Serono initiates clinical trial of Serostim® for aids-related metabolic complication

Study to identify potential benefits of recombinant human growth hormone for HIV-Associated Adipose Redistribution Syndrome (HARS)

22-Feb-2001

Serono, Inc. today announced the initiation of the Serostim® for Treatment of Adipose Redistribution Syndrome (STARS) study. This double blind, placebo-controlled study will evaluate Serostim® [somatropin (rDNA origin) for injection], a recombinant human growth hormone (rHGH) currently indicated for the treatment of AIDS wasting, as a potential therapy for HIV-Associated Adipose Redistribution Syndrome (HARS). HARS is a subset of abnormal disorders of fat distribution and altered metabolism often called HIV-related lipodystrophy syndrome.

"It is currently estimated that approximately 30% of HIV positive patients in the U.S. are affected by some form of fat maldistribution or lipodystrophy; however, the causes and etiologies of this group of disorders are still not well understood," said prominent investigator, Donald Kotler, M.D., St. Luke's Roosevelt Hospital, New York. "Clinical trials like STARS enable us to evaluate the benefits of potential therapies such as human growth hormone, while also increasing our knowledge of HIV-associated metabolic disorders."

The STARS trial will involve over 200 patients at trial sites located throughout the U.S. Serostim® has been evaluated for the treatment of HARS in several smaller trials and published studies 1,2, by leading researchers suggest theproduct may have utility in the treatment of HARS. However, no large placebo-controlled clinical trials investigating the effects of growth hormone on fat disturbances or associated metabolic complications have been completed to date. Further trials may be necessary for the submission of Serostim® to the FDA for registration as a treatment for patients with this condition.

1- Engelson ES, Glesby M, Sheikhan J, Albu J, Wang J, Heymsfield SB et al. Effect of recombinant human growth hormone in the treatment of visceral fat accumulation in HIV infection: interim analysis. Antiviral Therapy 4 (Supp. 2)[11], 6-6. 1999. 2- Wanke C, Gerrior J, Kantaros J, Coakley E, Albrecht M. Recombinant human growth hormone improves the fat redistribution syndrome (lipodystrophy) in patients with HIV. AIDS 1999; 13:1099-2103.

What is HARS/Lipodystrophy? HIV-associated lipodystrophy is characterized by a variety of metabolic disturbances and body shape abnormalities that may present individually or in combination. These abnormalities include elevated cholesterol levels, increased insulin resistance, abnormal fat depletion and/or abnormal fat accumulation. Patients with HARS, a subset of HIV-associated lipodystrophy, 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 pad of fat on the upper back commonly known as a "buffalo hump." Unlike the excess subcutaneous fat seen in obesity, visceral adipose tissue lies deep within the abdominal cavity. Persons with visceral fat accumulation are at increased risk to develop metabolic abnormalities.

"The STARS trial is an example of Serono's ongoing commitment to and investment in research related to the treatment of metabolic disorders that affect people with HIV/AIDS," said Dr. Joseph Gertner, Medical Director, Serono, Inc. "It is our hope that the results of the STARS trial will demonstrate that Serostim® can be beneficial in the treatment of HARS."

Patients and care providers in the US who wish to obtain information and patient enrollment in the clinical trial can call 1-888-566-5593 or visit www.seronostudies.com.

https://www.chemeurope.com/en/news/1425/serono-initiates-clinical-trial-of-serostim-for-aids-related-metabolic-complication.html