The purpose of this pilot study is to obtain a preliminary assessment of the antiviral activity and tolerability of Kaletra single agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
138
400 mg lopinavir/ 100 mg ritonavir, BID
300mg lamivudine/150mg zidovudine, BID
Antiviral efficacy by HIV RNA
Time frame: 48 Weeks
Arm comparisons: CD4 evolution, occurrence of HIV protease and RT mutation, occurrence of AIDS clinical events, safety of NRTI-sparing vs. a PI with 2 NRTIs regimen: clinical and biological tolerance, patient's adherence and quality of life.
Time frame: 48 weeks
To assess in the LPV/r single-drug regimen arm: virological control, CD4 evolution, safety
Time frame: 96 weeks
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