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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 2288

Contacts and Locations

Study Locations

• Czech Republic
  • Brno, Czech Republic, 639 00
    • Site Ref # / Investigator 57102
  • Ceske Budejovice, Czech Republic, 370 87
    • Site Ref # / Investigator 57054
  • Hradec Kralove, Czech Republic, 50005
    • Site Ref # / Investigator 57055
  • Ostrava, Czech Republic, 708 52
    • Site Ref # / Investigator 57056
  • Plzen, Czech Republic, 305 99
    • Site Ref # / Investigator 57052
  • Prague 8, Czech Republic, 180 01
    • Site Ref # / Investigator 5344
  • Usti nad Labem, Czech Republic, 40011
    • Site Ref # / Investigator 57053
• Georgia
  • Tbilisi, Georgia
    • Site Ref # / Investigator 7576
• Israel
  • Beer-Sheva, Israel, 84101
    • Site Ref # / Investigator 57050
  • Haifa, Israel, 31096
    • Site Ref # / Investigator 57048
  • Jerusalem, Israel, 91120
    • Site Ref # / Investigator 57049
  • Kfar Saba, Israel, 44281
    • Site Ref # / Investigator 6124
  • Rechovot, Israel, 76100
    • Site Ref # / Investigator 57047
  • Tel-Hashomer, Israel
    • Site Ref # / Investigator 57051
• Latvia
  • Riga, Latvia
    • Site Ref # / Investigator 7578
• Lithuania
  • Vilnius, Lithuania, LT-10105
    • Site Ref # / Investigator 6127
• Poland
  • Bialystok, Poland, 15540
    • Site Ref # / Investigator 6190
  • Bydgoszcz, Poland, 85-030
    • Site Ref # / Investigator 56885
  • Chorzow, Poland, 41-500
    • Site Ref # / Investigator 56887
  • Gdansk, Poland, 80-214
    • Site Ref # / Investigator 56883
  • Krakow, Poland, 31-531
    • Site Ref # / Investigator 56888
  • Lodz, Poland, 91-347
    • Site Ref # / Investigator 56889
  • Poznan, Poland, 61-285
    • Site Ref # / Investigator 56884
  • Szczecin, Poland, 71-455
    • Site Ref # / Investigator 56886
  • Warsaw, Poland, 01-201
    • Site Ref # / Investigator 56882
  • Wroclaw, Poland, 51-149
    • Site Ref # / Investigator 56890
• Romania
  • Brasov, Romania, 500174
    • Site Ref # / Investigator 57064
  • Bucharest, Romania, 021105
    • Site Ref # / Investigator 6194
  • Bucharest, Romania, 030303
    • Site Ref # / Investigator 57062
  • Constanta, Romania, 900708
    • Site Ref # / Investigator 57063
  • Craiova, Romania, 200515
    • Site Ref # / Investigator 57067
  • Iasi, Romania, 700116
    • Site Ref # / Investigator 57068
  • Targu Mures, Romania, 540394
    • Site Ref # / Investigator 57065
  • Timisoara, Romania, 300310
    • Site Ref # / Investigator 57066
• Russian Federation
  • Barnaul, Russian Federation, 658610
    • Site Ref # / Investigator 57022
  • Chelyabinsk, Russian Federation, 454052
    • Site Ref # / Investigator 56918
  • Chita, Russian Federation, 672000
    • Site Ref # / Investigator 56963
  • Ekaterinburg, Russian Federation, 620102
    • Site Ref # / Investigator 56923
  • Ekaterinburg, Russian Federation, 620115
    • Site Ref # / Investigator 56903
  • Irkutsk, Russian Federation, 664043
    • Site Ref # / Investigator 56921
  • Irkutsk, Russian Federation, 664043
    • Site Ref #/Investigator 57104
  • Ivanovo, Russian Federation, 153000
    • Site Ref # / Investigator 57028
  • Izhevsk, Russian Federation, 426067
    • Site Ref # / Investigator 57036
  • Kaliningrad, Russian Federation, 2360000
    • Site Ref # / Investigator 56945
  • Kazan, Russian Federation, 420000
    • Site Ref # / Investigator 56909
  • Kemerovo, Russian Federation, 650056
    • Site Ref # / Investigator 57037
  • Kemerovo, Russian Federation, 650056
    • Site Ref #/Investigator 57105
  • Khabarovsk, Russian Federation, 680029
    • Site Ref # / Investigator 56948
  • Khanty-Mansiysk, Russian Federation, 628002
    • Site Ref # / Investigator 56932
  • Kirov, Russian Federation, 57107
    • Site Ref #/Investigator 57107
  • Kostroma, Russian Federation, 156007
    • Site Ref # / Investigator 57030
  • Krasnodar, Russian Federation, 350015
    • Site Ref # / Investigator 56943
  • Krasnoyarsk, Russian Federation, 660049
    • Site Ref # / Investigator 56928
  • Krasnoyarsk, Russian Federation, 660049
    • Site Ref #/Investigator 57106
  • Kurgan, Russian Federation, 640007
    • Site Ref # / Investigator 57021
  • Lipetsk, Russian Federation, 398043
    • Site Ref # / Investigator 57025
  • Magnitogorsk, Russian Federation, 350015
    • Site Ref # / Investigator 56944
  • Moscow, Russian Federation, 105275
    • Site Ref # / Investigator 56904
  • Moscow, Russian Federation, 105275
    • Site Ref # / Investigator 6209
  • Moscow, Russian Federation, 129110
    • Site Ref # / Investigator 56902
  • Murmansk, Russian Federation, 183047
    • Site Ref # / Investigator 57024
  • Nizhniy Novgorod, Russian Federation, 603005
    • Site Ref # / Investigator 56907
  • Norilsk, Russian Federation, 663318
    • Site Ref # / Investigator 56964
  • Novokuznetsk, Russian Federation, 654031
    • Site Ref # / Investigator 56929
  • Novosibirsk, Russian Federation, 630000
    • Site Ref # / Investigator 56942
  • Noyabrsk, Russian Federation, 629806
    • Site Ref # / Investigator 56926
  • Orenburg, Russian Federation, 460035
    • Site Ref # / Investigator 56915
  • Orenburg, Russian Federation, 460035
    • Site Ref # / Investigator 57031
  • Perm, Russian Federation, 614000
    • Site Ref # / Investigator 56930
  • Rostov-on-Don, Russian Federation, 344006
    • Site Ref # / Investigator 56911
  • Saint Petersburg, Russian Federation, 190103
    • Site Ref # / Investigator 56906
  • Saint Petersburg, Russian Federation, 191167
    • Site Ref # / Investigator 56905
  • Samara, Russian Federation, 443041
    • Site Ref # / Investigator 56931
  • Saratov, Russian Federation, 410009
    • Site Ref # / Investigator 56913
  • St. Petersburg, Russian Federation, 190000
    • Site Ref # / Investigator 57033
  • St. Petersburg, Russian Federation, 196645
    • Site Ref # / Investigator 56920
  • St. Petersburg, Russian Federation, 196645
    • Site Ref # / Investigator 57038
  • Surgut, Russian Federation, 628400
    • Site Ref # / Investigator 56908
  • Togliatti, Russian Federation, 445846
    • Site Ref # / Investigator 56962
  • Tula, Russian Federation, 300002
    • Site Ref # / Investigator 57034
  • Tver, Russian Federation, 170024
    • Site Ref # / Investigator 56947
  • Tver, Russian Federation, 170024
    • Site Ref # / Investigator 57035
  • Tyumen, Russian Federation, 628602
    • Site Ref # / Investigator 56910
  • Tyumen, Russian Federation, 628602
    • Site Ref # / Investigator 56919
  • Ufa, Russian Federation, 450077
    • Site Ref # / Investigator 57029
  • Ulan-Ude, Russian Federation, 670034
    • Site Ref # / Investigator 56949
  • Ulyanovsk, Russian Federation, 432071
    • Site Ref # / Investigator 56914
  • Vladimir, Russian Federation, 600023
    • Site Ref # / Investigator 57027
  • Volgograd, Russian Federation, 400040
    • Site Ref # / Investigator 56916
  • Vologda, Russian Federation, 160002
    • Site Ref #/Investigator 57103
  • Yakutsk, Russian Federation, 677004
    • Site Ref # / Investigator 56946
  • Yaroslavl, Russian Federation, 150000
    • Site Ref # / Investigator 57026
• Serbia
  • Belgrade, Serbia, 11 000
    • Site Ref # / Investigator 7579
• Slovakia
  • Bratislava, Slovakia, 813 69
    • Site Ref # / Investigator 6208
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Site Ref # / Investigator 6199
• Ukraine
  • Dnepropetrovsk, Ukraine, 49115
    • Site Ref # / Investigator 57042
  • Donetsk, Ukraine, 83045
    • Site Ref # / Investigator 57043
  • Kyiv, Ukraine, 01015
    • Site Ref # / Investigator 57045
  • Kyiv, Ukraine, 01015
    • Site Ref # / Investigator 6191
  • Kyiv, Ukraine, 03115
    • Site Ref # / Investigator 57046
  • Mykolaiv, Ukraine, 54003
    • Site Ref # / Investigator 57044
  • Odessa, Ukraine, 565031
    • Site Ref # / Investigator 57039
  • Simferopol, Ukraine, 95006
    • Site Ref # / Investigator 57040

