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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00119769
First received: July 7, 2005
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to investigate the effect of low-dose human growth hormone therapy on immune status and fat morphology.


Condition Intervention Phase
HIV Infections
Lipodystrophy
Drug: Placebo
Drug: Genotropin (human recombinant Growth hormone)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of hGH 0.7 mg/day at 9 months on thymic size [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Impact of hGH 0.7 mg/day at 9 months on lipid profile [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Impact of hGH 0.7 mg/day at 9 months on cytokines [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Impact of hGH 0.7 mg/day at 9 months on safety parameters [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: February 2005
Study Completion Date: July 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo, 0.7 mg/day injected subcutaneously
Active Comparator: 2 Drug: Genotropin (human recombinant Growth hormone)
Genotropin, 0.7 mg/day injected subcutaneously

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119769

Locations
Denmark
Clinical Research Unit, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Pfizer
Investigators
Principal Investigator: Birgitte R Hansen, MD
  More Information

Publications:

Responsible Party: Ove Andersen, Clinical Research Center, Copenhagen University Hospital Hvidovre, Denmark
ClinicalTrials.gov Identifier: NCT00119769     History of Changes
Other Study ID Numbers: KFE001
Study First Received: July 7, 2005
Last Updated: August 26, 2008
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
HIV
immune stimulation
lipodystrophy
growth hormone
recombinant growth hormone
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014