV-associated adipose redistribution syndrome or HARS is a subset of HIV lipodystrophy. HIV-associated lipodystrophy 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. In general, HARS patients accumulate excess visceral adipose tissue in the abdomen or may develop a fat pad on the upper back commonly known as a "buffalo hump."

About Serostim

Serostim(r) [somatropin (rDNAorigin) for injection] is the only growth hormone approved by the US Food and Drug Administration for the treatment of HIV wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6 mg/day for patients > 55 kg). Serostim(r) 0.1 mg/kg every other day should be considered as a starting dose in patients thought to be at risk of certain adverse effects, e.g., glucose intolerance.

Use of growth hormone is contraindicated in treatment of patients in intensive care units due to complications following open-heart surgery or abdominal surgery, multiple accidental trauma or acute respiratory failure; patients with active neoplasia; and patients with known hypersensitivity to growth hormone. Serostim(r) must be used in conjunction with antiretroviral therapy.

Full prescribing information for Serostim(r), including important safety information, is available at www.serostim.com.

Selected articles on Serostim on HIV and Hepatitis.com:

Growth Hormone - News Stories Main Page

New Data Indicate Growth Hormone Benefits Wasting, Lipodystrophy and Immunodeficiency

Studies Confirm Effectiveness of Serostim (Growth Hormone) for AIDS Wasting and Demonstrate Potential Benefits for Lipodystrophy

Serostim (Growth Hormone) Reduces Fat Accumulation and Cadiovascular Risk Factors

Phase III Trial of Human Growth Hormone for HIV-related Adipose Redistribution Syndrome

Serono Announces New "Secured Distribution Plan" for Serostim (Human Growth Hormone)

FDA Approves Needle-Free Device to Deliver Serostim for AIDS Wasting 

HIV and Hepatitis.com Main Page for HIV-related Lipodystrophy

Guidelines: Management  of Metabolic Complications
   • IAS-USA Guidelines
   • Animated Presentation:
   • Metabolic and Morphologic Complications of HIV and HAART: An Overview
   • Metabolic Complications of HIV Therapy
   • UCSF Knowledge Base Chapter

01/26/05

Sources
SERONO ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III TRIAL OF SEROSTIM(r) (SOMATROPIN [rDNA ORIGIN] FOR INJECTION) IN HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS). Press Release. January 24, 2005.

http://www.serono.com        

www.serostim.com.