MEDICAL RECORD CONTINUATION SHEET for either: - 
NIH 2514-1. Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Part'jcipate In A Clinical Research Study 
STUDY NLMBBT: COfsmNUATOM: page 2 d 3 pages. 
lymphocytes will be separated into CDS (T8) cells and grown separately in the lab. After 1 to 4 days 
of growth, a new gene called [CD4-zeta] may be inserted into the cells. 
The process involved in introducing the new gene is accomplished by first inserting the gene into a 
vector (i.e., an organism that carries material from one cell to another). In this study, the vector to be 
used is prepared from a disabled mouse retrovirus-that is, a virus that is not able to reproduce and 
that normally infects only mice. The vector is mixed with the cells in the laboratory, enters the cells, 
and inserts the new gene into the cells* genetic material (chromosomes). Once inserted, the new 
gene will survive as long as the cell survives. The new gene will be used to direct your twin's 
lymphocytes to kill HIV-infected cells in your body. In this way, the total viral burden may be 
reduced. 
POTENTIAL RISKS 
The risks related to gene transfer are theoretical, since the experience with gene marking and gene 
therapy experiments in humans thus far demonstrates no serious side effects, toxicities, or other ill 
effects due to gene modification of cells using retroviral vectors. 
One potential risk relates to the vector. Even though the vector used to transfer the CD4-zeta 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. In human 
experiments, where more that 30 patients have received gene modified cells, no evidence for the 
presence of "growing vector" has been seen, and no lymphomas or other cancers related to the 
gene modified cells have occurred. 
Another theoretical risk is that the new gene may, by randomly inserting into the chromosome, 
disrupt a gene essential for maintaining cell function and that particular cell might die. 
We must emphasize that the technique of retroviral-mediated gene transfer has not been used 
extensively in humans. Because this is such a newly introduced procedure, it is possible that 
despite all of our efforts, other unforeseen, perhaps serious and life-threatening, problems may 
occur. 
Since this study involves a new treatment approach to patients with HIV infection, it will be 
important to maintain contact with you so that we can monitor your overall progress and monitor for 
any possible long term side effects. In the event of your death, we would request an autopsy for the 
purpose of determining the cause of death. 
Recombinant DNA Research, Volume 19 
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