RECIPIENT CONSENT 
PAGE 4 
the presence of helper virus has been seen and no lymphomas or other cancers 
related to the gene modified cells have occurred. 
Another theoretical risk is that the neoR gene may, by randomly inserting into 
the chromosome, disrupt a gene essential for maintaining cell function and that 
particular cell might die. Since cells that contain the neoR gene will be able to 
inactivate the antibiotics neomycin and amikacin, participants in this study may 
developLresistance to these antibiotics. If a bacterial infection should develop, these 
antibiotics would not be suitable for treatment and alternative agents (such as 
gentamicin or tobramycin) would need to be administered. 
The risks of infusing white blood cells, independent of gene marking, include 
fevers, chills, muscle aches, joint aches, local pain and redness at the site of infusion, 
skin rash, and severe allergic reactions. Depending on the severity of the reaction, the 
infusions may be slowed or stopped. In addition, medications such as aspirin, 
acetaminophen (Tylenol®), ibuprofen (Motrin®), meperidine (Demerol®), or 
antihistamines may be administered for relief of symptoms. In the unlikely event that 
the cell cultures become contaminated with bacteria or fungus, infusion of the 
contaminated cells may lead to infection of the bloodstream that may spread to other 
organs. To further reduce the potential for this already unlikely event to occur, the cell 
cultures will be monitored regularly for contamination up to the time of infusion. In the 
event of a severe reaction to the cells, emergency life support and skilled personnel 
will be immediately available. Other theoretical, but extremely rare, risks include blood 
clots that may form in your veins, irregular heart beat, and sudden death. - 
The placement of an intravenous catheter in an arm vein may be associated 
with localized pain and redness, and rarely, infection. If a central line must be placed 
into a larger vein of the neck or chest, additional risks must be considered; these 
include: infection, local irritation about the incision sites, and rarely, t?leeding in the 
chest cavity or a punctured lung. Should a central line be required, the potential risks 
will be discussed with you in greater detail and you will be asked to sign another 
consent form for that procedure. 
In addition to the possible risks already mentioned, you will be subjected to the 
risks of blood drawing. These include pain, redness, and swelling at the site of blood 
drawing and, rarely, fainting. Each time, about 2 to 10 tablespoons of blood will be 
drawn. The amount of blood drawn will not exceed 30 tablespoons (450 ml) in a six- 
week period, which is within the guidelines set by the Clinical Center of the National 
Institutes of Health. 
We must emphasize that the technique of retroviral-mediated gene transfer has 
not been used extensively in humans and has never been used in individuals infected 
with HIV-1 . Because this is the first gene transfer experiment in HIV-infected humans, 
Recombinant DNA Research, Volume 16 
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