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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795210
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : January 8, 2014
Last Update Posted : January 8, 2014
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Lipodystrophy
Interventions Drug: Growth hormone
Drug: Growth Hormone Releasing Hormone
Enrollment 25
Recruitment Details Recruitment occurred between January, 2009 and November, 2012, in the Boston area.
Pre-assignment Details Once patients were found to be eligible (after screen visit) and agreed to participate, there were no additional events prior to baseline.
Arm/Group Title GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Hide Arm/Group Description Recombinant human growth hormone 6mcg/kg SC once daily Recombinant human growth hormone 2mg SC once daily Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Period Title: Overall Study
Started 8 12 5
Completed 8 11 3
Not Completed 0 1 2
Arm/Group Title GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone Total
Hide Arm/Group Description Recombinant human growth hormone 6mcg/kg SC once daily Recombinant human growth hormone 2mg SC once daily Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 8 12 5 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 5 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
12
 100.0%
5
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 12 participants 5 participants 25 participants
49  (7) 49  (6) 47  (4) 48  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 12 participants 5 participants 25 participants
Female
0
   0.0%
2
  16.7%
0
   0.0%
2
   8.0%
Male
8
 100.0%
10
  83.3%
5
 100.0%
23
  92.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 12 participants 5 participants 25 participants
8 12 5 25
1.Primary Outcome
Title Overnight Mean Growth Hormone Secretion After 2 Weeks of Study Drug
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Overnight GH data were unavailable for 1 subject in the GH 6mcg/kg group and thus are not included in analysis.
Arm/Group Title GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Hide Arm/Group Description:
Recombinant human growth hormone 6mcg/kg SC once daily
Recombinant human growth hormone 2mg SC once daily
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Overall Number of Participants Analyzed 7 11 3
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
0.23
(0.08 to 0.68)
0.07
(0.04 to 0.12)
1.24
(0.76 to 1.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GH 6mcg/kg/d, GH 2mg Daily, Growth Hormone Releasing Hormone
Comments Kruskal-Wallis Test for overall difference between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Insulin Sensitivity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Hide Arm/Group Description:
Recombinant human growth hormone 6mcg/kg SC once daily
Recombinant human growth hormone 2mg SC once daily
Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
Overall Number of Participants Analyzed 8 7 3
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
9.0  (2.9) 7.5  (3.2) 9.9  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GH 6mcg/kg/d, GH 2mg Daily, Growth Hormone Releasing Hormone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame AE data were actively collected during the 4 weeks of the study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Hide Arm/Group Description Recombinant human growth hormone 6mcg/kg SC once daily Recombinant human growth hormone 2mg SC once daily Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
All-Cause Mortality
GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/11 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
GH 6mcg/kg/d GH 2mg Daily Growth Hormone Releasing Hormone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      3/11 (27.27%)      2/3 (66.67%)    
Blood and lymphatic system disorders       
Edema/Extremity Swelling  0/8 (0.00%)  0 2/11 (18.18%)  2 0/3 (0.00%)  0
Endocrine disorders       
hyperglycemia [1]  0/8 (0.00%)  0 2/11 (18.18%)  2 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain  1/8 (12.50%)  1 0/11 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders       
headache  0/8 (0.00%)  0 0/11 (0.00%)  0 1/3 (33.33%)  1
dizziness  0/8 (0.00%)  0 0/11 (0.00%)  0 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders       
Sinus Infection  1/8 (12.50%)  1 0/11 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
injection site bruising  0/8 (0.00%)  0 1/11 (9.09%)  1 0/3 (0.00%)  0
[1]
elevated fasting blood sugar
The study was completed early due to the lack of availability of study drug for one of the arms.
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
Layout table for Results Point of Contact information
Name/Title: Steven Grinspoon, MD
Organization: Massachusetts General Hospital
Phone: 617-724-9109
EMail: sgrinspoon@partners.org
Layout table for additonal information
Responsible Party: Steven K. Grinspoon, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00795210    
Other Study ID Numbers: DK63639A
R01DK063639 ( U.S. NIH Grant/Contract )
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: October 9, 2013
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014