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

105

1 And the summary of that is we have a
2 product which has been given to seropositive
3 individuals which by the criteria that have been
4 observed rather carefully in more than one trial is,
5 in fact, safe.
6 Secondly, it is inducing a new immune
7 response, both humoral and cellular immune response,
8 that, in fact, the virus itself in those infected
9 individuals did not induce.
10 With regard to CD4 levels, CD4 levels,
11 although it is an uncontrolled study, -- all of the
12 studies involved have been uncontrolled -- appear to
13 stabilize.
14 In other words, if you would look
15 historically at a comparable group of individuals who
16 were HIV-infected, you would see a diminution from a
17 historical control of CD4 cells.
18 In more than one study, the original
19 published study in the New England Journal of
20 Medicine, as well as subsequent other studies that
21 have been reported at different meetings in Sweden and
22 elsewhere, there appears to be and, I emphasize again,
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]