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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 ottobre 2011 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

2288

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

2 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
CD4 Count
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reasons for Discontinuation of Lopinavir/Ritonavir
Lasso di tempo: 9 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
Lasso di tempo: 18 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
18 months
Compliance With Lopinavir/Ritonavir
Lasso di tempo: 9 months
Participants reported whether they had missed doses of their antiretroviral treatment.
9 months
Compliance With Lopinavir/Ritonavir
Lasso di tempo: 18 months
Participants reported whether they had missed any doses of their antiretroviral treatment.
18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott

Investigatori

  • Direttore dello studio: Maja Hojnik, MD, PhD, Abbott International

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2004

Completamento primario (Effettivo)

1 febbraio 2010

Completamento dello studio (Effettivo)

1 febbraio 2010

Date di iscrizione allo studio

Primo inviato

22 giugno 2011

Primo inviato che soddisfa i criteri di controllo qualità

22 giugno 2011

Primo Inserito (Stima)

23 giugno 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 ottobre 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 ottobre 2011

Ultimo verificato

1 ottobre 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • PMOS-EAST-04-1

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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