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

HIV Infection Clinical Trial

— EOLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103596
• Other study ID #: P06-124
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: December 13, 2011
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: December 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infection

Locations

Country	Name	City	State
France	Site Reference ID/Investigator# 27801	Angers
France	Site Reference ID/Investigator# 27799	Bordeaux
France	Site Reference ID/Investigator# 27790	Grenoble
France	Site Reference ID/Investigator# 27796	Lille
France	Site Reference ID/Investigator# 27786	Montpellier
France	Site Reference ID/Investigator# 27800	Nantes
France	Site Reference ID/Investigator# 27798	Nice
France	Site Reference ID/Investigator# 27792	Nimes
France	Site Reference ID/Investigator# 27783	Paris
France	Site Reference ID/Investigator# 27785	Paris
France	Site Reference ID/Investigator# 27787	Paris
France	Site Reference ID/Investigator# 27802	Paris
France	Site Reference ID/Investigator# 5595	Paris
France	Site Reference ID/Investigator# 27797	Paris Cedex 12
France	Site Reference ID/Investigator# 27791	Rennes
France	Site Reference ID/Investigator# 27788	Rouen
France	Site Reference ID/Investigator# 27789	Toulon
France	Site Reference ID/Investigator# 27794	Toulouse
France	Site Reference ID/Investigator# 27784	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Lincoln Medical and Mental Health Center, Readitwell

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotype for resistance determination		Over the duration of the enrollment for each wave, over a total period of 18 months	No
Primary	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	No