[Minutes, Advisory Committee to the Director GP-160 Meeting (1992: Bethesda, Maryland)]

68

1 I'd like to make that comment or read it
2 to you, the following, is that -- Next slide, in
3 which, obviously, the nonresponders have been -- you
4 know, have a lower CD4 count than responders who are
5 reported to have a "higher" or more sustained CD4
6 count. Next slide.
7 Number one is that natural history
8 studies, especially the Max study, have shown that
9 twenty to thirty percent of untreated patients with
10 CD4 counts greater than 400 will maintain their CD4
11 counts in and of themselves over a twelve to eighteen
12 month period of time.
13 One explanation for the difference in
14 responders versus nonresponders in any Phase I trial,
15 whether it be the Walter Reed trial or the trial that
16 was presented earlier, is that response to an
17 immunogen is the better measure of innate host
18 resistance than the absolute CD4 count.
19 Hence, response to an in vivo immunogen is
20 a marker of better host immunity than the therapeutic
21 cause of the higher CD4 count. I just would like to
22 make that point to people, that we are essentially
NEAL R. GROSS
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