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
  Purpose

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
HIV-1 Patients

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 2288
Study Start Date: February 2004
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single patients group
Single HIV-1 infected patients group

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
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: NCT01379703

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01379703     History of Changes
Other Study ID Numbers: PMOS-EAST-04-1
Study First Received: June 22, 2011
Results First Received: August 9, 2011
Last Updated: October 10, 2011
Health Authority: Romania: Ethics Committee
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Slovenia: Ethics Committee
Slovak Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014