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Etravirine (formerly TMC125) is an NNRTI with some documented activity against NNRTI-resistant viruses. To assess the efficacy and safety of this drug, investigators are conducting DUET-1 and -2 — identical ongoing, multinational, industry-sponsored, double-blind, phase III trials.
The studies involve 1203 triple-class–experienced HIV-infected individuals with documented resistance to PIs and NNRTIs who, at enrollment, were experiencing treatment failure on their current regimens. Patients were randomized to receive investigator-selected NRTIs, darunavir with low-dose ritonavir, and either etravirine (200 mg twice daily) or placebo. T-20 use was optional.
In both studies, the proportion of patients at week 24 who had confirmed viral loads <50…