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single patients group; Single HIV-1 infected patients group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 Count	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.	Baseline
Changes in CD4 Count	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.	Baseline to 1 month
Changes in CD4 Count	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.	Baseline to 3 months
Changes in CD4 Count	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.	Baseline to 6 months
Changes in CD4 Count	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.	Baseline to 9 months
Changes in CD4 Count	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.	Baseline to 12 months
Changes in CD4 Count	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.	Baseline to 15 months
Changes in CD4 Count	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.	Baseline to 18 months
Viral Load	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.	Baseline
Viral Load	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.	1 month
Viral Load	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.	3 months
Viral Load	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.	6 months
Viral Load	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.	9 months
Viral Load	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 months
Viral Load	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 months
Viral Load	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.	18 months
Laboratory Parameter Blood Glucose	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.	Baseline, 9 months, 18 months
Laboratory Parameter Transaminases	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.	Baseline, 9 months, 18 months
Laboratory Parameter Lipids	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.	Baseline, 9 months, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for Discontinuation of Lopinavir/Ritonavir	For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.	9 months
Reasons for Discontinuation of Lopinavir/Ritonavir	For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.	18 months
Compliance With Lopinavir/Ritonavir	Participants reported whether they had missed doses of their antiretroviral treatment.	9 months
Compliance With Lopinavir/Ritonavir	Participants reported whether they had missed any doses of their antiretroviral treatment.	18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.	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.	18 months

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Maja Hojnik, MD, PhD, Abbott International

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 22, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): October 17, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Kaletra®; Protease inhibitor; HIV-1 infected patients
• Other Study ID Numbers: PMOS-EAST-04-1