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Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

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ClinicalTrials.gov Identifier: NCT01379703
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : September 12, 2011
Last Update Posted : October 17, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Description
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Brief Summary:

KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.

The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.

The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.


Condition or disease
HIV-1 Patients

Detailed Description:
As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months.

Study Design
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Study Type : Observational
Actual Enrollment : 2288 participants
Time Perspective: Prospective
Official Title: Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Study Start Date : February 2004
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Single patients group
Single HIV-1 infected patients group


Outcome Measures
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Primary Outcome Measures :
  1. CD4 Count [ Time Frame: Baseline ]
    CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.

  2. Changes in CD4 Count [ Time Frame: Baseline to 1 month ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  3. Changes in CD4 Count [ Time Frame: Baseline to 3 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  4. Changes in CD4 Count [ Time Frame: Baseline to 6 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  5. Changes in CD4 Count [ Time Frame: Baseline to 9 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  6. Changes in CD4 Count [ Time Frame: Baseline to 12 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  7. Changes in CD4 Count [ Time Frame: Baseline to 15 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  8. Changes in CD4 Count [ Time Frame: Baseline to 18 months ]
    Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.

  9. Viral Load [ Time Frame: Baseline ]
    Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.

  10. Viral Load [ Time Frame: 1 month ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  11. Viral Load [ Time Frame: 3 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  12. Viral Load [ Time Frame: 6 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  13. Viral Load [ Time Frame: 9 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  14. Viral Load [ Time Frame: 12 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  15. Viral Load [ Time Frame: 15 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  16. Viral Load [ Time Frame: 18 months ]
    Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.

  17. Laboratory Parameter Blood Glucose [ Time Frame: Baseline, 9 months, 18 months ]
    Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.

  18. Laboratory Parameter Transaminases [ Time Frame: Baseline, 9 months, 18 months ]
    Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.

  19. Laboratory Parameter Lipids [ Time Frame: Baseline, 9 months, 18 months ]
    A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.


Secondary Outcome Measures :
  1. Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 9 months ]
    For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.

  2. Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 18 months ]
    For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.

  3. Compliance With Lopinavir/Ritonavir [ Time Frame: 9 months ]
    Participants reported whether they had missed doses of their antiretroviral treatment.

  4. Compliance With Lopinavir/Ritonavir [ Time Frame: 18 months ]
    Participants reported whether they had missed any doses of their antiretroviral treatment.

  5. Adverse Events Observed on Treatment With Lopinavir/Ritonavir. [ Time Frame: 18 months ]

    Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.

    All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.
Criteria

Inclusion Criteria:

Patients infected by HIV-1 infection who are either:

  • Antiretroviral treatment (ART) naive or
  • Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
  • Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).

A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.

Exclusion Criteria:

  • Treatment with drugs at risk for interactions with lopinavir/ritonavir
  • Uncontrolled AIDS defining disease
  • Two or more previous Protease inhibitors (PIs)
  • Participation in another study or clinical trial
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379703


  Show 103 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Maja Hojnik, MD, PhD Abbott International
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
First Posted: June 23, 2011    Key Record Dates
Results First Posted: September 12, 2011
Last Update Posted: October 17, 2011
Last Verified: October 2011

Keywords provided by Abbott:
HIV-1 infected patients
Protease inhibitor
Kaletra®

Additional relevant MeSH terms:
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors