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

NCT00381212 | Completed Phase 1 DMC

• 3 other identifiers: BMB#06-003CAN-HIV-001CTN229
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Seropositivity; Acquired Immunodeficiency Syndrome

Keywords

Immunotherapeutic injection

Outcome Measures

Primary Outcomes (1)

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

  18 weeks

Secondary Outcomes (1)

• To determine the safety of AGS-004 in the entire study population by frequency and severity of treatment emergent adverse events

  66 weeks

Study Arms (1)

1

EXPERIMENTAL

AGS-004 immunotherapeutic injections.

Biological: AGS-004

Interventions

AGS-004 BIOLOGICAL

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

Also known as: AGS-004 immunotherapeutic

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Université de Montréal: collaborator
• Argos Therapeutics: collaborator

Study Sites (1)

Immunodeficiency Service/Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

MeSH Terms

Conditions

HIV Seropositivity; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Jean-Pierre Routy, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

CA (1)