Recombinant DNA Advisory Committee - 06/1-2/92 
the syngeneic protocol. He stated that the results from the IL-2 transduction procedure 
and refining of the competitive PCR assay is anticipated within the next several months. 
Regarding the use of the SIV animal model, Dr. Smith said the he has not completed 
these studies due to cost restraints. These in vivo experiments may take several years to 
complete. 
Dr. Smith said that he will make the appropriate additions to the informed consent 
document stating that patients may not receive an immediate therapeutic effect as a 
result of participating in the protocol, and that there will be a request for autopsy. He 
will readdress the issue of costs associated with research procedures with his IRB since 
changes cannot be made without their approval. 
Dr. Smith stated that pregnant or lactating women have been excluded only because of 
the remote possibility that replication competent murine or human xenotropic retrovirus 
may be generated and transferred to a newborn child. 
Dr. Smith stated that the informed consent document for the syngeneic protocol will be 
presented along with other treatment options available to the patient and the twin at a 
very early stage. 
Dr. Smith stated that the toxicity issues were addressed at the Food and Drug 
Administration's (FDA) pre-investigational new drug (IND) meeting. In response to the 
FDA's concerns, the DCTAR transduced PBL will be injected into the severe combine 
immune deficiency (SCID) human/mouse model. Histology will be performed on these 
animals, and fatalities will be documented. 
Mr. Capron inquired as to how the costs incurred by HIV patients not covered by private 
insurance are currently being covered at Memorial Sloan-Kettering? Dr. Smith 
responded that he did not know how these costs are covered; however, treatment at this 
institution generally requires that the patient already be covered by private insurance or 
provide a cash payment. Mr. Capron asked if Memorial Sloan-Kettering has a medicare 
contract? Dr. Smith said he did not know and would have to contact knowledgeable 
personnel at his institution. 
Dr. Leventhal stated that the investigators had not adequately addressed her questions 
regarding the inclusion of a statement in the informed consent document requesting 
biopsies. Also, no answer has been provided regarding the number of patients being 
proposed for treatment and how the investigators arrived at this number. Dr. Smith 
stated that the number of patients proposed was provided by statisticians at Memorial 
Sloan-Kettering. These statisticians said that this number of patients would provide 
statistically significant information over a two-year period. 
Recombinant DNA Research, Volume 15 
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