Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)

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®.

Inclusion criteria

• Patient aged under 18 years,
• 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 having received less than three months of Kaletra®,
• 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®.