A trial is underway for a new dosage of Merck's HIV-1 therapy.
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Jamie Barrand | Feb 24, 2016

Trial underway for new dosage of HIV-1 therapy

Isentress (raltegravir), a product of American pharmaceutical company Merck indicated for treatment of HIV-1 infections in patients four weeks of age or older, was the subject of a recent phase-three trial, ONCEMRK.

Isentress was tested as a once-daily oral dose of 1,200 milligrams. The study found this dosage not to be inferior to the formulation of Isentress that is currently on the market -- 400 milligrams twice a day. Both dosages were administered in combination with Truvada, a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV and AIDS; the 1,200-milligram dose has not yet been approved by the U.S. Food and Drug Administration (FDA).

The new dosage is also comparable to the current dosage with regard to tolerability and immunologic efficacy.

“Merck has never wavered in our commitment to develop meaningful therapeutic options for people with HIV-1 infection,” Eliav Barr, vice president of clinical development and infectious diseases, Merck Research Laboratories, said. “We are pleased that this study has met its primary endpoint and look forward to presenting the data at a future congress.”

The ongoing trial is a 96-week, multi-center, double-blind, randomized, active comparator-controlled study of HIV-1-infected adults who have received no prior treatment.

When the study concludes later this year, Merck researchers will present their findings at scientific conferences and will likely be ready to submit licensure applications to the FDA for the new dosage.

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