Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000782
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase III Study of Delayed-Type Hypersensitivity DTH Reactions to Intradermal HIV Envelope Antigen
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Study of Delayed-Type Hypersensitivity DTH Reactions to Intradermal HIV Envelope Antigen
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 4595 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
PER 4595 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
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 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 4595 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
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 4595 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11198 | REGISTRY | DAIDS ES Registry Number | None |