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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01379703
First received: June 22, 2011
Last updated: October 10, 2011
Last verified: October 2011

June 22, 2011
October 10, 2011
February 2004
February 2010   (final data collection date for primary outcome measure)
  • CD4 Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 Count [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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.
  • Viral Load [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.
  • Laboratory Parameter Blood Glucose [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
    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.
  • Laboratory Parameter Transaminases [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
    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.
  • Laboratory Parameter Lipids [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
    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.
  • Changes in CD4 count [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Changes in CD4 count [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART
  • Viral load [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Viral load [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Laboratory parameter blood glucose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Laboratory parameter Transaminases [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
  • Laboratory parameter lipids [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Clinical, biological and virological outcomes of lopinavir/ritonavir containing anti-retroviral treatment (ART)
Complete list of historical versions of study NCT01379703 on ClinicalTrials.gov Archive Site
  • Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
  • Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
  • Compliance With Lopinavir/Ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Participants reported whether they had missed doses of their antiretroviral treatment.
  • Compliance With Lopinavir/Ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Participants reported whether they had missed any doses of their antiretroviral treatment.
  • Adverse Events Observed on Treatment With Lopinavir/Ritonavir. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    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.

  • Reasons for discontinuation of lopinavir/ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Reasons for discontinuation of lopinavir/ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Compliance with lopinavir/ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Compliance with lopinavir/ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Adverse events observed on treatment with the Kaletra® [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV-1 Patients
Not Provided
Single patients group
Single HIV-1 infected patients group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2288
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Georgia,   Israel,   Latvia,   Lithuania,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Ukraine
 
NCT01379703
PMOS-EAST-04-1
No
Abbott
Abbott
Not Provided
Study Director: Maja Hojnik, MD, PhD Abbott International
Abbott
October 2011

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