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New Trial to Study Investigational Integrase Inhibitor in Combination with FUZEON® Once-Daily Dosing Strategy


Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced that patient dosing has begun in a new trial designed to evaluate the efficacy and safety of FUZEON® (enfuvirtide) in combination with an investigational integrase inhibitor. The trial will also determine whether a novel, simplified FUZEON dosing strategy – switching from twice-daily dosing to once-daily dosing – can effectively maintain an undetectable viral load. This study, known as AMICI, is open to patients who are enrolling in an Expanded Access Program (EAP) for an investigational integrase inhibitor. AMICI is also open to additional integrase inhibitor EAP sites interested in becoming an AMICI trial site. FUZEON, co-developed by Roche and Trimeris (Nasdaq: TRMS), is the first and only fusion inhibitor available for the treatment of HIV.

“As new anti-HIV drugs enter the treatment landscape, it is important to conduct studies that provide detailed guidance to clinicians on how to use these agents with drugs, such as FUZEON, that are already in wide use in treatment-experienced patients. This trial is designed to shed light on several key questions,” said Calvin J. Cohen, M.D., Research Director, Community Research Initiative of New England. “In addition to providing new data on the combination of FUZEON and an integrase inhibitor in a significant patient cohort, AMICI will provide insight on whether it is possible to simplify dosing of FUZEON to once-daily after undetectable HIV has been achieved. If shown to be a viable option, simplified dosing of FUZEON would be a welcome advance.”


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