Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)
NCT ID: NCT01103596
Last Updated: 2011-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
94 participants
OBSERVATIONAL
2008-03-31
2009-07-31
Brief Summary
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Detailed Description
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* Characterisation of the changes in the resistance genotype in protease and reverse transcriptase,
* Description of the nature and frequency of selected mutations under Kaletra®,
* Description of the predictive factors for mutations and of the impact they could have on other PIs used as maintenance treatment (analysis based on available algorithms).
EOLE is a prospective, multicentre observation study offered to French virology laboratories and involving clinical teams .
It is a transversal study with retrospective data collection for patients meeting the study criteria (virological failure under Kaletra® after at least first line PI treatment).
The study comprises two enrolment periods, separated by an interval of one year, over a period ranging from 2007 to 2011. During this period, virological failures under Kaletra® are identified. For each period, the virologists collect data only from the moment when virological failure under Kaletra® is identified.
The first wave of data collection is now completed and occurred from December 5, 2007 to July 03, 2009.
It is not planned to collect follow-up data in connection with alternative treatment with other antiretrovirals after failure under Kaletra®.
Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Study Groups
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HIV-infected patients, 1st wave
HIV-infected ARV-experienced patients treated by a combination including Kaletra
No interventions assigned to this group
HIV-infected patients, 2nd wave
HIV-infected ARV-experienced patients treated by a combination including Kaletra
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pre-treated by at least one protease inhibitor (PI) line,
* In therapeutic failure of the antiretroviral (ARV) maintenance treatment containing Kaletra®.
Therapeutic failure is defined by a viral load\> 50 copies/ml after at least three months' treatment with an ARV combination containing Kaletra®, always provided that genotyping is possible .
Exclusion Criteria
* Patients for whom the genotype information before starting Kaletra® and at the time of the failure of Kaletra® was not available,
* Patients receiving another protease inhibitor (PI) concomitantly with Kaletra®.
18 Years
ALL
No
Sponsors
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Readitwell
UNKNOWN
Lincoln Medical and Mental Health Center
OTHER
Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Isabelle Cohen Codar, PharmD
Role: STUDY_DIRECTOR
Abbott France
Locations
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Site Reference ID/Investigator# 27801
Angers, , France
Site Reference ID/Investigator# 27799
Bordeaux, , France
Site Reference ID/Investigator# 27790
Grenoble, , France
Site Reference ID/Investigator# 27796
Lille, , France
Site Reference ID/Investigator# 27786
Montpellier, , France
Site Reference ID/Investigator# 27800
Nantes, , France
Site Reference ID/Investigator# 27798
Nice, , France
Site Reference ID/Investigator# 27792
Nîmes, , France
Site Reference ID/Investigator# 5595
Paris, , France
Site Reference ID/Investigator# 27787
Paris, , France
Site Reference ID/Investigator# 27797
Paris, , France
Site Reference ID/Investigator# 27783
Paris, , France
Site Reference ID/Investigator# 27802
Paris, , France
Site Reference ID/Investigator# 27785
Paris, , France
Site Reference ID/Investigator# 27791
Rennes, , France
Site Reference ID/Investigator# 27788
Rouen, , France
Site Reference ID/Investigator# 27789
Toulon, , France
Site Reference ID/Investigator# 27794
Toulouse, , France
Site Reference ID/Investigator# 27784
Villejuif, , France
Countries
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Other Identifiers
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P06-124
Identifier Type: -
Identifier Source: org_study_id