Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use (KaleEAST)
10. Oktober 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
2288
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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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, Lettland
- Site Ref # / Investigator 7578
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Vilnius, Litauen, LT-10105
- Site Ref # / Investigator 6127
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Bialystok, Polen, 15540
- Site Ref # / Investigator 6190
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Bydgoszcz, Polen, 85-030
- Site Ref # / Investigator 56885
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Chorzow, Polen, 41-500
- Site Ref # / Investigator 56887
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Gdansk, Polen, 80-214
- Site Ref # / Investigator 56883
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Krakow, Polen, 31-531
- Site Ref # / Investigator 56888
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Lodz, Polen, 91-347
- Site Ref # / Investigator 56889
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Poznan, Polen, 61-285
- Site Ref # / Investigator 56884
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Szczecin, Polen, 71-455
- Site Ref # / Investigator 56886
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Warsaw, Polen, 01-201
- Site Ref # / Investigator 56882
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Wroclaw, Polen, 51-149
- Site Ref # / Investigator 56890
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Brasov, Rumänien, 500174
- Site Ref # / Investigator 57064
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Bucharest, Rumänien, 021105
- Site Ref # / Investigator 6194
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Bucharest, Rumänien, 030303
- Site Ref # / Investigator 57062
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Constanta, Rumänien, 900708
- Site Ref # / Investigator 57063
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Craiova, Rumänien, 200515
- Site Ref # / Investigator 57067
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Iasi, Rumänien, 700116
- Site Ref # / Investigator 57068
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Targu Mures, Rumänien, 540394
- Site Ref # / Investigator 57065
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Timisoara, Rumänien, 300310
- Site Ref # / Investigator 57066
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Barnaul, Russische Föderation, 658610
- Site Ref # / Investigator 57022
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Chelyabinsk, Russische Föderation, 454052
- Site Ref # / Investigator 56918
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Chita, Russische Föderation, 672000
- Site Ref # / Investigator 56963
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Ekaterinburg, Russische Föderation, 620102
- Site Ref # / Investigator 56923
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Ekaterinburg, Russische Föderation, 620115
- Site Ref # / Investigator 56903
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Irkutsk, Russische Föderation, 664043
- Site Ref # / Investigator 56921
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Irkutsk, Russische Föderation, 664043
- Site Ref #/Investigator 57104
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Ivanovo, Russische Föderation, 153000
- Site Ref # / Investigator 57028
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Izhevsk, Russische Föderation, 426067
- Site Ref # / Investigator 57036
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Kaliningrad, Russische Föderation, 2360000
- Site Ref # / Investigator 56945
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Kazan, Russische Föderation, 420000
- Site Ref # / Investigator 56909
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Kemerovo, Russische Föderation, 650056
- Site Ref # / Investigator 57037
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Kemerovo, Russische Föderation, 650056
- Site Ref #/Investigator 57105
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Khabarovsk, Russische Föderation, 680029
- Site Ref # / Investigator 56948
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Khanty-Mansiysk, Russische Föderation, 628002
- Site Ref # / Investigator 56932
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Kirov, Russische Föderation, 57107
- Site Ref #/Investigator 57107
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Kostroma, Russische Föderation, 156007
- Site Ref # / Investigator 57030
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Krasnodar, Russische Föderation, 350015
- Site Ref # / Investigator 56943
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Krasnoyarsk, Russische Föderation, 660049
- Site Ref # / Investigator 56928
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Krasnoyarsk, Russische Föderation, 660049
- Site Ref #/Investigator 57106
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Kurgan, Russische Föderation, 640007
- Site Ref # / Investigator 57021
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Lipetsk, Russische Föderation, 398043
- Site Ref # / Investigator 57025
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Magnitogorsk, Russische Föderation, 350015
- Site Ref # / Investigator 56944
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Moscow, Russische Föderation, 105275
- Site Ref # / Investigator 56904
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Moscow, Russische Föderation, 105275
- Site Ref # / Investigator 6209
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Moscow, Russische Föderation, 129110
- Site Ref # / Investigator 56902
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Murmansk, Russische Föderation, 183047
- Site Ref # / Investigator 57024
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Nizhniy Novgorod, Russische Föderation, 603005
- Site Ref # / Investigator 56907
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Norilsk, Russische Föderation, 663318
- Site Ref # / Investigator 56964
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Novokuznetsk, Russische Föderation, 654031
- Site Ref # / Investigator 56929
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Novosibirsk, Russische Föderation, 630000
- Site Ref # / Investigator 56942
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Noyabrsk, Russische Föderation, 629806
- Site Ref # / Investigator 56926
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Orenburg, Russische Föderation, 460035
- Site Ref # / Investigator 56915
