Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01389063
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2011-07-05
Brief Title:
Maraviroc Abacavir STudy - Effect on Endothelial Recovery
Sponsor:
SFL van Lelyveld
Organization:
UMC Utrecht
Study Overview
Official Title:
Maraviroc Abacavir STudy - Effect on Endothelial Recovery
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
RECRUITING
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:
MASTER
Brief Summary:
HIV infected patients treated with abacavir might have a higher risk for the occurrence of cardiovascular events At time of writing of this protocol the underlying mechanism is not yet elucidated however some studies find impaired endothelial function and elevated markers of chronic inflammation in these patientssuggesting a higher lever of chronic inflammation Recently maraviroc Celsentri a CCR5-receptor antagonist became available for treatment of patients infected with HIV-1
Improvement of endothelial function may be a potential beneficial side effect of treatment with maraviroc due to the potential reduction of immune activation and chronic inflammation as a result of blocking the CCR5-coreceptor Moreover treatment intensification of HAART with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below the cut-off of 50 copiesml as well
The investigators hypothesize that maraviroc intensification therapy in patients on an abacavir-containing regimen will improve endothelial function
The objectives of this study are First to assess the effect of addition of maraviroc to an abacavir-containing regimen on endothelial function second to assess the effect of this intervention on markers of immune activation and chronic inflammation and on plasma HIV-RNA below 50 copiesml
Improvement of endothelial function may be a potential beneficial side effect of treatment with maraviroc due to the potential reduction of immune activation and chronic inflammation as a result of blocking the CCR5-coreceptor Moreover treatment intensification of HAART with maraviroc in patients with suppressed plasma HIV_RNA may decrease plasma HIVRNA below the cut-off of 50 copiesml as well
The investigators hypothesize that maraviroc intensification therapy in patients on an abacavir-containing regimen will improve endothelial function
The objectives of this study are First to assess the effect of addition of maraviroc to an abacavir-containing regimen on endothelial function second to assess the effect of this intervention on markers of immune activation and chronic inflammation and on plasma HIV-RNA below 50 copiesml
Detailed Description:
The MASTER study is a phase IV randomized open label cross-over intervention study Study subjects who are on stable abacavir-containing regimen will be randomized into two arms In arm A maraviroc will be added to their regimen at baseline while study subjects in arm B will continue their abacavir-containing regimen After 8 weeks cross-over of the study arms will be performed Subjects in arm A will then stop maraviroc while in subjects in arm B maraviroc will be added to their regimen for 8 weeks again The total duration of the study will be 16 weeks
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