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

134

1 CD4 changes and clinical outcomes in early-stage
2 patients, and we certainly have no data on the
3 possible correlation of these changes and clinical
4 therapeutic effects in other classes of treatments,
5 like the therapeutic vaccines.
6 Next. So to sort of summarize, because of
7 these issues, the lack of data on CD4 patterns with
8 therapeutic vaccine, the small proportion of clinical
9 effects that are mediated through the CD4 count with
10 current anti-retroviral therapy, and also, as has been
11 mentioned, the excessive variability of CD4
12 measurements, our conclusion is that modest effects on
13 CD4 trajectories will be inadequate as indicators of
14 benefit in trials of therapeutic vaccines.
15 And I should note that the types of CD4
16 effects that have been mentioned in the trials that
17 are ongoing certainly don't suggest that any possible
18 effects, if there are any, will be anything other than
19 modest.
20 Next slide. Well, just to go back and
21 reprise what we're talking about, we're talking about
22 a trial in which virtually all seropositives would be
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]