Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145795
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2005-09-01
Brief Title:
A Research Study to See if a Change in Therapy for HIV Infection Can Improve the Immune Response to Treatment
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Randomized Trial of a Switch to a Kaletra Current Dual Nucleoside Reverse Transcriptase Inhibitor NRTI Backbone Versus Continuation of the Current Regimen in Patients With Poor Immune Responses to Highly Active Antiretroviral Therapy HAART in Patients With Complete Viral Suppression A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-05
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:
Our goal is to determine if a change in therapy to one containing Kaletra can improve the immune response in patients who have previously been immune partial responders or non-responders We also are interested in knowing if this agent improves immune response by affecting cluster of differentiation 4 CD4 T cell death apoptosis or by further inhibiting preventing ongoing low-level viral replication to levels below detection by current viral load measurements This will help us understand why immune responses to effective antiretroviral therapy are so different and help determine some possible guidelines for managing patients with poor immune responses
Hypothesis Patients with poor immune responses to HAART who receive Kaletra in place of their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs while continuing their current 2 NRTI backbone will have improved immune response to therapy compared to patients who continue their current regimen
Hypothesis Patients with poor immune responses to HAART who receive Kaletra in place of their current PI or Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs while continuing their current 2 NRTI backbone will have improved immune response to therapy compared to patients who continue their current regimen
Detailed Description:
To our knowledge our study is the first study showing persistent apoptosis in a subgroup of patients with complete viral suppression in association with poor immune recovery Immune alterations independent of active viral replication may be responsible Recent data suggests that immune responses to antiretroviral therapy depend on residual or restored thymic function Improved CD4 counts in patients despite virologic treatment failure are associated with greater thymic function while poor T cell responses despite suppression of HIV are seen with decreased thymic function Discordant immune responses may also be due to differential effects of particular antiretroviral agents on T cell apoptosis independent of viral suppression For example protease inhibitors have been shown to decrease rates of apoptosis of uninfected T cells Viral replication is never completely suppressed with HAART even when patients have undetectable plasma HIV RNA Therefore varying degrees of low level viral replication or replication in certain cellular compartments may continue to drive T cell apoptosis Finally our data suggests that ex vivo rates of Peripheral blood mononuclear cell PBMC apoptosis could potentially be used predict immune recovery or identify subgroups of patients who may benefit most from changes in HAART or adjunctive immunomodulatory therapies
At this time although there are excellent guidelines for how to evaluate and change therapy for patients with virologic failure there are no recommendation and little data on approaches or strategies to change therapy for patients with poor immune responses Kaletra lopinavirritonavir may be of benefit to patients with poor immune responses to HAART despite viral suppression Kaletra may have greater potency and better suppression of viral replication that is below the level of detection by plasma polymerase chain reaction PCR for HIV-1 RNA Kaletra also has an excellent pharmacokinetic profile which may result in superior inhibition of T cell apoptosis in vivo
At this time although there are excellent guidelines for how to evaluate and change therapy for patients with virologic failure there are no recommendation and little data on approaches or strategies to change therapy for patients with poor immune responses Kaletra lopinavirritonavir may be of benefit to patients with poor immune responses to HAART despite viral suppression Kaletra may have greater potency and better suppression of viral replication that is below the level of detection by plasma polymerase chain reaction PCR for HIV-1 RNA Kaletra also has an excellent pharmacokinetic profile which may result in superior inhibition of T cell apoptosis in vivo
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