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Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

16 novembre 2011 aggiornato da: Abbott
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

33

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
      • Berlin, Germania, 10243
        • Site Reference ID/Investigator# 27575
      • Berlin, Germania, 10961
        • Site Reference ID/Investigator# 27592
      • Dortmund, Germania, 44137
        • Site Reference ID/Investigator# 27588
      • Frankfurt, Germania, 60311
        • Site Reference ID/Investigator# 27583
      • Frankfurt, Germania, 60596
        • Site Reference ID/Investigator# 27587
      • Hamburg, Germania, 20099
        • Site Reference ID/Investigator# 27607
      • Krefeld, Germania, 47800
        • Site Reference ID/Investigator# 5355
      • Muenster, Germania, 48149
        • Site Reference ID/Investigator# 27604

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

Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

Descrizione

Inclusion Criteria:

  • Patients infected by HIV-1 and HBV or HCV
  • Age ≥18 years
  • Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Exclusion Criteria:

- Contraindications 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
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
Droga: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Baseline
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Baseline
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 4
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Week 4
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 12
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Week 12
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 24
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Week 24
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 36
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Week 36
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 48
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Week 48
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 60
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Week 60
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 72
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Week 72
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 84
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Week 84
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 96
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Week 96
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 108
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Week 108
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 120
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Week 120
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 132
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Week 132
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Lasso di tempo: Week 144
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Week 144
Viral Load
Lasso di tempo: Baseline
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Baseline
Viral Load
Lasso di tempo: Week 4
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Week 4
Viral Load
Lasso di tempo: Week 12
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Week 12
Viral Load
Lasso di tempo: Week 24
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Week 24
Viral Load
Lasso di tempo: Week 36
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Week 36
Viral Load
Lasso di tempo: Week 48
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Week 48
Viral Load
Lasso di tempo: Week 60
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Week 60
Viral Load
Lasso di tempo: Week 72
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Week 72
Viral Load
Lasso di tempo: Week 84
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Week 84
Viral Load
Lasso di tempo: Week 96
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Week 96
Viral Load
Lasso di tempo: Week 108
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Week 108
Viral Load
Lasso di tempo: Week 120
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Week 120
Viral Load
Lasso di tempo: Week 132
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Week 132
Viral Load
Lasso di tempo: Week 144
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Week 144
CD4 Cell Count
Lasso di tempo: Baseline
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.
Baseline
CD4 Cell Count
Lasso di tempo: Week 4
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.
Week 4
CD4 Cell Count
Lasso di tempo: Week 12
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.
Week 12
CD4 Cell Count
Lasso di tempo: Week 24
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.
Week 24
CD4 Cell Count
Lasso di tempo: Week 36
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.
Week 36
CD4 Cell Count
Lasso di tempo: Week 48
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.
Week 48
CD4 Cell Count
Lasso di tempo: Week 60
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.
Week 60
CD4 Cell Count
Lasso di tempo: Week 72
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.
Week 72
CD4 Cell Count
Lasso di tempo: Week 84
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.
Week 84
CD4 Cell Count
Lasso di tempo: Week 96
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.
Week 96
CD4 Cell Count
Lasso di tempo: Week 108
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.
Week 108
CD4 Cell Count
Lasso di tempo: Week 120
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.
Week 120
CD4 Cell Count
Lasso di tempo: Week 132
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.
Week 132
CD4 Cell Count
Lasso di tempo: Week 144
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.
Week 144

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 maggio 2001

Completamento primario (Effettivo)

1 novembre 2010

Completamento dello studio (Effettivo)

1 novembre 2010

Date di iscrizione allo studio

Primo inviato

26 febbraio 2010

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2010

Primo Inserito (Stima)

30 giugno 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 dicembre 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 novembre 2011

Ultimo verificato

1 novembre 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KAL 1 HO

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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