Efficacy Study of T Cell Vaccination in HIV Infection

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 10,000 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.

Inclusion criteria

• 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 criteria

• 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.