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临床试验/EUCTR2010-019518-25-IT
EUCTR2010-019518-25-IT进行中(未招募)不适用

(Maraviroc ENHancement of Immunological Response): A pilot study of maraviroc as an add-on in patients with reduced CD4 cell count despite full viral suppression - MENHIR

AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2010年5月13日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • i. Age > 18 years
  • ii. Informed consent signed (add. 1)
  • iii. Patients with a reduced CD4 cell count (<250 cells/mmc) response to HAART despite full viral suppression (HIV-RNA <50 copies/ml) for at least 6 months.
  • iv. Stable HAART for least 6 months.
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • i. Childbearing or breastfeeding. Women of childbearing potential will be asked to adopt effective contraceptive methods or behaviours
  • ii. Any ongoing grade 4 (WHO) AE or laboratory abnormality.
  • iii. Allergy/intolerance to the study drug
  • iv. Treatment with immunomodulatory agents
  • v. Treatment with steroids
  • vi. Radiotherapy or chemotherapy
  • vii. HAART consisting of a combination of tenofovir and didanosine
  • viii. Autoimmune disorder or chronic inflammatory disease

研究者

发起方
AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

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