You will be discharged from the hospital 14 days after you receive the altered 
virus. Before you go home, we will again test your blood, nose mucus, lung 
fluid, and stool. We must check to see if we can find the altered virus 
because we do not want you to spread this virus to other people. We do not 
expect to find altered virus in these tests. If we do find it, we will teach 
you how to protect others from being infected with the altered virus. 
After you go home, you will have to come back to the Cystic Fibrosis Clinic 
for testing. You must make six special visits (at 30, 60, 90, 180, 270, and 
365 days) after you have been given the altered virus. We will do tests each 
time you come to the clinic. We must check to find out if the altered virus is 
safe and will try to find out how it affects your disease. We will perform 
another chest X-ray and chest CT scan 90 days and 270 days after you get the 
altered virus. After one year from the date you go home, we will plan to 
continue to see you at least once a year when you come for your regular CF 
clinic visits. If you move, you should provide us with your new address. If we 
cannot find signs of the altered virus in your lungs on two successive 
bronchoscopies, we will not do any further bronchoscopies or nasal voltage 
tests. We will continue the other planned tests. 
RISKS AND DISCOMFORTS : We do not know what risks there are when people are 
given the altered AAV virus with the CFTR gene. Normally, the AAV virus does 
not make people sick, but we do not know what the altered virus will do. Since 
we do not know what the virus will do, women who are of childbearing age must 
not be pregnant while in this study. Any woman of childbearing age who joins 
the project must have a pregnancy test before they are enrolled. Both men and 
women that join this study must agree to use effective contraception during 
the study, as we do not know what the altered virus could do to a developing 
baby. 
One of the possible risks from having the virus put into your nose and lung is 
that it could cause wheezing or coughing. If this happens, it could make it 
difficult for you to breathe. The bronchoscopy procedures could also make it 
difficult for you to breathe. If this happens, we will be able to treat you by 
using oxygen, or with breathing treatments (such as bronchodi lator 
nebulizations similar to what you have had in the past) . If necessary, we 
would use other equipment to help you breathe. 
The altered virus may cause you to have problems that are like a cold, may 
produce asthma, or could produce pneumonia. You could have pain or bleeding 
from your lung or nose. Since you already have some problems with your lungs 
because of CF, cold-like symptoms that you might get from the altered virus 
could make you sick for a long time. Our studies in animals show that this is 
not likely to happen. 
There is a very small chance that the altered virus could damage the DNA in 
the cells of your lung and nose. If this happened, and we do not think this is 
likely, it could put you at a risk for developing cancer in the future. In 
animal studies to date, we have not seen the development of cancer and, 
therefore, we think the chance that cancer would develop is very small. 
It is possible that the altered virus could interact with other viruses with 
which you come in contact (like cold viruses). If this happened, the altered 
virus might form a new virus that produces new side effects. We do not think 
this will happen, but cannot be sure it will not happen. 
Recombinant DNA Research, Volume 20 
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