HIV/AIDS Vaccine

Enrollment in protease inhibitor program for HIV/AIDS patients to begin in fall

Published in Medical Letter on the CDC and FDA, July 24th, 2005

Tibotec, Inc. announced it plans to initiate an expanded access program (EAP) for its investigational protease inhibitor TMC114 in fall 2005 for people with HIV/AIDS who need the compound to construct a viable treatment regimen.

The company also announced that it plans to seek accelerated approval for TMC114 in the United States and Europe through regulatory submissions filed by early 2006 based principally on the 24-week primary analyses of the company's 2 phase 2B trials.

Initiation of enrollment into the expanded access program, which will be for heavily treatment experienced adults living with HIV/AIDS, is contingent on the approval of local...

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Source: Medical Letter on the CDC and FDA (2005-07-24)

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