Status:
COMPLETED
Efficacy Study of T Cell Vaccination in HIV Infection
Lead Sponsor:
Soroka University Medical Center
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
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 aut...
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 despi...
Eligibility Criteria
Inclusion
- CD4 cell counts -from 150 to 450/mm3 and stable for at least 12 months, and treatment with HAART for at least 6 months.
- Positive cell proliferation assay to CD4 molecule
- Low HIV viral load (\<400 - 5000 copies/ml) for at least 12 months
- No change of antiretroviral treatment for at least 6 months
- Signed informed consent
Exclusion
- Concomitant immunosuppressive or antineoplastic treatment as well as chronic systemic glucocorticoid therapy.
- Pregnancy and women without any efficacious contraception.
- Clinically relevant liver disease (AST and/or ALT \>2,5x upper limit of normal range, or total bilirubin \> 3,5 mg/dl).
- Serum creatinine \>1,8mg/dl or creatinine clearance \<30ml/min.
- Patients who cannot fully understand the treatment protocol or are unable to sign the informed consent.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00407836
Start Date
November 1 2006
End Date
November 1 2008
Last Update
December 2 2009
Active Locations (1)
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1
Soroka Medical Center
Beersheba, Israel