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
研究概览
地位
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
注册 (预期的)
联系人和位置
学习地点
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Aulnay sous Bois、法国、93602
- Hopital R.Ballanger
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接触:
- Delassus Jean-Luc, MD
- 电话号码:+33 1 49 36 72 81
- 邮箱:jean-luc.delassus@ch-aulnay.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
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
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 首席研究员:Delassus Jean-Luc, MD、Réseau Aulnay 93
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2010-021178-12
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