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
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Sponsor:
Theratechnologies
Information provided by (Responsible Party):
Theratechnologies
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE |
Visceral adipose tissue (VAT) | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image | |||
Current Other Pre-specified Outcome Measures |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
263 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |