Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286676
Status:
WITHDRAWN
Last Update Posted:
2018-12-26
First Post:
2006-02-01
Brief Title:
The Use of Nutropin Depot in HIV-infected Adult Males
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study We will treat 10 HIV-infected adults 12 with lipoatrophy with GH depot for one year Results will be compared to data from 10 HIV patients 12 with lipoatrophy treated with Nutropin AQ subcutaneously The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass LTM
The secondary endpoints are to document changes in 1 whole body protein turnover WBPT 2 gluconeogenesis 3 bone mineral density and markers of bone turnover 4 fat distribution lipoatrophy 5 thymus size 6 T-cell subsets and 7 TNF-µ levels Adverse events such as glucose intolerance and edema will be monitored at every visit
The secondary endpoints are to document changes in 1 whole body protein turnover WBPT 2 gluconeogenesis 3 bone mineral density and markers of bone turnover 4 fat distribution lipoatrophy 5 thymus size 6 T-cell subsets and 7 TNF-µ levels Adverse events such as glucose intolerance and edema will be monitored at every visit
Detailed Description:
Patients will be recruited from the HIV clinics at University of Texas Southwestern Medical School and the Veterans Administration Hospital by direct invitation from Dr Margolis adult HIV clinic director and University director for the NIH-ACTG We will recruit 20 HIV-infected adult males who have been treated with stable protease inhibitor therapy regimen for the past 6 months One half of the subjects will have evidence of lipoatrophy as defined by the ACTG29 Each subject will have baseline BL measures made and then will start on GH depot or subcutaneous AQ Patients will be followed every two weeks for the first six weeks then every three months for the remainder of the study Study parameters to be measured include also see flow chart in appendix
Baseline 3 6 and 12 months OGTT testosterone level whole body protein turnover hepatic glucose production and gluconeogenesis measures DXA scan for measuring lean tissue mass and bone density bone mineral markers resting energy expenditure calorie count T cell subsets TNF µ levels
Every 3 months IGF-1 will obtain every 2 weeks for first 6 weeks body weight and post-prandial glucose level
Baseline 6 and 12 months- CT scan for measurement of thymus size
Baseline 3 6 and 12 months OGTT testosterone level whole body protein turnover hepatic glucose production and gluconeogenesis measures DXA scan for measuring lean tissue mass and bone density bone mineral markers resting energy expenditure calorie count T cell subsets TNF µ levels
Every 3 months IGF-1 will obtain every 2 weeks for first 6 weeks body weight and post-prandial glucose level
Baseline 6 and 12 months- CT scan for measurement of thymus size
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