Status:
COMPLETED
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
Lead Sponsor:
Theratechnologies
Conditions:
Lipodystrophy
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 sub...
Eligibility Criteria
Inclusion
- Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
- Signed informed consent before any trial-related activities.
Exclusion
- Fasting blood glucose \>8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00608023
Start Date
August 1 2007
End Date
October 1 2008
Last Update
September 30 2022
Active Locations (47)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2170
2
Body Positive Inc.
Phoenix, Arizona, United States, 85006
3
Somero, Michael
Indio, California, United States, 92201
4
UCLA School of Medicine
Los Angeles, California, United States, 90035