Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic\ninteraction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients.\nMethods. After a two-week lead-in of two nucleoside reverse transcriptase inhibitors (NRTIs) and atazanavir/ritonavir 300/100mg,\n44 patients received etravirine 200mg bid with one NRTI, plus atazanavir/ritonavir 300/100mg or 400/100mg qd (n = 22 each\ngroup) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100mg qd or 400/100mg qd decreased\natazanavir Cmin by 18% and 9%, respectively, with no change in AUC24 h or Cmax versus atazanavir/ritonavir 300/100mg qd alone\n(Day -1). Etravirine AUC12 h was 24%higher and 16% lower with atazanavir/ritonavir 300/100 or 400/100mg qd, respectively, versus\nhistorical controls.At Week 48, no significant differences were seen between the atazanavir/ritonavir groups in discontinuations due\nto adverse events (9.1?ch group) and other safety parameters, the proportion of patientswith viral load <50 copies/mL (intent-totreat population, n (50.0%, atazanavir/ritonavir 300/100mg qd versus 45.5%, 400/100mg qd), and virologic\nfailures (31.8% versus 27.3%, resp.). Conclusions. Etravirine 200mg bid can be combined with atazanavir/ritonavir 300/100mg qd\nand an NRTI in HIV-1-infected, treatment-experienced patients without dose adjustment.
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