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MERCK TO MAKE EXPERIMENTAL DRUG AVAILABLE TO HIV PATIENTS

August 25, 2006

Merck announced that it will soon start allowing HIV/AIDS patients who are out of other options to take an experimental new drug it is developing.

The company said it will start enrolling HIV/AIDS patients "with limited or no treatment options" who are not currently participating in the Phase III clinical trial of its HIV integrase inhibitor, MK-0518, in the worldwide expanded access program for the drug in the next few months.

MK-0518 belongs to a new class of investigational antiretroviral therapy agents called integrase inhibitors, which hinder the insertion of HIV viral DNA into human DNA. According to Merck, there are as yet no approved drugs that target the integration stage of the HIV-1 life cycle, as MK-0518 is designed to do.

This is the third expanded access program for HIV drugs that Merck has offered, according to Randi Leavitt, senior director for infectious diseases and clinical research at Merck Research Laboratories and lead coordinator of the expanded access program. The company said the expanded access program for MK-0518 is a non-comparative, multicenter, open-label, voluntary treatment use study.

The study will continue until about three months after MK-0518 has been introduced in the market.