Physiologic Growth Hormone Effects in HIV Lipodystrophy

Mass General Brigham

Status

Completed

Conditions

AIDS

HIV Infections

Treatments

Drug: placebo

Drug: recombinant human growth hormone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00100698

DK63639

R01DK063639 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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