Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00916448
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2009-06-05
Brief Title:
The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Effects of Atazanavir-induced Hyperbilirubinemia on the Innate Immune Response During Human Endotoxemia A Parallel Double Blind Placebo Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-07
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:
Excessive inflammation production of free radicals and vascular injury are considered the main contributors to the development of organ dysfunction in patients with severe infections and sepsis The endogenously produced unconjugated bilirubin is one of the most powerful anti-oxidants of the human body and the administration of bilirubin in animal experiments has been shown to protect from inflammation-induced death However bilirubin for human administration is not yet available Therefore we wish to exploit one of the side effects of atazanavir a registered drug currently used as a protease inhibitor in HIV infected patients Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme UGT1A1 and therefore increases endogenously produced bilirubin levels moderately To study the effect of hyperbilirubinemia during inflammation we will apply the human endotoxemia model The human endotoxemia model permits elucidation of key players in the immune response to a gram negative stimulus in vivo therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting We hypothesize that atazanavir-induced hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human endotoxemia
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