Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006291
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-09-22
Brief Title:
Safety and Effectiveness of Adding Either an HIV Vaccine Interleukin-2 or Both to a Patients Anti-HIV Drug Combination
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Partially Blinded Trial of Combinations of Potent Antiretroviral Therapy HIV-Specific Immunizations and Cycles of Interleukin-2 to Promote Efficient Control of Viral Replication
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to see if adding an HIV vaccine ALVAC-HIV vCP1452 IL-2 interleukin-2 a protein found in the blood that helps boost the immune system or both to anti-HIV-drug therapy is safe tolerable and effective in controlling viral load level of HIV in the body This study has been changed to clarify drug name Anti-HIV drugs can help reduce a patients viral load However HIV can still remain in CD4 cells cells of the immune system that help fight infection Combining an HIV vaccine IL-2 or both with anti-HIV drugs may help reduce the number of HIV-infected cells
Detailed Description:
The most important goal for designing future therapeutic interventions is to understand the nature of persistent HIV infection in patients successfully treated with potent antiretroviral therapy and to develop strategies to promote the clearance of these reservoirs or at least long-term suppression of these reservoirs If latently infected cells are able to persist for a long period despite effective suppression of de novo infection primarily because immune clearance is not being adequately stimulated by viral antigen then HIV-specific immunization is a reasonable strategy to enhance the clearance of these cells Stimulating effective HIV-specific cellular immune responses at a time when plasma viremia is maximally suppressed also may contribute to the long-term containment of HIV replication on potent antiretroviral therapy A second component to be evaluated in this trial is whether broad cyclical activation of T cells with IL-2 will increase the activation of HIV proviral gene expression and thereby render target cells susceptible to immune-mediated clearance This pathogenesis-based clinical trial will explore the potential for these novel treatment strategies HIV-specific immunization and IL-2 alone and in combination to complement the effects of potent antiretroviral therapy by promoting more effective immunologic control of HIV-1 replication
This study is divided into 3 steps
STEP I Patients continue to receive their stable potent antiretroviral therapy and are randomized to 1 of 4 arms
Arm A Vaccine placebo AS PER AMENDMENT 082301 ALVAC Arm B Canarypox HIV-specific immunogen AS PER AMENDMENT 082301 ALVAC-HIV vCP1452 Arm C 8-week cycles of IL-2 plus vaccine placebo AS PER AMENDMENT 082301 ALVAC Arm D 8-week cycles of IL-2 plus canarypox HIV-specific immunogen AS PER AMENDMENT 082301 ALVAC-HIV vCP1452
Patients receive vaccine or vaccine placebo injections at Weeks 0 8 16 24 and 48 IL-2 injections are synchronized with vaccine injections IL-2 is given open-label while vCP1452 is double-blinded Patients must be on Step I for a minimum of 51 weeks AS PER AMENDMENT 082301 prior to entry into Step II
STEP II Patients stop study medications and interrupt potent antiretroviral therapy for AS PER AMENDMENT 082301 6 to 16 has been replaced by the following text a minimum of 12 weeks Patients whose viral load during Step II remains AS PER AMENDMENT 082301 at or below 5000 copiesml AS PER AMENDMENT 082301 and whose CD4 count is 200 cellsmm3 or more are encouraged to remain off antiretroviral medications and continue viral-load monitoring for up to an additional 10 weeks These patients are followed AS PER AMENDMENT 082301 for up to 16 weeks has been replaced by the following text through Week 74 on Step II and must register to Step III only if their viral load increases to 50000 copiesml or greater their CD4 count decreases to below 200 cellsmm3 or if their primary care physician recommends resuming antiretrovirals
STEP III Patients resume their original potent antiretroviral therapy regimen for 6 to 10 weeks and are monitored for a minimum of 6 weeks If patients do not achieve a viral load below 50 copiesml during those 6 weeks they continue to be monitored for up to an additional 4 weeks until this degree of suppression is achieved with the same potent antiretroviral therapy regimen or another appropriate regimen
This study is divided into 3 steps
STEP I Patients continue to receive their stable potent antiretroviral therapy and are randomized to 1 of 4 arms
Arm A Vaccine placebo AS PER AMENDMENT 082301 ALVAC Arm B Canarypox HIV-specific immunogen AS PER AMENDMENT 082301 ALVAC-HIV vCP1452 Arm C 8-week cycles of IL-2 plus vaccine placebo AS PER AMENDMENT 082301 ALVAC Arm D 8-week cycles of IL-2 plus canarypox HIV-specific immunogen AS PER AMENDMENT 082301 ALVAC-HIV vCP1452
Patients receive vaccine or vaccine placebo injections at Weeks 0 8 16 24 and 48 IL-2 injections are synchronized with vaccine injections IL-2 is given open-label while vCP1452 is double-blinded Patients must be on Step I for a minimum of 51 weeks AS PER AMENDMENT 082301 prior to entry into Step II
STEP II Patients stop study medications and interrupt potent antiretroviral therapy for AS PER AMENDMENT 082301 6 to 16 has been replaced by the following text a minimum of 12 weeks Patients whose viral load during Step II remains AS PER AMENDMENT 082301 at or below 5000 copiesml AS PER AMENDMENT 082301 and whose CD4 count is 200 cellsmm3 or more are encouraged to remain off antiretroviral medications and continue viral-load monitoring for up to an additional 10 weeks These patients are followed AS PER AMENDMENT 082301 for up to 16 weeks has been replaced by the following text through Week 74 on Step II and must register to Step III only if their viral load increases to 50000 copiesml or greater their CD4 count decreases to below 200 cellsmm3 or if their primary care physician recommends resuming antiretrovirals
STEP III Patients resume their original potent antiretroviral therapy regimen for 6 to 10 weeks and are monitored for a minimum of 6 weeks If patients do not achieve a viral load below 50 copiesml during those 6 weeks they continue to be monitored for up to an additional 4 weeks until this degree of suppression is achieved with the same potent antiretroviral therapy regimen or another appropriate regimen
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 |
|---|---|---|---|
| AACTG A5024 | Registry Identifier | DAIDS ES Registry Number | None |
| 10070 | REGISTRY | None | None |
| ACTG A5024 | None | None | None |