Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)
10 de octubre de 2011 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
2288
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bratislava, Eslovaquia, 813 69
- Site Ref # / Investigator 6208
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Ljubljana, Eslovenia, 1000
- Site Ref # / Investigator 6199
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Barnaul, Federación Rusa, 658610
- Site Ref # / Investigator 57022
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Chelyabinsk, Federación Rusa, 454052
- Site Ref # / Investigator 56918
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Chita, Federación Rusa, 672000
- Site Ref # / Investigator 56963
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Ekaterinburg, Federación Rusa, 620102
- Site Ref # / Investigator 56923
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Ekaterinburg, Federación Rusa, 620115
- Site Ref # / Investigator 56903
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Irkutsk, Federación Rusa, 664043
- Site Ref # / Investigator 56921
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Irkutsk, Federación Rusa, 664043
- Site Ref #/Investigator 57104
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Ivanovo, Federación Rusa, 153000
- Site Ref # / Investigator 57028
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Izhevsk, Federación Rusa, 426067
- Site Ref # / Investigator 57036
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Kaliningrad, Federación Rusa, 2360000
- Site Ref # / Investigator 56945
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Kazan, Federación Rusa, 420000
- Site Ref # / Investigator 56909
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Kemerovo, Federación Rusa, 650056
- Site Ref # / Investigator 57037
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Kemerovo, Federación Rusa, 650056
- Site Ref #/Investigator 57105
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Khabarovsk, Federación Rusa, 680029
- Site Ref # / Investigator 56948
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Khanty-Mansiysk, Federación Rusa, 628002
- Site Ref # / Investigator 56932
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Kirov, Federación Rusa, 57107
- Site Ref #/Investigator 57107
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Kostroma, Federación Rusa, 156007
- Site Ref # / Investigator 57030
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Krasnodar, Federación Rusa, 350015
- Site Ref # / Investigator 56943
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Krasnoyarsk, Federación Rusa, 660049
- Site Ref # / Investigator 56928
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Krasnoyarsk, Federación Rusa, 660049
- Site Ref #/Investigator 57106
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Kurgan, Federación Rusa, 640007
- Site Ref # / Investigator 57021
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Lipetsk, Federación Rusa, 398043
- Site Ref # / Investigator 57025
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Magnitogorsk, Federación Rusa, 350015
- Site Ref # / Investigator 56944
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Moscow, Federación Rusa, 105275
- Site Ref # / Investigator 56904
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Moscow, Federación Rusa, 105275
- Site Ref # / Investigator 6209
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Moscow, Federación Rusa, 129110
- Site Ref # / Investigator 56902
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Murmansk, Federación Rusa, 183047
- Site Ref # / Investigator 57024
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Nizhniy Novgorod, Federación Rusa, 603005
- Site Ref # / Investigator 56907
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Norilsk, Federación Rusa, 663318
- Site Ref # / Investigator 56964
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Novokuznetsk, Federación Rusa, 654031
- Site Ref # / Investigator 56929
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Novosibirsk, Federación Rusa, 630000
- Site Ref # / Investigator 56942
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Noyabrsk, Federación Rusa, 629806
- Site Ref # / Investigator 56926
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Orenburg, Federación Rusa, 460035
- Site Ref # / Investigator 56915
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Orenburg, Federación Rusa, 460035
- Site Ref # / Investigator 57031
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Perm, Federación Rusa, 614000
- Site Ref # / Investigator 56930
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Rostov-on-Don, Federación Rusa, 344006
- Site Ref # / Investigator 56911
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Saint Petersburg, Federación Rusa, 190103
- Site Ref # / Investigator 56906
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Saint Petersburg, Federación Rusa, 191167
- Site Ref # / Investigator 56905
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Samara, Federación Rusa, 443041
- Site Ref # / Investigator 56931
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Saratov, Federación Rusa, 410009
- Site Ref # / Investigator 56913
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St. Petersburg, Federación Rusa, 190000
- Site Ref # / Investigator 57033
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St. Petersburg, Federación Rusa, 196645
- Site Ref # / Investigator 56920
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St. Petersburg, Federación Rusa, 196645
- Site Ref # / Investigator 57038
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Surgut, Federación Rusa, 628400
- Site Ref # / Investigator 56908
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Togliatti, Federación Rusa, 445846
- Site Ref # / Investigator 56962
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Tula, Federación Rusa, 300002
- Site Ref # / Investigator 57034
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Tver, Federación Rusa, 170024
- Site Ref # / Investigator 56947
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Tver, Federación Rusa, 170024
- Site Ref # / Investigator 57035
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Tyumen, Federación Rusa, 628602
- Site Ref # / Investigator 56910
