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;   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 
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 ]

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 ]

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
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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

Serious Adverse Events
    Tesamorelin 52 Weeks   Tesamorelin (26 Weeks) - Placebo (26 Weeks)   Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Total, Serious Adverse Events       
# participants affected / at risk   3/92 (3.26%)   1/85 (1.18%)   3/86 (3.49%) 
Eye disorders       
Retinopathy       
# participants affected / at risk   1/92 (1.09%)   0/85 (0.00%)   0/86 (0.00%) 
Gastrointestinal disorders       
Abdominal pain       
# participants affected / at risk   0/92 (0.00%)   1/85 (1.18%)   0/86 (0.00%) 
General disorders       
Chest pain       
# participants affected / at risk   1/92 (1.09%)   0/85 (0.00%)   0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hodgkin disease       
# participants affected / at risk   0/92 (0.00%)   0/85 (0.00%)   1/86 (1.16%) 
Psychiatric disorders       
Mental status changes       
# participants affected / at risk   1/92 (1.09%)   0/85 (0.00%)   0/86 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis       
# participants affected / at risk   0/92 (0.00%)   0/85 (0.00%)   1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea       
# participants affected / at risk   0/92 (0.00%)   0/85 (0.00%)   1/86 (1.16%) 




  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