6.6 Conditions Which May Necessitate Discontinuation of a Subject's Treatment 
6.6.1 If recurrent ACTG grade 3 or greater toxicity, possibly or probably related to study 
therapy, is encountered; or 
6.6.2 If, in stratum #2, subjects with entry CD4+ T cell counts from 200-499/p.L or from 
15-29% repeated CD4 + T-cell counts obtained at least 72 hours apart decline to < 
50% of pre-treatment values. 
6.6.3 If, in the attending physician’s judgment, the subject's condition precludes even 
temporary suspension of approved anti-retroviral drug therapy; or 
6.6.4 If there are any willful protocol violations; or 
6.6.5 If a subject develops another illness which requires treatment with a drug or agent 
(e.g., any immunosuppressive or chemotherapeutic agent) which is likely to interfere 
with the activity of the gene-based immunostimulatory product investigated under this 
protocol; or 
6.6.6 If the subject elects to withdraw from the study; or 
6.6.7 If, in the opinion of the attending physician, it is in the subject's best interest to 
withdraw from the study. 
6.7 Termination of Study and Follow-Up Evaluation 
6.7. 1 Product administration may be terminated at any time, at the subject's request. 
6.7.2 Subject participation may be terminated by the attending physician if justified by the 
subject's clinical status or if deemed in the subject's best interest. 
6.7.3 The protocol or any individual subject's study may be terminated by written 
communication from Viagene. 
6.7.4 Anyone receiving experimental treatment will be followed for at least 3 years. 
7.0 Potential Benefits 
Society and those infected with HIV-1 will benefit if this therapy is tolerated and proves to be 
effective in larger trials. HIV-IT (V) has the theoretical possibility of generating an increased 
immune response, particularly CD8 + CTL activation, which may retard HIV-1 spread and 
progression towards AIDS. 
8.0 Benefit/Risk Ratio 
The benefit/risk ratio is justifiable because many precautions are taken to minimize the risk 
associated with the HIV-IT (V) product for recipient subjects. There is the possibility that 
HIV-IT (V) may stimulate an immune response that may help control HIV-1 disease 
progression. 
9.0 Plan of Analysis 
9. 1 Data collected during this Phase I/II study will include the following variables; clinical history 
and physical examination parameters, vital signs, report of adverse events, chemistry profile, 
CBC and differential, platelet count, urinalysis, CD4 + T-cell count, HIV-1 antibody titer, 
leukocyte viral load by PCR and CTL response. These variables will be measured at multiple 
time periods. Findings from this study will be tabulated and presented, and results will be 
analyzed. All out of range laboratory data will be addressed. 
9.2 Pre-treatment versus post-treatment comparisons of selected continuous variables will be made 
using analyses of variance (ANOVAs). Pre-treatment versus post-treatment comparisons of 
selected categorical variables will be made using Fisher's Exact tests or categorical log-linear 
models. 
9.3 Upper 95% exact binomial confidence limits will be performed for any toxicides whic.. . 
Recombinant DNA Research, Volume 18 
[705] 
