occur. These limits will be used to predict the maximum toxicity rate which might be expected 
to occur in the larger population of the same subject subset. 
The table below illustrates this analysis. For example, if a single ACTG Toxicity Scale Grade 
I or greater toxic event is observed within ten subjects, then, with a power equal to 80% and 
an alpha of 5% (one-sided), the true, expected toxicity rate in the larger population would be 
unlikely to exceed 40%. 
Upper 95% exact binomial confidence limits: 
Number Percent of subjects likely to experience 
of Subjects a Grade I or greater toxic reaction 
when number of observed reactions is 
Q 1 2 
5 
45 
66 
82 
10 
26 
40 
51 
15 
19 
28 
37 
10.0 Consent Procedures 
Subjects will receive a copy of the "Patient Brochure", fully describing the nature of the vector, 
the purpose of the study, and its design, including the relevant background and research 
findings, a comprehensive description of dose administration, and attendant 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 Appendix 1 . 
11.0 Appendices 
Appendix 1: 
Appendix 2: 
Appendix 3: 
Appendix 4: 
Appendix 5: 
Informed Consent 
CDC HIV Classification (MMWR 12/18/92) 
Table 1 — Study Plan 
CCTG Study Schedule 
ACTG Toxicity Scale 
[706] 
Recombinant DNA Research, Volume 18 
