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

Acquired Immunodeficiency Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381212
• Other study ID #: BMB#06-003
• Secondary ID: CAN-HIV-001CTN22
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 25, 2006
• Last updated: January 28, 2009
• Start date: September 2006
• Est. completion date: November 2008

Study information

• Verified date: January 2009
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seropositivity
• Immunologic Deficiency Syndromes

Intervention

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

Locations

Country	Name	City	State
Canada	Immunodeficiency Service/Montreal Chest Institute	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	Argos Therapeutics, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunologic activity of AGS-004 will be as measured by flow cytometry		18 weeks	No
Secondary	To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events		66 weeks	Yes