MEDICAL RECORD 
STU0YNLM8ff(; 
CONTINUATION SHEET for either: - 
NIH 2514-1 . Consent to Parlicipale In A Clinical Research Study 
NIH 2514-2. Minor Patient's Assent to Participate In A Clinical Research Study 
COMTINUATXDN; page 3 c< 8 pages. 
than 24 hours, as was done for the first infusion), at the discretion of the principal investigator. If any;, 
cell infusion is complicated by significant side effects, all subsequent infusions may be performed ^ 
on an inpatient basis with monitoring for at least 24 hours post infusion, at the discretion of the 
principal investigator. [ 
For the first week after each lymphocyte infusion, we will monitor on a daily basis (that is, Mondays i 
through Thursdays only) CD4 counts, viral burden and p24 antigen levels, and the presence of the \ 
gene modified lymphocytes. Thereafter these tests and others monitoring blood and urine 
chemistry, blood counts, and markers of immune function will be obtained every two to four weeks. ^ 
Six weeks after the final lymphocyte infusion has been administered, visits to NIH will be scaled ^ 
back to monthly. Six months after the final lymphocyte infusion, your participation in the protocol ‘ 
will be completed and you will return to the sole care of your private physician. 
POTENTIAL RISKS 
The procedures involved in this study carry several potential risks. The risks can be divided into |- 
those related to the gene modification, those related to cell infusions, and those related to the other ^ 
protocol procedures. The risks related to gene modification are discussed in a separate consent | 
form that you will also be asked to sign. j 
The risks of infusing white blood cells. Independent of gene modification, 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 unlikel)!; 
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 1 
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. il 
It is possible that giving you activated cells may make your HIV infection worse rather than better, I 
which could conceivably hasten the progression of your disease. In a small number of people with i 
HIV infection who received activated CDS cells on other protocols, no worsening was reported, but ; 
these results are still preliminary. In studies conducted at NIH, interleukin-2 infusions have been 
given to HIV patients for as long as 28 days without evidence of acceleration of their disease. 
Interleukin-2 is a lymphocyte activator, and giving it intravenously should produce a degree of 
lymphocyte stimulation similar to that which we hope to achieve on this protocol. Because of the ; 
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Recombinant DNA Research, Volume 19 
