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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2288
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Barnaul, Den Russiske Føderation, 658610
- Site Ref # / Investigator 57022
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Chelyabinsk, Den Russiske Føderation, 454052
- Site Ref # / Investigator 56918
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Chita, Den Russiske Føderation, 672000
- Site Ref # / Investigator 56963
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Ekaterinburg, Den Russiske Føderation, 620102
- Site Ref # / Investigator 56923
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Ekaterinburg, Den Russiske Føderation, 620115
- Site Ref # / Investigator 56903
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Irkutsk, Den Russiske Føderation, 664043
- Site Ref # / Investigator 56921
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Irkutsk, Den Russiske Føderation, 664043
- Site Ref #/Investigator 57104
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Ivanovo, Den Russiske Føderation, 153000
- Site Ref # / Investigator 57028
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Izhevsk, Den Russiske Føderation, 426067
- Site Ref # / Investigator 57036
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Kaliningrad, Den Russiske Føderation, 2360000
- Site Ref # / Investigator 56945
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Kazan, Den Russiske Føderation, 420000
- Site Ref # / Investigator 56909
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Kemerovo, Den Russiske Føderation, 650056
- Site Ref # / Investigator 57037
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Kemerovo, Den Russiske Føderation, 650056
- Site Ref #/Investigator 57105
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Khabarovsk, Den Russiske Føderation, 680029
- Site Ref # / Investigator 56948
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Khanty-Mansiysk, Den Russiske Føderation, 628002
- Site Ref # / Investigator 56932
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Kirov, Den Russiske Føderation, 57107
- Site Ref #/Investigator 57107
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Kostroma, Den Russiske Føderation, 156007
- Site Ref # / Investigator 57030
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Krasnodar, Den Russiske Føderation, 350015
- Site Ref # / Investigator 56943
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Krasnoyarsk, Den Russiske Føderation, 660049
- Site Ref # / Investigator 56928
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Krasnoyarsk, Den Russiske Føderation, 660049
- Site Ref #/Investigator 57106
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Kurgan, Den Russiske Føderation, 640007
- Site Ref # / Investigator 57021
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Lipetsk, Den Russiske Føderation, 398043
- Site Ref # / Investigator 57025
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Magnitogorsk, Den Russiske Føderation, 350015
- Site Ref # / Investigator 56944
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Moscow, Den Russiske Føderation, 105275
- Site Ref # / Investigator 56904
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Moscow, Den Russiske Føderation, 105275
- Site Ref # / Investigator 6209
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Moscow, Den Russiske Føderation, 129110
- Site Ref # / Investigator 56902
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Murmansk, Den Russiske Føderation, 183047
- Site Ref # / Investigator 57024
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Nizhniy Novgorod, Den Russiske Føderation, 603005
- Site Ref # / Investigator 56907
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Norilsk, Den Russiske Føderation, 663318
- Site Ref # / Investigator 56964
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Novokuznetsk, Den Russiske Føderation, 654031
- Site Ref # / Investigator 56929
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Novosibirsk, Den Russiske Føderation, 630000
- Site Ref # / Investigator 56942
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Noyabrsk, Den Russiske Føderation, 629806
- Site Ref # / Investigator 56926
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Orenburg, Den Russiske Føderation, 460035
- Site Ref # / Investigator 56915
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Orenburg, Den Russiske Føderation, 460035
- Site Ref # / Investigator 57031
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Perm, Den Russiske Føderation, 614000
- Site Ref # / Investigator 56930
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Rostov-on-Don, Den Russiske Føderation, 344006
- Site Ref # / Investigator 56911
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Saint Petersburg, Den Russiske Føderation, 190103
- Site Ref # / Investigator 56906
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Saint Petersburg, Den Russiske Føderation, 191167
- Site Ref # / Investigator 56905
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Samara, Den Russiske Føderation, 443041
- Site Ref # / Investigator 56931
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Saratov, Den Russiske Føderation, 410009
- Site Ref # / Investigator 56913
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St. Petersburg, Den Russiske Føderation, 190000
- Site Ref # / Investigator 57033
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St. Petersburg, Den Russiske Føderation, 196645
- Site Ref # / Investigator 56920
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St. Petersburg, Den Russiske Føderation, 196645
- Site Ref # / Investigator 57038
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Surgut, Den Russiske Føderation, 628400
- Site Ref # / Investigator 56908
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Togliatti, Den Russiske Føderation, 445846
- Site Ref # / Investigator 56962
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Tula, Den Russiske Føderation, 300002
- Site Ref # / Investigator 57034
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Tver, Den Russiske Føderation, 170024
- Site Ref # / Investigator 56947