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Tyumen, Federación Rusa, 628602
- Site Ref # / Investigator 56919
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Ufa, Federación Rusa, 450077
- Site Ref # / Investigator 57029
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Ulan-Ude, Federación Rusa, 670034
- Site Ref # / Investigator 56949
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Ulyanovsk, Federación Rusa, 432071
- Site Ref # / Investigator 56914
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Vladimir, Federación Rusa, 600023
- Site Ref # / Investigator 57027
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Volgograd, Federación Rusa, 400040
- Site Ref # / Investigator 56916
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Vologda, Federación Rusa, 160002
- Site Ref #/Investigator 57103
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Yakutsk, Federación Rusa, 677004
- Site Ref # / Investigator 56946
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Yaroslavl, Federación Rusa, 150000
- Site Ref # / Investigator 57026
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Tbilisi, Georgia
- Site Ref # / Investigator 7576
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Beer-Sheva, Israel, 84101
- Site Ref # / Investigator 57050
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Haifa, Israel, 31096
- Site Ref # / Investigator 57048
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Jerusalem, Israel, 91120
- Site Ref # / Investigator 57049
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Kfar Saba, Israel, 44281
- Site Ref # / Investigator 6124
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Rechovot, Israel, 76100
- Site Ref # / Investigator 57047
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Tel-Hashomer, Israel
- Site Ref # / Investigator 57051
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Riga, Letonia
- Site Ref # / Investigator 7578
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Vilnius, Lituania, LT-10105
- Site Ref # / Investigator 6127
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Bialystok, Polonia, 15540
- Site Ref # / Investigator 6190
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Bydgoszcz, Polonia, 85-030
- Site Ref # / Investigator 56885
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Chorzow, Polonia, 41-500
- Site Ref # / Investigator 56887
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Gdansk, Polonia, 80-214
- Site Ref # / Investigator 56883
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Krakow, Polonia, 31-531
- Site Ref # / Investigator 56888
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Lodz, Polonia, 91-347
- Site Ref # / Investigator 56889
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Poznan, Polonia, 61-285
- Site Ref # / Investigator 56884
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Szczecin, Polonia, 71-455
- Site Ref # / Investigator 56886
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Warsaw, Polonia, 01-201
- Site Ref # / Investigator 56882
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Wroclaw, Polonia, 51-149
- Site Ref # / Investigator 56890
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Brno, República Checa, 639 00
- Site Ref # / Investigator 57102
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Ceske Budejovice, República Checa, 370 87
- Site Ref # / Investigator 57054
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Hradec Kralove, República Checa, 50005
- Site Ref # / Investigator 57055
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Ostrava, República Checa, 708 52
- Site Ref # / Investigator 57056
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Plzen, República Checa, 305 99
- Site Ref # / Investigator 57052
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Prague 8, República Checa, 180 01
- Site Ref # / Investigator 5344
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Usti nad Labem, República Checa, 40011
- Site Ref # / Investigator 57053
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Brasov, Rumania, 500174
- Site Ref # / Investigator 57064
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Bucharest, Rumania, 021105
- Site Ref # / Investigator 6194
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Bucharest, Rumania, 030303
- Site Ref # / Investigator 57062
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Constanta, Rumania, 900708
- Site Ref # / Investigator 57063
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Craiova, Rumania, 200515
- Site Ref # / Investigator 57067
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Iasi, Rumania, 700116
- Site Ref # / Investigator 57068
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Targu Mures, Rumania, 540394
- Site Ref # / Investigator 57065
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Timisoara, Rumania, 300310
- Site Ref # / Investigator 57066
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Belgrade, Serbia, 11 000
- Site Ref # / Investigator 7579
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Dnepropetrovsk, Ucrania, 49115
- Site Ref # / Investigator 57042
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Donetsk, Ucrania, 83045
- Site Ref # / Investigator 57043
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Kyiv, Ucrania, 01015
- Site Ref # / Investigator 57045
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Kyiv, Ucrania, 01015
- Site Ref # / Investigator 6191
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Kyiv, Ucrania, 03115
- Site Ref # / Investigator 57046
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Mykolaiv, Ucrania, 54003
- Site Ref # / Investigator 57044
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Odessa, Ucrania, 565031
- Site Ref # / Investigator 57039
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Simferopol, Ucrania, 95006
- Site Ref # / Investigator 57040
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
2 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Single patients group
Single HIV-1 infected patients group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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CD4 Count
Periodo de tiempo: Baseline
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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.
