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Study of Serostim® for HARS, What is the purpose of the study? AIDS Community Research Initiative of America (ACRIA):"This research study will look at the effectiveness and safety of Serostim® when used to treat the abnormal fat distribution that occurs in patients treated with antiviral drugs for HIV infection. Patients with these changes in fat distribution often have increased amounts of fat in the abdomen, the upper back, and (especially in women) in the breasts. This condition is known as HARS (HIV-related adipose redistribution syndrome)."
http://www.criany.org/clinical/clinical_res_serostim.html
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Danger: Counterfeit Serostim(R) (Human Growth Hormone)
AIDS TREATMENT NEWS Issue #365, May 25, 2001:"On May 17 Serono, Inc. and the U.S. FDA warned that new counterfeit drug labeled Serostim had been found. There had been a warning of a previous case of counterfeit Serostim in January of this year. From the press release:
"Serono, Inc. and the U.S. Food and Drug Administration (FDA) are informing distributors, pharmacies, physicians and patients of the existence of a new counterfeit lot of Serono's Serostim(R) 6 mg [somatropin (rDNA origin) for injection]. The counterfeit material, which is made to resemble Serostim(R), bears lot number MNH605A. Any product labeled as Serostim(R) and carrying this lot number should be considered to be counterfeit."
http://www.aegis.com/pubs/atn/2001/ATN36503.html
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Serostim for Wasting, Recombinant Human Growth Hormone, Aidsmap.com:"This study is designed to assess the efficacy of Serostim in the treatment of HIV-related wasting. The effectiveness of Serostim will be assessed by monitoring improvements in physical function and changes in lean body mass."
http://www.aidsmap.com/treatments/ixdata/english/41FF0DCC-2072-4C49-AF4E-0D9E86A8645A.htm
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Serostim™/Lipodystrophy: A study testing the effectiveness of a growth hormone in alleviating HIV-related fat redistribution, AIDS Research Alliance of America:"A range of side-effects and abnormalities have been reported since the introduction of HAART (Highly Active Retroviral Therapy). One of these is Human Immuno-deficiency Virus-Associated Adipose Redistribution Syndrome (HARS). The key feature of HARS is abnormal accumulation of internal abdominal fat, and may also involve abnormal fat accumulation in other areas: back of the neck, mammary/pectoral, lipomas (tumor-like fatty deposits) and other areas."
http://www.aidsresearch.org/onepage_13.html
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Serostim, somatropin, Aidswasting.com:"Serostim® is the only growth hormone approved by the U.S. Food and Drug Administration for the treatment of AIDS wasting or cachexia. This indication is based on the analysis of changes in body weight and lean body mass in studies of up to 12 weeks in duration.
http://www.aidswasting.com/aids/serostim/
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Serono to Start Clinical Trial of Serostim (Growth Hormone) for Treatment of HIV-Related Fat Accumulation (Lipodystrophy), hivandhepatitis.com:"It is currently estimated that approximately 30% of HIV positive patients in the US 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 researcher Donald Kotler, MD, of St. Luke's Roosevelt Hospital, New York. "Clinical trials like STARS (Serostim for the Treatment of Adipose Redistribution Syndrome) enable us to evaluate the benefits of potential therapies such as human growth hormone, while also increasing our knowledge of HIV-associated metabolic disorders."
http://www.hivandhepatitis.com/recent/hormone/022101.html
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Serostim Approved In Canada For Treatment Of HIV Wasting, PSLGroup.com:"Serono Canada, Inc.'s human growth hormone, Serostim(R) [somatropin (rDNA origin) for injection], has been approved in Canada for the treatment of HIV wasting associated with catabolism or cachexia."
http://www.pslgroup.com/dg/c89e6.htm
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Serostim Growth Hormone: How Much Muscle Does It Really Build? Medibolics.com:"I am confused. You say that Serostim growth hormone is not very anabolic, but it seems like everyone else thinks it is. It's supposed to be something that is used when steroids don't work for someone who has AIDS, so it must be more powerful as an anabolic hormone."
http://www.medibolics.com/GHMuscle2.htm
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News & Notes, thebody.com:"Under pressure from the National Association for People With AIDS (NAPWA) and members of the HIV/AIDS community, the Health Care Finance Administration (HCFA) has reversed an early statement that allowed the state of Texas to deny Medicaid reimbursement for Serostim®, the first biotechnology drug ever to be approved for the treatment of AIDS wasting, based on a loophole in the United States Social Security Act. HCFA, which is the federal agency responsible for administering Medicaid policy, had previously stated that Serostim could be considered a drug for cosmetic weight gain, which gave states the option of refusing Medicaid coverage of Serostim for AIDS wasting. HCFA now confirms the clinical benefits of Serostim, a recombinant human growth hormone (r-hGH), for use in fighting this life-threatening condition, and will require Medicaid reimbursement for the drug by all states. The mandate took effect April 5."
http://www.thebody.com/bp/may99/news.html
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