Definitely an interesting change. Hopefully they talked to the FDA, but on the other hand, the exclusion of previous Maraviroc use sounds like a protective clause for Cytodyn - ostensibly, you'd want to avoid that in case patients developed some resistance to a CCR5 inhibitor class drug prior to using PRO 140 in the trial. That's speculation on my part though.
I still have no doubt in the science or the efficacy of the drug, but I'll admit that I don't like seeing an unannounced change in the protocol this late in the game. Misiu or others with experience in clinical trials, care to weigh in?
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