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

This study has been completed.
Sponsor:
Collaborator:
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
  Purpose

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 Intervention
HIV Lipodystrophy
Drug: Growth hormone
Drug: Growth Hormone Releasing Hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Short-term Growth Hormone in HIV-infected Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 25
Study Start Date: February 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795210

Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Steven K Grinspoon, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00795210     History of Changes
Other Study ID Numbers: DK63639A, R01DK063639
Study First Received: November 20, 2008
Results First Received: October 9, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
HIV lipodystrophy
growth hormone
growth hormone releasing hormone

Additional relevant MeSH terms:
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014