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TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608023
First Posted: February 6, 2008
Last Update Posted: April 17, 2014
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.
Information provided by (Responsible Party):
Theratechnologies
Results First Submitted: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Lipodystrophy
HIV Infections
Interventions: Drug: Tesamorelin
Drug: Placebo for Tesamorelin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tesamorelin (52 Weeks) Tesamorelin 2 mg/day for 52 Weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo-Tesamorelin (P-T) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Participant Flow:   Overall Study
    Tesamorelin (52 Weeks)   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo-Tesamorelin (P-T)
STARTED   92   85   86 
COMPLETED   80   63   72 
NOT COMPLETED   12   22   14 
Withdrawal by Subject                8                10                7 
Adverse Event                1                4                5 
Lost to Follow-up                2                2                1 
Protocol Violation                1                3                1 
Unknown reason                0                3                0 



  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
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Total Total of all reporting groups

Baseline Measures
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks)   Total 
Overall Participants Analyzed 
[Units: Participants]
 92   85   86   263 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (6.9)   48.9  (7.2)   48.4  (7.9)   48.3  (7.3) 
Gender 
[Units: Participants]
       
Female   9   9   11   29 
Male   83   76   75   234 


  Outcome Measures
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1.  Primary:   Changes From Baseline in Fasting Blood Glucose at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Primary
Measure Title Changes From Baseline in Fasting Blood Glucose at Week 52
Measure Description Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Time Frame Baseline and Week 52  

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
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Measured Values
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks) 
Participants Analyzed 
[Units: Participants]
 92   85   86 
Changes From Baseline in Fasting Blood Glucose at Week 52 
[Units: mg/dL]
Mean (Standard Deviation)
 0  (16)   -2  (34)   1  (21) 


Statistical Analysis 1 for Changes From Baseline in Fasting Blood Glucose at Week 52
Groups [1] Tesamorelin 52 Weeks vs. Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.



2.  Primary:   Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Primary
Measure Title Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Measure Description Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.
Time Frame Baseline and Week 52  

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
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Measured Values
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks) 
Participants Analyzed 
[Units: Participants]
 92   85   86 
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 
[Units: mg/dL]
Mean (Standard Deviation)
 -2  (38)   2  (35)   7  (37) 


Statistical Analysis 1 for Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Groups [1] Tesamorelin 52 Weeks vs. Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.



3.  Secondary:   Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Secondary
Measure Title Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Measure Description Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.
Time Frame Baseline and Week 52  

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.
All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug).

Reporting Groups
  Description
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Measured Values
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks) 
Participants Analyzed 
[Units: Participants]
 92   85   86 
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 
[Units: Cm^2]
Mean (Standard Deviation)
 -41  (57)   0  (53)   -26  (47) 


Statistical Analysis 1 for Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Groups [1] Tesamorelin 52 Weeks vs. Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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 Pre-specified:   Changes From Baseline in Triglycerides at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Other Pre-specified
Measure Title Changes From Baseline in Triglycerides at Week 52
Measure Description Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
Time Frame Baseline and Week 52  

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
Tesamorelin (52 Weeks) Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.

Measured Values
   Tesamorelin (52 Weeks)   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks) 
Participants Analyzed 
[Units: Participants]
 92   85   86 
Changes From Baseline in Triglycerides at Week 52 
[Units: mg/dL]
Mean (Standard Deviation)
 -37  (196)   4  (177)   1  (120) 


Statistical Analysis 1 for Changes From Baseline in Triglycerides at Week 52
Groups [1] Tesamorelin (52 Weeks) vs. Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.



5.  Other Pre-specified:   Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52   [ Time Frame: Baseline and Week 52 ]

Measure Type Other Pre-specified
Measure Title Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Measure Description Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.
Time Frame Baseline and Week 52  

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
Tesamorelin 52 Weeks Tesamorelin 2 mg/day for 52 weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks) Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo (26 Weeks) - Tesamorelin (26 Weeks) Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks

Measured Values
   Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks) 
Participants Analyzed 
[Units: Participants]
 92   85   86 
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 
[Units: Ratio]
Mean (Standard Deviation)
 -0.23  (1.75)   0.13  (1.19)   0.06  (1.01) 


Statistical Analysis 1 for Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Groups [1] Tesamorelin 52 Weeks vs. Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] >0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.




  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