The Use of Nutropin Depot in HIV-Infected Adult Males

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00286676
First received: February 1, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

February 1, 2006
February 1, 2006
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  • 1) body weight
  • 2) lean tissue mass (LTM).
Same as current
No Changes Posted
  • 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
  • 7) TNF-µ level
Same as current
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The Use of Nutropin Depot in HIV-Infected Adult Males
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This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 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.

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
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infection
  • Drug: Nutropin
  • Procedure: Oral Glucose Tolerance Test
  • Procedure: Dual Energy X-ray Absorptiometry (DEXA)
  • Procedure: Computed Tomography (CT) Scan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
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Inclusion Criteria:

  • adult males ≥ 18 years of age
  • mild to moderate lipoatrophy
  • stable protease inhibitor therapy for at least six months.

Exclusion Criteria:

  • Con-current supra-infection with acute illness defined by fever or bacterial culture
  • malignancy
  • females
  • diabetes mellitus
  • CNS tumors.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286676
0103-045
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Not Provided
University of Texas Southwestern Medical Center
Genentech, Inc.
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center at Dallas
University of Texas Southwestern Medical Center
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP