C. In addition, there are the other potential disappointments and uncertainties. 
For example, it may not be possible: 
1. To measure whether my immune response has been helped by the 
treatment. 
2. To determine whether any immune system changes will actually help 
control my HIV disease. 
3 . To receive the experimental treatment. 
NOTE: The above complications were not observed in animal studies using 
HIV-IT (V) or in those related types of human gene therapy studies that 
have reported their results. The viral vector will be tested for safety before 
I am injected to reduce any risk of their causing illness or side effects. My 
CD4 cell count will be checked regularly and I will not be given additional 
injections if my CD4 count suggests that the Treatment or other factors 
might be making my HIV infection worse. 
SAFEGUARDS 
To further protect my health and safety, a Monitoring Board, independent of the 
sponsor and investigators, will review data about my condition after each injection to 
determine whether it is safe for me to receive continued injections. This Board will consist 
of at least three professionals, one or more of which will be a physician. 
FINANCIAL CONSIDERATIONS 
If I experience an adverse reaction during the Study, I should immediately contact 
the Investigator at (818) 344-611 1. If I require medical treatment for an adverse reaction, 
the Sponsor, Viagene, Inc., will pay for reasonable costs of such treatment under the 
following conditions: 
A. The Investigator determines, based on reasonable evidence, that the adverse 
reaction was a direct result of the Treatment administered during the Study; 
B. The costs of treatment are not covered by any other health insurance, 
government health program or other third party providing coverage for health 
care. 
Recombinant DNA Research, Volume 17 
[919] 
