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

Primary Purpose

HIV Lipodystrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growth hormone
Growth Hormone Releasing Hormone
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Lipodystrophy focused on measuring HIV lipodystrophy, growth hormone, growth hormone releasing hormone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MGH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

GH 6mcg/kg/d

GH 2mg daily

Growth Hormone Releasing Hormone

Arm Description

Recombinant human growth hormone 6mcg/kg SC once daily

Recombinant human growth hormone 2mg SC once daily

Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks

Outcomes

Primary Outcome Measures

Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
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
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

Full Information

First Posted
November 20, 2008
Last Updated
December 6, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00795210
Brief Title
Effects of Short-term Growth Hormone in HIV-infected Patients
Official Title
Effects of Short-term Growth Hormone in HIV-infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Lipodystrophy
Keywords
HIV lipodystrophy, growth hormone, growth hormone releasing hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GH 6mcg/kg/d
Arm Type
Experimental
Arm Description
Recombinant human growth hormone 6mcg/kg SC once daily
Arm Title
GH 2mg daily
Arm Type
Experimental
Arm Description
Recombinant human growth hormone 2mg SC once daily
Arm Title
Growth Hormone Releasing Hormone
Arm Type
Experimental
Arm Description
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
rhGH from Teva Pharmaceuticals
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Growth Hormone Releasing Hormone
Intervention Description
Tesamorelin (GHRH) 2mg SC QD x 2 weeks
Primary Outcome Measure Information:
Title
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
Description
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.
Time Frame
after 2 weeks treatment
Secondary Outcome Measure Information:
Title
Insulin Sensitivity
Description
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
Time Frame
after two weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven K Grinspoon, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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