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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:
Information provided by (Responsible Party):

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

  Participant Flow


  Baseline Characteristics

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

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


  Limitations and Caveats

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

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 ( 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