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

35

1 Phase II trials.
2 We know, with respect to MicroGeneSys,
3 there are at least two trials. The group at Walter
4 Reed is conducting a mid-size -- or actually a fairly
5 modest for a Phase II trial -- study of 600 patients,
6 randomized placebo versus vaccine in patients greater
7 than 400.
8 This study has been ongoing for a couple
9 of years now, has been recently closed to accrual
10 after the addition of other patients, additional
11 patients, from the NIAID's community program for
12 clinical research on AIDS, and has a planned follow-up
13 of five additional years.
14 There is a much smaller study ongoing, a
15 randomized comparative study, in Canada. Genentech,
16 with their gp-120, now the MN strain, plans to open a
17 multi-center study in a few weeks involving about 500
18 patients and a similar patient population.
19 Immune Response Corporation's whole and
20 activated vaccine is in trial, has now closed to
21 accrual, a very small study. No results have been
22 reported to date from that trial.
NEAL R. GROSS
COURT REPORTERS AND TRANSCRIBERS
1323 RHODE ISLAND AVENUE, N.W.
[phone] WASHINGTON, D.C. 20005 [phone]