Expanded Access For Nevirapine

Boehringer Ingelheim has said that it is setting up an expanded access program for Viramune (nevirapine) for people with AIDS. Nevirapine is an investigational non-nucleoside reverse transcriptase inhibitor. The target date for commencement of the expanded access program is in March, pending finalization of the protocol with the US Food and Drug Administration.

Patients eligible for the program will be over 13 years of age with HIV-1 infection and a CD4 cell count at or below 50/mm3, who have failed or are intolerant of approved treatments for HIV-1 infection. They must also be ineligible to enter an actively accruing nevirapine trial.

Boehringer Ingelheim plans to file a New Drug Application for Viramune with the FDA in the first quarter of 1996 under the accelerated approval review process.