Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01712256
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2012-10-16
Brief Title:
Re-boosting of HIV-1 Infected Subjects With Vacc-4x
Sponsor:
Bionor Immuno AS
Organization:
Bionor Immuno AS
Study Overview
Official Title:
Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 20071 Study An Open Multicenter Immunogenicity Follow-up Re-boosting Study With Vacc-4x in Subjects Infected With HIV-1 Who Have Maintained an Adequate Response to ART
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Re-boost
Brief Summary:
During the course of HIV infection the number of CD4 cells decreases resulting in a reduced immunological response and eventually immune deficiency Vacc-4x is a peptide-based HIV immunotherapy vaccine and is anticipated to strengthen the immune systems response to HIV
All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response
All patients participating in this trial have previously received the vacc-4x vaccine in order to reduce the amount of HIV-1 virus in the blood and increase the immune response The primary objective of this study is to evaluate if a re-boost with Vacc-4x could further reduce the amount of HIV-1 virus and increase the immune response
Detailed Description:
Human immunodeficiency virus HIV infects the cluster of differentiation 4 CD4 subset of T-cells that are critical for initiating immune responses to infection The level of CD4 cells in the blood is a marker of a patients immunological status During the course of an HIV infection the number of CD4 cells decreases resulting in reduced immunological responsiveness and ultimately immune deficiency
Current management of an HIV infection includes antiretroviral therapy ART The advent of effective ART in 1996 led to a profound decrease in type 1 HIV HIV-1-associated morbidity and mortality in developed countries where ART has been available
Despite the ability of ART to inhibit HIV-1 replication it cannot cure infection making ART a lifelong treatment that requires sustained compliance and imposes significant individual and societal financial burdens on healthcare services Furthermore ART side effects eg metabolic toxicity and stigmatizing body fat redistribution often require medication that further increases the inconveniences and financial burdens of HIV management Of additional concern is the emergence of viruses resistant to ART that can result in treatment failure
Vacc-4x is a peptide-based HIV therapeutic vaccine The primary objective of Vacc-4x therapeutic vaccine is to strengthen the immune systems response to HIV p24 ART dramatically reduces the level of virus in circulation in the body thereby allowing the immune system to focus on the therapeutic vaccine that is administered ART also allows for the generation of new naïve CD4 cells that can be triggered by the therapeutic vaccine to generate new immune responses to HIV-1 Subjects are therefore immunized with Vacc-4x in the presence of ART to generate new HIV-specific immune responses that can sustain immunological fitness for prolonged periods when patients are removed from ART It is likely that periodic boosting on ART will be required to sustain the immunotherapeutic effect - in this way ART may become an intermittent therapy
This study is a follow-up re-boosting study of Study CT-BI Vacc-4x 20071 EudraCT Number 2007-006302-13 performed in US and Europe UK Germany Spain and Italy All subjects to be included have been given a therapeutic immunization with Vacc-4x during the CT-BI Vacc-4x 20071 study During the study a reduction in the viral load set-point mean viral load at Week 48 and Week 52 or if Week 52 not reached mean viral load of the last two measured values before restart of ART was seen in the Vacc-4x group compared to placebo group Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral load set-point further
Current management of an HIV infection includes antiretroviral therapy ART The advent of effective ART in 1996 led to a profound decrease in type 1 HIV HIV-1-associated morbidity and mortality in developed countries where ART has been available
Despite the ability of ART to inhibit HIV-1 replication it cannot cure infection making ART a lifelong treatment that requires sustained compliance and imposes significant individual and societal financial burdens on healthcare services Furthermore ART side effects eg metabolic toxicity and stigmatizing body fat redistribution often require medication that further increases the inconveniences and financial burdens of HIV management Of additional concern is the emergence of viruses resistant to ART that can result in treatment failure
Vacc-4x is a peptide-based HIV therapeutic vaccine The primary objective of Vacc-4x therapeutic vaccine is to strengthen the immune systems response to HIV p24 ART dramatically reduces the level of virus in circulation in the body thereby allowing the immune system to focus on the therapeutic vaccine that is administered ART also allows for the generation of new naïve CD4 cells that can be triggered by the therapeutic vaccine to generate new immune responses to HIV-1 Subjects are therefore immunized with Vacc-4x in the presence of ART to generate new HIV-specific immune responses that can sustain immunological fitness for prolonged periods when patients are removed from ART It is likely that periodic boosting on ART will be required to sustain the immunotherapeutic effect - in this way ART may become an intermittent therapy
This study is a follow-up re-boosting study of Study CT-BI Vacc-4x 20071 EudraCT Number 2007-006302-13 performed in US and Europe UK Germany Spain and Italy All subjects to be included have been given a therapeutic immunization with Vacc-4x during the CT-BI Vacc-4x 20071 study During the study a reduction in the viral load set-point mean viral load at Week 48 and Week 52 or if Week 52 not reached mean viral load of the last two measured values before restart of ART was seen in the Vacc-4x group compared to placebo group Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral load set-point further
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