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Evaluation of Kaletra Therapy Over the Long-term

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

284

Kontakter og plasseringer

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

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

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Abbott

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. juni 2001

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først innsendt

26. februar 2010

Først innsendt som oppfylte QC-kriteriene

8. mars 2010

Først lagt ut (Anslag)

10. mars 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2011

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KAL 1 RO

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