9.0 Study Parameters (revised) 
Parameters 
r~ 
Pre- Study 1 
Physical exam X 
History X 
Performance Status X 
Chemistry Survey ^ X 
Vital Signs X 
Weight X 
CBC , Diff, Platelet X 
PT , PIT X 
EKG X 
CXR X 
U/A and Culture X 
Hb s Ag , HIV X 
Assess for adverse 
events status X 
PCR on PBL and serum 
to detect recombinant 
genes X 
Assay for Rev M10 
cytotoxic T cells X 
Assay for Rev M10 
antibody X 
Pregnancy test 
(if relevant) X 
CD4 counts X 
Viral load (RNA analysis) X 
ANA, ESR, CH 50 
X 
X 
X 
X 
X 
X 
X 
X 
Day 
During Treatment 
Week 
12 16 
20 
X X 
X X X X X 
X X 
X X 
X X 
X X 
X 
X 
X 
X 
X 
X 
XXX 
X X X X 
X X X X 
X X X X 
X X X X 
XXX 
X X 
X X X X X 
X 
X 
X X X X X 
X XXX 
X X 
X X X X X 
X X X X X 
* An additional sample will be taken several minutes after injection to 
examine for the presence of DNA in circulatory PBL. 
1 Routine laboratory tests include glucose, electrolytes, BUN, creatinine 
9.1 Pre-treatment (see Table) 
The following studies will be performed as summarized in 
Table 1. 
a. Complete physical examination noting in detail any 
infections that might exist. 
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Recombinant DNA Research, Volume 18 
