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Posted On: 10/01/2025 4:06:40 PM
Post# of 157634
Plotinus: Thank you for your thoughtful and erudite response to the admittedly pedestrian reasoning on display in my post delving into the possible impact that the 350 mg dosing requirement may be having on enrollment. Clearly, I'm outside my lane here and solidly within the I don't know what I don't know lane. Nevertheless, my concern on the 350mg dosing issue is twofold.
The first stems from my understanding (which apparently may be wrong) that prior trials/studies have repeatedly shown that the 350 mg dose, while beneficial, has never/seldom produced efficacy results at or near those achieved with 525 or 700 mg doses, and that ohm, et al, have attributed this disparity to the inability of the 350 mg dose to fully cover and disrupt the CCR5 cell. The second is that a plethora of fully informed patient/doctor enrollment candidates would therefore pass on LL at 350 mg.
The thrust of your post and others, if I am interpreting them correctly, is that a fully informed patient should readily be able to understand that the difference to him/her between 350 and 700 mgs of LL will be negiigible (analogous perhaps to a pro golfer needing to make a 2 foot putt vs 1 foot nine inches). Assuming you and the others are correct, and that the 350 mg dose requirement for the initial 5 patients is likely a non issue, then I'm a bit concerned that the pace of enrollment will dramatically increase after patient number 5 finally enrolls. I know more sites are coming on board, but the current pace, to reach 60 patients, projects to 42 more months. So I guess I'm hoping that the 350 mg dose requirement has actually been a severe drag on enrollment, and that once that dam bursts, we'll be heading toward open water with the CRC trial.
Thanks again and all the best.
The first stems from my understanding (which apparently may be wrong) that prior trials/studies have repeatedly shown that the 350 mg dose, while beneficial, has never/seldom produced efficacy results at or near those achieved with 525 or 700 mg doses, and that ohm, et al, have attributed this disparity to the inability of the 350 mg dose to fully cover and disrupt the CCR5 cell. The second is that a plethora of fully informed patient/doctor enrollment candidates would therefore pass on LL at 350 mg.
The thrust of your post and others, if I am interpreting them correctly, is that a fully informed patient should readily be able to understand that the difference to him/her between 350 and 700 mgs of LL will be negiigible (analogous perhaps to a pro golfer needing to make a 2 foot putt vs 1 foot nine inches). Assuming you and the others are correct, and that the 350 mg dose requirement for the initial 5 patients is likely a non issue, then I'm a bit concerned that the pace of enrollment will dramatically increase after patient number 5 finally enrolls. I know more sites are coming on board, but the current pace, to reach 60 patients, projects to 42 more months. So I guess I'm hoping that the 350 mg dose requirement has actually been a severe drag on enrollment, and that once that dam bursts, we'll be heading toward open water with the CRC trial.
Thanks again and all the best.
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