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 range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.