A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
Tracking Information | |||||
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First Received Date ICMJE | September 25, 2006 | ||||
Last Updated Date | January 28, 2009 | ||||
Start Date ICMJE | September 2006 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Immunologic activity of AGS-004 will be as measured by flow cytometry [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Immunologic activity of AGS-004 will be as measured by flow cytometry | ||||
Change History | Complete list of historical versions of study NCT00381212 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events [ Time Frame: 66 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent. | ||||
Official Title ICMJE | A Pilot Study (Phase I/II) Testing the Immunologic Activity and Safety of AGS-004, an Autologous HIV Immunotherapeutic, in HIV-Infected Adults on HAART | ||||
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. |
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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 patient's 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: AGS-004
Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
Other Name: AGS-004 immunotherapeutic |
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Study Arm (s) | Experimental: 1
AGS-004 immunotherapeutic injections.
Intervention: Biological: AGS-004 |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 10 | ||||
Completion Date | November 2008 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00381212 | ||||
Other Study ID Numbers ICMJE | BMB#06-003, CAN-HIV-001, CTN229 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Jean-Pierre Routy, MD, McGill University Health Centre | ||||
Study Sponsor ICMJE | McGill University Health Center | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | McGill University Health Center | ||||
Verification Date | January 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |