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

AIDS Clinical Trial

— EVATAT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01793818
• Other study ID #: EVATAT
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 14, 2013
• Last updated: February 9, 2016
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2016
• Source: BIOSANTECH
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 64 years old for the pre inclusion visit.

• Documented HIV-1 Infection

• Preferentially, group A patients from CDC classification but no group C patients.

• HIV-1 patients treated with three antiretroviral drugs since 12 months not changed since three months and having an undetectable viremia since 12 months.

• HIV-1 Chronic infection defined by a positive HIV-1 ELISA and HIV-1 proteins characterized in a full HIV-1 Western blot. Stable undetectable plasmatic HIV RNA (lower than 40 copies/ml) since 12 months. Lymphocyte CD4 cells higher than 350/mm3 with a NADIR higher than 200/mm3 since 12 months.

• Free engagement, fully explained and wrote with the patient signature for the inclusion visit and before any test required for the clinical trial.

• Patient affiliated to a social security system.

• No vaccination against influenza or other pathogens since three months.

• No chemotherapy or treatments with corticosteroid

• HIV-1 patients being abstinent former drug users or drug users following substitution training.

Exclusion Criteria:

• HIV-1 patient protected regarding French law (articles L1121-5, L1121-6, L1121-7, L1121-8 & L1122-2)

• No HIV-1 infection

• Patient infected with HIV-2

• Patient in HIV-1 primo infection or recently in primo infection

• Patient in symptomatic primo infection or CD4 cells lower than 200/mm3

• Women sexually active with no efficient contraception

• Pregnant women or brass feeding.

• Patient with an opportunistic infection in the CDC group C.

• Patient with a cancer and/or under chemotherapy or radiotherapy.

• Patient with an evolutive psychiatric pathology

• Patient being HBV and/or HCV positive

• Patient being ELISA positive for HTLV-1

• Patient being cirrhotic (Child and Pugh level A, B and C)

• Patient under criminal investigation

• Patients with abnormal blood formulation

• Patient participating to another clinical research

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS

Intervention

Biological:
• Tat Oyi
Three injections in the arm

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique - Universitary Hospital Centre Conception	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
BIOSANTECH	Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

References & Publications (1)

Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal vaccine dose (phase I/II)	No undesirable events due to vaccination and viremia remaining < 100 copies/ml after interruption of ART.	Two years	Yes
Secondary	Optimal Vaccine Dose (phase I/II)	An immune response against Tat characterized by the cross recognition of Tat variants representative of the five main HIV-1 clades.	Two years	No