The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Autologous dendritic cells (3x10e7)
Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
Number of participants with ≥ grade 3 adverse events related to product
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
Time frame: 51 weeks
Number of participants with change in plasma viral load from baseline, over the observation period
Log10 change in HIV RNA
Time frame: Baseline to 51 weeks
Number of participants with change in CD4+T cells from baseline, over the observation period
Absolute number change of CD4+T cells
Time frame: Baseline to 51 weeks
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