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Physiologic Growth Hormone Effects in HIV Lipodstrophy - Article


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AIDS and HIV

 




Clinical Trial: Physiologic Growth Hormone Effects in HIV Lipodstrophy

This study is currently recruiting patients.

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

Purpose

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 and increase lean body mass, with minimal effects to disturb insulin sensitivity. Secondary endpoints will include measures of growth hormone secretion, bone density, cardiovascular risk and safety parameters.

Condition Treatment or Intervention
AIDS
HIV Infections
 Drug: recombinant human growth hormone

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: Insulin-like Growth Factor I (IGF-I); visceral adiposity; lean body mass
Secondary Outcomes: bone density; total and regional body fat; glucose and insulin; safety parameters
Expected Total Enrollment:  60

Study start: January 2004;  Expected completion: July 2009
Last follow-up: January 2005;  Data entry closure: July 2009

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  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

Location and Contact Information


Massachusetts
      MGH, Boston,  Massachusetts,  02114,  United States; Recruiting
Steven K Grinspoon, MD  617-724-9109    sgrinspoon@partners.org 
Polyxeni Koutkia, MD  617 726-8277    pkoutkiamylonakis@partners.org 

More Information

Study ID Numbers:  DK63639
Record last reviewed:  January 2005
Last Updated:  February 11, 2005
Record first received:  January 4, 2005
ClinicalTrials.gov Identifier:  NCT00100698
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 1, 2009



Page Updated: May 11, 2006
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