A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients

Inclusion Criteria Concurrent Medication: Allowed: Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements. Patients must have: Asymptomatic HIV infection with no acute related infection. CD4 count >= 500 cells/mm3. Normal hematologic, renal, hepatic, metabolic, and endocrine function. NOTE: No more than one patient over 50 years of age is permitted at each dose level. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Residual toxicity from prior drug treatment. Hypersensitivity to bupivacaine or amide-type local anesthetic. Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases. Concurrent Medication: Excluded: Medications that affect immune function. Antiretrovirals. Patients with the following prior conditions are excluded: Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. History of anaphylaxis to vaccines. Prior Medication: Excluded: Prior immunization with any experimental HIV vaccines. Other experimental therapy within 30 days prior to study entry. Prior cancer chemotherapy. Antiretrovirals within 3 months prior to study entry. Prior Treatment: Excluded: Prior radiotherapy. IV drug use or any other high-risk behavior.