Evaluated, Naive Patients, Non B Subtype
Conditions
Keywords
Raltegravir, non B subtype, naive patients
Brief summary
Pilot open label multicentric study
Detailed description
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.
Interventions
None listed
Sponsors
Centre Hospitalier Intercommunal Robert Ballanger
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
France
Outcome results
None listed