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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 octobre 2011 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

HIV-1 Patients

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

2288

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Single patients group Single HIV-1 infected patients group

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
CD4 Count Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Reasons for Discontinuation of Lopinavir/Ritonavir Délai: 9 months	For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.	9 months
Reasons for Discontinuation of Lopinavir/Ritonavir Délai: 18 months	For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.	18 months
Compliance With Lopinavir/Ritonavir Délai: 9 months	Participants reported whether they had missed doses of their antiretroviral treatment.	9 months
Compliance With Lopinavir/Ritonavir Délai: 18 months	Participants reported whether they had missed any doses of their antiretroviral treatment.	18 months
Adverse Events Observed on Treatment With Lopinavir/Ritonavir. Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Abbott

Les enquêteurs

Directeur d'études: Maja Hojnik, MD, PhD, Abbott International

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2004

Achèvement primaire (Réel)

1 février 2010

Achèvement de l'étude (Réel)

1 février 2010

Dates d'inscription aux études

Première soumission

22 juin 2011

Première soumission répondant aux critères de contrôle qualité