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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. oktober 2011 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

2288

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Single patients group
Single HIV-1 infected patients group

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Baseline
Changes in CD4 Count
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
Changes in CD4 Count
Tidsramme: 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
Tidsramme: 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
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.
Baseline
Viral Load
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
Viral Load
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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.
Baseline, 9 months, 18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reasons for Discontinuation of Lopinavir/Ritonavir
Tidsramme: 9 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
9 months
Reasons for Discontinuation of Lopinavir/Ritonavir
Tidsramme: 18 months
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
18 months
Compliance With Lopinavir/Ritonavir
Tidsramme: 9 months
Participants reported whether they had missed doses of their antiretroviral treatment.
9 months
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott

Etterforskere

  • Studieleder: Maja Hojnik, MD, PhD, Abbott International

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2004

Primær fullføring (Faktiske)

1. februar 2010

Studiet fullført (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først innsendt

22. juni 2011

Først innsendt som oppfylte QC-kriteriene

22. juni 2011

Først lagt ut (Anslag)

23. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. oktober 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. oktober 2011

Sist bekreftet

1. oktober 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PMOS-EAST-04-1

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Forhold

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