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

Study Overview
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Brief Summary
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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

Detailed Description
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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®.

Official Title
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Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE

Conditions
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HIV Infection

Participation Criteria
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Eligibility Criteria
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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®.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected patients, 1st wave<br>HIV-infected ARV-experienced patients treated by a combination including Kaletra | |
| HIV-infected patients, 2nd wave<br>HIV-infected ARV-experienced patients treated by a combination including Kaletra | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype for resistance determination |  | Over the duration of the enrollment for each wave, over a total period of 18 months | 
| Description of the predictive factors for mutations and of the impact they could have on other protease inhibitors (PIs) used as maintenance treatment (analysis based on available algorithms). |  | Over the duration of the enrollment for each wave, over a total period of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluation of the impact of Kaletra on antiretroviral resistance