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Baseline
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Changes in CD4 Count
Periodo de tiempo: Baseline to 1 month
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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.
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Baseline to 1 month
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Changes in CD4 Count
Periodo de tiempo: Baseline to 3 months
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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.
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Baseline to 3 months
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Changes in CD4 Count
Periodo de tiempo: Baseline to 6 months
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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.
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Baseline to 6 months
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Changes in CD4 Count
Periodo de tiempo: Baseline to 9 months
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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.
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Baseline to 9 months
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Changes in CD4 Count
Periodo de tiempo: Baseline to 12 months
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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.
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Baseline to 12 months
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Changes in CD4 Count
Periodo de tiempo: Baseline to 15 months
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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.
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Baseline to 15 months
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Changes in CD4 Count
Periodo de tiempo: Baseline to 18 months
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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.
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Baseline to 18 months
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Viral Load
Periodo de tiempo: Baseline
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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.
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Baseline
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Viral Load
Periodo de tiempo: 1 month
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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.
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1 month
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Viral Load
Periodo de tiempo: 3 months
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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.
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3 months
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Viral Load
Periodo de tiempo: 6 months
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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.
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6 months
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Viral Load
Periodo de tiempo: 9 months
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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.
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9 months
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Viral Load
Periodo de tiempo: 12 months
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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.
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12 months
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Viral Load
Periodo de tiempo: 15 months
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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.
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15 months
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Viral Load
Periodo de tiempo: 18 months
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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.
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18 months
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Laboratory Parameter Blood Glucose
Periodo de tiempo: Baseline, 9 months, 18 months
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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.
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Baseline, 9 months, 18 months
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Laboratory Parameter Transaminases
Periodo de tiempo: Baseline, 9 months, 18 months
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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.
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Baseline, 9 months, 18 months
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Laboratory Parameter Lipids
Periodo de tiempo: Baseline, 9 months, 18 months
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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.
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Baseline, 9 months, 18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Reasons for Discontinuation of Lopinavir/Ritonavir
Periodo de tiempo: 9 months
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For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
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9 months
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Reasons for Discontinuation of Lopinavir/Ritonavir
Periodo de tiempo: 18 months
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For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
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18 months
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Compliance With Lopinavir/Ritonavir
Periodo de tiempo: 9 months
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Participants reported whether they had missed doses of their antiretroviral treatment.
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9 months
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Compliance With Lopinavir/Ritonavir
Periodo de tiempo: 18 months
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Participants reported whether they had missed any doses of their antiretroviral treatment.
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18 months
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Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Periodo de tiempo: 18 months
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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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Maja Hojnik, MD, PhD, Abbott International
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2004
Finalización primaria (Actual)
1 de febrero de 2010
Finalización del estudio (Actual)
1 de febrero de 2010
Fechas de registro del estudio
Enviado por primera vez
22 de junio de 2011
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2011
Publicado por primera vez (Estimar)
23 de junio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de octubre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
10 de octubre de 2011
Última verificación
1 de octubre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PMOS-EAST-04-1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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