Ignite Creation Date:
2024-05-05 @ 11:12 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01289951
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2011-02-01
Brief Title:
Pharmacokinetic Study of Raltegravir in Human Immunodeficiency VirusHepatitis C Virus HIVVHC Coinfected Patients With Advanced Child-Pugh C Hepatic Cirrhosis
Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Organization:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Study Overview
Official Title:
Phase I Open Label Unicentric Study of Multiple-dose Pharmacokinetics of Raltegravir in Patients Infected With Human Immunodeficiency Virus and Hepatitis C Virus With and Without Advanced Child-Pugh C Hepatic Cirrhosis
Status:
COMPLETED
Status Verified Date:
2013-01
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:
LIVERAL
Brief Summary:
Raltegravir is the first integrase inhibitor used in humans It has been shown to be highly efficacious and well tolerated in phase III clinical trials in multidrug experienced human immunodeficiency virusHIV-infected patients as well as initial therapy in untreated patients Pharmacokinetic studies in healthy adult subjects indicate that the major mechanism of clearance of the drug is glucuronidation mediated by UGT1A1 with a minor contribution of renal excretion of unchanged parent compound Unlike CYP-based metabolism glucuronidation is generally found to be relatively unaffected by hepatic disease A single dose pharmacokinetic study of raltegravir in patients with mild to moderate hepatic insufficiency Steigbigel et al 2008 found no clinically important effect on the drug pharmacokinetic profile with no dosage adjustment being necessary The liver safety and tolerability of boosted atazanavir ATVr has been evaluated in human immunodeficiency virus and hepatitis C virus HIVHCV coinfected patients with advanced liver disease decompensated cirrhosis Hermida JM et al 4th IAS Sidney 2007 Similar to Raltegravir ATV is also mainly metabolized by conjugation through UGT1A1 There is an urgent need for potent and efficacious ARV drugs with a clean safety liver profile even in patients with severe liver disease The investigators hypothesized that pharmacokinetics will not be altered in HIVHCV patients with advanced Child-Pugh grade C cirrhosis or in those with no histologic liver damage
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