Popis K další podpoře hodnocení poměru prospěchu a rizik se žadatel zavazuje poskytnout CHMP k posouzení 48- týdenní data o bezpečnosti a účinnosti z probíhající studie fáze III, protokol 018 (A Multicenter, Double- Blind, Randomized, Placebo- Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV- Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies) a protokol 019 (A Multicenter, Double- Blind, Randomized, Placebo- Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV- Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies).
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