Physiologic Growth Hormone Effects in HIV Lipodystrophy

Condition(s) targeted: AIDS; HIV Infections

Intervention: recombinant human growth hormone (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven Grinspoon, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Official title: Physiologic Growth Hormone Effects in HIV Lipodystrophy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Visceral Adipose Tissue Area From Baseline to 18 Months

Secondary outcome:

Change in Insulin-like Growth Factor-I From Baseline to 18 Months

Change in Trunk Fat

Change in Fasting Glucose

Change in Trunk to Extremity Ratio

Change in Triglycerides

Change in Subcutaneous Adipose Tissue

Change in CD4 Cells

Change in Logarithm HIV Viral Load

Change in Lean Body Mass

Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months

Change in Diastolic Blood Pressure

Change in Adiponectin

Change in Carotid Intima Media Thickness (IMT)

Change in Body Mass Index

Change in Extremity Fat

Change in 2-hour Glucose

Change in Systolic Blood Pressure

Detailed 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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

MGH, Boston, Massachusetts 02114, United States

Starting date: January 2004
Last updated: July 22, 2010