ascertain whether meaningful changes will occur in CTL activities, in antibody responses or 
in viral burden. 
3.0 Subject Selection 
3. 1 Subjects will include up to 25 eligible male and female HIV- 1 -infected individuals previously 
or currently enrolled in the CCTG-704 (UCSD 91-786) phot protocol: "CTL Studies in 
HIV-1 Infected Subjects Using Retroviral Vector-Transduced Cells." All eligible subjects 
will receive the immunostimulant HIV-IT (V). Specifically, subjects must meet the following 
criteria: 
3.2 Inclusion Criteria: 
3.2.1 Be HIV- 1 -infected as demonstrated by a Federally licensed positive ELISA Assay for 
HIV-1 antibodies and confirmed by Western blot analysis. 
3.2.2 Be an adult (age 18 to 65). 
3.2.3 Have acceptable laboratory values, including hematocrit > 34% for men and > 30% for 
women, granulocytes > 1500 cells per mm 3 , platelet count > 100,000 per mm 3 , SGOT 
(AST) < 2.5 x the upper limit of normal, SGPT (ALT) < 2.5 x the upper limit of 
normal and creatinine, within normal limits. 
3.2.4 Have CD4 + T cell levels > 500/(iL or > 30% and have a positive DTH skin test 
(Stratum #1) and reside in CDC HIV classification categories A1 or B 1 (see CDC HIV 
Classification from MMWR of 12/18/92 included as Appendix A) or have CD4 + T cell 
levels from 200-499/p.L or 15-29% or have a negative DTH skin test (Stratum #2) and 
reside in CDC HIV classification categories A2 or B2 (Appendix A). 
3.2.5 Female subjects must have a negative serum pregnancy test. Both male and female 
subjects must use barrier birth control measures adequate to block HIV-1 transmission. 
3.2.6 Commit to a 3 year follow-up evaluation schedule in order to properly evaluate safety 
and biologic activity. 
3.2.7 Render an Informed Consent in accordance with institutional policies. 
3.3 Exclusion Criteria: 
3.3.1 Pregnant or lactating females. 
3.3.2 Persons of both sexes, with or without reproductive potential, who do not use barrier 
birth control measures adequate to prevent HIV-1 transmission. 
3.3.3 Subjects with CD4+ T cells levels < 200 or < 15% who reside in CDC HIV 
classification categories A3, B3 or C (see Appendix A). 
3.3.4 Previous treatment with an anti-HIV- 1 immunotherapeutic or vaccine. 
3.3.5 Recipients of a major organ allograft, or history of significant cardiac, hepatic, 
pulmonary, reticuloendothelial, renal or central nervous system disease or malignancy. 
3.3.6 Previous treatment with anti-neoplastic chemotherapy within six months, experimental 
therapy within 45 days, or immunomodulators or corticosteroids within four weeks or 
other medications which might interact with or be contraindicated in association with 
HIV-IT (V) administration. 
3.3.7 The clinical inadvisability of, or participant's unwillingness to suspend anti- viral and/or 
anti-retroviral therapy for a period three days before and three days after each scheduled 
dosing of HIV-IT (V). 
Tih/HIV-|.03-393.RAC. Vereioo 1.4/October 8, 1993 
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