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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus. Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4
Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG\_INF Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 and INF during weeks 4,5 and 6
Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4
Hospital Clínic
Barcelona, España, Spain
Number of Participants with adverse events of grade 3 or higher
* Local adverse events of grade 3 or higher (pain and skin reactions including induration) * Systemic adverse events of grade 3 or higher (fever, chills, headache, nausea, vomiting, malaise and myalgia) * Clinical or laboratory confirmed grade 3 or higher on physical examination or retests adverse events Any event attributable to the vaccine involving a discontinuation of vaccination regime.
Time frame: 28 weeks
Virological
Proportion of patients with undetectable viral load (\<37 copies / mL) at 12 weeks
Time frame: 12 weeks
Number of adverse events grade 1 and 2 within 14 days after each immunization (weeks 2, 4 and 6)
Time frame: 6 weeks
Changes in the specific immune response
Measured by ELISPOT visits in weeks 2, 4, 8, 12, 16 and 28 compared to baseline and screening for dendritic cell vaccine and pegylated interferon.
Time frame: 28 weeks
Changes in levels of viral reservoir.
Measure the proviral DNA visits in the weeks -44, -36, 4, 8, 12, 16 and 28 compared to baseline and screening.
Time frame: 28 weeks
Proportion of patients with changes in any value of the levels of inflammatory markers, microbial translocation and immune activation
In visits at weeks 4, 16 and 28 compared compared to baseline and screening
Time frame: 28 weeks
Proportion of patients with viral rebound
Two consecutive obtaining measurements of plasma viral load\> 37 copies / mL separated by at least 15 days after discontinuation of antiretroviral therapy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG\_INF Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 and INF during weeks 4,5 and 6.
Time frame: 15 days
Proportion of patients with autoimmunity markers induced by the vaccine as measured by: antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factors.
Evaluation on autoimmunity with antithyroid antibodies (antithyroglobulin, antithyroid peroxidase), antinuclear antibodies, antiphospholipid antibodies and rheumatoid factor at screening, baseline and week 16.
Time frame: 16 weeks
Changes in the transcriptome of patients visits weeks 4, 16 and 28 compared to baseline (week -12)
Weeks 4, 16 and 28 compared to baseline
Time frame: 28 weeks
Evaluation of the specific immune response trought IFN-gamma production in vitro at screening and baseline
Proportion of patients with IFN-gamma production in vitro measured by ELISPOT at screening and baseline
Time frame: week 0
Evaluation of the specific immune response thought dendritic cell maturation markers in vitro at screening and baseline
Proportion of patients with dendritic cell maturation markers in vitro measured by flow cytometry at screening and baseline
Time frame: week 0
Evaluation of the specific immune response thought T-cell proliferation in vitro at screening and baseline
Proportion of patients with T-cell proliferation in vitro measured by CFSE (carboxyfluorescein succinimidyl ester) at screening and baseline
Time frame: week 0