A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, Injections, Intradermal, HIV Antigens, HIV-1, HIV Envelope Protein gp160, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed, AIDS Vaccines, HIV Therapeutic Vaccine
Eligibility Criteria
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.
Sites / Locations
- Stanford CRS
- Santa Clara Valley Med. Ctr.
- San Mateo County AIDS Program
- NY Univ. HIV/AIDS CRS