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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: margie who wrote (2925)	11/21/1997 12:35:00 PM
From: Peter Singleton	Read Replies (2) \| Respond to of 6136

JLL or Izzy, VRTX's PIII for VX-478, initiated in February, is evaluating 478+AZT+3TC vs AZT+3TC in anti-retroviral naive patients. At what point is it medically unethical IYO to give two RTI's only, especially with one of them AZT, as an arm in a trial. I'm not questioning Glaxo or Vertex ... just wondering if a trial were initiated now would it be possible to have such an arm. If not, how would you design a trial to give you the necessary efficacy information? I know the oncologists wrestle with this issue all the time ... I just don't know how you would in AIDS. Peter from VRTX's 2/19/97 press release announcing PIII "Glaxo Wellcome's double-blind, placebo-controlled Phase III pivotal clinical trial is designed to evaluate the tolerability, antiviral efficacy, and durability of antiviral response of the triple combination of 141/VX-478, AZT and 3TC compared to the double combination of AZT and 3TC. Entry requirements for the study are antiretroviral naive patients with CD4+ counts greater than 200 mm3, and HIV RNA counts greater than 10,000 copies/mL. The study is expected to enroll approximately 240 HIV-positive adults, and will be conducted at approximately 30 clinical trial sites in the United States, Canada and Europe."