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

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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)

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Impact of hGH 0.7 mg/day at 9 months on thymic size

Condition

HIV Infections

Intervention

Placebo

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

46

Start Date

February 2005

Completion Date

July 2008

Primary Completion Date

May 2007

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
      

Gender

Male

Ages

21 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Birgitte R Hansen, MD, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT00119769

Organization ID

KFE001



Study Sponsor

Hvidovre University Hospital

Collaborators

 Pfizer

Study Sponsor

Birgitte R Hansen, MD, Principal Investigator, 


Verification Date

August 2008