Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435929
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2007-02-15
Brief Title:
A Study of SaquinavirRitonavir in Liver-Impaired Patients With HIV Infection
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Effect of Moderate Liver Impairment on the Pharmacokinetics of Saquinavir After Administration of SaquinavirRitonavir 1000100mg BID in HIV Patients
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavirritonavir 1000mg100mg po bid in HIV patients Saquinavirritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease The anticipated time on study treatment is 3 months and the target sample size is 100 individuals
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