Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein (NCT01793818) | Clinical Trial Compass
UnknownPhase 1/2
Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein
France50 participantsStarted 2013-02
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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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 opportun…