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

131

1 infection prophylaxis, but the vaccine itself would
2 need to be placebo-controlled.
3 We would try to do a trial where we could
4 get a result in a relatively short period of time, say
5 three to five years. The primary endpoint that has
6 been discussed a lot today should be clinical.
7 Next slide. The big question -- maybe
8 it's not such a big question anymore, but in the ACTG,
9 it's often a big question -- is why clinical
10 endpoints.
11 Next slide. It's a good question.
12 There's certainly a rationale for CD4 as a surrogate
13 endpoint in HIV trials, and CD4 as a surrogate has, in
14 fact, been discussed as a possibility in these trials,
15 particularly for patients with very early-stage
16 disease, who are going to take a very long time to
17 progress clinically.
18 There's a strong biologic rationale for
19 CD4 as a surrogate. After all, it's a measure of the
20 immune system. That's what we're worried about in
21 AIDS.
22 Lots of natural history data are available
NEAL R. GROSS
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