Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3|
- 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
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|San Sebastian, Giputzkoa, Spain, 20014|
|Barcelona, Spain, 08036|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Hospital Vall d'Hebron|
|Barcelona, Spain, 08035|
|Hospital Universitario La Paz|
|Madrid, Spain, 28046|
|Study Chair:||Jose M Gatell, MD||Hospital Clinic de Barcelona|