Effects of Short-term Growth Hormone in HIV-infected Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00795210
First received: November 20, 2008
Last updated: December 6, 2013
Last verified: October 2013
Results First Received: October 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Lipodystrophy
Interventions: Drug: Growth hormone
Drug: Growth Hormone Releasing Hormone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred between January, 2009 and November, 2012, in the Boston area.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Once patients were found to be eligible (after screen visit) and agreed to participate, there were no additional events prior to baseline.

Reporting Groups
  Description
GH 6mcg/kg/d Recombinant human growth hormone 6mcg/kg SC once daily
GH 2mg Daily Recombinant human growth hormone 2mg SC once daily
Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks

Participant Flow:   Overall Study
    GH 6mcg/kg/d     GH 2mg Daily     Growth Hormone Releasing Hormone  
STARTED     8     12     5  
COMPLETED     8     11     3  
NOT COMPLETED     0     1     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GH 6mcg/kg/d Recombinant human growth hormone 6mcg/kg SC once daily
GH 2mg Daily Recombinant human growth hormone 2mg SC once daily
Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Total Total of all reporting groups

Baseline Measures
    GH 6mcg/kg/d     GH 2mg Daily     Growth Hormone Releasing Hormone     Total  
Number of Participants  
[units: participants]
  8     12     5     25  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     8     12     5     25  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  49  ± 7     49  ± 6     47  ± 4     48  ± 6  
Gender  
[units: participants]
       
Female     0     2     0     2  
Male     8     10     5     23  
Region of Enrollment  
[units: participants]
       
United States     8     12     5     25  



  Outcome Measures
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1.  Primary:   Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug   [ Time Frame: after 2 weeks treatment ]

2.  Secondary:   Insulin Sensitivity   [ Time Frame: after two weeks treatment ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame AE data were actively collected during the 4 weeks of the study period.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
GH 6mcg/kg/d Recombinant human growth hormone 6mcg/kg SC once daily
GH 2mg Daily Recombinant human growth hormone 2mg SC once daily
Growth Hormone Releasing Hormone Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks

Other Adverse Events
    GH 6mcg/kg/d     GH 2mg Daily     Growth Hormone Releasing Hormone  
Total, other (not including serious) adverse events        
# participants affected / at risk     1/8     3/11     2/3  
Blood and lymphatic system disorders        
Edema/Extremity Swelling        
# participants affected / at risk     0/8 (0.00%)     2/11 (18.18%)     0/3 (0.00%)  
# events     0     2     0  
Endocrine disorders        
hyperglycemia [1]      
# participants affected / at risk     0/8 (0.00%)     2/11 (18.18%)     0/3 (0.00%)  
# events     0     2     0  
Musculoskeletal and connective tissue disorders        
Back Pain        
# participants affected / at risk     1/8 (12.50%)     0/11 (0.00%)     0/3 (0.00%)  
# events     1     0     0  
Nervous system disorders        
headache        
# participants affected / at risk     0/8 (0.00%)     0/11 (0.00%)     1/3 (33.33%)  
# events     0     0     1  
dizziness        
# participants affected / at risk     0/8 (0.00%)     0/11 (0.00%)     1/3 (33.33%)  
# events     0     0     1  
Respiratory, thoracic and mediastinal disorders        
Sinus Infection        
# participants affected / at risk     1/8 (12.50%)     0/11 (0.00%)     0/3 (0.00%)  
# events     1     0     0  
Skin and subcutaneous tissue disorders        
injection site bruising        
# participants affected / at risk     0/8 (0.00%)     1/11 (9.09%)     0/3 (0.00%)  
# events     0     1     0  
[1] elevated fasting blood sugar



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was completed early due to the lack of availability of study drug for one of the arms.


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