Pfizer announced today that it plans to establish a multi-national Expanded Access Program (EAP) to make the investigational CCR5 antagonist maraviroc, currently in ongoing phase 3 clinical trials, available to HIV/AIDS patients with CCR5-tropic HIV-1 who have limited or no approved treatment options due to resistance or intolerance.
Pending regulatory review and approvals of the EAP study protocol, the program will begin enrolling patients in the next few months, with a target to enroll patients from over 30 countries.
Maraviroc is in a new class of investigational HIV drugs known as CCR5 antagonists, designed to work differently from currently available HIV/AIDS antiretroviral medicines.
Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus from entering cells by blocking its predominant entry route, the CCR5 co-receptor.