10. Quantitive immunoglobulins on day 84, absolute CD4, CD8 lymphocyte counts on 
day 84. 
1 1 . RFLP analyses or in situ hybridization for patients with opposite sex donors to 
determine donor/host origin on PBMC and bone marrow on days 14, 28, 56, and 84 
12. Weekly throat, urine and blood cultures for CMV and other viruses and weekly CMV 
serologies. 
Following day 100, HIV-1 studies of peripheral blood and bone marrow, Zidovudine 
drug levels and RFLP analyses monitoring will be done as outlined every three 
months for the next twelve months. After 1 year, the HIV tests should be obtained 
ever four months. 
F. Long Term Clinical Follow-up Evaluations 
1. Following discharge from Seattle (around 100 days following the transplantation 
procedure), patients will be seen monthly for the first year and every four months 
thereafter. For stable patients, a two month schedule will be permitted during the 
first year. 
2. At each visit vital signs will be recorded, histories will be taken and the following will 
be recorded: 
a. Signs and symptoms of HIV disease and secondary illnesses or malignancies. 
b. Karnofsky performance score 
c. Adverse experiences and CBC (differential, platelet count and MCV), 
chemistry panel (serum creatinine, BUN, bilirubin (total), SGPT, SGOT, 
alkaline phosphatase, LDH, CPK, and amylase) and routine urinalysis 
d. Concomitant medications 
e. Modifications of Zidovudine dose regimen 
f. Occurrence of secondary illnesses or malignancies 
Study Discontinuation 
Patients will be removed from the study for the following medical or administrative reasons. 
A. Non-compliance - a patient who is not taking medication as directed or who is not keeping 
appointments will be discontinued. 
B. Voluntary withdrawal - any patient may remove himself from the study at any time without 
prejudice to his medical care. 
C. Experimental therapy - a patient may not receive concurrent therapy with other anti-retroviral 
agents. 
D. Severe bone marrow toxicity felt to be secondary to AZT or T cells which cannot be managed 
by dose reductions or temporary interruption of therapy (i.e. failure to engraft, prolonged 
hypoplasia after engraftment which becomes life threatening). 
E. Other life-threatening adverse experience felt to be secondary to the treatment. 
Statistical Analysis 
This is a Phase I study of cellular adoptive immunotherapy using genetically modified CD8 + HIV- 
specific T cells for HIV seropositive patients undergoing allogenic bone marrow transplant. 
Demographic and background characteristics obtained at enrollment will be tabulated. 
To describe the survival and activity of the T cell clones, the presence (or absence) of the vector 
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