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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

Tracking Information
First Submitted Date  ICMJE January 23, 2008
First Posted Date  ICMJE February 6, 2008
Results First Submitted Date  ICMJE November 27, 2013
Results First Posted Date  ICMJE January 15, 2014
Last Update Posted Date September 30, 2022
Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • Changes From Baseline in Fasting Blood Glucose at Week 52 [ Time Frame: Baseline and Week 52 ]
    Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
  • Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 [ Time Frame: Baseline and Week 52 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Visceral adipose tissue (VAT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 [ Time Frame: Baseline and Week 52 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2008)
Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image
Current Other Pre-specified Outcome Measures
 (submitted: March 27, 2014)
  • Changes From Baseline in Triglycerides at Week 52 [ Time Frame: Baseline and Week 52 ]
    Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
  • Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 [ Time Frame: Baseline and Week 52 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation
Brief Summary Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation
Detailed Description HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lipodystrophy
  • HIV Infections
Intervention  ICMJE
  • Drug: Tesamorelin
    Other Name: Egrifta
  • Drug: Placebo for Tesamorelin
Study Arms  ICMJE
  • Experimental: Tesamorelin 12 months (T-T)
    Tesamorelin 2 mg/day for 12 months
    Intervention: Drug: Tesamorelin
  • Experimental: Tesamorelin-Placebo (T-P)
    Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
    Interventions:
    • Drug: Tesamorelin
    • Drug: Placebo for Tesamorelin
  • Experimental: Placebo-Tesamorelin (P-T)
    Placebo 6 months - Tesamorelin 2 mg/day for 6 months
    Interventions:
    • Drug: Tesamorelin
    • Drug: Placebo for Tesamorelin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2014)
263
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2008)
300
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
  • Signed informed consent before any trial-related activities.

Exclusion Criteria:

  • Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608023
Other Study ID Numbers  ICMJE TH9507-CTR-1012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Theratechnologies
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Theratechnologies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
PRS Account Theratechnologies
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP