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TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theratechnologies
ClinicalTrials.gov Identifier:
NCT00608023
First received: January 23, 2008
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: November 27, 2013  
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: 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
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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.
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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 (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  
Number of Participants  
[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 ]

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

3.  Secondary:   Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52   [ Time Frame: Baseline and Week 52 ]
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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  
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.
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)  
Number of 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)
Method [2] ANCOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[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 Pre-specified:   Changes From Baseline in Triglycerides at Week 52   [ Time Frame: Baseline and Week 52 ]

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


  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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