Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients
Safety and Immunogenicity of a Vaccine Dendritic Cell-based Pulsed With Autologous Heat-inactivated in HIV-1 Infected Patients
single-center, national clinical trial, phase I, randomized (1: 1: 1: 1), prospective,
 placebo-controlled, partially masked, parallel group. Patients will be assigned to one of the
 following four arms: 3 immunizations of dendritic cells / 3 immunizations of dendritic cells
 with pegylated interferon + / 3 immunizations of placebo / 3 immunizations of placebo with
 pegylated interferon.
Inclusion Criteria:

 1. Patient > 18 years of age;

 2. Voluntarily sign informed consent;

 3. Men or women with a negative pregnancy test before inclusion in the study;

 4. HIV infection tested (with positive antibodies to HIV-1 and a detectable viral load);

 5. Patient must be on stable treatment with cART at least 1 year

 6. The average of all measurements of CD4 during the year before starting cART should be
 equal or greater than 350 cells / mm3

 7. The number of CD4 + at enrollment must be equal or greater than 450 cells / mm3;

 8. Plasma HIV viral load undetectable at least 6 months before the inclusion in the
 study, at least two determinations (occasional blips above the undetectable level are
 allowed).

 Exclusion Criteria:

 1. Treatment with suboptimal regimen (less than 3 antiretroviral drugs) before starting
 cART;

 2. History of C CDC events;

 3. Interruption of cART during the inclusion in the study;

 4. Pregnancy woman or becoming pregnant in the next months;

 5. Active opportunistic infections, or any active infection or cancer within 30 days
 prior to the screening visit;

 6. Therapy with immunomodulatory agents, including cytokines (eg IL-2) and gamma
 globulins or chemotherapy within 90 days prior to the screening visit;

 7. Use of anticoagulant medication;

 8. Use of any investigational drug within 90 days prior to study entry;

 9. Virological failure prior to antiretroviral treatment and / or mutations that confer
 resistance to antiretroviral drugs;

 10. Uncontrolled psychiatric disorder;

 11. Platelet count <80,000 / mm3;

 12. Values ??of hemoglobin <12g / dL;

 13. Patients with active uncontrolled autoimmune diseases;

 14. Using contraindicated drugs in accordance with the Summary of Product Specifications
 of pegylated interferon;

 15. Childbearing, or potential childbearing not using highly effective contraception;

 16. Any other problem that according to the investigator could interfere with the
 evaluation of the objectives.

 17. Any contraindication for the use of interferon peg in accordance with the Summary of
 Product Characteristics.