The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 \< 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
CSU Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
and levels of CD8 cells (CD28+ y CD38+)
Incidence of adverse events
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Donostia Ospitaleak
Donostia / San Sebastian, Giputzkoa, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain