CONTINUATION SHEET for cither: - 
NIH 2514-1 , Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study 
V 
CONTINUATION: page POpes. 
' possible risk that infusing activated cells may make the HIV virus more active, we will be monitoring 
I blood mart<ers of viral activity and CD4 counts frequently. We will discuss these test results with 
you at regular Intervals and will provide an ongoing assessment of the potential risks of your 
'continued participation in the protocol. These ongoing assessments will be based on your own test 
' results and on those of other participants in the study. 
'The placement of an intravenous catheter in an arm vein may be associated with localized pain and 
1 redness, and rarely, infection. If a central line must be placed Into a larger vein of the neck or chest, 
i additional risks must be considered. These include infection, local irritation about the incision sites, 
I and rarely, bleeding 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. 
I 
If you have a history of an allergic reaction to cow's milk or other beef products, you will undergo a 
I series of skin tests and an evaluation by the Allergy Consultation service at NIH. This is because 
the lymphocytes you are to receive, when grown in the lab, may be mixed with growth products 
derived from calf blood. The lymphocytes may therefore transfer a minute amount of calf products 
to you and, in an allergic person, this could result in a severe allergic reaction. During a skin test a 
Ismail amount of liquid material is injected into the skin of the forearm. If your immune system shows 
a response to the test solution, a small bump similar to a mosquito bite may form at the site. Rarely, 
the site may become inflamed or ulcerated. There is also the rare possibility that you could develop 
!a severe allergic reaction, known as anaphylaxis, to one of the test substances. This condition may 
ibe associated with low blood pressure, wheezing, difficulty breathing, and if left untreated, can even 
! jresult In death. If anaphylaxis occurs, it usually does so within minutes of injection and responds to 
jtreatment with adrenaline and other medications. 
!ln addition to the possible risks already mentioned, you will be subjected to the risks of multiple 
: ibiood drawing. These include pain, redness, and swelling at the site of blood drawing, and rarely, 
Ifainting. Each time, about 2 to 10 tablespoons (30 to 150 ml) 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. 
must emphasize that the technique of retroviral-mediated gene modification has not been used 
' pxtensively 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 
pccur. 
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Recombinant DNA Research, Volume 19 
medical record 
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