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Physiologic Growth Hormone Effects in HIV Lipodystrophy

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 5, 2005
Last Update Posted: July 27, 2010
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.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Massachusetts General Hospital
Results First Submitted: April 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: AIDS
HIV Infections
Interventions: Drug: recombinant human growth hormone
Drug: placebo

  Participant Flow

  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.
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Reporting Groups
Recombinant Human Growth Hormone recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
Placebo placebo subcutaneously once a day
Total Total of all reporting groups

Baseline Measures
   Recombinant Human Growth Hormone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   29   56 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   27   29   56 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 46.7  (7.9)   47.4  (6.1)   47.1  (6.9) 
[Units: Participants]
Female   1   3   4 
Male   26   26   52 
Region of Enrollment 
[Units: Participants]
United States   27   29   56 

  Outcome Measures
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1.  Primary:   Change in Visceral Adipose Tissue Area From Baseline to 18 Months   [ Time Frame: 18 months ]

2.  Secondary:   Change in Insulin-like Growth Factor-I From Baseline to 18 Months   [ Time Frame: 18 months ]

3.  Secondary:   Change in Trunk Fat   [ Time Frame: 18 months ]

4.  Secondary:   Change in Fasting Glucose   [ Time Frame: 18 months ]

5.  Secondary:   Change in Trunk to Extremity Ratio   [ Time Frame: 18 months ]

6.  Secondary:   Change in Triglycerides   [ Time Frame: 18 months ]

7.  Secondary:   Change in Subcutaneous Adipose Tissue   [ Time Frame: 18 months ]

8.  Secondary:   Change in CD4 Cells   [ Time Frame: 18 months ]

9.  Secondary:   Change in Logarithm HIV Viral Load   [ Time Frame: 18 months ]

10.  Secondary:   Change in Lean Body Mass   [ Time Frame: 18 months ]

11.  Secondary:   Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months   [ Time Frame: 18 months ]

12.  Secondary:   Change in Diastolic Blood Pressure   [ Time Frame: 18 months ]

13.  Secondary:   Change in Adiponectin   [ Time Frame: 18 months ]

14.  Secondary:   Change in Carotid Intima Media Thickness (IMT)   [ Time Frame: 18 months ]

15.  Secondary:   Change in Body Mass Index   [ Time Frame: 18 months ]

16.  Secondary:   Change in Extremity Fat   [ Time Frame: 18 months ]

17.  Secondary:   Change in 2-hour Glucose   [ Time Frame: 18 months ]

18.  Secondary:   Change in Systolic Blood Pressure   [ Time Frame: 18 months ]

  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
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  More Information