Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082628
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2004-05-13
Brief Title:
Treatment of Abnormal Adipose Tissue Accumulation in Human Immunodeficiency Virus HIV Patients
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None