Physiologic Growth Hormone Effects in HIV Lipodystrophy

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Hormones

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