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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Page 1 of 1 (4 locations)

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