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

Completed

• Conditions: HIV Infection

• Registration Number: NCT01103596
• Lead Sponsor: Abbott

Brief 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®.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-13
• Last Update Posted: 2011-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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®.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Site Reference ID/Investigator# 27801; 🇫🇷 Angers, France

Site Reference ID/Investigator# 27799; 🇫🇷 Bordeaux, France

Site Reference ID/Investigator# 27800; 🇫🇷 Nantes, France

Site Reference ID/Investigator# 27796; 🇫🇷 Lille, France

Site Reference ID/Investigator# 27802; 🇫🇷 Paris, France

Site Reference ID/Investigator# 27788; 🇫🇷 Rouen, France

Site Reference ID/Investigator# 27783; 🇫🇷 Paris, France

Site Reference ID/Investigator# 27790; 🇫🇷 Grenoble, France

Site Reference ID/Investigator# 27786; 🇫🇷 Montpellier, France

Site Reference ID/Investigator# 27798; 🇫🇷 Nice, France

Site Reference ID/Investigator# 27792; 🇫🇷 Nimes, France

Site Reference ID/Investigator# 5595; 🇫🇷 Paris, France

Site Reference ID/Investigator# 27797; 🇫🇷 Paris Cedex 12, France

Site Reference ID/Investigator# 27787; 🇫🇷 Paris, France

Site Reference ID/Investigator# 27794; 🇫🇷 Toulouse, France

Site Reference ID/Investigator# 27789; 🇫🇷 Toulon, France

Site Reference ID/Investigator# 27784; 🇫🇷 Villejuif, France

Site Reference ID/Investigator# 27785; 🇫🇷 Paris, France

Site Reference ID/Investigator# 27791; 🇫🇷 Rennes, France