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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00082628 |
The primary objective of the study is to determine if Serostim® 4 mg administered daily for 12 weeks as treatment for the abnormal fat accumulation and distribution associated with HIV-associated Adipose Redistribution Syndrome (HARS) reduces Visceral Adipose Tissue (VAT, measured by CT scan) more effectively than placebo.
Condition | Intervention | Phase |
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HIV Infections Lipodystrophy |
Drug: Serostim®[somatropin (rDNA origin) for injection] |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of Serostim®, r-hGH in the Treatment and Maintenance of Human Immunodeficiency HIV-Associated Adipose Redistribution Syndrome, or HARS |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have written laboratory documentation of an HIV infection by one of the following methods:
Written laboratory documentation of an HIV infection must be obtained prior to randomization. In the absence of documented historical confirmation, an assay of HIV antibodies will be included in the Screening Laboratory Panel. Results will be confirmed with a Western Blot.
Have evidence of excess abdominal adipose deposition when measured by the anthropometric methodology, using the following cut off values:
Have parameter values less than the following limits (using results from the central laboratory):
Female subjects must:
Be post menopausal (>= 1 year) or surgically sterilized (i.e., have undergone tubal ligation or hysterectomy)
or
Use a contraceptive method for the duration of the study such as:
And
Exclusion Criteria:
Are unable to comply with the Concomitant Therapy restrictions including:
Have EVER BEEN DIAGNOSED with any of the following conditions:
In order to participate in this trial a subject must meet all of the inclusion and exclusion criteria specified above. Requests for protocol exceptions/exemptions must come from a participating, fully initiated site at which a prospective patient has consented to undergo screening. Exceptions/exemptions are only allowed by the Trial Director. There is no program in place to allow drug for a single patient IND, or for an expanded access protocol. This statement holds true for both children and adults.
Study Director: | Norma Muurahainen, MD | Sponsor GmbH |
Study ID Numbers: | 24380 |
Study First Received: | May 13, 2004 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00082628 |
Health Authority: | United States: Food and Drug Administration |
growth hormone Serostim® Human Adipose Redistribution Syndrome Human Immunodeficiency Virus lipodystrophy Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases HIV Infections Sexually Transmitted Diseases |
Lipodystrophy Acquired Immunodeficiency Syndrome Metabolic disorder Retroviridae Infections Immunologic Deficiency Syndromes Lipid Metabolism Disorders |
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Skin Diseases, Metabolic Lentivirus Infections Infection |