Recombinant DNA Advisory Committee - 06/7-8/93 
Informed Consent document, etc. Responses by the PI subsequently clarified most of 
these questions. The investigators must provide a more detailed description of the 
transduction procedure. 
Review-Dr. Straus (presented by Dr. Smith) 
In Dr. Straus' absence, Dr. Smith summarized his review of the protocol. Dr. Straus 
raised similar concerns to those outlined previously. He was satisfied with the responses 
to his questions by the PI and recommends approval of the protocol. 
Review-Dr. Zallen 
Dr. Zallen explained that her initial concerns were about the number of patients that 
will be accrued onto this study and the criteria for patient selection. Several 
modifications were suggested regarding the Informed Consent document. The PI 
responded to one of her concerns stating that 3 patients will be treated in each arm of 
this study with different transduction vectors. There are still several questions remaining 
about patient selection, and the Informed Consent language is too technical and needs 
simplification. 
Other Comments 
Ms. Meyers commented that the Informed Consent document should include the 
following: (1) a recommendation that contraception be used by males, (2) a section 
about compensation for research-related injury, (3) a description of long-term patient 
follow-up, and (4) a request for autopsy. Mr. Capron explained that the insurance 
company will cover the costs associated with standard treatment, and that the research 
grants will cover costs related to research. Dr. Nabel agreed. 
Dr. Parkman asked two questions: (1) Is there data demonstrating that transduction of 
the mutant rev gene blocks HIV production in lymphocytes infected with HIV? and (2) 
Since there are 2 transduction schemes and 2 perturbations of each scheme, CD3/II^2 
and CD3/CD28 lymphocyte stimulation, are there 2 or 4 patient groups in this study? 
Dr. Miller stated that all 3 vector sequences were screened through GenBank, and that 
no open reading frames or harmful sequences were identified. 
Investigator Response-Dr. Nabel 
Dr. Nabel explained that the objective of this study is to introduce a protective gene into 
the uninfected CD4( + ) lymphocytes of HIV patients to prevent HIV replication when 
later infected with the virus. Rev is one of the essential HIV genes required for the 
transition from latent to active infection. The function of the rev gene product is to 
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