Clinical trial NCT01103596: Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to Antiretrovirals (ARVs)
Official title: Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Evaluation of the impact of Kaletra on antiretroviral resistance
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Readitwell
name: Lincoln Medical and Mental Health Center
First posted: 2010-04-14
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Virology laboratories

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®.

Eligibility criteria: 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®.

Primary outcomes:
measure: Genotype for resistance determination
timeFrame: Over the duration of the enrollment for each wave, over a total period of 18 months
measure: 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).
timeFrame: Over the duration of the enrollment for each wave, over a total period of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Site Reference ID/Investigator# 27801
city: Bordeaux
country: France
facility: Site Reference ID/Investigator# 27799
city: Grenoble
country: France
facility: Site Reference ID/Investigator# 27790
city: Lille
country: France
facility: Site Reference ID/Investigator# 27796
city: Montpellier
country: France
facility: Site Reference ID/Investigator# 27786
city: Nantes
country: France
facility: Site Reference ID/Investigator# 27800
city: Nice
country: France
facility: Site Reference ID/Investigator# 27798
city: Nimes
country: France
facility: Site Reference ID/Investigator# 27792
city: Paris Cedex 12
country: France
facility: Site Reference ID/Investigator# 27797
city: Paris
country: France
facility: Site Reference ID/Investigator# 5595
city: Paris
country: France
facility: Site Reference ID/Investigator# 27787
city: Paris
country: France
facility: Site Reference ID/Investigator# 27783
city: Paris
country: France
facility: Site Reference ID/Investigator# 27802
city: Paris
country: France
facility: Site Reference ID/Investigator# 27785
city: Rennes
country: France
facility: Site Reference ID/Investigator# 27791
city: Rouen
country: France
facility: Site Reference ID/Investigator# 27788
city: Toulon
country: France
facility: Site Reference ID/Investigator# 27789
city: Toulouse
country: France
facility: Site Reference ID/Investigator# 27794
city: Villejuif
country: France
facility: Site Reference ID/Investigator# 27784
Study officials:
affiliation: Abbott France
name: Isabelle Cohen Codar, PharmD
role: STUDY_DIRECTOR
References: