Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420355
Status:
TERMINATED
Last Update Posted:
2009-02-06
First Post:
2007-01-09
Brief Title:
Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
The Pharmacokinetics of LopinavirRitonavir in Combination With Atazanavir in HIV-Infected Subjects
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unexpected adverse event
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to determine the pharmacokinetics of lopinavir ritonavir and atazanavir when lopinavirritonavir and atazanavir are used in combination
Detailed Description:
Thirty patients with HIV infection will be enrolled in this open-label parallel arm pharmacokinetic study Subjects receiving either lopinavirritonavir or atazanavirritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent The safety of these agents in combination will also be explored
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