Recombinant DNA Advisory Committee - 09/14-15/92 
acquired immunodeficiency syndrome (AIDS). The investigators state that this latitude 
will yield valuable information regarding the various stages of the disease. There will be 
no restrictions on patients obtaining concurrent therapy. Patients will have the option to 
enroll in other experimental protocols. Overall, the investigators adequately responded 
to Dr. Post's concerns and he requested that they address the few remaining questions 
presented in his review. He recommended that the RAC approve the protocol. 
Review-Dr. Dronamraju 
Dr. Dronamraju inquired if the investigators will make a conscious attempt to randomize 
the patient population with regard to the stage of their disease, or is the twin population 
so limited that latitude is necessary in order to obtain a sufficient number of patients 
entering the protocol? Are there patients already available to enter the protocol? What 
will be the investigator's next step? What is the rationale for having not provided in vivo 
animal data to support the protocol? 
Review-Dr. Carmen 
Dr. Carmen stated that the protocol understates its prospects for broad theoretical 
contributions to the determination of how genetic factors trigger specific behavior 
patterns in humans. Identical twin literature has its own place on the natural science, 
neuroscientific, and social science research agenda. He recommended approval of this 
protocol because valuable information will be obtained regarding the relevant 
parameters of sexual orientation. 
Other Comments 
Dr. Parkman asked if the clinical protocol (without gene marking) involves the 
administration of CD4( + ) and CD8( + ) cells. If the clinical protocol is identical exept 
for the addition of gene marking, then the RAC should only consider the gene marking 
portion of this protocol. If the analogous protocol uses only nonactivated CD4( + ) and 
CD8( + ) cells, then the entire protocol would fall under the purview of the RAC. 
Dr. Parkman stated that no information was provided by the investigators regarding the 
transduction efficiencies in these fractionated subpopulations of lymphocytes. Since 
CD4( + ) cells are being administered in the activated state, could they also become 
infected with HIV? The protocol states that if there is an overall increase in vital 
activation or decrease in CD4 counts, the protocol will be stopped. Will samples be 
obtained from the patients after the cells have been administered and cultured in order 
to determine the presence of HIV in gene marked cells? If there is evidence that gene 
marked cells have been infected, will the investigators stop or continue the protocol? 
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