Merck to launch third HIV expanded access program

Expanded access is a mechanism supported by regulatory agencies for getting investigational treatment to patients who have a life-threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. These programs are initiated and supported by drug manufacturers in recognition of the promise an unapproved drug may hold for patients facing a life-threatening disease.

The expanded access program with MK-0518 is a non-comparative, multicenter, open-label, voluntary treatment use study. Investigators will follow patients according to standard of care. The study will continue until approximately three months after MK-0518 has been launched in the local market.

To be eligible to participate, patients must have documented HIV-1 infection, be at least 16 years old, have limited or no treatment options available to them due to resistance or intolerance to multiple anti-retroviral regimens, are not achieving adequate virologic suppression on current regimen and be at risk of clinical or immunologic progression, and be clinically stable.

Patients will receive open-label MK-0518 400mg twice daily, in addition to optimized background therapy (OBT). Investigators will select the OBT based on the patient’s prior treatment history and anti-retroviral resistance testing. OBT will not be provided by Merck.

The program will be managed by a clinical research organization, which will collect all case report information, including serious adverse events and drug-related adverse events that result in grade 3 or above laboratory toxicity, leading to treatment interruption or discontinuation. No efficacy data will be collected.

Merck said that program enrollment will begin in the next few months, pending regulatory review and approvals.