Physiologic Growth Hormone Effects in HIV Lipodystrophy

HIV Infections Clinical Trial

Official title:

Physiologic Growth Hormone Effects in HIV Lipodystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100698
• Other study ID #: DK63639
• Secondary ID: R01DK063639
• Status: Completed
• Phase: N/A
• First received: January 4, 2005
• Last updated: July 22, 2010
• Start date: January 2004
• Est. completion date: April 2009

Study information

• Verified date: July 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV Infections
• Lipodystrophy

Intervention

Drug:
• recombinant human growth hormone
growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
• placebo
placebo subcutaneously once a day, 18 months

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Insulin-like Growth Factor-I From Baseline to 18 Months	Change in insulin-like growth factor-1	18 months	Yes
Secondary	Change in Trunk Fat		18 months	No
Secondary	Change in Fasting Glucose	change in fasting glucose	18 months	Yes
Secondary	Change in Trunk to Extremity Ratio	change in trunk to extremity ratio	18 months	No
Secondary	Change in Triglycerides	Change in triglycerides	18 months	No
Secondary	Change in Subcutaneous Adipose Tissue	Change in subcutaneous adipose tissue	18 months	No
Secondary	Change in CD4 Cells	Change in CD4 cells	18 months	Yes
Secondary	Change in Logarithm HIV Viral Load	Change in logarithm base 10 HIV viral load	18 months	Yes
Secondary	Change in Lean Body Mass	change in lean body mass	18 months	No
Secondary	Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months	Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.	18 months	No
Secondary	Change in Diastolic Blood Pressure	Change in diastolic blood pressure	18 months	No
Secondary	Change in Adiponectin	Change in adiponectin	18 months	No
Secondary	Change in Carotid Intima Media Thickness (IMT)	change in carotid intima media thickness (IMT)	18 months	No
Secondary	Change in Body Mass Index	Change in body mass index	18 months	No
Secondary	Change in Extremity Fat	Change in extremity fat	18 months	No
Secondary	Change in 2-hour Glucose	Change in 2-hour glucose	18 months	No
Secondary	Change in Systolic Blood Pressure	Change in systolic blood pressure	18 months	No