4.9.5 If, in the opinion of the attending physician, subjects develop symptoms which 
justify further diagnostic tests and/or procedures, results of such tests and/or 
procedures should be reported in appropriate Case Report Forms. Such Case 
Report Forms will be submitted to Viagene at follow-up Day 70 of each cycle even 
if test results are still pending. Any follow-up test/procedure information should be 
forwarded to Viagene when results are available. 
4.10 Potential Benefits 
HIV-IT (V) may generate an immune response (CD8 + CTL and/or antibody) which will 
retard HIV-1 spread and progression towards AIDS. Information generated by this study 
will increase scientific knowledge about the safety and possible therapy effectiveness of a 
gene- transfer approach to HTV-1. 
4.11 Risk/Benefit Ratio 
The risk/benefit ratio seems justifiable because many precautions are taken to ensure the 
safety of the HIV-IT (V) product and of the placebo for recipient subjects. There is the 
possibility that HTV-IT (V) may stimulate an immune response that may help control HTV-1 
disease progression. 
4.12 Informed Consent 
Subjects will receive a copy of the "Patient Brochure", fully describing the nature and 
purpose of the study, including the relevant background and research findings, a 
comprehensive description of risks, discomforts, and potential benefits. After this 
brochure has been reviewed by the subject and discussed with the Principal Investigator, 
informed consent will be obtained by the investigators prior to initiating the protocol. The 
Informed Consent follows in Section 5.0 
4.13 Subject Study Schedule 
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