Status:
COMPLETED
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Université de Montréal
Argos Therapeutics
Conditions:
HIV Seropositivity
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 suppressi...
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 associate...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00381212
Start Date
September 1 2006
End Date
November 1 2008
Last Update
January 29 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Immunodeficiency Service/Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4