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The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients

Primary Purpose

HIV Infections, Lipodystrophy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Genotropin (human recombinant Growth hormone)
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, immune stimulation, lipodystrophy, growth hormone, recombinant growth hormone, Treatment Experienced

Eligibility Criteria

21 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male Caucasian race Age >21 years, <60 years HIV-1 infection HAART treated > 12 months HIV-RNA < 100 copies/ml CD4 count > 200 Fasting plasma glucose < 6.1 mM Stable weight Exclusion Criteria: BMI > 28 kg/m2 and BMI < 18.5 kg/m2 Wasting or AIDS defining disease Severe chronic diseases other than HIV Cancer, previous transplantation Previous AMI Diabetes Hormonal substitution therapy Lipid lowering or antidiabetic therapy within 3 months Abuse of narcotics or alcohol Major psychiatric disorders Adverse reactions towards Genotropin Calcium-ion < 1.15 or > 1.35 mM D-vitamin < 19 nM TSH < 0.1 or > 10 mIU/l

Sites / Locations

  • Clinical Research Unit, Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months

Secondary Outcome Measures

Impact of hGH 0.7 mg/day at 9 months on thymic size
Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans
Impact of hGH 0.7 mg/day at 9 months on glucose metabolism i.e.glucose tolerance, insulin sensitivity and beta cell function as measured by OGTT
Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
Impact of hGH 0.7 mg/day at 9 months on lipid profile
Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART
Impact of hGH 0.7 mg/day at 9 months on cytokines
Impact of hGH 0.7 mg/day at 9 months on safety parameters

