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临床试验/ISRCTN08592155
ISRCTN08592155已完成4 期

Switching from efavirenz/tenofovir/emtricitabine (TDF/FTC/EFV) to abacavir/lamivudine/maraviroc (ABC/3TC/MVC) to assess antiretroviral activity in cerebrospinal fluid: a prospective one-arm pilot study

Institute of Biomedical Investigations of Bellvitge [Institut d'Investigació Biomèdica de Bellvitge (IDIBELL)] (Spain)0 个研究点目标入组 15 人开始时间: 2011年4月18日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
15

研究概览

简要总结

  1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25721471 (added 21/01/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Human immunodeficiency virus positive (HIV+)
  • 2. Adults aged over 18 years
  • 3. HLA-B*57:01:01 negative
  • 4. On TDF/FTC/EFV treatment for at least 24 weeks and undetectable HIV viral load in the last 24 weeks
  • 5. Neurocognitive impairment
  • 6. CCR5+ (pro-viral deoxyribonucleic acid [DNA])
  • 7. Signed informed consent

排除标准

  • 1. Alanine aminotransferase (ALT) greater than 5 fold upper normal limit
  • 2. Renal impairment (creatinine clearance [Cl cr] less than 50 ml/min)
  • 3. Haemoglobin less than 9 g/dl
  • 4. Neutropenia (PMN) less than 1000/ml
  • 5. Platelets less than 30,000/mm3
  • 6. Opportunistic infection, cancer and /or any disease which could alter blood brain barrier permeability (meningitis, cancer, etc.)
  • 7. Neuro-psychiatric disease (previous or current)
  • 8. Illicit drugs use

研究者

发起方
Institute of Biomedical Investigations of Bellvitge [Institut d'Investigació Biomèdica de Bellvitge (IDIBELL)] (Spain)

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