CTL obtained from HIV- 1 infected individuals. These data provide the 
impetus to initiate studies of HIV-IT (V) in humans. Based on the 
successful production of CTL responses achieved in Rhesus macaques 
that received three doses of HIV-IT (V) given at 2 week intervals and on 
a careful analysis of these data. Phase I clinical trial subjects will receive 
three doses of HIV-IT (V) at monthly intervals given in two 
successively escalating dosage groups (see Section 4.4.3). Control 
subjects will receive a placebo comprised of HIV-IT (V) formulation 
media. After an appropriate evaluation interval, these control subjects 
may have the option of receiving the highest tolerated dose of HTV-1T 
(V). 
4.3 Patient Eligibility For the Provisional (Pre-treatment) Phase of Study 
4.3.1 The Following Criteria are Required for Subjects to be Eligible for 
Provisional Admission. All Candidate Subjects Must: 
4. 3 . 1 . 1 Be HIV- 1 infected as demonstrated by a confirmed positive test for 
HIV-1 antibodies, an HIV-1 positive virus culture, or a positive test for 
circulating p24 antigen. 
4. 3 . 1 . 2 Have two or more baseline CD4 + T-cell counts > 400 or an absolute 
CD4 + T-cell percentage of >20% which have been obtained at least 28 
days apart, with the most recent count obtained within the last 30 days. 
4.3. 1 .3 Have a performance status of > 80% on the Kamofsky Scale, or 
equivalent. 
4.3. 1 .4 Be an adult male or female (age 18 to 65). Both male and female 
subjects must use barrier birth control measures. 
4. 3 . 1 . 5 Have acceptable clinical chemistry and hematology laboratory findings 
within the normal range, including hematocrit > 34% for men and > 
30% for women, hemoglobin > 10 g/dl, granulocytes > 1500 cells per 
mm^, platelet count > 75,000 per mm3, SGOT (AST) < 3 the upper 
limit of normal, SGPT (ALT) < 3 the upper limit of normal, creatinine < 
2 the upper limit of normal or a creatinine clearance of > 50 ml per 
minute. 
4.3. 1.6 Render an Informed Consent in accordance with institutional policies. 
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