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.