Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02366026
Status:
UNKNOWN
Last Update Posted:
2016-02-23
First Post:
2015-02-06
Brief Title:
REMUNE AMPLIVAX IR103 HIVAIDS Phase III Safety Efficacy Study
Sponsor:
Immune Response BioPharma Inc
Organization:
Immune Response BioPharma Inc
Study Overview
Official Title:
REMUNE AMPLIVAX IR103 HIVAIDS Phase III Safety Efficacy Study
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
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:
RAISE
Brief Summary:
The primary objective is to compare evaluate between the treatment groups the changes in declinereduction of HIV viral load changes in the Remune Amplivax group vs the Amplivax placebo groups Additional objectives include changes in WBC White Blood Cell counts CD4 CD8 T cell counts along with increased HIV immunity
Detailed Description:
This is a 500 subject Multi Center double-blind randomized Safety Efficacy HIVAIDS Phase III study to primarily to evaluate the safety and efficacy of HIV-1 immunogen Amplivax compared to placebo group Amplivax in viral load and secondarily to examine changes in CD4 CD8 T cell counts determine Remune vaccines effect of multiple inoculations of HIV-1 immunogen Amplivax on viral replication in adults with HIV-1 infection to examine immunogenicity of Remune Amplivax in a Multi-center randomized double-blind placebo-controlled two arm parallel design study of Remune Amplivax
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