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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)

10 oktober 2011 bijgewerkt door: Abbott

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

2288

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Single patients group
Single HIV-1 infected patients group

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
CD4 Count
Tijdsspanne: 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.
Baseline
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 1 month
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 3 months
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 6 months
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 9 months
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 12 months
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 15 months
Changes in CD4 Count
Tijdsspanne: 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.
Baseline to 18 months
Viral Load
Tijdsspanne: 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.
Baseline
Viral Load
Tijdsspanne: 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.
1 month
Viral Load
Tijdsspanne: 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.
3 months
Viral Load
Tijdsspanne: 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.
6 months
Viral Load
Tijdsspanne: 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.
9 months
Viral Load
Tijdsspanne: 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.
12 months
Viral Load
Tijdsspanne: 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.
15 months
Viral Load
Tijdsspanne: 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.
18 months
Laboratory Parameter Blood Glucose
Tijdsspanne: 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.
Baseline, 9 months, 18 months
Laboratory Parameter Transaminases
Tijdsspanne: 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.
Baseline, 9 months, 18 months
Laboratory Parameter Lipids
Tijdsspanne: 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.
Baseline, 9 months, 18 months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Abbott

Onderzoekers

  • Studie directeur: Maja Hojnik, MD, PhD, Abbott International

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2004

Primaire voltooiing (Werkelijk)

1 februari 2010

Studie voltooiing (Werkelijk)

1 februari 2010

Studieregistratiedata

Eerst ingediend

22 juni 2011

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2011

Eerst geplaatst (Schatting)

23 juni 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

17 oktober 2011

Laatste update ingediend die voldeed aan QC-criteria

10 oktober 2011

Laatst geverifieerd

1 oktober 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PMOS-EAST-04-1

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