NCT00944541已完成2 期
Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO
French National Agency for Research on AIDS and Viral Hepatitis2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年9月1日最近更新:
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试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
研究概览
简要总结
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).
The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •maraviroc-naives patients
- •CD4 less than 350 cells/mm3
- •viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months
排除标准
- •HIV-2 infection
- •X4 tropism at inclusion
- •pregnancy and breast feeding
- •interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
- •hypersensibility of peanut or soya
结局指标
主要结局
Evaluation of maraviroc intensification during 24 weeks in HIV infected patients with insufficient immune restoration despite controlled viral load
时间窗: immunologic benefit at week 24
次要结局
- Maraviroc efficacy at W24 (virological and immunological efficacy); Durability of maraviroc efficacy between W24 & W36; Cmin of maraviroc and other molecules at W4,12,24; Evaluation of the safety of maraviroc between W0 and W36.(immuno-virologic evolution between week 0 and week 36)
研究者
研究点 (2)
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