Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-02 @ 9:04 AM
Study NCT ID:
NCT01793818
Status:
UNKNOWN
Last Update Posted:
2016-02-10
First Post:
2013-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
Sponsor:
BIOSANTECH
Organization:
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 I/II clinical trial to test the Tat Oyi vaccine. Volunteers will have an undetectable viremia (lower than 40 copies/ml) 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 copies/ml 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 copies/ml 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:
True
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?: