of doses of one million and 10 million HIV-IT (V) cfu, respectively. 
The first HTV-IT (V) treatment group will be paralleled by a concurrent 
placebo control group. All placebo control subjects will be provided the 
opportunity for crossover to the highest well tolerated dose of HIV-IT 
(V). 
4. 4. 3. 2 Subjects will be randomly assigned to HIV-IT (V) and control groups at 
the time of their formal admission to the study. Control subjects will 
have the option to cross-over to the highest well tolerated dose of HIV- 
IT (V) after at least three subjects in the high dose group have been 
evaluated for two weeks beyond their final HIV-IT (V) injections. 
4. 4. 3. 3 Each subject in the HTV-IT (V) groups and in the placebo control group 
will receive four 0.5 ml product injections IM on each injection day. 
Injections will be made bilaterally into the deltoid and into the gluteus 
maximus. 
4. 4. 3. 4 The first dosage group will complete all three injections, given at 28 day 
intervals, followed by a two-week safety evaluation. Thereafter HTV-IT 
(V) will be administered to the higher dosage group. 
4. 4. 3. 5 Safety will be evaluated by physical examination, interim clinical 
history, and laboratory analyses. Any deviations from normal will be 
scored according to the BRMP toxicity scale included in Section 4.14.0. 
4. 4. 3. 6 The minimum number of patients for each of the three subject groups in 
this study is provided in Table I (4.4.1). 
4.4.4 Summary of Blood and Urine Samples to be Collected from all 
Subjects for Both Routine and Specialized Laboratory Tests 
4.4.4. 1 Blood samples will be drawn at Days -4 and 24 to assess by PCR 
possible migration of the neo r marker gene. On follow-up Day 70 and 
Month 12, further blood samples will be drawn and assessed by PCR to 
R 
detect evidence of persistence or spread of the NEO marker from HTV- 
IT (V). Additional blood samples will be drawn at Days -4, 12, 24, 36, 
52, and during follow-up at Days 70 and 84, and Months 6, 12, 18, 24, 
30 and 36 to assess safety and tolerability, to measure the 
immunostimulatory effect of HIV-IT (V), and to identify changes in 
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