MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
® Adult Patient or “Parent, for Minor Patient 
rv^rmnE- NLAID 
STUDY NUMBER 
PRINCIPAL INVESTIGATOR: Robert Waker. M D 
-STUDY TITLE; A Phase l/II Pilot Studv of the Safety of the Adootive Transfer of Cvlotoxic Svnaeneic Lviriohocvles 
n HIV itTeded IdenfcaJ Twins 
RECIPIENT-6 
9/21/93 
INTRODUCTION 
ri. 
We invite you (or your child) to take part in a research study at the National Institutes of Health. It is innportant that you read 
and understand several general principles that apply to all who take part In our studies: (a) taking part in the study is entirely 
voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that wiil benefit 
others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you are otherwise 
entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information about the study 
are discussed below. You are urged to discuss any questions you have about this study with the staff members who 
explain it to you 
OBJECTIVE OF THE STUDY 
This study has been designed to evaluate the safety and tolerance of administering lymphocytes 
that have been removed from your twin’s blood, marked (or labeled) with a new gene in the lab, 
stimulated to grow to large numbers of cells in cell cultures, and then infused into you. We hope to 
learn not only about the safety of such cell transfers, but whether the gene we are introducing will 
help you clear HIV from your body. The potential benefit of participating in this study is that you may 
reduce your HIV viral burden after receiving genetically modified, activated .lymphocytes. The 
potential benefit to others would be the development of further knowledge about the use and side • 
effects of this approach for treating HIV-infected patients, and possibly the development of a new 
strategy for treating HIV infection. 
DESCRIPTION OF THE STUDY 
As part of your participation in the above study, you may undergo a procedure known as gene 
transfer depending upon a random assignment of treatments. Because gene transfer is a special 
procedure that has its own unique risks and precautions, you are being asked to sign a separate 
consent form. 
After your tvrin sibling has had a portion of his/her blood cells removed by lymphapheresis, these I 
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Recombinant DNA Research, Volume 19 
