EUCTR2017-003081-27-GB进行中（未招募）1 期
EHVA T01(European HIV Vaccine Alliance Therapeutic Trial 01)/ANRS VRI05: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection - EHVA T01(European HIV Vaccine Alliance Therapeutic Trial01)/ANRS VRI05
Inserm-ANRS0 个研究点目标入组 192 人开始时间: 2017年9月25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
- 192
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
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 child-bearing potential, willing to undergo urine pregnancy tests prior to administration of an injection or an infusion.
- •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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 192
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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 the trial
- •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.History of clinical autoimmune disease or reactive arthritis
- •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. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
研究者
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