EUCTR2017-003081-27-IT进行中（未招募）1 期
A Phase I/II randomised therapeutic HIV vaccine trial in individuals who startedantiretrovirals during primary or chronic infection. - EHVA T01 - (European HIV Vaccine Alliance Therapeutic Trial 01/ANRS VRI05)
INSERM-ANRS0 个研究点目标入组 1 人开始时间: 2021年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. HIV-1-infected
- •2.Aged 18 – 65 years old on the day of screening
- •3. Weight >50kg
- •4. Written informed consent
- •5. Nadir CD4 count > 300 cells/mm3
- •6. CD4 count at screening > 600 cells/mm3
- •7. Viral load ,<50 copies/ml at screening.
- •8. Started cART after 2009 and on cART for at least one year prior to screening .
- •9. Willing to interrupt cART for up to 24weeks and change cART regimen if required.
- •10. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment
- •interruption (which could include PrEP for their sexual partners)
- •11. If heterosexually active and able to have children, willing to use a highly effective method of contraception with partner
- •(combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; physiological or anatomical sterility (in self or
- •partner) from 2 weeks before enrolment until 18 weeks after the last injection/infusion.
- •12. If women of childbearing potential, willing to undergo urine pregnancy tests prior to administration of an injection or an
- •13. Willing to avoid all other vaccines within 4 weeks of scheduled study injections
- •14. Willing and able to comply with visit schedule and provide blood samples
- •15. Being covered by medical insurance or in National Healthcare System
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant or lactating
- •2.HIV-2 infection (either isolated or associated with HIV-1)
- •3.VL >200 copies/ml on 2 occasions in the 12 months prior to screening
- •4.Previous interruptions in cART
- •5.Previous virological failures defined by loss of virological suppression with the presence of resistant mutations
- •6.Haemoglobin (Hb<12g/dL for males, <11g/dL for females)
- •7.Concomitant or previous conditions that preclude injection of vaccines/infusion of monoclonal antibody and PML in the past
- •8.History of experimental vaccinations against HIV
- •9.Previous treatment with chemotherapy (except for chemotherapy injected into skin lesions for Kaposi’s sarcoma)
- •10.Treatment with systemic corticoids or immuno-suppressive agents ongoing or in the previous 12 weeks before randomisation in
- •11.Received natalizumab or rituximab ever in the past.
- •12.Received a TNF blocker in the past 60 days.
- •13.Administration of an inactivated vaccine within 30 days or a live vaccine within 60 days prior to randomisation
- •14.Presence of a skin condition or marking that precludes inspection of the injection/infusion site
- •15.History of cancer (except basal cellular skin carcinoma or Kaposi’s sarcoma)
- •16.History of significant neurological disease, cardiovascular disease (angina, myocardial infarction, transient ischemic attack,
- •stroke); participants with controlled blood pressure are eligible.
- •17. Personal history of clinical autoimmune disease or reactive arthritis or family history of rheumtaoid arthritis (parents or siblings)
- •18.Ongoing diseases including uncontrolled active severe infection, cardiac, pulmonary (excluding mild asthma), thyroid, renal or
- •neurological (peripheral or central) diseases
- •19.Active or latent tuberculosis (unless prophylaxis in past as per local practice) - (participant must be screened for tuberculosis
- •before starting infusions, according to routine practice)
- •20.Presence of pathogenic bacteria or parasites in faeces at screening
- •21.Participating in another biomedical research study within 30 days of randomisation.
- •22.Known hypersensitivity to any component of the vaccine formulations used in this trial including aminoglycosides and eggs or
- •have severe or multiple allergies to drugs or pharmaceutical agents, or any hypersensitivity to the active substance or to any of
- •the excipients of vedolizumab.
- •23.Liver disease including hepatitis B (surface antigen positive) or hepatitis C (antigen or PCR positive)
- •24.A clinically significant abnormality on ECG
- •25.Hypernatraemia or hyperchloraemia.
- •26.History of severe local or general reaction to vaccination defined as
- •a.local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
- •b.general: fever >= 39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or
- •encephalopathy within 72 hours
- •27.Grade 2 or worse routine laboratory parameters (see Appendix 4 for definitions). Hyperbilirubinaemia to be considered an
- •exclusion criterion only when confirmed to be conjugated bilirubinaemia
研究者
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