Clinical trial NCT00100698: Physiologic Growth Hormone Effects in HIV Lipodystrophy
Official title: Physiologic Growth Hormone Effects in HIV Lipodystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AIDS
HIV Infections
Keywords: HIV
lipodystrophy
growth hormone
visceral fat
IGF-I
Treatment Experienced
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2005-01-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in Visceral Adipose Tissue Area From Baseline to 18 Months
timeFrame: 18 months
Secondary outcomes:
measure: Change in Insulin-like Growth Factor-I From Baseline to 18 Months
timeFrame: 18 months
measure: Change in Trunk Fat
timeFrame: 18 months
measure: Change in Fasting Glucose
timeFrame: 18 months
measure: Change in Trunk to Extremity Ratio
timeFrame: 18 months
measure: Change in Triglycerides
timeFrame: 18 months
measure: Change in Subcutaneous Adipose Tissue
timeFrame: 18 months
measure: Change in CD4 Cells
timeFrame: 18 months
measure: Change in Logarithm HIV Viral Load
timeFrame: 18 months
measure: Change in Lean Body Mass
timeFrame: 18 months
measure: Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
timeFrame: 18 months
measure: Change in Diastolic Blood Pressure
timeFrame: 18 months
measure: Change in Adiponectin
timeFrame: 18 months
measure: Change in Carotid Intima Media Thickness (IMT)
timeFrame: 18 months
measure: Change in Body Mass Index
timeFrame: 18 months
measure: Change in Extremity Fat
timeFrame: 18 months
measure: Change in 2-hour Glucose
timeFrame: 18 months
measure: Change in Systolic Blood Pressure
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.