Recombinant DNA Advisory Committee - 09/9-10/93 
amendment. 
Review— Dr. Carmen 
Dr. Carmen commented that the Informed Consent document is lucid and well written. 
He suggested a minor revision that would more succinctly inform the patients about this 
study. The investigators agreed to incorporate Dr. Carmen's suggestion. 
Other Comments 
Dr. Walters summarized Ms. Meyers' written comments about the Informed Consent 
document: (1) Will a request for autopsy be included? and (2) Will the patient's medical 
records be made available to other physicians, NIH, and others? Mr. Capron asked the 
investigators why they did not apply for a certificate of confidentiality under Section 
301(d) of the Public Health Service Act as suggested by their IRB. Dr. Post asked the 
investigators to summarize the status of patients who were enrolled in the previous study. 
Mr. G'dali Braverman from ACT UP expressed his disappointment that patients with 
CD4 counts below 200 will be excluded from participation in this study, but he was 
pleased that patients receiving antiviral treatment will not be excluded. 
Investigator Response-Dr. Greenberg 
Dr. Greenberg explained that the existing protocol has very stringent entrance criteria, 
i.e., only patients with HIV-related lymphoma receiving BMT are eligible. A total of 8 
patients have been evaluated to date, and only 4 have had human leukocyte antigen 
(HLA) matches for BMT. Of the 4 eligible patients, only one was treated. The other 3 
patients had rapidly progressive lymphoma relapse which prevented their entrance into 
this study. This problem of low patient accrual is the reason for the present amendment. 
Preliminary data on the one treated patient indicates that CTL activity to HTV can be 
reconstituted. Similar activity directed toward cytomegalovirus (CMV) infection has 
been demonstrated previously in a much larger study. Unfortunately, the single HTV 
patient who received this treatment, died of severe graft-versus-host (GVH) disease as a 
consequence of the transplantation procedure. No long-term efficacy data are available. 
Dr. Greenberg explained that the rationale behind selecting HIV seropositive individuals, 
who have CD4 counts between 200 to 500, is that this group of patients elicit a better 
CD8 response and demonstrate fewer complications associated with disease progression. 
Therefore, a more definitive evaluation of safety and toxicity is possible. In regard to 
the issue of patient confidentiality, he cannot guarantee that every patient will be 
codified; however, he is applying for a certificate of confidentiality as noted by Mr. 
Capron. 
Dr. Chase inquired about the rationale for selecting the sample size of 15. Dr. Riddell 
said that this number was chosen based on other similar Phase I toxicity studies. The 
primary objective of this study is to determine a dose range that is safe and biologically 
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