Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407836
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2006-12-03
Brief Title:
Efficacy Study of T Cell Vaccination in HIV Infection
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Phase II Study of Efficacy Tolerability and Safety of CD4-Specific T-cell Vaccine in HIV Infection
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The study will be based on forty HIV infected patients receiving anti retroviral treatment HAART with CD4 levels between 150-350 and HIV plasma viral load 5000 for at least 12 months and despite continuous anti-retroviral treatment The patients will be randomly divided into two groups one that will get the T cell vaccination and the other that will serve as controls The T cell vaccine will be prepared from autologous T cells that responded by specific proliferation to recombinant CD4 further expanded in vitro by IL-2 and then fixed by glutaraldehyde Each vaccine portion will consist of 10000 such cells suspended in saline and given subcutaneously every three months during the first year of the trial The outcome measures will be CD4 levels specific immunity to HIV antigens immune activation profile and HIV plasma viral loads determined sequentially during the 24 months of the trial These outcome measures will be compared between the experimental and the control groups to determine if this mode of treatment is effective in influencing CD4 levels as an additional mode of treatment during HIV infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None