NCT01103596

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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®.

Conditions

• HIV Infection

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2010-04-14
• Last updated: 2011-12-14

Locations

19 sites across 1 country: France