Recombinant DNA Advisory Committee - 06/1-2/92 
Dr. Haselkom asked the investigators to describe the preliminary experiments that have 
been performed and to provide evidence that the proposed PCR assay will be 
quantitative and sensitive enough to measure the persistence of the transduced PBL in 
these patients. 
Dr. Haselkom noted that there are actually two separate protocols. The first protocol 
involved the autologous infusion of transduced HIV( + ) PBL. The second is a syngeneic 
protocol that involves the transduction of non-HIV infected PBL obtained from an 
identical twin and subsequent infusion into the HIV(+) twin. 
Review-Dr. Schaechter 
Dr. Schaechter agreed with all of the comments made by Dr. Haselkom. Also, the 
investigators still have not responded to questions regarding the length of time that the 
transduced cells were coincubated with the HTV, and why this incubation had not been 
performed for a period of time longer than 21 days. 
Dr. Schaechter noted that the investigators comments suggest that they will not proceed 
with the human protocol until certain in vitro experiments have been performed. If this 
interpretation is accurate, the RAC should not consider this protocol at this time. 
Dr. Schaechter noted that this protocol is presented as a protocol designed to study 
safety issues. It should be viewed more accurately as a therapeutic protocol. 
Review-Dr. Walters 
Dr. Walters stated that he had four concerns that he would like the investigators to 
address regarding this protocol: (1) a discussion of the animal model used for these 
experiments; (2) an explanation regarding the exclusion of pregnant and lactating 
women, without justification; (3) a statement about the proposed control group; and (4) 
the costs defrayed by research versus costs incurred by the patient are not clearly 
addressed in the section of the informed consent document that discusses the 
transduction and reinfusion procedures. Dr. Walters stated that the investigators 
responded to these initial questions; however, he asked them to elaborate on their 
responses. 
Other Comments 
Dr. D. Miller said that he had scanned the vector sequence for open reading frames. 
The DCTAR vector has no additional open reading frames in the TAR or neomycin 
resistance coding regions; however, there is a region in the front end of the vector that 
Recombinant DNA Research, Volume 15 
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