Physiologic Growth Hormone Effects in HIV Lipodystrophy

NCT00100698 | Completed Results DMC

• 2 other identifiers: DK63639R01DK063639
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 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.

Conditions

AIDS; HIV Infections

Keywords

HIV; lipodystrophy; growth hormone; visceral fat; IGF-I; Treatment Experienced

Outcome Measures

Primary Outcomes (1)

• Change in Visceral Adipose Tissue Area From Baseline to 18 Months

  change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan

  18 months

Secondary Outcomes (17)

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

  18 months

• Change in Trunk Fat

  18 months

• Change in Fasting Glucose

  18 months

• Change in Trunk to Extremity Ratio

  18 months

• Change in Triglycerides

  18 months

Study Arms (2)

1

ACTIVE COMPARATOR

recombinant human growth hormone subcutaneously once a day

Drug: recombinant human growth hormone

2

PLACEBO COMPARATOR

placebo subcutaneously once a day

Drug: placebo

Interventions

recombinant human growth hormone DRUG

growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months

Also known as: Serostim

1

placebo DRUG

placebo subcutaneously once a day, 18 months

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Lo J, You SM, Canavan B, Liebau J, Beltrani G, Koutkia P, Hemphill L, Lee H, Grinspoon S. Low-dose physiological growth hormone in patients with HIV and abdominal fat accumulation: a randomized controlled trial. JAMA. 2008 Aug 6;300(5):509-19. doi: 10.1001/jama.300.5.509.

  PMID: 18677023 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections; Lipodystrophy

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Janet Lo
• Organization: Massachusetts General Hospital

jlo@partners.org

617-724-9109

Study Officials

• Steven Grinspoon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2005
• First Posted: January 5, 2005
• Study Start: January 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2009
• Last Updated: July 27, 2010
• Results First Posted: July 22, 2010

Record last verified: 2010-07

Locations

US (1)