This is a pilot study designed to determine a dose and schedule of Tucaresol that can be administered to HIV-1 infected subjects on HAART (highly active antiretroviral therapy) with viral suppression without occurrence of significant adverse events and that results in significant changes in cell mediated immunity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
GSK Investigational Site
Bergamo, Lombardy, Italy
GSK Investigational Site
Busto Arsizio (VA), Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
Significant increase from baseline in IFN-g (Interferon gamma) EliSpot cellular responses at day 70 following peptide stimulation of PBMC (peripheral blood monocytic cells) of subjects after the second dosing cycle of study drug (days 56 to 62).
Proportion of subjects developing drug related and treatment-limiting Adverse Events leading to discontinuation of study drug during the period of study and follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Bagno A Ripoli (FI), Tuscany, Italy
GSK Investigational Site
Florence, Tuscany, Italy
GSK Investigational Site
Padova, Veneto, Italy