Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140751
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2005-08-30
Brief Title:
Comparison of Treatment Simplification by LPVr vs Current Treatment Continuation in HIV-Infected Patients
Sponsor:
Institut de Médecine et dEpidémiologie Appliquée - Fondation Internationale Léon MBa
Organization:
Institut de Médecine et dEpidémiologie Appliquée - Fondation Internationale Léon MBa
Study Overview
Official Title:
A 48-Weeks National Multicenter Randomized Open Clinical Trial Evaluating Tolerance and Efficacy of a Treatment Simplification by LopinavirRitonavir Versus Continuation of Current Treatment in HIV-Infected Patients With a Viral Load Inferior to 50 CopiesmL Since 6 Months At Least
Status:
COMPLETED
Status Verified Date:
2013-09
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:
KALESOLO
Brief Summary:
The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavirritonavir monotherapy versus continuation of current treatment in HIV-infected patients
Detailed Description:
Highly active antiretroviral therapy HAART has made a significant impact on the natural history of HIV-1 infection but toxicities and complexities of therapy limit long-term efficacy and make simpler yet effective HAART regimens highly desirable Previous attempts to de-intensify protease inhibitor PI-based therapy by discontinuing reverse transcriptase inhibitors RTI after achieving viral suppression met with failure probably because plasma levels of most individually administered PI are too low to inhibit viral replication consistently
Low-dose ritonavir substantially enhances lopinavir plasma levels and lopinavirritonavir LPVr is effective as part of a combination therapy in both naive and PI-experienced patients Furthermore lopinavir is known to have a high genetic barrier to selection of resistance LPVr monotherapy could thus have the right combination of potency favorable pharmacokinetics and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance Preliminary results with maintenanceLPVr monotherapy show interesting results but data from randomized studies are needed
Low-dose ritonavir substantially enhances lopinavir plasma levels and lopinavirritonavir LPVr is effective as part of a combination therapy in both naive and PI-experienced patients Furthermore lopinavir is known to have a high genetic barrier to selection of resistance LPVr monotherapy could thus have the right combination of potency favorable pharmacokinetics and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance Preliminary results with maintenanceLPVr monotherapy show interesting results but data from randomized studies are needed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KALESOLO | None | None | None |