Merck has halted a Phase III study of Isentress (raltegravir) once-daily in treatment-naïve adult patients infected with HIV-1 after recording negligible safety and efficacy results.
The study found that although the treatment regimen involving Isentress once-daily enabled more than 80% of the patients to achieve viral suppression, it did not demonstrate non-inferiority to the treatment regimen that involved Isentress twice-daily.
Based on the initial results and recommendations of an independent data monitoring committee, Merck has decided to end the study.
Isentress in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults.
Merck is notifying the clinical investigators about the decision and is recommending the patients belonging to the once-daily dosing arm to be switched to the Isentress twice-daily, the US Food and Drug Administration approved dose.
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