Merck has started patient enrollment in its global Phase III clinical trial 'ONCEMRK', which is evaluating a once-daily investigational formulation of Isentress (raltegravir), known as reformulated raltegravir, as part of combination HIV therapy for treatment-naïve HIV-1-infected adults.
Currently, Isentress film-coated tablets are administered twice daily in accordance with the approved Prescribing Information.
Isentress is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents to treat HIV-1 infection in patients four weeks of age and older.
The company said that the use of other active agents with Isentress is associated with a greater likelihood of treatment response.
In addition, during the initial phase of combination ARV treatment, immune reconstitution syndrome may occur.
University of Bonn clinical investigator on this trial Jürgen Rockstroh said Isentress has been a significant component of first-line HIV-1 treatment for more than six years, as a twice-daily component of antiretroviral therapy.
"We look forward to advancing our understanding of this new formulation of once-daily raltegravir with this new trial," Rockstroh said.
The multicenter, double-blind, randomized, active-controlled ONCEMRK trial is assessing the safety, efficacy, tolerability and pharmacokinetics of reformulated raltegravir 1200mg (dosed as two 600mg tablets) once daily, compared with Isentress 400mg twice daily, both in combination with once-daily tenofovir/emtricitabine over 96 weeks.
The trial’s primary endpoint is the proportion of patients achieving viral suppression (<40 copies/mL) at Week 48, which the company estimates will occur in the first half of 2016.
Image: In Merck’s Phase III ONCEMRK trial, Isentress film-coated tablets are administered twice daily to HIV-1-infected adults. Photo: courtesy of Grant Cochrane/ freedigitalphotos.net