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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK063639 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | recombinant human growth hormone subcutaneously once a day |
|
| 2 | Placebo Comparator | placebo subcutaneously once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human growth hormone | Drug | growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin-like Growth Factor-I From Baseline to 18 Months | Change in insulin-like growth factor-1 | 18 months |
| Change in Trunk Fat | 18 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18677023 | Derived | 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. |
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Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.
Patients with HIV and lipodystrophy were recruited between November 2003 and March 2006 via community advertisement, HIV support and advocacy groups, and infectious disease or primary care physician referral.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Human Growth Hormone | recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously |
| FG001 | Placebo | placebo subcutaneously once a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Human Growth Hormone | recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | centimeters squared | 18 months |
|
18 months
1 participant in the growth hormone group dropped out of the study before ever receiving study drug and therefore was not included in the adverse event safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recombinant Human Growth Hormone | recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tingling and paresthesia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Lo | Massachusetts General Hospital | 617-724-9109 | jlo@partners.org |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| placebo | Drug | placebo subcutaneously once a day, 18 months |
|
| Change in Fasting Glucose | change in fasting glucose | 18 months |
| Change in Trunk to Extremity Ratio | change in trunk to extremity ratio | 18 months |
| Change in Triglycerides | Change in triglycerides | 18 months |
| Change in Subcutaneous Adipose Tissue | Change in subcutaneous adipose tissue | 18 months |
| Change in CD4 Cells | Change in CD4 cells | 18 months |
| Change in Logarithm HIV Viral Load | Change in logarithm base 10 HIV viral load | 18 months |
| Change in Lean Body Mass | change in lean body mass | 18 months |
| 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. | 18 months |
| Change in Diastolic Blood Pressure | Change in diastolic blood pressure | 18 months |
| Change in Adiponectin | Change in adiponectin | 18 months |
| Change in Carotid Intima Media Thickness (IMT) | change in carotid intima media thickness (IMT) | 18 months |
| Change in Body Mass Index | Change in body mass index | 18 months |
| Change in Extremity Fat | Change in extremity fat | 18 months |
| Change in 2-hour Glucose | Change in 2-hour glucose | 18 months |
| Change in Systolic Blood Pressure | Change in systolic blood pressure | 18 months |
placebo subcutaneously once a day
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Insulin-like Growth Factor-I From Baseline to 18 Months | Change in insulin-like growth factor-1 | Posted | Mean | Standard Error | nanograms/milliliter | 18 months |
|
|
|
| Secondary | Change in Trunk Fat | Posted | Mean | Standard Error | kilograms | 18 months |
|
|
|
| Secondary | Change in Fasting Glucose | change in fasting glucose | Posted | Mean | Standard Error | mg/dL | 18 months |
|
|
|
| Secondary | Change in Trunk to Extremity Ratio | change in trunk to extremity ratio | Posted | Mean | Standard Error | kilogram per kilogram | 18 months |
|
|
|
| Secondary | Change in Triglycerides | Change in triglycerides | Posted | Median | Inter-Quartile Range | mg/dL | 18 months |
|
|
|
| Secondary | Change in Subcutaneous Adipose Tissue | Change in subcutaneous adipose tissue | Posted | Mean | Standard Error | centimeters squared | 18 months |
|
|
|
| Secondary | Change in CD4 Cells | Change in CD4 cells | Posted | Mean | Standard Error | cells/microliter | 18 months |
|
|
|
| Secondary | Change in Logarithm HIV Viral Load | Change in logarithm base 10 HIV viral load | Posted | Mean | Standard Error | log base 10 copies of RNA/milliliter | 18 months |
|
|
|
| Secondary | Change in Lean Body Mass | change in lean body mass | Posted | Mean | Standard Error | kilograms | 18 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | 18 months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure | Posted | Mean | Standard Error | mm Hg | 18 months |
|
|
|
| Secondary | Change in Adiponectin | Change in adiponectin | Posted | Mean | Standard Error | mcg/mL | 18 months |
|
|
|
| Secondary | Change in Carotid Intima Media Thickness (IMT) | change in carotid intima media thickness (IMT) | Posted | Mean | Standard Error | millimeter | 18 months |
|
|
|
| Secondary | Change in Body Mass Index | Change in body mass index | Posted | Mean | Standard Error | kilogram/meters squared | 18 months |
|
|
|
| Secondary | Change in Extremity Fat | Change in extremity fat | Posted | Mean | Standard Error | kilograms | 18 months |
|
|
|
| Secondary | Change in 2-hour Glucose | Change in 2-hour glucose | Posted | Mean | Standard Error | mg/dL | 18 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Change in systolic blood pressure | Posted | Mean | Standard Error | mm Hg | 18 months |
|
|
|
| 4 |
| 26 |
| 3 |
| 26 |
| EG001 | Placebo | placebo subcutaneously once a day | 1 | 29 | 5 | 29 |
| anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| hospitalization | Infections and infestations | Non-systematic Assessment | hospitalization for confusion and transaminitis thought to be related to HIV disease progression |
|
| hip fracture requiring surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | hip fracture requiring surgery |
|
| appendicitis requiring surgery | Gastrointestinal disorders | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| hyperglycemia | Endocrine disorders | Systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |