• Hematology and coagulation (as before) at baseline and every 2 weeks 
thereafter (weeks 3, 5, 7); 
• Blood chemistries (as before) at baseline and every 2 weeks thereafter (weeks 
3. 5, 7); 
• Blood sample for special laboratory studies: 
• • CD4, acid-dissociated p24 antigen, viral burden (e.g., branched DNA 
or bDNA) days 1-4, then every 2 weeks thereafter (weeks 1,3, 5,7); 
• • PCR for CD4-zeta gene days 1-4 and every 2 weeks thereafter or until 
no detectable signal on 2 consecutive samples; 
• • RCR testing monthly (e.g., weeks 5 and 9); 
• Urinalysis at baseline and every 2 weeks thereafter (weeks 3, 5, 7); 
• Continuous record of adverse events (see Sections 10 and Appendix D). 
Treatment Period II 
• Vital signs at times 0, 15, 30, and 60 minutes during the infusion on day 1; 
• Oxygen saturation by continuous pulse oximetry throughout the infusion 
period; 
• Complete physical examination (as before) at start of period (week 1), and at 
week 5 of each 8- week treatment); 
• Hematology and coagulation (as before) monthly (weeks 1 and 5) of each 8- 
week treatment); 
• Blood chemistries (as before) monthly (weeks 1 and 5) of each 8-week 
treatment); 
• Blood sample for special laboratory studies: 
•• CD4, acid-dissociated p24 antigen, viral burden (e.g., bDNA) days 1-4 
then at week 5 of each 8-week treatment; 
•• PCR for CD4-zeta gene days 1-4 and every 2 weeks or until no 
detectable signal on 2 consecutive samples; 
•• RCR testing monthly (weeks 1 and 5); 
• Urinalysis monthly (weeks 1 and 5); 
• Continuous record of adverse events until resolution unless deemed non-drug 
related or irreversible. 
7.3 Off-Study 
When the patient completes the study or terminates early for any reason, the following 
should he performed if at all possible: 
• Complete physical examination and performance status; 
• Disease evaluation; 
• Final laboratories (hematology and coagulation, blood chemistries, RCR 
testing, urinalysis); 
• Status of adverse events; 
• Reason for study removal. 
7.4 Follow-up 
The Investigator will assess the patient after the last treatment period for the following: 
• Treatment and monitoring of all adverse events until resolution, unless disease- 
related, non-drug related, or irreversible; 
• RCR testing (as before) monthly for 3 months after study completion, quarterly 
for one year, then annually thereafter; 
• Performance and disease status monthly for 6 months. 
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