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 ]

Measure Type Primary
Measure Title Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
Measure Description Serum was sampled for growth hormone concentrations every 20 minutes between 20:00 (8pm) and 07:40 (7:40am). Subjects in GH 6mcg/kg/day and GH 2mg daily groups received their final dose of study drug approximately 36 hours prior to start of sampling. Subjects in Growth Hormone Releasing Hormone group received their final dose of study drug approximately 8 hours prior to start of sampling.
Time Frame after 2 weeks treatment  
Safety Issue No  

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.
Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.

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

Measured Values
    GH 6mcg/kg/d     GH 2mg Daily     Growth Hormone Releasing Hormone  
Number of Participants Analyzed  
[units: participants]
  7     11     3  
Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug  
[units: ng/mL]
Median ( Inter-Quartile Range )
  0.23  
  ( 0.08 to 0.68 )  
  0.07  
  ( 0.04 to 0.12 )  
  1.24  
  ( 0.76 to 1.52 )  


Statistical Analysis 1 for Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
Groups [1] All groups
Method [2] Kruskal-Wallis
P Value [3] 0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Kruskal-Wallis Test for overall difference between groups
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Insulin Sensitivity
Measure Description insulin-stimulated glucose uptake as measured by euglycemic hyperinsulinemic clamp; "M" value (infusion rate with space correction, using method of DeFronzo) for the steady state between 100-120 minutes of clamp is given
Time Frame after two weeks treatment  
Safety Issue No  

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.
Insulin stimulated glucose uptake data were unavailable for 4 subjects in the GH 2mg group. Two subjects did not have sufficient IV access and thus could not complete the clamp procedure. Two subjects did not reach target glucose and thus their data could not be used.

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

Measured Values
    GH 6mcg/kg/d     GH 2mg Daily     Growth Hormone Releasing Hormone  
Number of Participants Analyzed  
[units: participants]
  8     7     3  
Insulin Sensitivity  
[units: mg/kg/min]
Mean ± Standard Deviation
  9.0  ± 2.9     7.5  ± 3.2     9.9  ± 1.2  


Statistical Analysis 1 for Insulin Sensitivity
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.42
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  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


No publications provided


Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00795210     History of Changes
Other Study ID Numbers: DK63639A, R01DK063639
Study First Received: November 20, 2008
Results First Received: October 9, 2013
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration