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." |
