Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346580
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2006-06-28
Brief Title:
The Effects of HIV Protease Inhibitors in Severe Sepsis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
The Effects of HIV Protease Inhibitors in Severe Sepsis
Status:
COMPLETED
Status Verified Date:
2011-04
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:
Sepsis is the leading cause of death in critically ill patients in the United States It develops in approximately 750000 Americans annually and more than 210000 of them die Despite improvements in supportive treatment mortality has changed very little and until recently no sepsis-specific treatments were available Protease inhibitors have seemed to have an immune benefit that extends beyond their ability to prevent HIV replication T cells in those patients treated with protease inhibitors have reduced rates of death than in those patients not receiving therapy
Detailed Description:
Our hypothesis is that protease inhibitor therapy will prevent apoptosis associated with sepsis and this will be manifested as improved clinical outcome as assessed by 28-day mortality APACHE II and III and SOFA scores All patients enrolled in the study will receive the standard of care for sepsis at Mayo Clinic Rochester Patients will receive 1250 mg of Nelfinavirplacebo twice each day for seven days with regularly scheduled blood draws Days 0 4 and 7
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