To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients

NCT ID: NCT01162538

Last Updated: 2010-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Evaluated; Non B Subtype; Naive Patients

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Robert Ballanger

OTHER

Sponsor Role: lead

Responsible Party

Réseau Aulnay 93

Principal Investigators

Delassus Jean-Luc, MD

Role: PRINCIPAL_INVESTIGATOR

Réseau Aulnay 93

Locations

Hopital R.Ballanger

Aulnay-sous-Bois, , France

Countries

France

Facility Contacts

Delassus Jean-Luc, MD

Role: primary

jean-luc.delassus@ch-aulnay.fr

1 49 36 72 81 ext. +33

Other Identifiers

2010-021178-12

Identifier Type: -

Identifier Source: org_study_id