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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00795210
First received: November 20, 2008
Last updated: December 6, 2013
Last verified: October 2013
History of Changes

November 20, 2008
December 6, 2013
February 2009
November 2012   (final data collection date for primary outcome measure)
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug [ Time Frame: after 2 weeks treatment ] [ Designated as safety issue: No ]
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.
Overnight mean growth hormone secretion [ Time Frame: after 2 weeks treatment and 2 weeks withdrawal ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795210 on ClinicalTrials.gov Archive Site
Insulin Sensitivity [ Time Frame: after two weeks treatment ] [ Designated as safety issue: No ]
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
insulin sensitivity [ Time Frame: after two weeks treatment and two weeks withdrawal ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Short-term Growth Hormone in HIV-infected Patients
Effects of Short-term Growth Hormone in HIV-infected Patients

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Lipodystrophy
  • 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
  • Drug: Growth Hormone Releasing Hormone
    Tesamorelin (GHRH) 2mg SC QD x 2 weeks
  • Experimental: GH 6mcg/kg/d
    Recombinant human growth hormone 6mcg/kg SC once daily
    Intervention: Drug: Growth hormone
  • Experimental: GH 2mg daily
    Recombinant human growth hormone 2mg SC once daily
    Intervention: Drug: Growth hormone
  • Experimental: Growth Hormone Releasing Hormone
    Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
    Intervention: Drug: Growth Hormone Releasing Hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795210
DK63639A, R01DK063639
No
Steven K. Grinspoon, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Steven K Grinspoon, M.D. Massachusetts General Hospital
Massachusetts General Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP