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

130

1 the primary endpoints?
2 Next slide. In our thinking, we're going
3 to start with some of these parameters. We really
4 think for these kinds of trials, the relevant
5 population is also seropositive patients.
6 It's been noted that there's perhaps more
7 of a rationale in the earlier stage and the later
8 stage patients. As I've heard today, nobody can say
9 that this is not going to work in the more advanced
10 patients, and it seems important to look at them.
11 That three up there should really just say
12 "multiple." This is for purposes of discussion. It's
13 going to be more efficient to look at multiple
14 products at the same time.
15 We feel very strongly that there will be
16 a need for placebo controls in this trial, although I
17 should point out that we're talking about placebo only
18 for the vaccine.
19 The patients who ought to be on other
20 types of medications, according to what they and their
21 doctor prefer, could be on, and that would include
22 other anti-retroviral medications or opportunistic
NEAL R. GROSS
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