The Use of Nutropin Depot in HIV-Infected Adult Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286676
Recruitment Status : Unknown
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2006
Last Update Posted : February 3, 2006
Genentech, Inc.
Information provided by:
University of Texas Southwestern Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: Nutropin Procedure: Oral Glucose Tolerance Test Procedure: Dual Energy X-ray Absorptiometry (DEXA) Procedure: Computed Tomography (CT) Scan Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. 1) body weight
  2. 2) lean tissue mass (LTM).

Secondary Outcome Measures :
  1. 1) whole body protein turnover (WBPT)
  2. 2) gluconeogenesis
  3. 3) bone mineral density and markers of bone turnover
  4. 4) fat distribution (lipoatrophy)
  5. 5) thymus size
  6. 6) T-cell subsets
  7. 7) TNF-µ level

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286676

United States, Texas
Aston Ambulatory Care Center
Dallas, Texas, United States, 75390
Parkland Health & Hospital System
Dallas, Texas, United States, 75390
Veteran’s Affairs Medical Center
Dallas, Texas, United States
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Genentech, Inc.
Principal Investigator: Dana S Hardin, MD University of Texas, Southwestern Medical Center at Dallas Identifier: NCT00286676     History of Changes
Other Study ID Numbers: 0103-045
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: February 3, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases