Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344487
Status:
TERMINATED
Last Update Posted:
2022-01-24
First Post:
2006-06-22
Brief Title:
Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive Patients With Viral Suppression KIMBO Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Effect of Kaletra on CD4 Immune Reconstitution in HIV-infected Patients With Long-term Virologic Suppression on a Non-Kaletra Containing ART Regimen But With a Blunted Immune Response
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to enroll subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To explore the hypothesis that the use of Lopinavirritonavir will be associated with improved CD4 immune reconstitution in volunteers who fail to demonstrate a significant CD4 cell increase while on their first antiretroviral treatment regimen despite sustained viral suppression by a non-Lopinavirritonavir-containing regimen
Detailed Description:
This is an open-labeled non-randomized exploratory trial in selected volunteers who meet the stated enrollment criteria This study will assess the impact of Lopinavirritonavir on CD4 immune reconstitution All volunteers must have been on antiretroviral therapy with sustained viral load suppression of 400 copiesmL for at least 24 months or HIV-1 RNA 400 copiesmL for 12 months during which HIV-1 RNA was 50 copiesmL for 6 months prior to screen Despite induction of viral suppression all volunteers must have demonstrated limited post-antiretroviral CD4 increase
Lopinavirritonavir will be substituted for one of the 3 ARV drugs in the current baseline antiretroviral treatment regimen Lopinavirritonavir will be substituted for any of the following 3rd NRTI an NNRTI a PI or a boosted PI while the nucleoside backbone will remain the same If the subject is currently on a three-drug nucleosidenucleotide plus a 4th anchor drug such as a NRTI NNRTI PI or boosted PI regimen the triple nucleoside will remain constant and only the anchor drug is to be substituted with Lopinavirritonavir Patients on 2 NRTIs with an NNRTI and a PI combination will not be allowed in the study
Patients will be evaluated frequently to include physical examination assessment for the development of AIDS-defining conditions hematology chemistry lipid profile CD4 CD8 cell counts plasma HIV-1 RNA ultrasensitive and assessment of adverse events If HIV-1 RNA becomes detectable this will be repeated for confirmation with 2 weeks HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of 1000 copiesmL
An assessment of memory and naïve T cell response to antiretroviral regimen change will be performed in this study
Dose and dose selection Lopinavirritonavir is also approved for once a day dosing The dose of lopinavirritonavir Kaletra for this study will be 400100mg BID or 800200mg qd New tablet formulation no longer requires that lopinavirritonavir be taken with food We will give the volunteer the option for once a day dosing or BID dosing of Kaletra However those switching from an NNRTI to Kaletra will initially be placed on BID dosing of Kaletra and allowed to switch to once-a-day dosing of Kaletra after 4 weeks on study drug
Lopinavirritonavir will be substituted for one of the 3 ARV drugs in the current baseline antiretroviral treatment regimen Lopinavirritonavir will be substituted for any of the following 3rd NRTI an NNRTI a PI or a boosted PI while the nucleoside backbone will remain the same If the subject is currently on a three-drug nucleosidenucleotide plus a 4th anchor drug such as a NRTI NNRTI PI or boosted PI regimen the triple nucleoside will remain constant and only the anchor drug is to be substituted with Lopinavirritonavir Patients on 2 NRTIs with an NNRTI and a PI combination will not be allowed in the study
Patients will be evaluated frequently to include physical examination assessment for the development of AIDS-defining conditions hematology chemistry lipid profile CD4 CD8 cell counts plasma HIV-1 RNA ultrasensitive and assessment of adverse events If HIV-1 RNA becomes detectable this will be repeated for confirmation with 2 weeks HIV genotyping and phenotyping will be performed on patients who demonstrate repetitive plasma viral load levels of 1000 copiesmL
An assessment of memory and naïve T cell response to antiretroviral regimen change will be performed in this study
Dose and dose selection Lopinavirritonavir is also approved for once a day dosing The dose of lopinavirritonavir Kaletra for this study will be 400100mg BID or 800200mg qd New tablet formulation no longer requires that lopinavirritonavir be taken with food We will give the volunteer the option for once a day dosing or BID dosing of Kaletra However those switching from an NNRTI to Kaletra will initially be placed on BID dosing of Kaletra and allowed to switch to once-a-day dosing of Kaletra after 4 weeks on study drug
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