and will include: 
5.5. 2.1 serial quantitative determination of neoR gene in DNA 
extracted from patient's peripheral blood lymphocytes 
by PCR 
5. 5. 2. 2 serial determination of CD4 and CD8 counts and 
percentages, T cell proliferative responses and 
cytotoxicity 
5.5.2. 3 serial serum p24 antigen levels 
5. 5. 2. 4 serial quantitative determination of HIV viremia . 
Cells, serum, and plasma will be stored and these tests run in 
batches. 
5.6 Management of Toxicity 
Children with SCID treated by bone marrow transplantation have 
been given up to 109 bone marrow cells/kg intravenously; cell 
infusion is usually without complications. In the treatment of children 
with ADA deficiency with approximately 2 x 1 genetically-modified 
lymphocytes, no complications other than transient low grade fevers 
have been observed in association with the infusions. 
This protocol is classified as research involving greater than minimal 
risk but presenting the prospect of direct benefit to the individual 
subject. Discomforts to the patient may include venipuncture and/or 
other modes of vascular access. Potential side effects that may occur 
during the cell infusion are chills, fever, tachycardia, nausea, 
vomiting, and/or shortness of breath. Cancer patients treated with IL2' 
infusions alone or with IL2 plus 2-4x1 Oil cultured expanded 
autologous T cells have experienced transient symptoms which may 
reflect immune phenomena such as joint aches (not arthritis) and skin 
rashes. Such symptoms occur in less than 1/3 of patients and have 
been associated with IL2 treatment alone at similar frequencies, 
making any potential contribution by the T cell infusions uncertain. 
The infusion of a large number of cells is associated with additional 
theoretical risks that have not been seen to date in the ongoing 
clinical studies using activated cells with or without gene 
modification; these include vascular thrombosis, pulmonary embolus, 
Recombinant DNA Research, Volume 16 
