HIV Infection Clinical Trial
Official title:
Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE
The purpose of this study is to evaluate, in patients in at least the second protease inhibitor (PI) line, the virological failures under Kaletra® and their consequences on protease and reverse transcriptase genotypes
The purpose of this study is to evaluate, in patients in at least the second PI line, the
virological failures under Kaletra® and their consequences on protease and reverse
transcriptase genotypes:
- 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®.
;
Time Perspective: Retrospective
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