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

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ClinicalTrials.gov Identifier: NCT01162538
Recruitment Status : Unknown
Verified May 2010 by Centre Hospitalier Intercommunal Robert Ballanger.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2010
Last Update Posted : July 14, 2010
Sponsor:
Information provided by:
Centre Hospitalier Intercommunal Robert Ballanger

Tracking Information
First Submitted Date July 9, 2010
First Posted Date July 14, 2010
Last Update Posted Date July 14, 2010
Study Start Date September 2010
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients
Official Title 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
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Evaluated
  • Non B Subtype
  • Naive Patients
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July¬†13,¬†2010)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2012
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01162538
Other Study ID Numbers 2010-021178-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Jean-Luc Delassus, Réseau Aulnay 93
Study Sponsor Centre Hospitalier Intercommunal Robert Ballanger
Collaborators Not Provided
Investigators
Principal Investigator: Delassus Jean-Luc, MD Réseau Aulnay 93
PRS Account Centre Hospitalier Intercommunal Robert Ballanger
Verification Date May 2010