Full Information

First Posted
July 7, 2005
Last Updated
August 26, 2008
Sponsor
Hvidovre University Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00119769
Brief Title
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
Official Title
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.
Detailed Description
Following the introduction of highly active antiretroviral therapy (HAART) in the mid-nineties, the improvement in the clinical course of HIV has lead to a dramatic reduction in morbidity and mortality. However, a growing concern has been the emergence of an increasing number of drug therapy failure, mainly caused by rebounding virus. This effect in turn is prompted respectively by developing resistance and failing compliance mainly due to early or late adverse reactions. These adverse reactions mainly consists of a number of metabolic and morphologic changes, known as HIV associated lipodystrophy syndrome (HALS) and affects approximately 40 % of HIV infected patients on HAART. HALS is characterized by lipoatrophy on extremities, gluteal and facial regions combined with intraabdominal lipoaccumulation, "buffalo hump" and lipomas. Thus, despite progress in the development of new drugs with new targets and resistance profiles the need for agents with immune modulating properties is evident, both as a way to overcome the problems of resistance and hopefully modify treatment regimens in order to reduce the exposure to late adverse reactions caused by HAART. A number of studies have addressed the problems of modulating the immune response during HIV infection. Results are promising but a major obstacle seems to be adverse effects. In the pre-HAART era high dose human growth hormone (hGH) therapy has been used for HIV wasting and in the HAART era the impact on fat distribution in HIV infected patients have been investigated based on the lipolytic properties of hGH. However high dosage of hGH has been associated with severe adverse effects limiting the usefulness in daily clinical practice. One recent study demonstrated increments in thymic mass and a rise in the number of circulating naïve CD4 T cells upon treatment with high dose hGH. Our group has conducted a 60 week pilot study with daily injection of 0.7 mg genotropin, demonstrating an immune stimulating effect as well as an increased limb fat/truncal fat ratio, without metabolic and clinically recognizable side effects. Based on these findings we plan to perform a randomized, double blind, prospective, interventional study including 50 HIV infected patients on HAART, investigating the effect of low dose hGH on immune status and fat distribution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipodystrophy
Keywords
HIV, immune stimulation, lipodystrophy, growth hormone, recombinant growth hormone, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 0.7 mg/day injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Genotropin (human recombinant Growth hormone)
Intervention Description
Genotropin, 0.7 mg/day injected subcutaneously
Primary Outcome Measure Information:
Title
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Impact of hGH 0.7 mg/day at 9 months on thymic size
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on glucose metabolism i.e.glucose tolerance, insulin sensitivity and beta cell function as measured by OGTT
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on lipid profile
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on cytokines
Time Frame
9 months
Title
Impact of hGH 0.7 mg/day at 9 months on safety parameters
Time Frame
9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male Caucasian race Age >21 years, <60 years HIV-1 infection HAART treated > 12 months HIV-RNA < 100 copies/ml CD4 count > 200 Fasting plasma glucose < 6.1 mM Stable weight Exclusion Criteria: BMI > 28 kg/m2 and BMI < 18.5 kg/m2 Wasting or AIDS defining disease Severe chronic diseases other than HIV Cancer, previous transplantation Previous AMI Diabetes Hormonal substitution therapy Lipid lowering or antidiabetic therapy within 3 months Abuse of narcotics or alcohol Major psychiatric disorders Adverse reactions towards Genotropin Calcium-ion < 1.15 or > 1.35 mM D-vitamin < 19 nM TSH < 0.1 or > 10 mIU/l
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitte R Hansen, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit, Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
15764170
Citation
Andersen O, Haugaard SB, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Different growth hormone sensitivity of target tissues and growth hormone response to glucose in HIV-infected patients with and without lipodystrophy. Scand J Infect Dis. 2004;36(11-12):832-9. doi: 10.1080/00365540410021162.
Results Reference
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PubMed Identifier
15762193
Citation
Haugaard SB, Andersen O, Dela F, Holst JJ, Storgaard H, Fenger M, Iversen J, Madsbad S. Defective glucose and lipid metabolism in human immunodeficiency virus-infected patients with lipodystrophy involve liver, muscle tissue and pancreatic beta-cells. Eur J Endocrinol. 2005 Jan;152(1):103-12. doi: 10.1530/eje.1.01835.
Results Reference
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PubMed Identifier
15730419
Citation
Haugaard SB, Andersen O, Volund A, Hansen BR, Iversen J, Andersen UB, Nielsen JO, Madsbad S. Beta-cell dysfunction and low insulin clearance in insulin-resistant human immunodeficiency virus (HIV)-infected patients with lipodystrophy. Clin Endocrinol (Oxf). 2005 Mar;62(3):354-61. doi: 10.1111/j.1365-2265.2005.02223.x. Erratum In: Clin Endocrinol (Oxf). 2006 Oct;65(4):554.
Results Reference
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PubMed Identifier
15690310
Citation
Haugaard SB, Andersen O, Hansen BR, Andersen UB, Volund A, Iversen J, Nielsen JO, Madsbad S. In nondiabetic, human immunodeficiency virus-infected patients with lipodystrophy, hepatic insulin extraction and posthepatic insulin clearance rate are decreased in proportion to insulin resistance. Metabolism. 2005 Feb;54(2):171-9. doi: 10.1016/j.metabol.2004.08.009.
Results Reference
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PubMed Identifier
15562401
Citation
Haugaard SB, Andersen O, Hansen BR, Orskov H, Andersen UB, Madsbad S, Iversen J, Flyvbjerg A. Insulin-like growth factors, insulin-like growth factor-binding proteins, insulin-like growth factor-binding protein-3 protease, and growth hormone-binding protein in lipodystrophic human immunodeficiency virus-infected patients. Metabolism. 2004 Dec;53(12):1565-73. doi: 10.1016/j.metabol.2004.06.025.
Results Reference
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PubMed Identifier
15305891
Citation
Andersen O, Haugaard SB, Flyvbjerg A, Andersen UB, Orskov H, Madsbad S, Nielsen JO, Iversen J. Low-dose growth hormone and human immunodeficiency virus-associated lipodystrophy syndrome: a pilot study. Eur J Clin Invest. 2004 Aug;34(8):561-8. doi: 10.1111/j.1365-2362.2004.01380.x.
Results Reference
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The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients

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