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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Pilot open label multicentric study
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •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.
排除标准
- •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