Physiologic Growth Hormone Effects in HIV Lipodystrophy
AIDS, HIV Infections
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
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
Active Comparator
Placebo Comparator
1
2
recombinant human growth hormone subcutaneously once a day
placebo subcutaneously once a day