HIV Infections Clinical Trial
Official title:
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
NCT number | NCT00000782 |
Other study ID # | ACTG 221 |
Secondary ID | 11198 |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Est. completion date | October 1996 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB vero cell expressed (Immuno-AG). PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN (Immuno-AG). 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 vaccination.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 1996 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | NY Univ. HIV/AIDS CRS | New York | New York |
United States | Stanford CRS | Palo Alto | California |
United States | Santa Clara Valley Med. Ctr. | San Jose | California |
United States | San Mateo County AIDS Program | San Mateo | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. — View Citation
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