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Methods Study drugs were dosed for three days to achieve maximal exposure, as RTV-mediated CYP3A4 inhibition is complete and induction is minimal at Day 3. LPV/r was administered at 400/100 mg BID and at supratherapeutic dose of 800/200 mg BID. RTV was dosed at 400 mg BID. Digital EKGs were performed in triplicate on Study Day 3 and compared to time-matched baseline. No effect on QTcF was concluded if the 95% upper confidence bound for the difference of drug mean from placebo mean was less than 10 msec for all times of measurement (Per ICH Guidance). Pharmacokinetic samples were obtained and exposure and QTcF relationship was analyzed.

Evaluation of the impact of lopinavir/ritonavir (LPV/r) and ritonavir (RTV) on QTcF: results of a thorough QT study