June 26, 1992 (Recipient) 
Consent for protocol entitled “A Study of the Safety and Survival of the 
Adoptive Transfer of Genetically Marked Syngeneic Lymphocytes in HIV 
Infected Identical Twins” 
You are invited to participate in a study to evaluate the safety and side effects of 
administering genetically modified white blood cells (lymphocytes) to individuals with 
HIV-1 infection . You are 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. 
To participate in this study, your history, physical examination, and laboratory 
studies must show that you are able to provide informed consent, that you do not suffer 
from a serious emotional or psychological disorder, that you do not have lymphoma (a 
cancer of the lymph glands), and that your expected survival is greater than at least 3 
months. If you have used drugs or alcohol to excess in the past, or if you are currently 
using these substances, you must agree to refrain from any further use and may be 
asked to participate in regular substance abuse counseling and/or therapy. If you have 
''-pcsi’s sarcoma (a skin cancer associated with HIV infection), you must have had 
this diagnosis confirmed by a biopsy specimen and must not have received radiation 
therapy, chemotherapy, or other intravenous or oral drug therapy for this tumor within 4 
weeks of beginning lymphocyte infusions. If you are a woman capable of child- 
bearing, you must have a negative pregnancy test within 2 weeks prior to entry into 
this study, and again within 24 hours before receiving lymphocyte infusions. You also 
must agree to avoid pregnancy during ybur participation in this study through the use 
of effective birth control or abstinence. If you are a male of reproductive ability, you 
must agree to use effective barrier contraception or abstinence. 
Before entering this study, you may be treated with zidovudine (also called 
azidothymidine or AZT), dideoxyinosine (ddl), dideoxycytidine (ddC), or a combination 
of these agents by your personal physician unless you are unable to tolerate these 
therapies or unless you wish to decline such therapy after consultation with your 
personal physician. If your CD4+ lymphocyte count is less than 200 cells per cubic 
millimeter, you should also be receiving preventive therapy for Pneumocystis carinii 
pneumonia (PCP) by your personal physician with either aerosolized pentamidine, 
trimethoprim-sulfamethoxazole (Bactrim, Septra), dapsone, or dapsone plus 
pyrimethamine unless you cannot tolerate these agents or unless you wish to decline 
such therapy after consultation with your personal physician. 
This study has been designed to evaluate the safety and tolerance of 
administering lymphocytes that have been removed from the body of your twin, 
marked (or labelled) with a new gene in the lab, stimulated to grow to large numbers of 
cells in cell cultures, and then infused into your veins. We hope to learn not only about 
the safety of such cell transfers, but also about how long these gene marked cells will 
survive in the bloodstream after being treated in this way. 
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Recombinant DNA Research, Volume 16 