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Orenburg, Russische Föderation, 460035
- Site Ref # / Investigator 57031
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Perm, Russische Föderation, 614000
- Site Ref # / Investigator 56930
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Rostov-on-Don, Russische Föderation, 344006
- Site Ref # / Investigator 56911
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Saint Petersburg, Russische Föderation, 190103
- Site Ref # / Investigator 56906
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Saint Petersburg, Russische Föderation, 191167
- Site Ref # / Investigator 56905
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Samara, Russische Föderation, 443041
- Site Ref # / Investigator 56931
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Saratov, Russische Föderation, 410009
- Site Ref # / Investigator 56913
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St. Petersburg, Russische Föderation, 190000
- Site Ref # / Investigator 57033
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St. Petersburg, Russische Föderation, 196645
- Site Ref # / Investigator 56920
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St. Petersburg, Russische Föderation, 196645
- Site Ref # / Investigator 57038
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Surgut, Russische Föderation, 628400
- Site Ref # / Investigator 56908
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Togliatti, Russische Föderation, 445846
- Site Ref # / Investigator 56962
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Tula, Russische Föderation, 300002
- Site Ref # / Investigator 57034
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Tver, Russische Föderation, 170024
- Site Ref # / Investigator 56947
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Tver, Russische Föderation, 170024
- Site Ref # / Investigator 57035
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Tyumen, Russische Föderation, 628602
- Site Ref # / Investigator 56910
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Tyumen, Russische Föderation, 628602
- Site Ref # / Investigator 56919
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Ufa, Russische Föderation, 450077
- Site Ref # / Investigator 57029
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Ulan-Ude, Russische Föderation, 670034
- Site Ref # / Investigator 56949
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Ulyanovsk, Russische Föderation, 432071
- Site Ref # / Investigator 56914
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Vladimir, Russische Föderation, 600023
- Site Ref # / Investigator 57027
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Volgograd, Russische Föderation, 400040
- Site Ref # / Investigator 56916
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Vologda, Russische Föderation, 160002
- Site Ref #/Investigator 57103
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Yakutsk, Russische Föderation, 677004
- Site Ref # / Investigator 56946
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Yaroslavl, Russische Föderation, 150000
- Site Ref # / Investigator 57026
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Belgrade, Serbien, 11 000
- Site Ref # / Investigator 7579
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Bratislava, Slowakei, 813 69
- Site Ref # / Investigator 6208
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Ljubljana, Slowenien, 1000
- Site Ref # / Investigator 6199
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Brno, Tschechische Republik, 639 00
- Site Ref # / Investigator 57102
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Ceske Budejovice, Tschechische Republik, 370 87
- Site Ref # / Investigator 57054
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Hradec Kralove, Tschechische Republik, 50005
- Site Ref # / Investigator 57055
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Ostrava, Tschechische Republik, 708 52
- Site Ref # / Investigator 57056
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Plzen, Tschechische Republik, 305 99
- Site Ref # / Investigator 57052
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Prague 8, Tschechische Republik, 180 01
- Site Ref # / Investigator 5344
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Usti nad Labem, Tschechische Republik, 40011
- Site Ref # / Investigator 57053
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Dnepropetrovsk, Ukraine, 49115
- Site Ref # / Investigator 57042
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Donetsk, Ukraine, 83045
- Site Ref # / Investigator 57043
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Kyiv, Ukraine, 01015
- Site Ref # / Investigator 57045
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Kyiv, Ukraine, 01015
- Site Ref # / Investigator 6191
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Kyiv, Ukraine, 03115
- Site Ref # / Investigator 57046
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Mykolaiv, Ukraine, 54003
- Site Ref # / Investigator 57044
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Odessa, Ukraine, 565031
- Site Ref # / Investigator 57039
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Simferopol, Ukraine, 95006
- Site Ref # / Investigator 57040
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
2 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Single patients group
Single HIV-1 infected patients group
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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CD4 Count
Zeitfenster: 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.
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Baseline
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Changes in CD4 Count
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
12 months
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Viral Load
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Reasons for Discontinuation of Lopinavir/Ritonavir
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Maja Hojnik, MD, PhD, Abbott International
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2004
Primärer Abschluss (Tatsächlich)
1. Februar 2010
Studienabschluss (Tatsächlich)
1. Februar 2010
Studienanmeldedaten
Zuerst eingereicht
22. Juni 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juni 2011
Zuerst gepostet (Schätzen)
23. Juni 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. Oktober 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Oktober 2011
Zuletzt verifiziert
1. Oktober 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PMOS-EAST-04-1
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .