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Interest continues in finding long-term antiretroviral treatment (ART) strategies involving two-drug regimens and nucleoside reverse transcriptase inhibitors (NRTIs) sparing regimens. The DUALIS study was conducted at 27 clinics in Germany and enrolled patients who were virally suppressed (HIV RNA <50 copies/mL) for ≥6 months on a stable daily regimen of ritonavir-boosted darunavir (r-darunavir; separate 100-mg ritonavir and 800-mg darunavir tablets) plus two NRTIs. Enrolled patients were randomized 1:1 to either continue the three-drug regimen (3DR) or switch to the two-drug regimen (2DR) of r-darunavir plus 50-mg dolutegravir. For this noninferiority trial, the primary endpoint was maintenance of viral suppression at week 48.
The study inc…