1. Dose and administration of Zidovudine will be recorded, doses and administration of 
HIV-specific T cells will be recorded. 
2. Records of concomitant medications and blood products administration will be kept. 
3. Patients will be continually evaluated for signs and symptoms characteristic of 
infections or neoplasms. 
4. Adverse experiences will be assessed and the results of a CBC (with differential, 
platelet count and MCV), chemistry panel (including serum creatinine, BUN, bilirubin 
(total), SGPT, SGOT, alkaline phosphatase, LDH, CPK, and amylase) and routine 
urinalysis will be evaluated for abnormalities. 
D. 
Evaluations during and following HIV-specific T cell Infusion 
1 . During T Cell infusion: 
a. Vital signs will be monitored every fifteen minutes during the T cell infusion 
and Q1H for 2 hours post T cell infusion. 
b. Oximetry will be monitored by finger oximeter during and 2 hours post T cell 
infusions. 
2. 24 hours post T cell infusion: 
a. CBC with differential and platelet count. 
b. Na, K, BUN, Cl, Cr, Calcium. 
c. Chest X-ray PA & lateral 
d. Neurological examination 
3. Days 1, 7 and 13 post each T cell infusion (50 ml of peripheral blood): 
a. Direct assay of PBL for retroviral vector DNA by polymerase chain reaction 
(PCR) and Southern blot analysis. 
b. HIV-specific CTL generation, with reactive cells assayed for hygromycin- 
resistant T cells and for vector DNA by PCR and Southern blot. 
c. T cell proliferation responses to HIV gp 160, Candida, tetanus, CMV and 
PHA 
4. Monthly following completion of therapy for four months and then every two months 
for six months: 
a. 10 ml blood for S + /L' assay. 
b. T cell proliferation responses to HIV gpl60, Candida, tetanus, CMV, HSV 
and PHA 
c. Assays of the peripheral blood to detect the development of donor T c 
reactivity to host lymphocytes expressing the hygromycin resistance or HSV- 
TK gene products. 
E. Additional Follow-up Laboratory Evaluations 
1. HIV-1 Western Blot on serum on days 14, 28, 56, 84 
2. HIV-1 p24 antigen on serum on days 14, 28, 56, 84 
3. HIV-1 culture on PBMCs on days 14, 28, 56, 84; viral isolates will be saved for 
sensitivity screening 
4. HIV-1 culture on bone marrow on days 14, 28, 56, 84 
5. HIV-1 RNA/DNA on PBMCs on days 14, 28, 56, 84 
6. HIV-1 RNA/DNA on bone marrow on days 14, 28, 56, 84 
7. Zidovudine peak and trough levels on days 0, 4, 14, 28, 49, 70 and 98 
8. Zidovudine peak CSF levels on days 32, and 60 
9. HIV-1 CSF culture on days 32, 60 
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Recombinant DNA Research, Volume 15 
