Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381212
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2006-09-25
Brief Title:
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
A Pilot Study Phase III Testing the Immunologic Activity and Safety of AGS-004 an Autologous HIV Immunotherapeutic in HIV-Infected Adults on HAART
Status:
COMPLETED
Status Verified Date:
2009-01
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:
None
Brief Summary:
To Investigate the safety and immunologic activity of AGS-004 an autologous HIV Immunotherapeutic in HIV-infected adults currently on stable antiretroviral therapy ART with durable viral suppression
Detailed Description:
Although an HIV infection can induce weak immune responses current HIV immunotherapy using consensus antigens has not shown consistent clinical activity The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes CTL against HIV antigens and a failure to induce T cell memory While strong immune responses may be generated to a consensus antigen those responses do not offer antiviral protection against a patients individual viral burden The infecting virus antigen variability likely prevents the establishment of effective CD4 T cell memory and a strong CD8 T cell effector arm
We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent AGS-004 in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date
This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent
We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent AGS-004 in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date
This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent
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 |
|---|---|---|---|
| CTN229 | None | None | None |
| CAN-HIV-001 | None | None | None |