A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3

Inclusion Criteria

Required immediately prior to study entry:

• A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).

Concurrent Medication:

Allowed:

• PCP prophylaxis.
• Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
• Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
• Short intermittent cycles of acyclovir.

Patients must have:

• HIV infection, with CD4 count of 50-500 cells/mm3.
• No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection).
• Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
• B-cell lines established in order to be vaccinated.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Known or suspected allergies to any vaccine components.

Concurrent Medication:

Excluded:

• Agents with immunosuppressive activity.
• Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
• Interferon.
• Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
• Steroids.
• Hematopoietins.

Prior Medication:

Excluded within 12 weeks prior to study entry:

• Agents with immunosuppressive activity.
• Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3).
• Interferon.
• Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
• Steroids.
• Hematopoietins.

Active drug abuse.