4.3.2 The Following Criteria Will Make Subjects Ineligible for Entry into 
this Study: 
4.3.2. 1 Pregnant or lactating females, and all other persons of both sexes with 
4. 3. 2. 2 
or without reproductive potential who do not use barrier birth control 
measures adequate to prevent HIV transmission. 
Active drug or alcohol abuse. 
4.3. 2. 3 
Candidates who have received anti-neoplastic chemotherapy within six 
months of entering the study, candidates who have received non-HTV 
related experimental therapy within 45 days of entering the study, 
candidates who, within 45 days of commencing treatment, have 
received anti-retroviral therapy, and candidates who, within four weeks 
of commencing treatment, have received therapy with 
immunomodulators or corticosteroids. 
4. 3. 2. 4 
Subjects who have previously received an anti-HTV- 1 
immunotherapeutic or vaccine, unless such an anti-HIV- 1 product has 
become approved and is universally recommended for HIV-1 positive 
subjects. 
4. 3.2. 5 
Subjects who currently have or develop, during the baseline of 
observation or before crossover, any HIV-1 related opportunistic 
infection, malignancy or AIDS defining event involving any system. 
Exceptions are Herpes zoster , Herpes simplex , psoriasis, seborrheic 
dermatitis, sinusitis and lymphadenopathy. 
4. 3. 2. 6 
Subjects who have received a major organ allograft or who have 
significant cardiac, pulmonary, autoimmune, renal or central nervous 
system disease or malignancy. 
4. 3. 2. 7 
Subjects identified as anergic by delayed type cutaneous hypersensitivity 
(DTHT) testing. DTHT testing will employ at least four recall antigens. 
If the erythematous response invoked by every test antigen is less than 2 
mm in diameter, the subject will be considered anergic. 
Recombinant DNA Research, Volume 17 
