跳至主要内容
临床试验/EUCTR2009-011273-32-IT
EUCTR2009-011273-32-IT进行中(未招募)不适用

Pilot study for the evaluation of the safety and the feasibility of treatment simplification to atazanavir/ritonavir + lamivudine in patients on stable treatment with two NRTIs + atazanavir/ritonavir with optimal virologic response (AtLaS). - ND

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2009年4月1日最近更新:
适应症
相关药物

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

  • Patients treated with a stable regimen including 2NRTIs + ATV/r for at least 6 months
  • Aged 18 years or older
  • With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
  • With CD4 cell count >200 cells/ &#956;L for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
  • Who gave informed consent to the participation to 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Pregnancy or breast feeding, desire of pregnancy in the short term
  • Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues.
  • Previous major toxicity to any of the study drugs
  • Patients with insufficient atazanavir plasma concentration (lower than 0.23 &#956;g/mL at 12 &#61617;2 hours or 0.15 &#956;g/mL at 24 &#61617;2 hours post-dosing) at screening
  • Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid levels)
  • Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications (as per product information)
  • Detection of HBsAg in plasma

研究者

发起方
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

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