Vaccination of HIV-1 Infected Patients With Dendritic Cells in Addition to Antiretroviral Treatment - (DALIA Trial)
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination of HIV-1 Infected Patients With Ex-vivo Generated Interferon-α Dendritic Cells Loaded With HIV-1 Lipopeptides and Activated With Lipopolysaccharide in Addition to Antiretroviral Treatment: Exploratory Phase I Study-(DALIA Trial)|
- To evaluate the safety of the vaccination schedule at week 24 and the safety of the Analytical Treatment Interruption at week 48 in HIV-1 infected patients. [ Time Frame: May 2010 ] [ Designated as safety issue: Yes ]
- To evaluate immune responses using several defined assays as well as viral and CD4+ T cell status [ Time Frame: May 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Dendritic Cell Vaccine
Autologous dendritic cells generated using GM-CSF and interferon alpha, loaded with HIV lipopeptides and activated with lipopolysaccharide
Biological: Dendritic Cell Vaccine
Biological/Vaccine: Experimental: Dendritic Cell Vaccine Patients will receive 4 doses of the vaccine at weeks 0, 4, 8 and 12. The vaccine will be injected subcutaneously, in 3 separate injection sites in the upper and lower extremities.
At week 24, patients will have HAART treatment interrupted. The HAART treatment will be resumed at week 48 or earlier at any time point if one of the following occur:
Patients will have follow-up visits on weeks: 22, 24, 25, 26, 27, 28, 32, 36, 40, 44, and 48.
The purpose of this study is to determine whether the administration of a dendritic cell vaccine is a safe and effective treatment for HIV-1 patients. This will be a phase I, single-center, study in HIV infected patients. The primary objective is to evaluate safety of the vaccination schedule (from apheresis procedure to week 24) at week 24 and safety of the Analytical Treatment Interruption (ATI; from week 24 to week 48) at week 48 in HIV-1 infected patients who have been receiving antiretroviral therapy for at least 12 months with HIV-1 RNA ≤50 copies/mL and CD4+ T cell counts >500/mm3 at entry in the trial and who received, in addition to anti-retroviral therapy for 24 weeks, vaccination with ex vivo generated interferon-alpha dendritic cells loaded with HIV-1 lipopeptides and activated with lipopolysaccharide (BIIR/ANRS-HIVax-001, the DC vaccine product).
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75204|
|Principal Investigator:||Jacques Banchereau, PhD||Baylor Research Institute|