To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients (Ral'inNONB)

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

Pilot open label multicentric study

Study Overview

• Status: Unknown
• Conditions: Evaluated; Non B Subtype; Naive Patients

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Aulnay sous Bois, France, 93602
    • Hopital R.Ballanger
    • Contact: Delassus Jean-Luc, MD; Phone Number: +33 1 49 36 72 81; Email: jean-luc.delassus@ch-aulnay.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It's a pilot open label, multicentric, national, prospective and descriptive study to evaluate effectiveness and safety of regimen containing Raltegravir (400mg x 2) in 40 treatment naive HIV non B infected subjects versus in 20 treatment naive HIV B infected sujects.

The patients will be matched according to:

• basal viral load (< 10 000 copies/ml, ≥100 000 copies/ml)
• rate of basal CD4 (<200 cell/mm3, ≥ 200 cell/mm3)

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Robert Ballanger
• Investigators: Principal Investigator: Delassus Jean-Luc, MD, Réseau Aulnay 93

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: July 9, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 14, 2010
• Last Update Submitted That Met QC Criteria: July 13, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Raltegravir, non B subtype, naive patients
• Other Study ID Numbers: 2010-021178-12