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Physiologic Growth Hormone Effects in HIV Lipodystrophy

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00100698
First received: January 4, 2005
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.


Condition Intervention
AIDS
HIV Infections
 Drug: recombinant human growth hormone
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiologic Growth Hormone Effects in HIV Lipodystrophy

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Visceral Adipose Tissue Area From Baseline to 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan


Secondary Outcome Measures:
  • Change in Insulin-like Growth Factor-I From Baseline to 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Change in insulin-like growth factor-1

  • Change in Trunk Fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in Fasting Glucose [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    change in fasting glucose

  • Change in Trunk to Extremity Ratio [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    change in trunk to extremity ratio

  • Change in Triglycerides [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in triglycerides

  • Change in Subcutaneous Adipose Tissue [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in subcutaneous adipose tissue

  • Change in CD4 Cells [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Change in CD4 cells

  • Change in Logarithm HIV Viral Load [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Change in logarithm base 10 HIV viral load

  • Change in Lean Body Mass [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    change in lean body mass

  • Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.

  • Change in Diastolic Blood Pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in diastolic blood pressure

  • Change in Adiponectin [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in adiponectin

  • Change in Carotid Intima Media Thickness (IMT) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    change in carotid intima media thickness (IMT)

  • Change in Body Mass Index [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in body mass index

  • Change in Extremity Fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in extremity fat

  • Change in 2-hour Glucose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in 2-hour glucose

  • Change in Systolic Blood Pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Change in systolic blood pressure


Enrollment: 56
Study Start Date: January 2004
Study Completion Date: April 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
recombinant human growth hormone subcutaneously once a day
 Drug: recombinant human growth hormone
growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
Other Name: Serostim
Placebo Comparator: 2
placebo subcutaneously once a day
 Drug: placebo
placebo subcutaneously once a day, 18 months

Detailed Description:

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women age 18-60
  • Previously diagnosed HIV infection
  • Stable antiviral regimen for at least 12 weeks prior to enrollment
  • Waist-to-hip ratio >0.90 for men and >0.85 for women

  • Evidence of at least one of the following recent changes: *increased abdominal girth,

    *relative loss of fat in the extremities, *relative loss of fat in the face

  • Simulated peak GH response to arginine/GHRH of less than 7.5 mcg/dL

Exclusion Criteria:

  • Use of Megace, anti-diabetic agents, GH, or other anabolic agents, pharmacologic glucocorticoid (prednisone >5 mg/day or its equivalent) for 3 months prior to enrollment. Patients on a standard dose of testosterone for documented hypogonadism will be allowed to enter the protocol. Women taking standard estrogen replacement therapy for >3 months will be allowed in the study.
  • Diabetes mellitus
  • Other severe chronic illness
  • HgB <9.0 g/dL, creatinine >1.4 mg/dL, or PSA >4 ng/mL
  • Positive BHCG or failure to use appropriate birth control during study. Acceptable methods include oral contraceptives, depo provera or combined progesterone-estrogen injections, transdermal contraceptive patches, IUD's, barrier devices (condoms, diaphragms), and abstinence.
  • Carpal tunnel syndrome
  • Active malignancy or history of pituitary malignancy, history of colon cancer or prostate malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100698

Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Steven Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00100698     History of Changes
Other Study ID Numbers: DK63639, R01DK063639
Study First Received: January 4, 2005
Results First Received: April 9, 2010
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
HIV
lipodystrophy
growth hormone
 visceral fat
IGF-I
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
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
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 07, 2013