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

138

1 later stage patients, mortality would be the primary
2 endpoint; for the most part in the other strata, first
3 AIDS-defining event, although I should say that while
4 those would be the primary endpoints, there might be
5 a possibility to include in sub-studies in here to try
6 and get some more information on some of the other
7 intermediate endpoints, but that would have to be very
8 carefully thought out.
9 Next slide. Again, for purposes of
10 calculation, taking the best data I was able to get,
11 I assumed an event rate in the CD4 less than 200 of 10
12 percent per year, 3 percent per year progression of
13 AIDS in the CD4 200 to 500, and 1.5 percent per year
14 in the CD4 greater than 500, and looking for a
15 one-third reduction of risk in each strata. So the
16 numbers to the right are what might be hoped for, what
17 you would want to detect in the treated arm.
18 Next slide. I have a conundrum, as Dr.
19 Hoth mentioned, that probably should be mentioned in
20 that patients who are going to progress the fastest
21 are probably, certainly from the immunogenicity data,
22 may be the least likely to benefit. Those with the
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBER8
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]