subsequent laboratory evaluations as indicated by the results of the trial. The informed 
consent form will ask for permission for autopsy. 
4. SUBJECT POPULATION 
Four to six carefully selected patients with Human Immunodeficiency Virus-1 (HIV-1) 
infection will be enrolled. The following eligibility criteria will be used: 
4.1 Inclusion Criteria 
a. HIV-1 infection documented by ELISA and confirmatory western blot. 
b. Age > 1 8 and < 65 years. 
c. Patients of either sex are eligible. All patients with reproductive potential, male or 
female, must agree to use an effective method of contraception during the study 
period. 
d. The patient must be able to provide informed consent. 
e. Karnofsky score > 80% at enrollment. 
f. The patients must take zidovudine (AZT). This criterion is included after extensive 
debate among the authors of this proposal and with acknowldegement of its inclusion 
in one previously RAC-approved protocol; for a discussion of our reservations about 
mandating AZT use, please see Appendix 1. Briefly, the rationale for the 
criterion is that AZT would inhibit replication-competent murine helper virus, a 
risk also addressed comprehensively by other measures (see sections on risk 
management). It is understood that AZT intolerance (resulting from toxicities 
including, but not limited to, bone marrow supression, intractable nausea, 
myopathy) could occur on study in any given patient and necessitate withdrawal of 
the drug. 
4.2 Exclusion Criteria: 
a) Laboratory parameters: 
i. CD4 + cell count < 250 cells/mm 3 . This baseline CD4 level will be established by 
two or more measurements at least two weeks apart. 
ii. Hematocrit < 30%. 
iii. Platelet count < 50,000/mm 3 - 
iv. White blood cell count < 3000/mm 3 . 
Recombinant DNA Research, Volume 18 
[389] 
