potential surrogate measures of outcome. See the Subject Schedule 
(Section 4.13.0). 
4. 4.4. 2 Urine samples will be collected prior to injection on Treatment Days -4, 
24, and 52, and on follow-up Day 70 and Months 6, 12, 18, 24, 30 and 
36. 
4.4.5 Sample Shipment Instructions 
4.4.5. 1 Whole blood and serum samples will be labeled with the appropriate 
subject identification number, time and date of collection, wrapped in 
absorbent material and packaged in leak-proof, crush-resistant mailers 
following standard bio-hazard materials transportation regulations. All 
samples will be transported immediately by courier to Viagene's 
BioSafety Level 3 laboratory or to contracted vendor laboratories for 
processing. 
4.5. Formal Admission and Evaluation During the Treatment Phase of the Study 
4.5.1 To be eligible for Cycle I product administration (see Table I), subjects must have a 
reconfirmed, mean, CD4 + T-cell count that is either > 400 or > 20% or approaches 
either of these values and is within the range of experimental error for the laboratory 
performing the CD4 assay. Subjects must continue to meet the inclusion and 
exclusion criteria as stipulated in Sections 4.3.1 and 4.3.2. 
4.5.2 To be eligible for crossover administration of HIV-IT (V), control subjects must not 
have developed any AIDS defining conditions, although their CD4+ T-cell counts 
may have dropped below 400. Subjects must continue to meet all the inclusion and 
exclusion criteria as stipulated in Sections 4.3.1 and 4.3.2. 
4.5.3 Subjects will be required to provide a blood sample 4 days prior to each injection 
day. 
4.5.4 A chem profile, CBC/diff, platelet count, and urinalysis will be performed on Days 
-4, 12, 24 36, and 52, and on follow-up Day 70, and Months 6, 12, 18, 24, 30 and 
36. An interim clinical history and relevant physical examination will be performed 
on Days 28 and 56 to detect the occurrence of any adverse reactions since the 
previous injection, and on follow-up Days 70 and 84 and Months 6, 12, 18, 24, 30 
and 36. 
Recombinant DNA Research, Volume 17 
