Clinical trial NCT01162538: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluated
Non B Subtype
Naive Patients
Keywords: Raltegravir, non B subtype, naive patients
Lead sponsor: Centre Hospitalier Intercommunal Robert Ballanger
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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)

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aulnay sous Bois
country: France
facility: Hopital R.Ballanger
Study officials:
affiliation: Réseau Aulnay 93
name: Delassus Jean-Luc, MD
role: PRINCIPAL_INVESTIGATOR
References: