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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:

Study Description
Brief Summary:
Pilot open label multicentric study

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 60 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Jean-Luc Delassus, Réseau Aulnay 93
ClinicalTrials.gov Identifier: NCT01162538     History of Changes
Other Study ID Numbers: 2010-021178-12
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action