跳至主要内容
临床试验/NCT00719823
NCT00719823撤回3 期

Maraviroc Compassionate Use

ViiV Healthcare0 个研究点开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
主要终点
Safety analysis will include all subjects who receive at least one dose of study drug

研究概览

简要总结

The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen.

详细描述

This study was cancelled prior to enrollment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
  • Have only CCR5-tropic HIV-1 virus
  • CD4+ cell count < 200 cells/mm3

排除标准

  • CXCR4- or dual/mixed-tropic HIV-1 virus
  • Patients who in the opinion of investigator are unlikely to derive benefit from maraviroc as a result of severity of illness
  • Patients who are pregnant or breast feeding an infant or planning to become pregnant.

研究组 & 干预措施

1

Other

干预措施: Maraviroc (Drug)

结局指标

主要结局

Safety analysis will include all subjects who receive at least one dose of study drug

时间窗: Two Years

次要结局

  • Safety analysis will include all subjects who receive at least one dose of study drug(Two years)

研究者

申办方类型
Industry
责任方
Sponsor

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