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
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
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286676

Locations
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
Investigators
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286676     History of Changes
Other Study ID Numbers: 0103-045
Study First Received: February 1, 2006
Last Updated: February 1, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 10, 2014