A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen

Concurrent Medication:

Allowed in Step 2 (PER 4/5/95 AMENDMENT):

• Approved antiretroviral drugs.

Patients must have:

• Documented HIV infection.
• CD4 count >= 400 cells/mm3.
• NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Known hypersensitivity to insect proteins.

Concurrent Medication:

Excluded:

• Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading.
• Topical steroids.

Prior Medication:

PER 4/5/95 AMENDMENT -

Excluded:

• Prior immunization with experimental HIV vaccines (strata 2 and 3 only).
• Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry.
• Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections.

PREVIOUS VERSION -

Excluded within 30 days prior to study entry:

• Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3).
• Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents.

Excluded within 72 hours prior to intradermal injections:

• Antihistamine or anti-inflammatory medications.