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临床试验/EUCTR2015-002682-30-ES
EUCTR2015-002682-30-ES进行中(未招募)1 期

Raltegravir-based regimen versus raltegravir-based regimen plus atorvastatin for reducing ?inflamaging? (aging-related complication) in HIV-infected patients older than 60 years.

Fundació Lluita contra la SIDA0 个研究点目标入组 60 人开始时间: 2015年7月31日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

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. Patient having a diagnosis of HIV-1 infection.
  • 2. Age higher or equal to 60 years old.
  • 3. Current HAART including Truvadaâ or Kivexaâ plus a ritonavir boosted PI started at least 6 months before.
  • 4. Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) for at least 12 months.
  • 5. Voluntary written informed consent.
  • 6. In women of childbearing age, commitment to use barrier contraceptive method throughout the study.
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • 1. History of virological failure to integrase inhibitors.
  • 2. Suspected or documented resistance mutations to the integrase, as well as NRTI?related mutations that may impact nucleoside activity in current regimen.
  • 3. Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, etc.
  • 4. Treatment with other drugs with anti-inflammatory, anticoagulant or antiplatelet effect (for instance corticosteroids, aspirin, etc?)
  • 5. Therapy with statins within the last 6 months.
  • 6. Pregnant or lactating women.

研究者

发起方
Fundació Lluita contra la SIDA

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