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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

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.
 
ClinicalTrials.gov Identifier: NCT00608023
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : January 15, 2014
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
Theratechnologies

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
Enrollment 263
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tesamorelin (52 Weeks) Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo-Tesamorelin (P-T)
Hide Arm/Group Description Tesamorelin 2 mg/day for 52 Weeks Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Period Title: Overall Study
Started 92 85 86
Completed 80 63 72
Not Completed 12 22 14
Reason Not Completed
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
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks) Total
Hide Arm/Group Description Tesamorelin 2 mg/day for 52 weeks Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks Total of all reporting groups
Overall Number of Baseline Participants 92 85 86 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 85 participants 86 participants 263 participants
47.7  (6.9) 48.9  (7.2) 48.4  (7.9) 48.3  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 85 participants 86 participants 263 participants
Female
9
   9.8%
9
  10.6%
11
  12.8%
29
  11.0%
Male
83
  90.2%
76
  89.4%
75
  87.2%
234
  89.0%
1.Primary Outcome
Title Changes From Baseline in Fasting Blood Glucose at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description:
Tesamorelin 2 mg/day for 52 weeks
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Overall Number of Participants Analyzed 92 85 86
Mean (Standard Deviation)
Unit of Measure: mg/dL
0  (16) -2  (34) 1  (21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tesamorelin 52 Weeks, Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description:
Tesamorelin 2 mg/day for 52 weeks
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Overall Number of Participants Analyzed 92 85 86
Mean (Standard Deviation)
Unit of Measure: mg/dL
-2  (38) 2  (35) 7  (37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tesamorelin 52 Weeks, Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description:
Tesamorelin 2 mg/day for 52 weeks
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Overall Number of Participants Analyzed 92 85 86
Mean (Standard Deviation)
Unit of Measure: cm^2
-41  (57) 0  (53) -26  (47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tesamorelin 52 Weeks, Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Changes From Baseline in Triglycerides at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tesamorelin (52 Weeks) Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description:
Tesamorelin 2 mg/day for 52 weeks
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
Overall Number of Participants Analyzed 92 85 86
Mean (Standard Deviation)
Unit of Measure: mg/dL
-37  (196) 4  (177) 1  (120)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tesamorelin (52 Weeks), Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description:
Tesamorelin 2 mg/day for 52 weeks
Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
Overall Number of Participants Analyzed 92 85 86
Mean (Standard Deviation)
Unit of Measure: ratio
-0.23  (1.75) 0.13  (1.19) 0.06  (1.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tesamorelin 52 Weeks, Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Hide Arm/Group Description Tesamorelin 2 mg/day for 52 weeks Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
All-Cause Mortality
Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/92 (3.26%)   1/85 (1.18%)   3/86 (3.49%) 
Eye disorders       
Retinopathy   1/92 (1.09%)  0/85 (0.00%)  0/86 (0.00%) 
Gastrointestinal disorders       
Abdominal pain   0/92 (0.00%)  1/85 (1.18%)  0/86 (0.00%) 
General disorders       
Chest pain   1/92 (1.09%)  0/85 (0.00%)  0/86 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hodgkin disease   0/92 (0.00%)  0/85 (0.00%)  1/86 (1.16%) 
Psychiatric disorders       
Mental status changes   1/92 (1.09%)  0/85 (0.00%)  0/86 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis   0/92 (0.00%)  0/85 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea   0/92 (0.00%)  0/85 (0.00%)  1/86 (1.16%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tesamorelin 52 Weeks Tesamorelin (26 Weeks) - Placebo (26 Weeks) Placebo (26 Weeks) - Tesamorelin (26 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/92 (18.48%)   11/85 (12.94%)   28/86 (32.56%) 
Gastrointestinal disorders       
Diarrhoea   3/92 (3.26%)  4/85 (4.71%)  5/86 (5.81%) 
General disorders       
Injection site erythema   3/92 (3.26%)  0/85 (0.00%)  5/86 (5.81%) 
Injection site pain   0/92 (0.00%)  0/85 (0.00%)  5/86 (5.81%) 
Musculoskeletal and connective tissue disorders       
Musculosketal stiffness   1/92 (1.09%)  0/85 (0.00%)  5/86 (5.81%) 
Nervous system disorders       
Paresthesia   2/92 (2.17%)  3/85 (3.53%)  5/86 (5.81%) 
Psychiatric disorders       
Insomnia   0/92 (0.00%)  0/85 (0.00%)  5/86 (5.81%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract infection   8/92 (8.70%)  4/85 (4.71%)  3/86 (3.49%) 
Indicates events were collected by systematic assessment
As this trial was completed in October 2008 hence, the primary Completion Date is prior to January 18, 2017, therefore the Protocol, and Statistical Analysis Plan have not been uploaded to the Document Section.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marilyn de Chantal, Global Senior Medical Director
Organization: Theratechnologies
Phone: 1 438-315-6624
EMail: Mdechantal@theratech.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT00608023    
Other Study ID Numbers: TH9507-CTR-1012
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: November 27, 2013
Results First Posted: January 15, 2014
Last Update Posted: September 30, 2022