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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 de outubro de 2011 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

2288

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

2 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Single patients group
Single HIV-1 infected patients group

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
CD4 Count
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Reasons for Discontinuation of Lopinavir/Ritonavir
Prazo: 9 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
Prazo: 18 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
18 months
Compliance With Lopinavir/Ritonavir
Prazo: 9 months
Participants reported whether they had missed doses of their antiretroviral treatment.
9 months
Compliance With Lopinavir/Ritonavir
Prazo: 18 months
Participants reported whether they had missed any doses of their antiretroviral treatment.
18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Abbott

Investigadores

  • Diretor de estudo: Maja Hojnik, MD, PhD, Abbott International

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2004

Conclusão Primária (Real)

1 de fevereiro de 2010

Conclusão do estudo (Real)

1 de fevereiro de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

22 de junho de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de junho de 2011

Primeira postagem (Estimativa)

23 de junho de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

17 de outubro de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de outubro de 2011

Última verificação

1 de outubro de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • PMOS-EAST-04-1

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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