Title: An Open Label, Phase I/II Clinical Trial to Evaluate the Safety and 
Biological Activity of HIV-IT (V) (HIV-1 IIIBcwv/rev-Retroviral Vector) in 
HIV-l-Infected Subjects 
S ponsor: 
Viagene, Inc. 
11075 Roselle Street 
San Diego, CA 92121 
Protocol 
Principal Investigator: 
Richard Haubrich, M.D. 
Co-Investigator: 
Site of Study: 
Sponsor’s Representatives: 
J. Allen McCutchan, M.D. 
UCSD Treatment Center 
2760 Fifth Avenue, Suite 300 
San Diego, CA 92103-6325 
John Warner, Ph.D. 
HIV-IT Project Leader 
Bruce Merchant, M.D., Ph.D. 
Vice President, Clinical Development 
and Regulatory Affairs 
TABLE OF CONTENTS 
1.0 Objectives 2 
2.0 Background and Rationale 2 
3 . 0 Subject Selection 10 
4.0 Procedures 11 
5.0 Risks and Discomforts 11 
6 . 0 Risk Management 13 
7.0 Potential B enefits 14 
8 . 0 Benefit/Risk Rati o 14 
9 . 0 Plan of Analysis 14 
10.0 Consent Procedure 15 
11.0 Appendices 
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Recombinant DNA Research, Volume 18 
