MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
° Adult Patient or “Parent, for Minor Patient 
NKim/TE- NIAID ■ 
.STUDY NUMBB^ 
PRINCIPAL INVESTIGATOR: Robert Waker. M D. 
STUDY TITLE: A Phase I/ll Pilot Studv of the Safety of the Adoolive Transfer of Cvlotoxic Svnaeneic Lvmohocvies 
n HfV IrYecfed Idertca) Twins 
RECIPIENT-A 
9/21/93 j 
INTRODUCTION f 
V7e invite you (or your child) to take part in a research study at the National Institutes of Health. It is important that you read 
arvj understarxi several general prirrciples that apply to all who take part in our studies: (a) taking part in the study is entirety 
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 i 
entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information about the study i 
are discussed below. You are urged to discuss any questions you have about this study with the staff members who 1 
explain it to you p 
OBJECTIVE OF THE STUDY 
You are invited to participate in a study to evaluate the safety and side effects of administering i 
genetically modified white blood cells (lymphocytes) to Individuals with HIV-1 Infection. You are j 
invited to participate in this study because you are Infected with HIV-1 and because you have an 
identical twin who tests negative for HIV. 
This study has been designed to evaluate the safety and tolerance of administering lymphocytes 
that have been removed from your twin’s blood, mar1<ed (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 j 
help you clear HIV from your body. The potential benefit of participating in this study Is that you may I 
reduce your HIV viral burden after receiving genetically modified, activated lymphocytes. The t 
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 I 
strategy for treating HIV infection. f 
DESCRIPTION OF THE STUDY j 
After you and your twin have had screening blood tests, a tetanus booster injection, and a complete I 
history and physical examination performed at the NIH, your twin will be scheduled to have a [ 
[156] 
Recombinant DNA Research, Volume 19 
