Status:
COMPLETED
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patie...
Detailed Description
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1996
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00000782
End Date
October 1 1996
Last Update
November 4 2021
Active Locations (4)
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1
Stanford CRS
Palo Alto, California, United States, 943055107
2
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
3
San Mateo County AIDS Program
San Mateo, California, United States, 943055107
4
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016