Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1

Launched by INNAVIRVAX · Mar 10, 2015

Keywords

ClinConnect Summary

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Gender

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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.