Physiologic Growth Hormone Effects in HIV Lipodystrophy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00100698
First received: January 4, 2005
Last updated: July 22, 2010
Last verified: July 2010
Results First Received: April 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: AIDS
HIV Infections
Interventions: Drug: recombinant human growth hormone
Drug: placebo

  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
Patients with HIV and lipodystrophy were recruited between November 2003 and March 2006 via community advertisement, HIV support and advocacy groups, and infectious disease or primary care physician referral.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who do not meet growth hormone inclusion criteria were excluded from the trial before assignment to groups.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Recombinant Human Growth Hormone     Placebo  
STARTED     27     29  
COMPLETED     21     27  
NOT COMPLETED     6     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.
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Reporting Groups
  Description
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  
Number of Participants  
[units: participants]
  27     29     56  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     29     56  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.7  ± 7.9     47.4  ± 6.1     47.1  ± 6.9  
Gender  
[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 ]
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Measure Type Primary
Measure Title Change in Visceral Adipose Tissue Area From Baseline to 18 Months
Measure Description change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan
Time Frame 18 months  
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.
No text entered.

Reporting Groups
  Description
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

Measured Values
    Recombinant Human Growth Hormone     Placebo  
Number of Participants Analyzed  
[units: participants]
  27     29  
Change in Visceral Adipose Tissue Area From Baseline to 18 Months  
[units: centimeters squared]
Mean ± Standard Error
  -22  ± 6     -4  ± 4  


Statistical Analysis 1 for Change in Visceral Adipose Tissue Area From Baseline to 18 Months
Groups [1] All groups
Method [2] repeated measures mixed effects ANCOVA
P Value [3] 0.049
Mean Difference (Net) [4] -22
Standard Error of the mean ± 6
95% Confidence Interval ( -38 to -0.5 )
[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:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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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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