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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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-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  
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 ]

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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jean-Claude Mamputu, PhD, Senior Medical Advisor
Organization: Theratechnologies
phone: 514-336-7800
e-mail: jmamputu@theratech.com


No publications provided by Theratechnologies

Publications automatically indexed to this study:

Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT00608023     History of Changes
Other Study ID Numbers: TH9507-CTR-1012
Study First Received: January 23, 2008
Results First Received: November 27, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration