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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Seropositivity, Acquired Immunodeficiency Syndrome

Intervention / Treatment
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* Biological: AGS-004


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AGS-004 immunotherapeutic injections. | Biological: AGS-004<br>* Four intradermal injections of AGS-004-001 immunotherapeutic, 4 weeks apart.<br>* Other names: AGS-004 immunotherapeutic;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events |  | 66 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapeutic injection