Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)

10. října 2011 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

HIV-1 Patients

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

2288

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

2 roky a starší (Dítě, Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta Skupina / kohorta Skupina nebo podskupina účastníků pozorovací studie, která je hodnocena z hlediska biomedicínských nebo zdravotních výsledků.
Single patients group Single HIV-1 infected patients group

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
CD4 Count Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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

Sekundární výstupní opatření

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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Abbott

Vyšetřovatelé

Ředitel studie: Maja Hojnik, MD, PhD, Abbott International

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2004

Primární dokončení (Aktuální)

1. února 2010

Dokončení studie (Aktuální)

1. února 2010

Termíny zápisu do studia

První předloženo

22. června 2011

První předloženo, které splnilo kritéria kontroly kvality