Physiologic Growth Hormone Effects in HIV Lipodystrophy - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00100698

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. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Condition	Intervention
AIDS HIV Infections	Drug: recombinant human growth hormone Drug: placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Physiologic Growth Hormone Effects in HIV Lipodystrophy

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

visceral adiposity [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IGF-I [ Time Frame: 18 months ] [ Designated as safety issue: No ]
trunk fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]
glucose homeostasis [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Trunk/extremity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Lipids [ Time Frame: 18 months ] [ Designated as safety issue: No ]
SAT [ Time Frame: 18 months ] [ Designated as safety issue: No ]
CD4 count [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
viral load [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
lean body mass [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Inflammatory markers [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Carotid IMT [ Time Frame: 18 months ] [ Designated as safety issue: No ]
BMI [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Extremity Fat [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	January 2004
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator recombinant human growth hormone sq once a day	Drug: recombinant human growth hormone growth hormone dosed by weight and IGF-1 level,sq qd. 18 months
2: Placebo Comparator placebo sq once a day	Drug: placebo placebo sq qd, 18 months

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100698

Locations

United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Steven Grinspoon, MD

Massachusetts General Hospital

More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Massachusetts General Hospital ( Steven Grinspoon, MD )
Study ID Numbers:	DK63639
Study First Received:	January 4, 2005
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00100698 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

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

HIV
lipodystrophy
growth hormone

visceral fat
IGF-I
Treatment Experienced

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones

Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Skin Diseases, Metabolic
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009