Status:
COMPLETED
The Effect of Low-Dose Human Growth Hormone Therapy in HIV Infected Patients
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Pfizer
Conditions:
HIV Infections
Lipodystrophy
Eligibility:
MALE
21-60 years
Phase:
PHASE4
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 mortalit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00119769
Start Date
February 1 2005
End Date
July 1 2008
Last Update
August 27 2008
Active Locations (1)
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1
Clinical Research Unit, Hvidovre University Hospital
Hvidovre, Denmark, 2650