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To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients (Ral'inNONB)

The Main Objective of This Study is to Evaluate the Virologic Effectiveness at M6 of Regimen Containing Raltegravir in Treatment Naive HIV Subtype Non B or B Infected Subjects

Pilot open label multicentric study

研究概览

地位

未知

详细说明

The population VIH1 not B is not unimportant in our region of the Seine St Denis, a tendency which seems to be in increase (47 % in 2006, 67 % in 2007).

Most of the studies evaluating the clinical, immunologic and virologic response to the ARV according to the viral subcategories are corresponding and show comparable results for patients infected by HIV 1 of subcategory B or non B. In spite of these reassuring results, it is necessary to evaluate the efficiency of a new ARV all the more a new class. It seems also necessary to observe attentively the profiles of resistance which will be selected at the carrier patient's of virus of subcategories not - B in failure of treatment. It will allow to determine if, because of the important polymorphisms of the viruses not - B, the evolution towards the resistance will be made differently.

研究类型

观察性的

注册 (预期的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

It's a pilot open label, multicentric, national, prospective and descriptive study to evaluate effectiveness and safety of regimen containing Raltegravir (400mg x 2) in 40 treatment naive HIV non B infected subjects versus in 20 treatment naive HIV B infected sujects.

The patients will be matched according to:

  • basal viral load (< 10 000 copies/ml, ≥100 000 copies/ml)
  • rate of basal CD4 (<200 cell/mm3, ≥ 200 cell/mm3)

描述

Inclusion Criteria:

  • In order to be eligible to take part in this study, patients should meet all of the following criteria:

Patient aged at least 18 years; Treatment naive patient infected with HIV-1; Patients indicated for treatment containing raltegravir Patient has at least 2 activates molecules in combination therapy according genotype realized in the visit of selection.

Patient has not a history or current evidence of opportunist infection within the 4 weeks before the selection Patient who has received oral and written (information sheet) information about the study and who has agreed for the computer processing of his/her personal data.

Patients with chronic hepatitis, including chronic hepatitis B and/or C may enter the study as.

Exclusion Criteria:

  • Patients meeting one or both of the following criteria may not take part in the study
  • Patient is reproductive potential without requiring the use of contraception
  • Patient is pregnant or breast-feeding
  • Patient using alcohol and\or drug and\or the other substance that might interfere with the patient participation
  • Patient infected by HIV2
  • Patient has severe hepatic insufficiency. (liver enzymes > 5N)
  • Patient has the following laboratory values during selection
  • Platelets < 40.000 cell / mm3
  • Haemoglobin < 8 g / dl during the selection
  • Neutrophils < 500 / mm3
  • Patient has associated treatments which can have interactions with Raltegravir (Cf RCP Isentress ®)
  • Patient should be considered by the investigator able to conform to the imperatives of the study procedures

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Delassus Jean-Luc, MD、Réseau Aulnay 93

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年9月1日

初级完成 (预期的)

2011年3月1日

研究完成 (预期的)

2012年3月1日

研究注册日期

首次提交

2010年7月9日

首先提交符合 QC 标准的

2010年7月13日

首次发布 (估计)

2010年7月14日

研究记录更新

最后更新发布 (估计)

2010年7月14日

上次提交的符合 QC 标准的更新

2010年7月13日

最后验证

2010年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2010-021178-12

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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