Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000755
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase III Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cellsmm3
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 Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cellsmm3
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 examine the response of HIV-1 infected patients to vaccination with gp120HIV-1MN antigen To determine the effect of antiretroviral therapy on vaccine responsiveness
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens
Detailed Description:
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens
Patients are randomized to receive rgp120HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0 4 8 12 16 and 20 with or without daily oral zidovudine AZT or their current stable dose of antiretroviral therapy After completing the primary vaccination series patients are permitted to continue into an extension phase in which they receive a booster vaccination at weeks 28 36 and 44 Patients will be stratified by CD4 count 350-500 200-349 and 50-199 cellsmm3 A fourth group with counts of 350-500 cellsmm3 will serve as a pilot group and receive vaccine only
Patients are randomized to receive rgp120HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0 4 8 12 16 and 20 with or without daily oral zidovudine AZT or their current stable dose of antiretroviral therapy After completing the primary vaccination series patients are permitted to continue into an extension phase in which they receive a booster vaccination at weeks 28 36 and 44 Patients will be stratified by CD4 count 350-500 200-349 and 50-199 cellsmm3 A fourth group with counts of 350-500 cellsmm3 will serve as a pilot group and receive vaccine only
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11186 | REGISTRY | DAIDS ES Registry Number | None |