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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Aulnay sous Bois, Frankrig, 93602
- Hopital R.Ballanger
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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)
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Delassus Jean-Luc, MD, Réseau Aulnay 93
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2010-021178-12
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