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

January 28, 2009 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AGS-004 immunotherapeutic injections.
Biological: AGS-004
Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.
Other Names:
  • AGS-004 immunotherapeutic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunologic activity of AGS-004 will be as measured by flow cytometry
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
66 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Université de Montréal
Argos Therapeutics

Investigators

  • Principal Investigator: Jean-Pierre Routy, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 25, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMB#06-003
  • CAN-HIV-001
  • CTN229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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