Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148850
Status:
TERMINATED
Last Update Posted:
2005-10-20
First Post:
2005-09-07
Brief Title:
Effect of Pioglitazone on HIV-1 Related Lipoatrophy a Randomized Double Blind Placebo-Controlled Trial in 130 Patients
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
A Randomized Phase 3 Double Blind Multicentre Trial Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 MonthsANRS 113 LIPIOT Study
Status:
TERMINATED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy
Detailed Description:
Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment increased risk of cardiovascular complications and induce insulinoresistance The pathophysiology of lipodystrophy remains poorly understood Some antiretroviral drugs could be involved Therefore using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes These PPARG agonist which mainly promote the differentiation of adipocytes decrease circulating plasma free fatty acids In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot
Different previous studies were performed with that aim most of them using rosiglitazone
We designed a prospective randomized double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy
Different previous studies were performed with that aim most of them using rosiglitazone
We designed a prospective randomized double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy
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