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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.
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
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
  Hide All Outcome Measures

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

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:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title Change in Insulin-like Growth Factor-I From Baseline to 18 Months
Measure Description Change in insulin-like growth factor-1
Time Frame 18 months  
Safety Issue Yes  

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 Insulin-like Growth Factor-I From Baseline to 18 Months  
[units: nanograms/milliliter]
Mean ± Standard Error
  109  ± 11     -25  ± 8  

No statistical analysis provided for Change in Insulin-like Growth Factor-I From Baseline to 18 Months



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

Measure Type Secondary
Measure Title Change in Trunk Fat
Measure Description No text entered.
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 Trunk Fat  
[units: kilograms]
Mean ± Standard Error
  -0.5  ± 0.2     0.2  ± 0.2  

No statistical analysis provided for Change in Trunk Fat



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

Measure Type Secondary
Measure Title Change in Fasting Glucose
Measure Description change in fasting glucose
Time Frame 18 months  
Safety Issue Yes  

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 Fasting Glucose  
[units: mg/dL]
Mean ± Standard Error
  6  ± 1     5  ± 1  

No statistical analysis provided for Change in Fasting Glucose



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

Measure Type Secondary
Measure Title Change in Trunk to Extremity Ratio
Measure Description change in trunk to extremity ratio
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 Trunk to Extremity Ratio  
[units: kilogram per kilogram]
Mean ± Standard Error
  -0.4  ± 0.1     0  ± 0  

No statistical analysis provided for Change in Trunk to Extremity Ratio



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

Measure Type Secondary
Measure Title Change in Triglycerides
Measure Description Change in triglycerides
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 Triglycerides  
[units: mg/dL]
Median ( Inter-Quartile Range )
  -7  
  ( -43 to 41 )  
  0  
  ( -56 to 51 )  

No statistical analysis provided for Change in Triglycerides



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

Measure Type Secondary
Measure Title Change in Subcutaneous Adipose Tissue
Measure Description Change in subcutaneous adipose tissue
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 Subcutaneous Adipose Tissue  
[units: centimeters squared]
Mean ± Standard Error
  4  ± 4     4  ± 4  

No statistical analysis provided for Change in Subcutaneous Adipose Tissue



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

Measure Type Secondary
Measure Title Change in CD4 Cells
Measure Description Change in CD4 cells
Time Frame 18 months  
Safety Issue Yes  

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 CD4 Cells  
[units: cells/microliter]
Mean ± Standard Error
  -19  ± 13     15  ± 21  

No statistical analysis provided for Change in CD4 Cells



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

Measure Type Secondary
Measure Title Change in Logarithm HIV Viral Load
Measure Description Change in logarithm base 10 HIV viral load
Time Frame 18 months  
Safety Issue Yes  

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 Logarithm HIV Viral Load  
[units: log base 10 copies of RNA/milliliter]
Mean ± Standard Error
  0  ± 0.1     0  ± 0.2  

No statistical analysis provided for Change in Logarithm HIV Viral Load



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

Measure Type Secondary
Measure Title Change in Lean Body Mass
Measure Description change in lean body mass
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 Lean Body Mass  
[units: kilograms]
Mean ± Standard Error
  0.8  ± 0.3     -0.5  ± 0.3  

No statistical analysis provided for Change in Lean Body Mass



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

Measure Type Secondary
Measure Title Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months
Measure Description Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.
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 Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months  
[units: units on a scale]
Mean ± Standard Error
  -4  ± 3     -4  ± 3  

No statistical analysis provided for Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months



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

Measure Type Secondary
Measure Title Change in Diastolic Blood Pressure
Measure Description Change in diastolic blood pressure
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 Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Error
  -3  ± 1     4  ± 1  

No statistical analysis provided for Change in Diastolic Blood Pressure



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

Measure Type Secondary
Measure Title Change in Adiponectin
Measure Description Change in adiponectin
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 Adiponectin  
[units: mcg/mL]
Mean ± Standard Error
  1.0  ± 0.3     0.5  ± 0.1  

No statistical analysis provided for Change in Adiponectin



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

Measure Type Secondary
Measure Title Change in Carotid Intima Media Thickness (IMT)
Measure Description change in carotid intima media thickness (IMT)
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 Carotid Intima Media Thickness (IMT)  
[units: millimeter]
Mean ± Standard Error
  0.003  ± 0.008     -0.003  ± 0.009  

No statistical analysis provided for Change in Carotid Intima Media Thickness (IMT)



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

Measure Type Secondary
Measure Title Change in Body Mass Index
Measure Description Change in body mass index
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 Body Mass Index  
[units: kilogram/meters squared]
Mean ± Standard Error
  0.2  ± 0.2     0.1  ± 0.1  

No statistical analysis provided for Change in Body Mass Index



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

Measure Type Secondary
Measure Title Change in Extremity Fat
Measure Description Change in extremity fat
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 Extremity Fat  
[units: kilograms]
Mean ± Standard Error
  0.3  ± 0.1     0.3  ± 0.1  

No statistical analysis provided for Change in Extremity Fat



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

Measure Type Secondary
Measure Title Change in 2-hour Glucose
Measure Description Change in 2-hour glucose
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 2-hour Glucose  
[units: mg/dL]
Mean ± Standard Error
  16  ± 5     -4  ± 4  

No statistical analysis provided for Change in 2-hour Glucose



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

Measure Type Secondary
Measure Title Change in Systolic Blood Pressure
Measure Description Change in systolic blood pressure
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 Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Error
  -5  ± 2     1  ± 2  

No statistical analysis provided for Change in Systolic Blood Pressure




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information