4.5.10 In order to assess the pharmacokinetics of the neo r marker by PCR at Viagene's 
laboratory, a 5 ml heparinized blood sample will be obtained on Days -4 and 24 
for participants in each treatment cycle. PCR assay for neo r on blood samples 
taken at follow-up Day 70 and Month 12 will also be performed to detect evidence 
of persistence or spread of HIV-IT (V). See Subject Schedule (Section 4. 13.0). 
4.5. 10. 1 Designated blood samples will be shipped to Viagene according to the 
specific procedures to be provided. 
4.5.11 The subject will be observed continuously for the first fifteen minutes following 
each injection and at 30, 60, and 120 minutes thereafter. Vital signs (BP, P, T, R) 
will be obtained prior to each injection and at 15, 30, 60 and 120 minutes 
following each injection. 
4.5.12 Adverse reactions will be noted on the Adverse Reaction Case Report Form as they 
occur. The Baseline Symptom Checklist will be completed on entering the study 
and before the first injection. 
4.6 Plan of Analysis 
4.6. 1 Data collected during this Phase I study will include the following variables: 
clinical history and physical examination parameters, vital signs, report of adverse 
events, chemistry profile, CBC and differential, platelet count, urinalysis, CD4 + T- 
cell count, HTV antibody titer, viral load, CTL response, neo r in blood by PCR, 
and selected surrogate markers. These variables will be measured at multiple time 
periods. Findings from this study will be tabulated and presented, and clinically 
meaningful results will be analyzed. For example, a drop of 40% in CD4+ T-cell 
count from the formal admission level might indicate a safety issue to be 
investigated. Likewise, all out of range laboratory data will also be addressed. 
4.6.2 Pre-treatment versus post- treatment comparisons of selected continuous variables 
will be made for individual HIV-IT (V) dosage groups and the Control Group, and 
for both HIV-IT (V) dosage groups combined versus the Control Group using 
analyses of variance (ANOVAs). Pre-treatment versus post-treatment comparisons 
of selected categorical variables will be made for the Control Group and individual 
HIV-IT (V) dosage groups combined using Fisher's Exact tests or categorical log- 
linear models. 
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