MEDICAL RECORD CONTINUATION SHEET for either: - i 
NIH 2514-1 , Consent to Participate In A Clinical Research Study ' 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study i 
^ ^ 
STUDY NUTvIBQ^; CONTINUATION; page ^ d Q papes. i 
i 
OTHER AVAILABLE THERAPIES 
Therapy for HIV infection is an area of intense research. Zidovudine (AZT) has been shown to be of| 
benefit and is currently licensed for treating HIV infection in those with less than 500 CD4 cells. •! 
Dideoxyinosine (ddl) has been approved by the FDA for treatment of patients who either cannot i 
tolerate or who are no longer responding to zidovudine. A third drug, dideoxycytidine (ddC), is also':] 
licensed for the treatment of HIV infection, in combination with zidovudine. In addition to these , 
available antiviral drugs, preventing pneumocystis pneumonia (PCP) with oral trimethoprim- i 
sulfamethoxazole or aerosolized pentamidine has also been shown to prolong the lives of patients 
at risk for PCP. Other potentially promising therapies for HIV infection are under study and may be 
available to you at this or another institution. 
PREMATURE TERMINATION OF THE STUDY | 
In certain circumstances, some participants may need to terminate their participation in the study. I 
You are free to withdraw at any time and for any reason without prejudice from the investigators. I 
Serious side effects may cause you to be removed from the study at the discretion of the principal I 
investigator. Other reasons for terminating your participation in the protocol include: the I 
development of a life-threatening malignancy; noncompliance with clinic visits and other terms of | 
the protocol; termination of the study by the principal investigator or the FDA; or judgment of the I 
principal investigator that it is in your best medical interest to leave the study. | 
REOUIREMENTS FOR STUDY ENTRY I 
To participate in this study, your history, physical examination, and laboratory studies must show I 
that you are able to provide informed consent and that you do not suffer from a serious emotional orj 
psychological disorder, that you do not have lymphoma (a cancer of the lymph gland), and that your 
expected survival is greater than at least 6 months. If you have Kaposi’s sarcoma (a skin cancer 
associated v/ith 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. 
The effects of infusions of activated gene-modified lymphocytes on the developing fetus are 
unknov/n and might possibly be harmful. Therefore, if you are a woman capable of childbearing, 
you must have a negative pregnancy test within 2 weeks prior to entry into this study and again 
v/ithin 24 hours before receiving lymphocyte infusions. You also must agree to avoid pregnancy 
during your 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. 
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Recombinant DNA Research, Volume 19 
