Physiologic Growth Hormone Effects in HIV Lipodystrophy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00100698
First received: January 4, 2005
Last updated: July 22, 2010
Last verified: July 2010

January 4, 2005
July 22, 2010
January 2004
October 2007   (final data collection date for primary outcome measure)
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
  • visceral adiposity
  • Insulin-like Growth Factor I (IGF-I)
  • lean body mass
Complete list of historical versions of study NCT00100698 on ClinicalTrials.gov Archive Site
  • 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
  • bone density
  • total and regional body fat
  • glucose and insulin
  • safety parameters
Not Provided
Not Provided
 
Physiologic Growth Hormone Effects in HIV Lipodystrophy
Physiologic Growth Hormone Effects in HIV Lipodystrophy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • AIDS
  • HIV Infections
  • Drug: recombinant human growth hormone
    growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
    Other Name: Serostim
  • Drug: placebo
    placebo subcutaneously once a day, 18 months
  • Active Comparator: 1
    recombinant human growth hormone subcutaneously once a day
    Intervention: Drug: recombinant human growth hormone
  • Placebo Comparator: 2
    placebo subcutaneously once a day
    Intervention: Drug: placebo
Lo J, You SM, Canavan B, Liebau J, Beltrani G, Koutkia P, Hemphill L, Lee H, Grinspoon S. Low-dose physiological growth hormone in patients with HIV and abdominal fat accumulation: a randomized controlled trial. JAMA. 2008 Aug 6;300(5):509-19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
April 2009
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100698
DK63639, R01DK063639
Yes
Steven Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2010

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