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

McGill University Health Centre/Research Institute of the McGill University Health Centre10 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Seropositivity Acquired Immunodeficiency Syndrome

Interventions

AGS-004BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,

Locations (1)

Immunodeficiency Service/Montreal Chest Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Immunologic activity of AGS-004 will be as measured by flow cytometry

Time frame: 18 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.