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.
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