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
  Purpose

Pilot open label multicentric study


Condition
Evaluated
Non B Subtype
Naive Patients

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Intercommunal Robert Ballanger:

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162538

Locations
France
Hopital R.Ballanger Not yet recruiting
Aulnay sous Bois, France, 93602
Contact: Delassus Jean-Luc, MD    1 49 36 72 81 ext +33    jean-luc.delassus@ch-aulnay.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Robert Ballanger
Investigators
Principal Investigator: Delassus Jean-Luc, MD Réseau Aulnay 93
  More Information

No publications provided

Responsible Party: Dr Jean-Luc Delassus, Réseau Aulnay 93
ClinicalTrials.gov Identifier: NCT01162538     History of Changes
Other Study ID Numbers: 2010-021178-12
Study First Received: July 9, 2010
Last Updated: July 13, 2010
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Hospitalier Intercommunal Robert Ballanger:
Raltegravir, non B subtype, naive patients

ClinicalTrials.gov processed this record on August 26, 2014