Statement of Nelson L. Michael, M.D., Ph.D

smaller group met in LTC Redfield's office 11 August 92.
Present were LTCs Redfield and Birx, Dr. Vahey and me. The
decision was made that viral burden data from 26 of the 29 Phase I
patients still living or in compliance would be presented at the
Chantilly meeting. Definitions of baseline and endpoint data
points were mutually'agreed upon and it was further decided that
LTC Brundage and Dr. McCarthy would evaluate the data statistically
prior to its presentation.
The data were evaluated per Dr. Redfield's request by Dr.
McCarthy and his group. His conclusion was that the viral burden
data showed a rise in some, a fall in some and some patients
remained static but, as a cohort, there was no significant change
in viral burden over an average of two years of follow-up. These
data were presented 31 August 92 by Dr. Vahey in a poster session;
her conclusions included that the lack of change in viral burden
was an additional evidence for safety. This conclusion was based
on evidence from our laboratory and several other groups that an
increasing viral burden was associated with the natural history of
the disease.
On the following day (1 September 92) of the Chantilly
meeting, the AIDS Clinical Trial Group (ACTG) conducted a workshop
on vaccine therapy. Six other groups had been notified that formal
presentations were to be given; LTCs Redfield and Birx were under
the impression that the presentations were to be informal as they
had been thp-revious year. The session Chairman, Dr. Steven
Schnittman, L