TABLE I 
PHASE I DOSE ESCALATION STUDY OF HIV-IT (V) 
Minimum # of 
Subjects 
Product Administration: 
Cycle I 
Product Administration: 
Cycle II (Crossover) 
Stage 1 
5 
106 HIV-IT (V) cfu 
5 
Placebo Control 
X 
10 7 HIV-IT (V) cfu 1 
Stage 2 
5 
10 7 HIV-IT (V) cfu (Control) 
15 Subjects 
1 All control subjects will be provided the opportunity for crossover to the highest well 
tolerated dose of HIV-IT (V). 
No control crossover injections will be initiated until at least three of the Stage 2 (highest dose) 
HIV-IT (V) recipients have been evaluated for at least two weeks after their third injection. 
4.4.2 General Plan for Provisional Admission 
4.4.2. 1 After completion of the screening evaluation and documentation of 
Informed Consent, qualified subjects will be admitted into this clinical 
study. Admission requires that: (1) the subjects meet all entrance 
criteria, and (2) the subject's peripheral blood leukocytes transform, 
transduce and propagate satisfactorily for CTL target cell development. 
4. 4. 2. 2 A portion of the 100 ml sample of blood will be used to generate an 
immortalized, autologous B cell line. The immortalized cells are 
transduced with a retroviral vector encoding the HIV- linB env, rev and 
the neo r genes. These cells are then used as in vitro stimulators and as 
immunological targets in the CTL assay. Additional laboratory tests 
may be performed on this and other blood samples to verify a subject's 
continued eligibility for the study. 
4.4.3 General Plan for Formal Admission and Treatment Phase of the 
Study 
4.4.3. 1 The clinical study will proceed in two successive stages represented by 
two HIV-IT (V) escalating dose groups. These two stages will consist 
[904] 
Recombinant DNA Research, Volume 17 
