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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

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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 Description
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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

Condition or disease Intervention/treatment Phase
Lipodystrophy HIV Infections Drug: Tesamorelin Drug: Placebo for Tesamorelin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Tesamorelin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
 Drug: Tesamorelin
Other Name: Egrifta
Experimental: Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
 Drug: Tesamorelin
Other Name: Egrifta

Drug: Placebo for Tesamorelin
Experimental: Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
 Drug: Tesamorelin
Other Name: Egrifta

Drug: Placebo for Tesamorelin


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608023


Locations
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Sponsors and Collaborators
Theratechnologies
Investigators
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Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT00608023    
Other Study ID Numbers: TH9507-CTR-1012
First Posted: February 6, 2008    Key Record Dates
Results First Posted: January 15, 2014
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Theratechnologies:
HIV
Lipodystrophy
Abdominal fat accumulation
 Growth hormone releasing hormone
HIV-associated lipodystrophy
Treatment experienced
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Tesamorelin
 Growth Hormone-Releasing Hormone
Growth Substances
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists