RECIPIENT CONSENT 
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4, and 6 hours after the start of the infusion to monitor for the presence of the neoR 
gene. If there are no complications, you may be discharged from the hospital the 
following day, but will need to return to the NIH daily for the first week for blood tests 
and then weekly for the next 5 weeks. 
For the second and third infusions, the identical schedule of tests and frequency 
of visits wiil be followed. However, if the first infusion was uncomplicated, these 
subsequent infusions may be administered on an outpatient basis and monitoring of 
vital signs, etc., may last for 4 hours (rather than 24 hours, as was done for the first 
infusion), at the discretion of the principal investigator. If any cell infusion is 
complicated by significant side effects, all subsequent infusions will be performed on 
an inpatiem basis with monitoring for at least 24 hours post infusion, at the discretion 
of the princoal investigator. 
For tne first week after each lymphocyte infusion, we will monitor on a daily 
basis CD4 counts, plasma viremia and p24 antigen levels for the amount of HIV in the 
bloodstream, and the presence of the neoR gene in the lymphocytes. Thereafter 
these tests and others monitoring blood and urine chemistry, blood counts, and 
markers of immune function wiil be obtained weekly. As the study proceeds and as we 
learn more about the tolerance of the cell infusions, we may reduce the frequency of 
those tests scheduled on a daily and weekly basis, at the discretion of the principal 
investigator. Six weeks after the third lymphocyte infusion has been administered, 
visits to the NIH will be scaled back to monthly. Six months after the third lymphocyte 
infusion, ycur participation in the protocol will be completed and you will return to the 
sole care of your private physician. 
The Drocedures involved in this study carry several potential risks. The risks 
can be diviced into those related to the gene modification, those related to cell 
infusions, and those related to the other protocol procedures. The risks related to 
gene modification are theoretical risks; to date, a small but important series of gene 
marking ana gene therapy experiments in humans demonstrates no side effects, 
toxicities, or other ill effects due to gene modification of cells using retroviraJ vectors. 
Even thougn the vector used to transfer the neomycin resistance genes into the cells 
cannot grow and is considered harmless to humans, it is possible that events could 
occur within the cell that would permit the vector to grow and/or make the cell 
cancerous. For instance, in several monkeys that received gene marked cells using a 
retroviral vector as part of a bone marrow reconstitution experiment, lymphomas 
(cancers of the lymph glands) did occur. However, this was an extraordinarily unique 
experiment where the monkeys were exposed to the disabled mouse retroviral vector 
as well as a second helper virus. Experimental evidence from this study shows that 
the helper virus, which is capable of self-replication, and not the mouse retroviral 
vector, was responsible for the cancers. In other animal and in human experiments, 
where now more than 30 patients have received gene-modified cells, no evidence for 
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