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Evaluation of Kaletra Therapy Over the Long-term

9. august 2011 opdateret af: Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

284

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Aachen, Tyskland, 52062
        • Site Ref # / Investigator 27706
      • Aachen, Tyskland, 52062
        • Site Ref # / Investigator 52972
      • Berlin, Tyskland, 10117
        • Site Ref # / Investigator 27660
      • Berlin, Tyskland, 10117
        • Site Ref # / Investigator 27937
      • Berlin, Tyskland, 10117
        • Site Ref # / Investigator 52973
      • Berlin, Tyskland, 10243
        • Site Reference ID/Investigator# 27629
      • Berlin, Tyskland, 10439
        • Site Ref # / Investigator 27651
      • Berlin, Tyskland, 10439
        • Site Ref # / Investigator 27912
      • Berlin, Tyskland, 10439
        • Site Reference ID/Investigator# 27544
      • Berlin, Tyskland, 10551
        • Site Reference ID/Investigator# 27567
      • Berlin, Tyskland, 10589
        • Site Ref # / Investigator 27929
      • Berlin, Tyskland, 10707
        • Site Ref # / Investigator 52971
      • Berlin, Tyskland, 10707
        • Site Ref # / Investigator 53468
      • Berlin, Tyskland, 10777
        • Site Ref # / Investigator 27965
      • Berlin, Tyskland, 10777
        • Site Reference ID/Investigator# 27547
      • Berlin, Tyskland, 10777
        • Site Reference ID/Investigator# 27552
      • Berlin, Tyskland, 10777
        • Site Reference ID/Investigator# 27562
      • Berlin, Tyskland, 10961
        • Site Ref # / Investigator 52984
      • Berlin, Tyskland, 13347
        • Site Ref # / Investigator 27639
      • Berlin, Tyskland, 13347
        • Site Ref # / Investigator 52970
      • Berlin, Tyskland, D-10243
        • Site Ref # / Investigator 27909
      • Berlin, Tyskland, D-10243
        • Site Ref # / Investigator 47113
      • Chemnitz, Tyskland, 09113
        • Site Reference ID/Investigator# 27574
      • Cologne, Tyskland, 50674
        • Site Ref # / Investigator 28060
      • Cologne, Tyskland, 50674
        • Site Ref # / Investigator 52978
      • Cologne, Tyskland, 50679
        • Site Ref # / Investigator 27932
      • Cologne, Tyskland, 50679
        • Site Ref # / Investigator 52979
      • Cologne, Tyskland, 50931
        • Site Ref # / Investigator 48233
      • Cologne, Tyskland, 50931
        • Site Ref # / Investigator 52985
      • Cologne, Tyskland, 50931
        • Site Ref # / Investigator 53464
      • Dortmund, Tyskland, 44137
        • Site Ref # / Investigator 27704
      • Dortmund, Tyskland, 44137
        • Site Ref # / Investigator 27947
      • Dortmund, Tyskland, 44137
        • Site Ref # / Investigator 52968
      • Duesseldorf, Tyskland, 40237
        • Site Ref # / Investigator 28056
      • Duisburg, Tyskland, 47259
        • Site Reference ID/Investigator# 27558
      • Frankfurt, Tyskland, 15232
        • Site Ref # / Investigator 52983
      • Frankfurt, Tyskland, 60311
        • Site Ref # / Investigator 27928
      • Frankfurt, Tyskland, 60311
        • Site Ref # / Investigator 52967
      • Freiburg, Tyskland, 79106
        • Site Reference ID/Investigator# 27565
      • Fuerth, Tyskland, 90762
        • Site Reference ID/Investigator# 27566
      • Fuerth, Tyskland, D-90762
        • Site Ref # / Investigator 53465
      • Hamburg, Tyskland, 20099
        • Site Ref # / Investigator 27931
      • Hamburg, Tyskland, 20099
        • Site Ref # / Investigator 27982
      • Hamburg, Tyskland, 20099
        • Site Ref # / Investigator 47114
      • Hamburg, Tyskland, 20099
        • Site Ref # / Investigator 47115
      • Hamburg, Tyskland, 20099
        • Site Reference ID/Investigator# 27551
      • Hamburg, Tyskland, 20099
        • Site Reference ID/Investigator# 27634
      • Hamburg, Tyskland, 20146
        • Site Ref # / Investigator 30864
      • Hamburg, Tyskland, 20146
        • Site Ref # / Investigator 5348
      • Hamburg, Tyskland, 20146
        • Site Reference ID/Investigator# 27546
      • Hamburg, Tyskland, 20246
        • Site Ref # / Investigator 28032
      • Hamburg, Tyskland, 20246
        • Site Ref # / Investigator 52969
      • Hamburg, Tyskland, 20246
        • Site Ref # / Investigator 53467
      • Hamburg, Tyskland, 20354
        • Site Ref # / Investigator 52980
      • Karlsruhe, Tyskland, 76135
        • Site Ref # / Investigator 27641
      • Karlsruhe, Tyskland, 76135
        • Site Ref # / Investigator 27964
      • Karlsruhe, Tyskland, 76135
        • Site Reference ID/Investigator# 27561
      • Koblenz, Tyskland, 56065
        • Site Ref # / Investigator 53466
      • Koblenz, Tyskland, 56065
        • Site Reference ID/Investigator# 27555
      • Krefeld, Tyskland, 47800
        • Site Ref # / Investigator 27905
      • Leipzig, Tyskland, 04107
        • Site Ref # / Investigator 27906
      • Leipzig, Tyskland, 04107
        • Site Ref # / Investigator 52975
      • Leipzig, Tyskland, 04107
        • Site Ref # / Investigator 53463
      • Ludwigshafen, Tyskland, 67063
        • Site Ref # / Investigator 27948
      • Ludwigshafen, Tyskland, 67063
        • Site Ref # / Investigator 52977
      • Mainz, Tyskland, 55116
        • Site Ref # / Investigator 27902
      • Mainz, Tyskland, 55116
        • Site Reference ID/Investigator# 27543
      • Moenchengladbach, Tyskland, 41061
        • Site Ref # / Investigator 28104
      • Moenchengladbach, Tyskland, 41061
        • Site Ref # / Investigator 52981
      • Muenster, Tyskland, 48149
        • Site Ref # / Investigator 27648
      • Muenster, Tyskland, 48149
        • Site Reference ID/Investigator# 27568
      • Munich, Tyskland, 80337
        • Site Ref # / Investigator 27949
      • Munich, Tyskland, 80337
        • Site Reference ID/Investigator# 27553
      • Munich, Tyskland, 80801
        • Site Ref # / Investigator 27926
      • Munich, Tyskland, 80801
        • Site Ref # / Investigator 53462
      • Nuernberg, Tyskland, 90419
        • Site Ref # / Investigator 52982
      • Oldenburg, Tyskland, 26121
        • Site Ref # / Investigator 27988
      • Oldenburg, Tyskland, 26121
        • Site Reference ID/Investigator# 27563
      • Osnabrueck, Tyskland, 49076
        • Site Ref # / Investigator 27637
      • Osnabrueck, Tyskland, 49076
        • Site Ref # / Investigator 27943
      • Osnabrueck, Tyskland, 49076
        • Site Ref # / Investigator 52974
      • Paderborn, Tyskland, 33100
        • Site Ref # / Investigator 27939
      • Rostock, Tyskland, 18057
        • Site Ref # / Investigator 27649
      • Rostock, Tyskland, D-18057
        • Site Reference ID/Investigator# 27569
      • Stuttgart, Tyskland, 70197
        • Site Ref # / Investigator 27647
      • Stuttgart, Tyskland, 70197
        • Site Ref # / Investigator 28047
      • Stuttgart, Tyskland, 70197
        • Site Ref # / Investigator 28048
      • Stuttgart, Tyskland, 70197
        • Site Reference ID/Investigator# 27631
      • Troisdorf, Tyskland, 53840
        • Site Ref # / Investigator 52976
      • Wuppertal, Tyskland, 42277
        • Site Ref # / Investigator 27961

