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

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

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


Condition
HIV Infection

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Evaluation of the Public Health Interest of Kaletra: Impact on Resistance to ARVs - EOLE

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 94
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Virology laboratories

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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103596

Locations
France
Site Reference ID/Investigator# 27801
Angers, France, 49100
Site Reference ID/Investigator# 27799
Bordeaux, France, 33075
Site Reference ID/Investigator# 27790
Grenoble, France, 38043
Site Reference ID/Investigator# 27796
Lille, France, 59037
Site Reference ID/Investigator# 27786
Montpellier, France, 34295
Site Reference ID/Investigator# 27800
Nantes, France, 44093
Site Reference ID/Investigator# 27798
Nice, France, 06202
Site Reference ID/Investigator# 27792
Nimes, France, 30029
Site Reference ID/Investigator# 27802
Paris, France, 75908
Site Reference ID/Investigator# 27783
Paris, France, 75877
Site Reference ID/Investigator# 5595
Paris, France, 75013
Site Reference ID/Investigator# 27787
Paris, France, 75475
Site Reference ID/Investigator# 27785
Paris, France, 75970
Site Reference ID/Investigator# 27797
Paris Cedex 12, France, 75571
Site Reference ID/Investigator# 27791
Rennes, France, 35700
Site Reference ID/Investigator# 27788
Rouen, France, 76000
Site Reference ID/Investigator# 27789
Toulon, France, 83056
Site Reference ID/Investigator# 27794
Toulouse, France, 31000
Site Reference ID/Investigator# 27784
Villejuif, France, 94804
Sponsors and Collaborators
Abbott
Readitwell
Lincoln Medical and Mental Health Center
Investigators
Study Director: Isabelle Cohen Codar, PharmD Abbott France
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01103596     History of Changes
Other Study ID Numbers: P06-124
Study First Received: February 24, 2010
Last Updated: December 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Abbott:
Evaluation of the impact of Kaletra on antiretroviral resistance

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lopinavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014