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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
NCT00608023 |
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Date of registration:
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23/01/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy
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Scientific title:
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A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study 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 |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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263 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00608023 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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France
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Steven Grinspoon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Lipodystrophy
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Intervention(s)
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Drug: Tesamorelin
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Drug: Placebo for Tesamorelin
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Primary Outcome(s)
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Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
[Time Frame: Baseline and Week 52]
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Changes From Baseline in Fasting Blood Glucose at Week 52
[Time Frame: Baseline and Week 52]
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Secondary Outcome(s)
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Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
[Time Frame: Baseline and Week 52]
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Secondary ID(s)
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TH9507-CTR-1012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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