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

This study has been completed.
Sponsor:
Collaborators:
Readitwell
Lincoln
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01103596
First received: February 24, 2010
Last updated: December 13, 2011
Last verified: December 2011

February 24, 2010
December 13, 2011
March 2008
July 2009   (final data collection date for primary outcome measure)
  • Genotype for resistance determination [ Time Frame: Over the duration of the enrollment for each wave, over a total period of 18 months ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: Over the duration of the enrollment for each wave, over a total period of 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01103596 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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®.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

Frozen plasma for determination of Lopinavir/ritonavir (LPV/r) Cmin

Non-Probability Sample

Virology laboratories

HIV Infection
Not Provided
  • HIV-infected patients, 1st wave
    HIV-infected ARV-experienced patients treated by a combination including Kaletra
  • HIV-infected patients, 2nd wave
    HIV-infected ARV-experienced patients treated by a combination including Kaletra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 2009
July 2009   (final data collection date for primary outcome measure)

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®.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01103596
P06-124
No
Abbott
Abbott
  • Readitwell
  • Lincoln
Study Director: Isabelle Cohen Codar, PharmD Abbott France
Abbott
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP