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Interest in boosted-PI monotherapy (in particular, lopinavir/ritonavir) was first sparked in 2003, when favorable results from a single-arm pilot study were presented (ACC Nov 1 2003). Since then, this strategy has been evaluated in several comparative clinical trials, two of which were recently published. Both studies were set in Europe and were supported by the maker of lopinavir/r.
In the OK04 study, 205 patients with virologic suppression and no history of PI resistance were randomized to continue triple therapy with lopinavir/r plus two NRTIs or to discontinue the NRTIs and receive lopinavir/r alone. If viral rebound occurred in patients who were assigned to monotherapy, they were allowed to resume NRTIs without being considered to have…