EUCTR2019-002818-40-ES招募中1 期
A Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic infection
Inserm-ANRS0 个研究点目标入组 69 人开始时间: 2020年1月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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. Willing and able to provide written informed consent
- •5. Nadir CD4 count > 350 cells/mm3
- •6. CD4 count at screening > 500 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 24 weeks 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 any injection or 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 69
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
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 or cardiovascular disease (angina, myocardial infarction, transient ischemic attack, stroke); participants with controlled blood pressure are eligible
- •17. History of clinical autoimmune disease
- •18. Ongoing diseases including uncontrolled active severe infectiona, 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 screeninga
- •21. Participating in another biomedical research study within 30 days of randomisation
- •22. Known hypersensitivity to any component of the vaccine formulation used in this trial including 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. Hypernatraemiab or hyperchloraemiac
- •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 >= 39.5°C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
- •27. Grade 2 or worse routine laboratory parameters.
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