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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Centre Hospitalier Intercommunal Robert Ballanger.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Centre Hospitalier Intercommunal Robert Ballanger
ClinicalTrials.gov Identifier:
NCT01162538
First received: July 9, 2010
Last updated: July 13, 2010
Last verified: May 2010

July 9, 2010
July 13, 2010
September 2010
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01162538 on ClinicalTrials.gov Archive Site
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To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients
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

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

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)
  • Evaluated
  • Non B Subtype
  • Naive Patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
March 2012
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
France
 
NCT01162538
2010-021178-12
No
Dr Jean-Luc Delassus, Réseau Aulnay 93
Centre Hospitalier Intercommunal Robert Ballanger
Not Provided
Principal Investigator: Delassus Jean-Luc, MD Réseau Aulnay 93
Centre Hospitalier Intercommunal Robert Ballanger
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP