Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123253
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-07-20
Brief Title:
TH9507 in Patients With HIV-Associated Lipodystrophy
Sponsor:
Theratechnologies
Organization:
Theratechnologies
Study Overview
Official Title:
A Phase 3 Multicenter Double-Blind Randomized Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507 a Growth Hormone Releasing Factor Analog in HIV Patients With Excess of Abdominal Fat Accumulation
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy ART and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat in association with dyslipidemia and insulin resistance Data from a previous randomized placebo-controlled trial demonstrated that daily administration of 2mg TH9507 a growth hormone releasing factor GRF to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue VAT and trunk fat with no significant changes in limb fat and subcutaneous adipose tissue SAT This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None