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

137

1 Next slide. So there is some experience,
2 and there are people who know how to do these trials.
3 It would seem important, given the
4 heterogeneity of the patient population, to at least
5 look separately at three stages of disease: patients
6 with low CD4s, under 200, who will progress more
7 rapidly; patients in the mid stage; and the kinds of
8 patients that have been treated mostly in the Phase I
9 trials, with CD4s over 500.
10 If possible, it would be good to accrue
11 these patients as rapidly as possible. And with the
12 interest in this, it may well be possible to accrue
13 the required patients in one year with perhaps two to
14 four years' follow-up.
15 And for purposes of sample size
16 calculations, you have to input something. I've
17 assumed three vaccine products in the placebo control,
18 although there clearly needs to be more discussion of
19 that.
20 Next slide. The primary endpoints of such
21 a trial in the early stage would essentially occur as
22 a first AIDS-defining event or death. And in the
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