For maraviroc, for resistance group, they did have
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(Total Views: 421)
Posted On: 09/08/2019 6:12:08 PM
For maraviroc, for resistance group, they did have to do two trials with a total of 1000 patient at 48 weeks, compared with combo leronlimab 50 patients at 24 weeks + safety data from mono trial. So the trial bar was much higher for them, but Pfizer had the resources to do it quickly globally. Look at how they got everyone enrolled in 2 years. The bar with just 40 patients, no additional safety data was much lower for IZ, but MDR3, maybe the difference.
https://www.frontiersin.org/articles/10.3389/...00277/full
https://www.frontiersin.org/articles/10.3389/...00277/full
Quote:
In late 2004, we initiated four large studies; MOTIVATE 1 and 2 in treatment-experienced patients with R5 HIV-1 (13, 14), MERIT (a phase 3 study with a phase 2b roll-in) in treatment-naïve patients with R5 HIV-1 (15), and study A4001029, a phase 2b safety study in treatment-experienced patients with non-CCR5 tropic virus (CXCR4-using or non-phenotypable virus) (16).
This was a massive undertaking, with 4794 patients screened at more than 200 sites in the USA, Canada, Europe, Australia, South Africa, Mexico, and Argentina.
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