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

16. listopadu 2011 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

33

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
Lék: Lopinavir/Ritonavir (Kaletra)
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Abbott

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2001

Primární dokončení (Aktuální)

1. listopadu 2010

Dokončení studie (Aktuální)

1. listopadu 2010

Termíny zápisu do studia

První předloženo

26. února 2010

První předloženo, které splnilo kritéria kontroly kvality

28. června 2010

První zveřejněno (Odhad)

30. června 2010

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

19. prosince 2011

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. listopadu 2011

Naposledy ověřeno

1. listopadu 2011

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KAL 1 HO

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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