RISKS 
The Treatment [HIV-IT (V)] has not been given to humans until now, 
so it is not known exactly which risks and discomforts might occur. 
A. Potential risks or discomforts include: 
1 . Blood sampling may cause pain, bruising or infection. 
2. The skin test may cause pain, itching, redness, blisters or sores at the 
application sites. Very rarely, a serious allergic reaction may occur. 
3. Injections may cause pain, soreness, redness, warmth, itching, 
numbness or swelling at the injection site. 
4. An allergic reaction to the injected materials could cause fever, chills, 
sweating, dizziness, shortness of breath, rash, itching, stomach or 
intestinal pain, nausea, vomiting, diarrhea, low blood pressure or 
fainting. Very rarely, some individuals could experience an allergic life- 
threatening reaction called "anaphylaxis"; however, this anaphylaxis is 
readily treatable. 
5 . Prior studies have been carried out at the National Institute of Health in 
which a similar disabled virus has been used. The disabled virus 
employed by Viagene has a common origin with the one used in the 
National Institute of Health studies; however, it is grown in dog rather 
than mouse producer cells and contains a different therapeutic gene, 
namely one aimed at instructing cells to produce an HIV- 1 -related protein 
which is intended to trigger active cytotoxic T lymphocyte responses. 
B. Unforeseen complications, which are concerns that are not expected, but 
conceivably could occur, include: 
1 . Unknown disease caused by the disabled virus that is used to insert the 
new gene into my cells. 
2. Unknown disease caused by genetic material activating an unknown 
virus in my body. 
3 . Unknown effects from undetected contaminants in the treatment. 
4. Malignant diseases, such as cancer or lymphoma. 
5. Changes in the genes of my sperm or ova which could have unknown 
effects on unborn or future children. 
6. Worsening of my HIV infection. 
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Recombinant DNA Research, Volume 17 
