This is a Phase 3, randomized, double blinded, placebo-controlled study designed to compare the safety, tolerability, antiviral activity and immunological effect of raltegravir added to a previously stable HAART regimen in the treatment of HIV-1 infected subjects with undetectable viraemia and low CD4 recovery. HYPOTHESIS: Adding raltegravir to a stable HAART in patients with undetectable plasma viral load and low CD4 recovery will result in further viral suppression and therefore higher CD4 recovery.
Although HAART has reduced the morbidity and mortality from HIV-1 infection, some patients experience a discordant response characterized by HIV-1 RNA plasma levels below the limit of detection and low CD4 T-cell recovery (immunologic discordant responders). At present, recommendations for the clinical management of patients with discordant responses to antiretroviral therapy are largely based on observational, uncontrolled data. The effect on CD4 count of adding raltegravir in already undetectable patients has not yet been evaluated. The primary purpose of this study is to assess the ability of the HIV-1 integrase inhibitor, raltegravir, added to a stable HAART, to increase CD4 count in patients with undetectable plasma viral load and low CD4 recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Raltegravir 400 mg BID added to stable HAART
Placebo BID added to stable HAART
Fundacion Huesped
Buenos Aires, Argentina
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Time frame: 48 weeks
Proportion of patients achieving plasma HIV-RNA < 5 copies/ml.
Time frame: 48 weeks
Proportion of subjects increasing CD4 count > 50 cells/mm³.
Time frame: 24 weeks
Proportion of patients achieving CD4 count > 250 cells/mm3
Time frame: 48 weeks
Proportion of patients achieving an increase of 5 percentual points in CD4 percentage
Time frame: 48 weeks
Median change from baseline in CD4 count.
Time frame: 48 weeks
Proportion of patients maintaining HIV RNA <50 copies/ml.
Time frame: 48 weeks
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