[Memo to Harry Dangerfield from Member of Walter Reed]

At the beginning of the meeting those present included COL Burke, L/COL
Redfield, most of the members of his Department (although at least three
were not present) and civilian scientists from the Henry M. Jackson
Foundation (HMJF). The meeting started later than usual that afternoon
(due to a farewell party for an Officer in the Division). The meeting
proceeded for over one hour, being interrupted only when a Department
member brought one of the lab technicians into the meeting room and
announced that the technician had been accepted to medical school. After
applause, the technician left the room and the meeting continued.
The discussion during this initial hour touched on several topics, with Dr
Vahey beginning by stating that she did not want to lead the discussion,
but had asked for the meeting to hear other peoples' comments on the data.
Multiple issues were then raised and discussed. Some of these issues
induded: intratest and intertest variability of the PCR assay, how the
"normalization" of CD4 T-cell counts to 1,000/mm3 influenced the
calculation of the viral burden, whether calculation of viral burden in this
way was not a "self-fulfilling prophesy", (i.e. to state that viral burden in
the blood increases as CD4+ T-cell counts decrease if you multiply the
measured viral burden by the same numerical correction factor used to
multiply the measured CD4+ T-cell count in order to normalize it to
1,000/mm3), how much money and time had been spent earlier in the
Phase I gpl 60 trial on a particular non-PCR assay and whether that assay
should be run again now that the Phase I gpl 60 patients had been
foiowed for a longer time. (The decision was not to restart the assay at
that time).
Futther discussion centered on the apparent bursts of HIV (viral burden) in#
certain patients, such as patient # 1, after starting the gpl 60
immunizations. What did these "bursts" mean and why did they occur?
Reference was made to previous discussions between certain individuals
about these "spikes", or sharp increases in the amount of HIV measured
in the peripheral blood white cells. The concensus appeared to be that no
one knew why they occurred, what they meant, or where in the body these
spikes in HIV went after the virus left the peripheral blood mononuclear
cells. Another person asked if there was an association between an
increase in the CD4+ T-cell counts and the bursts or increases in viral
burden. A question was asked about how the CD4+ T-cell counts were
actually determined, e.g. were they rolling mean averages and if so,
averages of how many consecutive CD4 counts (i.e. 3,4,5,6,7?); similiarly
how were the CD4 counts measured for the natural history control
patients?

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