NCT00407836|CompletedPhase 2
Efficacy Study of T Cell Vaccination in HIV Infection
Phase II Study of Efficacy, Tolerability and Safety of CD4-Specific T-cell Vaccine in HIV Infection
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Phase II Study of Efficacy, Tolerability and Safety of CD4-Specific T-cell Vaccine in HIV Infection
Sponsor study identifier
interventional
40
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)The hallmark of HIV infection and AIDS is the continuous attrition of CD4 T cells. One of the mechanisms that may account for the CD4 attrition , is autoimmunity against the CD4 T cells, caused by autologous immune cells. Vaccination against autoimmune reactive T cells has been successfully tried in animal models of autoimmune diseases and is now being tried in patients with Multiple Sclerosis. The purpose of the present study is to test this hypothesis in HIV infection. We will vaccinate HIV infected patients in whom specific autoimmune reactivity against CD4 is present , with their own CD4 reactive T cells. Following that, we shall study the patients and find out if the T cell vaccination caused a rise in CD4 T cell levels, and whether it influenced HIV viral load, as well as HIV and CD4 specific immunity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 3, 2006
Actual (reported)December 5, 2006
Actual (reported)November 2008
Actual (reported)November 2008
Actual (reported)CD4 T cell levels
one year follow up
HIV plasma viral load
one year follow up
Clinical HIV infection
one year follow up
HIV specific immune responses
One year follow up
CD4 specific responses
One year follow up
Immune profile
One year follow up
One arm of open label T cell vaccination in which all participants will receive the T cell vaccine
Approximately 10-20 million glutaraldehyde fixed CD4 responsive autologous T cells in 1-2 ml, per vaccine injection.
Approximately 10-20 million autologous CD4 reactive T cells per each vaccine injection
Soroka Medical Center
Beersheba, Israel
Abulafia-Lapid R, Bentwich Z, Keren-Zur Y, Cohen IR, Atlan H. T-cell vaccination against anti-CD4 autoimmunity in HIV-1 infected patients. J Clin Virol. 2004 Dec;31 Suppl 1:S48-54. doi: 10.1016/j.jcv.2004.09.017.
Abulafia-Lapid R, Mayan S, Bentwich Z, Keren-Zur Y, Avbramovitz Y, Cohen IR, Atlan H. T-cell vaccination against anti-CD4 autoimmunity in HIV-1 subtypes B and C-infected patients--an extended open trial. Vaccine. 2005 Mar 18;23(17-18):2149-53. doi: 10.1016/j.vaccine.2005.01.054.
Klaris Riesenberg, M.D.
Soroka U Medical Center
First Submitted
December 3, 2006
First Posted
December 5, 2006
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
November 2008
Actual (reported)Last Updated
December 2, 2009
Record last verified: 2006-11
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Source: ClinicalTrials.gov.
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