Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT01793818
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01793818
Study Brief:
Protocol Section:
NCT01793818