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
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveRésumé
Date de début de l'étude : 1 septembre 2010
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site