[Letter to Bob Nugent, Jack Moye, Anne Willouby, George Nemo, Elaine Sloand, Harvey Shifrin, Dacia Clayton from Lynne Mofenson]

systems at very low concentrations of antibody, the levels of antibody that
will exist in the mother after and between infusions are over 100-fold in
excess of the concentrations that enhancement was observed in vitro, and data
from human studies of HIVIG in HIV-infected men have shown a decrease in
plasma HIV viremia with HIVIG infusions (not the increase that would be
expected if enhancement occurred in vivo). The protocol team has specifically
built in extended follow-up of mothers (6 months post-partum) and infants (to
24 months of age) to monitor for any unexpected problems. Additionally, the
trial Data Safety Monitoring Board will routinely monitor the study for
toxicity as well as efficacy, and if an adverse effect were observed during
the course of the study, the trial would be stopped. Thus, portraying this as
a "new" issue for Abbott is not valid, as Dr. Cummins of Abbott was present at
all protocol meetings and conference calls, and has reviewed the protocol many
times during the course of its development.

PL 002864