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:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02390466
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 infected patient,
* Age between 18 and 60 years,
* ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
* Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
* Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
* CD4+ T cell count ≥ 200 cells/mm3,
* Nadir CD4+ T cell count ≥ 100 cells/mm3,
* Contraception in women with child-bearing potential,
* A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
* Per protocol subject having completed the IVVAC-3S/P1 study.
* Patient affiliated to a social security system,
* Patient who has understood the protocol design and provided a signed written informed consent form,
* Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
* Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.
Exclusion Criteria:
* Administration of VAC-3S in the past year,
* Chronic active liver disease,
* History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
* Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
* Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
* Ongoing pregnancy,
* Breastfeeding women,
* Patient with known sensitivities to investigational drug (see please the CIB),
* History of allergy to any vaccine,
* Any severe chronic condition that would interfere with the study,
* History of auto-immune disease,
* Organ transplant,
* Splenectomy,
* Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
* Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
* Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
* Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02390466
Study Brief:
Protocol Section:
NCT02390466