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Tver, Den Russiske Føderation, 170024
- Site Ref # / Investigator 57035
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Tyumen, Den Russiske Føderation, 628602
- Site Ref # / Investigator 56910
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Tyumen, Den Russiske Føderation, 628602
- Site Ref # / Investigator 56919
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Ufa, Den Russiske Føderation, 450077
- Site Ref # / Investigator 57029
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Ulan-Ude, Den Russiske Føderation, 670034
- Site Ref # / Investigator 56949
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Ulyanovsk, Den Russiske Føderation, 432071
- Site Ref # / Investigator 56914
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Vladimir, Den Russiske Føderation, 600023
- Site Ref # / Investigator 57027
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Volgograd, Den Russiske Føderation, 400040
- Site Ref # / Investigator 56916
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Vologda, Den Russiske Føderation, 160002
- Site Ref #/Investigator 57103
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Yakutsk, Den Russiske Føderation, 677004
- Site Ref # / Investigator 56946
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Yaroslavl, Den Russiske Føderation, 150000
- Site Ref # / Investigator 57026
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Tbilisi, Georgien
- 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, Letland
- 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, Rumænien, 500174
- Site Ref # / Investigator 57064
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Bucharest, Rumænien, 021105
- Site Ref # / Investigator 6194
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Bucharest, Rumænien, 030303
- Site Ref # / Investigator 57062
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Constanta, Rumænien, 900708
- Site Ref # / Investigator 57063
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Craiova, Rumænien, 200515
- Site Ref # / Investigator 57067
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Iasi, Rumænien, 700116
- Site Ref # / Investigator 57068
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Targu Mures, Rumænien, 540394
- Site Ref # / Investigator 57065
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Timisoara, Rumænien, 300310
- Site Ref # / Investigator 57066
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Belgrade, Serbien, 11 000
- Site Ref # / Investigator 7579
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Bratislava, Slovakiet, 813 69
- Site Ref # / Investigator 6208
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Ljubljana, Slovenien, 1000
- Site Ref # / Investigator 6199
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Brno, Tjekkiet, 639 00
- Site Ref # / Investigator 57102
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Ceske Budejovice, Tjekkiet, 370 87
- Site Ref # / Investigator 57054
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Hradec Kralove, Tjekkiet, 50005
- Site Ref # / Investigator 57055
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Ostrava, Tjekkiet, 708 52
- Site Ref # / Investigator 57056
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Plzen, Tjekkiet, 305 99
- Site Ref # / Investigator 57052
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Prague 8, Tjekkiet, 180 01
- Site Ref # / Investigator 5344
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Usti nad Labem, Tjekkiet, 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Single patients group
Single HIV-1 infected patients group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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CD4 Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Changes in CD4 Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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Baseline
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Viral Load
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
6 months
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Viral Load
Tidsramme: 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.
|
9 months
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Viral Load
Tidsramme: 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
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Viral Load
Tidsramme: 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.
|
15 months
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Viral Load
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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Baseline, 9 months, 18 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Reasons for Discontinuation of Lopinavir/Ritonavir
Tidsramme: 9 months
|
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
|
9 months
|
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Reasons for Discontinuation of Lopinavir/Ritonavir
Tidsramme: 18 months
|
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
|
18 months
|
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Compliance With Lopinavir/Ritonavir
Tidsramme: 9 months
|
Participants reported whether they had missed doses of their antiretroviral treatment.
|
9 months
|
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Compliance With Lopinavir/Ritonavir
Tidsramme: 18 months
|
Participants reported whether they had missed any doses of their antiretroviral treatment.
|
18 months
|
|
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Maja Hojnik, MD, PhD, Abbott International
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2004
Primær færdiggørelse (Faktiske)
1. februar 2010
Studieafslutning (Faktiske)
1. februar 2010
Datoer for studieregistrering
Først indsendt
22. juni 2011
Først indsendt, der opfyldte QC-kriterier
22. juni 2011
Først opslået (Skøn)
23. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. oktober 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. oktober 2011
Sidst verificeret
1. oktober 2011
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PMOS-EAST-04-1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .