To Evaluate Effectiveness and Safety of Containing Raltegravir in Naive HIV NON B or B Infected Patients (Ral'inNONB)
Recruitment status was Not yet recruiting
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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 |
| 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) |
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 |
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)
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| 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 | |
| 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 May 23, 2013