Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01793818
Status:
UNKNOWN
Last Update Posted:
2016-02-10
First Post:
2013-02-14
Brief Title:
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
Sponsor:
BIOSANTECH
Organization:
BIOSANTECH
Study Overview
Official Title:
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
ACTIVE_NOT_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:
EVATAT
Brief Summary:
Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells
Detailed Description:
The protocol got a favorable judgment from an ethic committee CPP SudMed 2 on November 9th 2012 and was authorized by the French drug agency ANSM on January 24th 2013 It will be proposed to HIV-1 infected volunteers to participate to a phase III clinical trial to test the Tat Oyi vaccine Volunteers will have an undetectable viremia lower than 40 copiesml and a level of CD4 cells higher than 350 mm3 since at least one year under Anti Retroviral Treatment ART It will be a randomized double blinded clinical trial with a placebo
Main Objective No undesirable events due to vaccination and viremia remaining 100 copiesml after interruption of cART
Secondary objective An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades
Main parameter of evaluation Plasma viremia Secondary parameter of evaluation Detection with ELISA of antibodies able to recognize Tat variants representative of the five main HIV-1 clades
Main Objective No undesirable events due to vaccination and viremia remaining 100 copiesml after interruption of cART
Secondary objective An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades
Main parameter of evaluation Plasma viremia Secondary parameter of evaluation Detection with ELISA of antibodies able to recognize Tat variants representative of the five main HIV-1 clades
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