TABLE OF CONTENTS (CONT.) 
7.0 CRITERIA FOR DISCONTINUATION OF STUDY PATIENTS 15 
7.1 Criteria for Treatment Discontinuation 15 
7.2 Criteria for Study Discontinuation 16 
8.0 ADVERSE EXPERIENCES 16 
Appendix III is Adverse Experience Reporting 
9.0 EVALUATION OF RESPONSE/ENDPOINTS 16 
9.1 Toxicity 16 
9.2 Clinical Responses 17 
9.3 Immunological End-Points 17 
10.0 DOCUMENTATION, RECORD KEEPING, CRFs 18 
11.0 DATA COLLECTION AND STUDY MONITORING 19 
12.0 BIOSTATISTIC AL CONSIDERATIONS 19 
13.0 ETHICAL CONSIDERATIONS 19 
13.1 Informed Consent 19 
(see Appendix VI) 
13.2 Patient Confidentiality 20 
13.3 Patient’s Financial Responsibilities During the Study 20 
14.0 CRITERIA AND PROCEDURES FOR PROTOCOL MODIFICATION 
AND STUDY TERMINATION 20 
15.0 REFERENCES 20 
APPENDICES : 
I SCHEDULE OF EVALUATIONS 
H TOXICITY GRADING TABLE 
HI ADVERSE EXPERIENCES REPORTING 
IV PRECLINICAL DATA (two manuscripts by Miller et al, one by Economou et al, one 
by Chiang el aD 
V RETROVIRAL VECTOR 
VI PATIENT INFORMED CONSENT 
VH BIOSKETCHES 
VIH INSTITUTIONAL APPROVALS 
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