4.5.5. The cumulative incidence rate of a set of early signs and symptoms of disease, 
termed Clinical Event Markers, will be developed from data obtained from the 
interim history records. This will provide a preliminary indication of possible 
effects on disease progress and will serve as another indicator of safety. These 
markers will include HIV-related symptoms as defined by CDC classification (and 
in addition Candida infections, Herpes zoster , hairy leukoplakia, seborrheic 
dermatitis, sinusitis, lymphadenopathy, and weight loss). These measures will be 
taken on Days -4, 28 and 56 prior to injection, and on follow-up Days 70 and 84, 
and Months 6 and 12. 
4.5.6 A blood sample will be obtained for measurement of circulating CTL at Viagene's 
laboratory, employing an experimental 51 Cr release assay, on Days -32, -18, -4, 
12, 24, 36, and 52 and on follow-up Days 70 arid 84, and Months 6 and 12. 
4.5.7 T-cell subset assays will be performed on Days -90, -18,-4, 24, and 52, and on 
follow-up Days 70 and 84, and Months 6, 12, 18, 24, 30 and 36. 
4.5.8 A blood sample for HIV-1 gpl20 ELISA antibody assay will be obtained on Days 
-90, -32, 12, 24, 36 and 52, and on follow-up Day 70, and Months 6, 12, 24, and 
36. Additionally, assays for anti-retroviral drugs may be performed at any time 
during treatment and follow-up at the discretion of the Investigators. 
4.5.9 A blood sample for measuring leukocyte viral load and other biological assays 
(potential surrogate markers) will be obtained on Days -90, -32, -4, 12 and 52 
(prior to injection), and on follow-up Day 70, and Months 6, 12, 24 and 36. 
Leukocyte viral load will be determined by p24 antigen levels following 
cocultivation of subject PBMC. An experimental assay employing PCR for HIV 
nucleotide sequences may also be used. 
4.5.9. 1 The selection of assays to be performed on a subject's blood sample at 
any given time point will depend on (1) specimen availability, (2) whether 
an assay(s) under development at Viagene has(have) been established for 
use, and (3) predetermined assay priorities. The assays have been 
grouped into three categories and, reflecting the trial's emphasis on safety, 
have been prioritized as follows: 
(1) Patient Health & Safety (e.g. clinical chemistry and hematology 
panels, CD4 + T lymphocyte counts), 
(2) HIV Disease Status (e.g. CD4 + T-cell counts, viral burden), 
(3) Biological Activity (e.g. CTL, and antibody assays). 
Recombinant DNA Research, Volume 17 
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