neurologic work up including lumbar puncture if clinically not 
contraindicated. [Note: a sample of CSF (1-3 cc) should be sent to Rm 
AC 125 FHCRC.] 
b. Pulmonary: The development of diffuse bilateral pulmonary infiltrates within 
96 hours of T cell administration or grade 3 pulmonary toxicity at any time 
after T cell infusion [see appendix 2] not attributed to an infectious etiology or 
fluid overload following Pulmonary evaluation including BAL. [An aliquot 
(25 cc) of BAL fluid should be sent to Rm AC 125 FHCRC.] 
c. Hematopoietic: A reduction in the ANC to < 500/mitf) persisting for two 
weeks and not responding to zidovudine dosage modification (Table 3) 
d. Grade III or IV organ toxicity [see Appendix 2] occurring following 
administration of HIV-specific T c and not attributable to other posttransplant 
complications. 
3. Ablation of T cell clones transduced with the HvTK suicide gene: 
There are two situations in which ganciclovir or acyclovir will be administered and 
the patients will then be evaluated for ablation of cell clones. ' 
a. As outlined in E2, patients developing toxicity attributed to the T cell infusion 
will receive ganciclovir. 
b. As outlined in H(l-3), patients requiring ganciclovir or acyclovir for the 
treatment of a herpes virus infection will also be evaluated for ablation of 
transferred T cell clones. 
c. Prior to initiating ganciclovir, 30 cc of heparinized blood should be drawn and 
sent to Rm AC 125 FHCRC. 
d. For the management of toxicities attributed to T cell therapy (E2), ganciclovir 
should be administered at a dose of 5 mg/kg IV q 12 h. for seven days. 
e. 30 cc of heparinized blood is to be drawn on days 2, 4, 7 and 10 following 
initiation of ganciclovir for PCR and functional analysis to detect HyTK 
positive HIV-specific T c [send to Rm AC125]. 
f. 10 cc serum tube for peak (1 hour post dose) and through (immediately pre 
dose) serum ganciclovir levels must be obtained on days 2 and 4 following 
initiation of ganciclovir therapy [send to room AC 125]. 
F. Zidovudine Dosage and Administration 
Zidovudine will be administered and monitored as described in protocol #526 and outlined 
below. 
1. Study Medication Supply 
a. Zidovudine will be supplied for intravenous administration as a 10 mg/ml 
solution in 20 ml amber glass ampules, with a sterile closure and overseal 
applied. Dilute with 5% Dextrose Injection, USP to 1-4 mg/ml in polyvinyl- 
chloride containers. Use within eight hours if stored at room temperature; 
twenty-four hours if stored at 5° C. 
b. Zidovudine capsules for oral administration are supplied as 100 mg in white, 
opaque bodies with maroon opaque caps. 
Zidovudine 100 mg capsules will be supplied to the study center pharmacy in 
bottles of 500 capsules each. During the time that the patient remains in the 
hospital during the posttransplant phase of the study, medication will be 
dispensed through the regular inpatient pharmacy system. During the 
Recombinant DNA Research, Volume 15 
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