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

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ClinicalTrials.gov Identifier: NCT00119769
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : August 27, 2008
Information provided by:
Hvidovre University Hospital

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : February 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hormones

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. Impact of hGH 0.7 mg/day at 9 months on thymic size [ Time Frame: 9 months ]
  2. Impact of hGH 0.7 mg/day at 9 months on fat distribution as measured with CT and DEXA scans [ Time Frame: 9 months ]
  3. 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 ]
  4. Impact of hGH 0.7 mg/day at 9 months on insulin sensitivity as measured by hyperinsulinaemic euglycaemic clamp [ Time Frame: 9 months ]
  5. Impact of hGH 0.7 mg/day at 9 months on lipid profile [ Time Frame: 9 months ]
  6. Impact of hGH 0.7 mg/day at 9 months on quality of life and adherence to HAART [ Time Frame: 9 months ]
  7. Impact of hGH 0.7 mg/day at 9 months on cytokines [ Time Frame: 9 months ]
  8. Impact of hGH 0.7 mg/day at 9 months on safety parameters [ Time Frame: 9 months ]

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119769

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Clinical Research Unit, Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Principal Investigator: Birgitte R Hansen, MD

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Responsible Party: Ove Andersen, Clinical Research Center, Copenhagen University Hospital Hvidovre, Denmark
ClinicalTrials.gov Identifier: NCT00119769    
Other Study ID Numbers: KFE001
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: August 27, 2008
Last Verified: August 2008
Keywords provided by Hvidovre University Hospital:
immune stimulation
growth hormone
recombinant growth hormone
Treatment Experienced
Additional relevant MeSH terms:
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Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs