Overview

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