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Physiologic Growth Hormone Effects in HIV Lipodystrophy

Primary Purpose

AIDS, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
recombinant human growth hormone
placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS focused on measuring HIV, lipodystrophy, growth hormone, visceral fat, IGF-I, Treatment Experienced

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

recombinant human growth hormone subcutaneously once a day

placebo subcutaneously once a day

Outcomes

Primary Outcome Measures

Change in Visceral Adipose Tissue Area From Baseline to 18 Months
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
Change in insulin-like growth factor-1
Change in Trunk Fat
Change in Fasting Glucose
change in fasting glucose
Change in Trunk to Extremity Ratio
change in trunk to extremity ratio
Change in Triglycerides
Change in triglycerides
Change in Subcutaneous Adipose Tissue
Change in subcutaneous adipose tissue
Change in CD4 Cells
Change in CD4 cells
Change in Logarithm HIV Viral Load
Change in logarithm base 10 HIV viral load
Change in Lean Body Mass
change in lean body mass
Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
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
Change in diastolic blood pressure
Change in Adiponectin
Change in adiponectin
Change in Carotid Intima Media Thickness (IMT)
change in carotid intima media thickness (IMT)
Change in Body Mass Index
Change in body mass index
Change in Extremity Fat
Change in extremity fat
Change in 2-hour Glucose
Change in 2-hour glucose
Change in Systolic Blood Pressure
Change in systolic blood pressure

Full Information

First Posted
January 4, 2005
Last Updated
July 22, 2010
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00100698
Brief Title
Physiologic Growth Hormone Effects in HIV Lipodystrophy
Official Title
Physiologic Growth Hormone Effects in HIV Lipodystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS, HIV Infections
Keywords
HIV, lipodystrophy, growth hormone, visceral fat, IGF-I, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
recombinant human growth hormone subcutaneously once a day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo subcutaneously once a day
Intervention Type
Drug
Intervention Name(s)
recombinant human growth hormone
Other Intervention Name(s)
Serostim
Intervention Description
growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo subcutaneously once a day, 18 months
Primary Outcome Measure Information:
Title
Change in Visceral Adipose Tissue Area From Baseline to 18 Months
Description
change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in Insulin-like Growth Factor-I From Baseline to 18 Months
Description
Change in insulin-like growth factor-1
Time Frame
18 months
Title
Change in Trunk Fat
Time Frame
18 months
Title
Change in Fasting Glucose
Description
change in fasting glucose
Time Frame
18 months
Title
Change in Trunk to Extremity Ratio
Description
change in trunk to extremity ratio
Time Frame
18 months
Title
Change in Triglycerides
Description
Change in triglycerides
Time Frame
18 months
Title
Change in Subcutaneous Adipose Tissue
Description
Change in subcutaneous adipose tissue
Time Frame
18 months
Title
Change in CD4 Cells
Description
Change in CD4 cells
Time Frame
18 months
Title
Change in Logarithm HIV Viral Load
Description
Change in logarithm base 10 HIV viral load
Time Frame
18 months
Title
Change in Lean Body Mass
Description
change in lean body mass
Time Frame
18 months
Title
Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
Description
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.
Time Frame
18 months
Title
Change in Diastolic Blood Pressure
Description
Change in diastolic blood pressure
Time Frame
18 months
Title
Change in Adiponectin
Description
Change in adiponectin
Time Frame
18 months
Title
Change in Carotid Intima Media Thickness (IMT)
Description
change in carotid intima media thickness (IMT)
Time Frame
18 months
Title
Change in Body Mass Index
Description
Change in body mass index
Time Frame
18 months
Title
Change in Extremity Fat
Description
Change in extremity fat
Time Frame
18 months
Title
Change in 2-hour Glucose
Description
Change in 2-hour glucose
Time Frame
18 months
Title
Change in Systolic Blood Pressure
Description
Change in systolic blood pressure
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grinspoon, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18677023
Citation
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. doi: 10.1001/jama.300.5.509.
Results Reference
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Physiologic Growth Hormone Effects in HIV Lipodystrophy

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