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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
Results First Received: October 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1

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


  Serious Adverse Events
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  Other Adverse Events
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  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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
phone: 617-724-9109
e-mail: sgrinspoon@partners.org



Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00795210     History of Changes
Other Study ID Numbers: DK63639A
R01DK063639 ( US NIH Grant/Contract Award Number )
Study First Received: November 20, 2008
Results First Received: October 9, 2013
Last Updated: December 6, 2013