Status:
UNKNOWN
To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients
Lead Sponsor:
Centre Hospitalier Intercommunal Robert Ballanger
Conditions:
Evaluated
Non B Subtype
Eligibility:
All Genders
18+ years
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, i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01162538
Start Date
September 1 2010
End Date
March 1 2012
Last Update
July 14 2010
Active Locations (1)
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1
Hopital R.Ballanger
Aulnay-sous-Bois, France, 93602