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Status:

COMPLETED

Physiologic Growth Hormone Effects in HIV Lipodystrophy

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

AIDS

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief 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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00100698

Start Date

January 1 2004

End Date

April 1 2009

Last Update

July 27 2010

Active Locations (1)

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MGH

Boston, Massachusetts, United States, 02114