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Protease inhibitors (PIs) are an integral part of combination antiretroviral therapy. However, new drugs are needed for treatment-experienced patients with PI-resistant virus. One such option is darunavir (TMC114), a new PI that has in vitro activity against both wild-type and multi-PI–resistant HIV.
To determine the safety and efficacy of darunavir in treatment-experienced patients, investigators conducted an industry-sponsored phase IIb study (called POWER 1) in Europe, Australia, Brazil, and Canada. A total of 318 patients were randomized to one of four doses of darunavir or to a comparator PI (CPI), each together with an optimized background regimen based on resistance testing and treatment history. Darunavir was given with low-dose rito…