Physiologic Growth Hormone Effects in HIV Lipodystrophy

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo subcutaneously once a day
1	recombinant human growth hormone	recombinant human growth hormone subcutaneously once a day

Primary Outcome Measures

Name	Time	Method
Change in Visceral Adipose Tissue Area From Baseline to 18 Months	18 months	change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan

Secondary Outcome Measures

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