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

Inclusion Criteria

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety