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

July 7, 2005
August 26, 2008
February 2005
May 2007   (final data collection date for primary outcome measure)
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 ]
Impact of hGH 0.7 mg/day on number of mature and naïve CD4 cells in HIV patients at 9 months
Complete list of historical versions of study NCT00119769 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Impact of hGH 0.7 mg/day at 9 months on:
  • thymic size
  • fat distribution as measured with CT and DEXA scans
  • glucose metabolism i.e.glucose tolerance, insulin sensitivity and beta cell function as measured by OGTT
  • insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp
  • lipid profile
  • quality of life and adherence to HAART
  • cytokines
  • safety parameters
Not Provided
Not Provided
 
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients on Highly Active Antiretroviral Therapy (HAART)

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infections
  • Lipodystrophy
  • Drug: Placebo
    Placebo, 0.7 mg/day injected subcutaneously
  • Drug: Genotropin (human recombinant Growth hormone)
    Genotropin, 0.7 mg/day injected subcutaneously
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Intervention: Drug: Genotropin (human recombinant Growth hormone)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2008
May 2007   (final data collection date for primary outcome measure)

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
Male
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00119769
KFE001
No
Ove Andersen, Clinical Research Center, Copenhagen University Hospital Hvidovre, Denmark
Hvidovre University Hospital
Pfizer
Principal Investigator: Birgitte R Hansen, MD
Hvidovre University Hospital
August 2008

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