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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000782 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: gp160 Vaccine (Immuno-AG) Biological: gp160 Vaccine (MicroGeneSys) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen |
| Estimated Enrollment: | 50 |
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.
Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading.
PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed in Step 2 (PER 4/5/95 AMENDMENT):
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
PER 4/5/95 AMENDMENT -
Excluded:
PREVIOUS VERSION -
Excluded within 30 days prior to study entry:
Excluded within 72 hours prior to intradermal injections:
Contacts and Locations| United States, California | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| United States, New York | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Study Chair: | Katzenstein D |
More Information
| Study ID Numbers: | ACTG 221 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000782 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases Hypersensitivity Hypersensitivity, Delayed HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |