Ral'inNONBThe 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
Data Collection
Collected from today forward - ProspectiveSummary
Study start date: September 1, 2010
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location