Effects of Short-term Growth Hormone in HIV-infected Patients
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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
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Sponsor:
Massachusetts General Hospital
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | GH 6mcg/kg/d | GH 2mg Daily | Growth Hormone Releasing Hormone | Total | |
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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 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 8 participants | 12 participants | 5 participants | 25 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
8 100.0%
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12 100.0%
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5 100.0%
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25 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 8 participants | 12 participants | 5 participants | 25 participants | |
Female |
0 0.0%
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2 16.7%
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0 0.0%
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2 8.0%
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Male |
8 100.0%
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10 83.3%
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5 100.0%
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23 92.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 8 participants | 12 participants | 5 participants | 25 participants |
8 | 12 | 5 | 25 |
Outcome Measures
Adverse Events
Limitations and Caveats
The study was completed early due to the lack of availability of study drug for one of the arms.
More Information
Results Point of Contact
Name/Title: | Steven Grinspoon, MD |
Organization: | Massachusetts General Hospital |
Phone: | 617-724-9109 |
EMail: | sgrinspoon@partners.org |
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 |