4.0 Procedures 
4. 1 Prior to enrollment, subjects will have a complete medical history and physical exam, chest X- 
ray and EKG as well as routine laboratory testing (CBC, platelet count, chemistry panel, 
urinalysis). In addition, up to a 120 ml blood sample will be drawn to assess baseline values 
of potential surrogate markers which will include CTL activity, CD4 and CD8 counts, HIV-1 
gpl20 antibody titer and leukocyte viral load which will be determined by a standardized 
PCR-based assay of cellular DNA. If it has not already been performed or has been 
performed more than one month prior to first injection, a delayed-type hypersensitivity (DTH) 
skin test will be administered intradermally to assess the degree of cell-mediated immunity. 
Early signs and symptoms of disease, e.g., CDC HIV classification conditions listed in 
Category B (see Appendix A) will be assessed by history and physical examination. 
4.2 Subjects will be subdivided into two strata based on CDC HIV classification criteria (see 
Section 3.2.4 above and Appendix A). Each stratum will have approximately half of all 
subjects in the study. Early safety data (day 90) from the first six subjects in Stratum #1 
(CD4 + T cell levels > 500/fiL or > 30%) or equivalent data from another study will be made 
available for IRB review and approval prior to treatment of any stratum #2 subjects (CD4 + T 
cell levels from 200-499/p.L or 15-29%). 
4.3 Following lyophilized product reconstitution, each eligible subject will receive a dose of 10 7 
cfu on each of 3 injection days spaced at 28 day intervals. Total dose volume may vary, but 
will not exceed 2.0 ml. A given dose will be delivered in from one to four IM injections made 
unilaterally or bilaterally into the deltoid and gluteus maximus muscles. If no severe product- 
attributable toxicities have occurred in a subject within six months of the third HIV-IT (V) 
administration, up to a full three dose course comparable to the initial treatment course 
described above may be repeated later in that subject. 
4.4 The subject will be observed continuously for the first fifteen minutes following each injection 
and at 30, 60, and 120 minutes thereafter. Vital signs (BP, P, T, R) will be obtained prior to 
each injection and at 15, 30, 60 and 120 minutes following each injection. 
4.5 Approximately four days prior to the first injection day (#1) and 14 days after each injection, 
subjects will undergo routine laboratory testing to determine whether it is clinically safe to 
proceed with treatment. On all injection days, an interim history and relevant physical exam 
will be performed prior to dose administration to assess clinical status, and to determine 
whether any toxicities have occurred which preclude further product administration. Injection 
schedules may vary by ± 1 day and laboratory testing schedules may vary by + 3 days. 
4.6 Subjects will return for follow-up at 70 days and at 3, 4, 5, 6 and 12 months following the 
first injection. Long term follow-up will be conducted at 6 month intervals thereafter for at 
least three years. Follow-up visits after day 70 may vary by ± 7 days. Follow-up measures 
\yill consist of interim health reports or complete history and physical exams, routine 
laboratory analyses, CTL activity, CD4 and CD8 counts, HIV-1 gpl20 antibody titer, 
leukocyte viral load, and the DTH skin test (see Subject Study Schedule, Section 1 1.0). 
4.7 The total volume of blood drawn for the first seven visits (up to day 70) will be approximately 
430 ml. The total volume drawn from visits 8 through 12 (months 3-12) will be 
approximately 505 ml. A total of approximately 442 ml of blood will be drawn during visit 13 
through 16(18 months through year 3). No more than 145 ml of blood will be drawn at any 
one visit. 
4.8 Refer to Study Plan, Table 1 and the Subject Study Schedule, Section 1 1.0, for the timing and 
frequency of subject evaluations. 
5.0 Risks and Discomforts 
Risks associated with blood drawing may include transient pain, bruising or lightheadedness, 
and a rare risk of local infection. Risks associated with DTH testing may include local itching, 
redness, pain, blister formation, ulceration or necrosis. Very rarely a more serious .systemic 
rah/HIV-1 -03-393. RAC, Version 1.4/October 8. 1993 
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Recombinant DNA Research, Volume 18 
