Antiretroviral naïve patients with \<350 xE6/l CD4 cells and a HIV-viral load of \> 30.000 cop/ml are started on combivir ® and Kaletra ®. When patients have reached an undetectable viral load of\< 50 cop/ml on two consecutive occasions at least at week 12, but no later than week 24, they are randomised in either continuation with Combivir/Kaletra or switch to Trizivir ® twice daily one pill during 96 weeks. All patients randomised in the combivir/Kaletra arm are eligible to switch to Trizivir at any post randomisation visit when they reach predefined switch criteria for elevated levels of fasting glucose or lipids.
The primary objective is to compare the antiviral efficacy of an early switch from a boosted PI/2NRTI regimen to Trizivir (after undetectability of HIV-RNA has been achieved on 2 consecutive occasions) with uninterrupted use of the PI/2NRTI regimen for 96 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
zidovudine 300 mg bid, lamivudine 150mg bid, abacavir 300mg bid
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Plasma HIV-RNA < 400 cop/ml at week 96 for the Intent- To-Treat (ITT).
HIV-RNA <50 cop at week 96
HIV-RNA <400 and <50 cop/ml at week 48
Time to virological failure
Immunological efficacy at week 48 and 96 measured by absolute change from baseline in CD4 cell counts
Duration of change in CD4 cell count from baseline to >200,
Proportion of subjects experiencing one or more predefined values of fasting glucose and triglycerides, LDL and LDL/HDL ratio
Development of adverse events
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