Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
NCT ID: NCT01793818
Last Updated: 2016-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2013-02-28
2016-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 Phase I/II
Three injections with no active principle
Tat Oyi
Three injections in the arm
Group 2 Phase I/II
Three injections of Tat Oyi vaccine containing 11 µg of active principle
Tat Oyi
Three injections in the arm
Group 3 Phase I/II
Three injections Tat Oyi vaccine containing 33 µg of active principle
Tat Oyi
Three injections in the arm
Group 4 Phase I/II
Three injections Tat Oyi vaccine containing 99 µg of active principle
Tat Oyi
Three injections in the arm
Interventions
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Tat Oyi
Three injections in the arm
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
BIOSANTECH
INDUSTRY
Responsible Party
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Principal Investigators
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Isabelle Ravaux, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique Hopitaux De Marseille
Locations
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Centre d'Investigation Clinique - Universitary Hospital Centre Conception
Marseille, , France
Countries
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References
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Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. doi: 10.2174/1570162x12666141202125643.
Other Identifiers
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EVATAT
Identifier Type: -
Identifier Source: org_study_id
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