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Effects of Short-term Growth Hormone in HIV-infected Patients

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ClinicalTrials.gov Identifier: NCT00795210
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
The purpose of this study is to examine the short-term effects of two different doses of growth hormone, compared to treatment with growth hormone releasing hormone, on the brain's secretion of growth hormone and the body's glucose metabolism. We hypothesize that growth hormone administration will alter the body's endogenous pulsatile growth hormone secretion and that higher dose growth hormone may decrease insulin sensitivity. We hypothesize that growth hormone releasing hormone will augment endogenous GH pulsatility and be neutral to insulin sensitivity.

Condition or disease Intervention/treatment Phase
HIV Lipodystrophy Drug: Growth hormone Drug: Growth Hormone Releasing Hormone Not Applicable

Detailed Description:
The primary objective of this study is to determine the differential effects of growth hormone releasing hormone (GHRH) vs. low dose physiologic growth hormone (GH) vs. higher dose GH treatment and withdrawal on endogenous overnight growth hormone secretion and pulsatility, as well as insulin-stimulated glucose uptake. Subjects with HIV-infection will be randomized to receive one of three treatments: GHRH 2mg/day, or growth hormone 6mcg/kg/day (physiologic "low" dose), or growth hormone 2mg/day ("higher" dose) for 2 weeks. At baseline and after two weeks of treatment, we will assess overnight growth hormone by frequent sampling as well as insulin stimulated glucose uptake by clamp. Subjects will then stop the treatment and will return for an identical assessment after a 2 week withdrawal period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Short-term Growth Hormone in HIV-infected Patients
Study Start Date : February 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GH 6mcg/kg/d
Recombinant human growth hormone 6mcg/kg SC once daily
 Drug: Growth hormone
Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
Other Name: rhGH from Teva Pharmaceuticals
Experimental: GH 2mg daily
Recombinant human growth hormone 2mg SC once daily
 Drug: Growth hormone
Recombinant Human Growth Hormone (Teva pharmaceuticals), with one arm receiving 6mcg/kg SC once daily for two weeks and the other arm receiving 2mg SC once daily for two weeks
Other Name: rhGH from Teva Pharmaceuticals
Experimental: Growth Hormone Releasing Hormone
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
 Drug: Growth Hormone Releasing Hormone
Tesamorelin (GHRH) 2mg SC QD x 2 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug [ Time Frame: after 2 weeks treatment ]
    Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.


Secondary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: after two weeks treatment ]
    insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previously diagnosed HIV infection
  • Stable antiretroviral regimen for at least 12 weeks prior to enrollment
  • Waist circumference >/= 95cm and waist-to-hip ratio >/= 0.94 for males or waist circumference >/=94cm and WHR >/= 0.88 for females, occurring in the context of treatment for HIV disease
  • Subjective evidence of at least one of the following changes, occurring during the treatment of HIV disease: increased abdominal girth, relative loss of fat in the extremities, or relative loss of fat in the face

Exclusion Criteria:

  • Use of anti-diabetic agents, Megace, testosterone, or any steroid use within 6 months of the study
  • Use of GH or Growth hormone releasing factor within six months of starting the study
  • Change in lipid lowering or antihypertensive regimen within 3 months of screening
  • Fasting blood sugar >126mg/dL, SGOT > 2.5 times ULN, Hgb < 12.0 g/dL, creatinine > 1.4 mg/dL, FSH > 20 IU/L in women, or CD4 count < 200
  • Carpal tunnel syndrome
  • Severe chronic illness or active malignancy or history of pituitary malignancy or history of colon cancer
  • For men, history of prostate cancer or evidence of prostate malignancy by PSA > 5ng/mL
  • Prior history of hypopituitarism, head irradiation, or any other condition known to affect the GH axis
  • positive beta-HCG (women only)
  • Oral contraceptives, depo provera, or combined progesterone-estrogen injections, transdermal contraceptive patches, estrogen or progestin coated IUD's within 6 months of the study
  • weight < 110 pounds
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795210


Locations
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United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Steven K Grinspoon, M.D. Massachusetts General Hospital
More Information
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Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00795210    
Other Study ID Numbers: DK63639A
R01DK063639 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2008    Key Record Dates
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014
Last Verified: October 2013
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
HIV lipodystrophy
growth hormone
growth hormone releasing hormone
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
 Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs