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Sponsored by: |
Theratechnologies |
Information provided by: | Theratechnologies |
ClinicalTrials.gov Identifier: | NCT00608023 |
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.
Condition | Intervention | Phase |
Lipodystrophy HIV Infections |
Drug: TH9507 |
Phase III |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Somatotropin Somatropin Somatorelin Sermorelin Sermorelin acetate Tesamorelin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Growth Hormone Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 51 Study Locations |
Theratechnologies |
Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
Study ID Numbers: | TH9507-CTR-1012 |
First Received: | January 23, 2008 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00608023 |
Health Authority: | United States: Food and Drug Administration |
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