UCSD Project 93-418 
7/22/93 
CCTG 705 
Version 1 .4 
Participation may involve some added risks or discomforts. These include: 
A. The risk of drawing blood includes pain, bruising, and rarely, local infection. 
B. The risk of skin testing includes pain, itching, redness, blisters, and very rarely, an 
allergic reaction. 
C. Injection with HIV-IT(V) may cause pain, soreness, redness, warmth, itching, 
numbness or swelling at the site of injection. 
D. Rarely an allergic reaction to any of the material injected could occur. If this 
happens fever, chills, sweating, dizziness, shortness of breath, rash,, itching, 
nausea, vomiting, or low blood pressure might occur. Very rarely an individual 
may experience a life threatening allergic reaction to any material. 
E. The risks of injection of HIV-IT (V) are unknown at this point. Potential risks 
include the following: 
i. Disease could be caused by the disabled virus which is used to insert a 
new gene into my cells. 
ii. Unknown disease could be caused by the genetic material activating an 
unknown virus in my body. 
iii. Effects could occur from undetected contaminants from the treatment. 
iv. Cancer or lymphoma could occur. 
v. HIV infection may be made worse by this therapy. 
F. HIV-IT(V) has a theoretical risk of changing the genes of my sperm or ova. This 
is considered unlikely because animal experiments have shown no evidence that 
HIV-IT(V) can change the genes in the sperm of the animals tested. However, the 
risk to a future child is unknown and information from animal studies may or 
may not predict what will happen in humans. 
G. The above complications were not observed in animal studies using HIV-IT(V). 
The viral vector (HIV-IT(V)) will be tested for safety before I am injected to reduce 
any risk of it causing illness or side effects. My CD4 cell count and other blood 
tests will be checked to assure that no health problems have occurred. If my CD4 
count or other lab tests suggest that the treatment is making my HIV infection 
worse, then I will not be given further injections. 
H. Participation in the study requires that I use a barrier form of contraception (ie 
condom). This is to prevent 1) pregnancy in myself or my partner and 2) the 
possibility of transmitting the disabled virus in HIV-IT(V). 
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Recombinant DNA Research, Volume 18 
