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: Active, not recruiting

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: visceral adiposity

Secondary outcome:

IGF-I

trunk fat

glucose homeostasis

Trunk/extremity

Lipids

SAT

CD4 count

viral load

lean body mass

Quality of life

Blood pressure

Inflammatory markers

Carotid IMT

BMI

Extremity Fat

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
Ending date: April 2009
Last updated: December 18, 2007