TABLE 1: HIV-Specific CTL Administration— Dose Escalation 
Dose Level Maximum CD8 + T Cells Administered 
1 lx 107m 2 
2 3.3 x 107m 2 
3 1 x 107m 2 
4 3.3 x 107m 2 
Note: If the transduced clones are non toxic but are subsequently ablated due to acyclovir or 
ganciclovir therapy for a herpes virus infection, repeat infusions of nontransduced T e 
clones may be given up to the dose level of transduced T cells previously 
administered to that patient. 
4. Each infusion will consist of a composite of up to ten T cell clones to achieve the cell 
dose under study. 
5. T cell clones will be harvested from the cultures, washed three times with RPMI- 
Hepes and resuspended in 100 ml of 0.9% NaCl with 2% human AB serum. 
6. T cells will be infused through the Hickman catheter over 30 minutes. 
7. Intravenous tubing will be provided for T cell administration and no filters will be 
used in the infusion line. The infusion bag will be gently mixed every five minutes 
during the infusion. 
8. Patients will have vital signs obtained pre infusion, every fifteen minutes during the 
infusion, at the end of the infusion and hourly for two hours following the infusion. 
A research nurse will be available to do vital signs. 
9. Patients will have oxygen saturation measured by oximetry pre infusion, immediately 
post infusion and two hours post infusion. The primary physician should be notified 
if the 0 2 saturations are less than 90%. 
10. The initial two patients will receive T cell therapy as inpatients. If no toxicities are 
observed, subsequent patients may receive T cell infusions in the outpatient 
department. 
E. Management of Toxicities and Complications 
1 . Constitutional Symptoms Mild symptoms have been observed with LAK and TIL cell 
infusions and might occur in patients receiving HIV-specific T c . The management of 
these transient toxicities is outlined below. 
a. Fever, chills and temperature elevations > 101 may be managed with 
acetaminophen 650 mg. p.o. q 4-6 h. All patients developing fever and chills 
will have blood cultures obtained. 
b. Headache: may be managed with Acetaminophen. 
c. Nausea, vomiting: may be managed with diphenhydramine 25-50 mg IV. 
d. Hypotension: may necessitate fluid replacement. 
2. Toxicities that might occur following T cell infusion warranting ablation of adoptively 
transferred T, clones 
a. Neurologic: focal neurologic signs, aseptic leptomeningitis or encephalopathy 
within 96 hours of T cell infusion or grade 3 CNS toxicity at any time after T 
cell infusion [see appendix 2] that is unexplained following complete 
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Recombinant DNA Research, Volume 15 
