Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184951
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2005-09-12
Brief Title:
Pharmacokinetic Study of Rosuvastatin and LopinavirRitonavir in HIV Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin Crestor and LopinavirRitonavir Kaletra in HIV-infected Patients With Hyperlipidemia ROSALKA
Status:
COMPLETED
Status Verified Date:
2020-11
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:
open-label multiple dose single-group 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavirritonavir both male or female subjects
Detailed Description:
To determine the effect of rosuvastatin on plasma lipids lipoproteins and endothelial function in HIV-infected patients on stable lopinavirritonavir therapy and to evaluate the safety of combined use of rosuvastatin and lopinavirritonavir Also to determine the effect of lopinavirritonavir on the pharmacokinetics of rosuvastatin compared to historical controls an to determine the effect of rosuvastatin on the pk of lopinavirritonavir compared to historical controls and by intrapatient comparison
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