NCT01793818

Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: BIOSANTECH · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AIDS

Interventions

Type	Name	Description
BIOLOGICAL	Tat Oyi	Three injections in the arm

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-02-18
• Last updated: 2016-02-10

Locations

1 site across 1 country: France