Clinical Trials


A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.

This study has been completed
McGill University Health Center

Université de Montréal
Argos Therapeutics

Information provided by (Responsible Party)
McGill University Health Center Identifier

First received: September 25, 2006
Last updated: January 28, 2009
Last Verified: January 2009
History of Changes


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.

Condition Intervention Phase
HIV Seropositivity
Acquired Immunodeficiency Syndrome

Biological : AGS-004
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by McGill University Health Center:

Primary Outcome Measures

  • Immunologic activity of AGS-004 will be as measured by flow cytometry [ Time Frame: 18 weeks ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: September 2006
Study Completion Date: November 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 1
AGS-004 immunotherapeutic injections.
Biological: AGS-004

Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.

Other Name: AGS-004 immunotherapeutic

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.



Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  


Inclusion Criteria:

  • Men or women age 18 years and over,
  • Documented HIV-1 infection,
  • Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
  • Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
  • CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
  • CD4+ T cell count of ≥350 cells/mm3 obtained within 4 weeks of study entry,

Exclusion Criteria:
  • No co-infection with HBV or HCV,
  • No history of lymph node irradiation or dissection,
  • No prior use of any HIV vaccine,
  • No use of hydroxyurea,
  • No use of systemic corticosteroids or other non-permitted medications,

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT00381212


Immunodeficiency Service/Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4

Sponsors and Collaborators

McGill University Health Center
Université de Montréal
Argos Therapeutics


Principal Investigator: Jean-Pierre Routy, MD McGill University Health Center
More Information

More Information

Responsible Party: Jean-Pierre Routy, MD, McGill University Health Centre Identifier: NCT00381212   History of Changes  
Other Study ID Numbers: BMB#06-003  
Study First Received: September 25, 2006  
Last Updated: January 28, 2009  

Keywords provided by McGill University Health Center:

Immunotherapeutic injection

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
HIV Seropositivity processed this data on July 23, 2018
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