4.4. Study Plan 
4.4.1 HIV-IT (V) Phase I Study Schema 
Informed Consent 
Clinical History & 
Physical Exam 
Prepare target cells for CTL 
assays 
Initial Screening 
Baseline blood and 
urine tests 
Formal Admission 
Dosaee GrouD I 
Follow-up at Day 70 
Safety Evaluation 
First Dosage Level; HIV-IT (V) on Days 0, 
28 and 56 (concurrent with Control Group) 
Control Group I 
Follow-up at Day 70 
Safety Evaluation 
Placebo on Days 0, 28 and 56 
Dosaee Group II 
Follow-up at Day 70 
Safety Evaluation 
Second Dosage Level HIV-IT (V) on Days 
0, 28 and 56 
Control GrouD-Crossover 
Follow-up at Day 70 
Safety Evaluation; Sponsor's 
Full Initial Evaluation and Study 
Reports to Regulatory Agencies 
Highest well tolerated dose of HIV-IT (V) 
on Days 0, 28 and 56. 
Follow-up 
Continuing follow-up 
Sponsor's Mid-Term 
Evaluation 
Sponsor's Interim Report(s) to 
Regulatory Agencies 
Month 12 
Long-Term Follow-Up 
Sponsor's Long- 
Term Evaluation 
Sponsor's Interim and Final 
Report(s) to Regulatory Agencies 
(Up to 3 years at 6 month intervals) 
Recombinant DNA Research, Volume 17 
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