A switch from protease inhibitors (PIs) to raltegravir (RAL) will be effective virologically and immunologically. Moreover, it will be associated with significant improvements in the lipid profile in HIV patients with undetectable viremia on PIs. In this setting, RAL once a day (QD) will perform as well as RAL twice a day (BID).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
RAL QD: RAL 800 mg/24 hs
RAL BID 400 mg/12 hs
RAL BID to QD
Hospital Carlos III
Madrid, Madrid, Spain
RECRUITINGProportion of patients with plasma HIV-RNA < 50 copies/ml at week 24 in each arm (RAL QD, RAL BID, RAL BID to QD)
Time frame: 24 weeks
CD4 gains, lipid profile, adverse events,
Time frame: 24 weeks
Drug resistance mutations
Time frame: 24 weeks
Raltegravir through plasma levels and correlation with virological failure
Time frame: 24 weeks
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