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Human Immunodeficiency Virus-infected, protease inhibitor-naïve patients from a clinical setting

Beskrivelse

Inclusion Criteria:

  • Patients infected by HIV-1
  • Age greater than or equal to 18 years

Exclusion Criteria:

  • as described in SmPC (summary of product characteristics) at the time of prescription

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
Intervention / Behandling
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Medicin: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andre navne:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Medicin: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andre navne:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
Medicin: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Andre navne:
  • Kaletra
  • Lopinavir/ritonavir
  • ABT-378/r

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Tidsramme: Baseline and at any timepoint where testing is possible
Standard genotypic resistance assays were developed for HIV-1 viral load levels greater than 500 to 1000 copies per milliliter (mL). All 3 protocols recommended this testing be done at Baseline prior to lopinavir/ritonavir therapy and (if possible) in cases of virologic failure. The exact timing varied and depended on whether there was an adequate viral load and physician clinical judgment. Participants with resistance to lopinavir/ritonavir, nucleoside reverse transcriptase inhibitors (NRTI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) at Baseline and follow-up are reported.
Baseline and at any timepoint where testing is possible

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Tidsramme: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 ribonucleic acid (RNA) less than 50 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 50 to <200 Copies/ml
Tidsramme: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 50 to less than 200 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA 200 to <500 Copies/ml
Tidsramme: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with HIV-1 RNA levels of 200 to less than 500 copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Percentage of Patients With HIV-1 RNA >500 Copies/ml
Tidsramme: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
All 3 protocols recommended that HIV viral load tests be performed at Baseline and each study visit. Study visits were to occur at approximately Weeks 4, 12, and 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. The percentage of participants with more than 500 HIV-1 RNA copies/mL at each time point is presented by subgroup.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
Change in Absolute CD4 Cell Count [CD4+ Cells/µL]
Tidsramme: Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks
The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. Study visits were to occur at approximately Weeks 4, 12, 24, followed by 12-week intervals up to Week 144 in therapy-naive participants and up to Week 240 in the pre-treated and non-B subtype groups. CD4+ cell count results are reported as the change from Baseline in the absolute number of CD4+ cells per microliter.
Baseline, Week 4, 12, 24, followed by 12-week intervals up to 144/240 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

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. juni 2001

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

26. februar 2010

Først indsendt, der opfyldte QC-kriterier

8. marts 2010

Først opslået (Skøn)

10. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2011

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KAL 1 RO

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 .

Kliniske forsøg med Humant immundefektvirus

Kliniske forsøg med Lopinavir/Ritonavir (Kaletra)

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Norway

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner