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Evaluation of Kaletra Therapy Over the Long-term

9 agosto 2011 aggiornato da: Abbott
Long term observation of patients under lopinavir/ritonavir containing therapy

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

284

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
therapy-naive
Patients who had not received prior antiretroviral drug therapy
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Altri nomi:
  • Kaletra
  • Lopinavir/Ritonavir
  • ABT-378/r
pre-treated
Patients that had previously received antiretroviral therapy, but are protease inhibitor naive
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Altri nomi:
  • Kaletra
  • Lopinavir/Ritonavir
  • ABT-378/r
non-B
Patients infected with non-B subtypes of HIV-1
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
Altri nomi:
  • Kaletra
  • Lopinavir/Ritonavir
  • ABT-378/r

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Patients With Virus That Develop Mutations Conferring Resistance to Lopinavir/Ritonavir, NRTIs or NNRTIs
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Patients With HIV-1 RNA <50 Copies/ml
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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]
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2001

Completamento primario (Effettivo)

1 giugno 2010

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

26 febbraio 2010

Primo inviato che soddisfa i criteri di controllo qualità

8 marzo 2010

Primo Inserito (Stima)

10 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 agosto 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 agosto 2011

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KAL 1 RO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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