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

16. november 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Human Immunodeficiency Virus-Infection

Intervention / Behandling

Medicin: Lopinavir/Ritonavir (Kaletra)

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

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

Studiesteder

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

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

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte	Intervention / Behandling
HIV-infected patients with hepatitis co-infection HIV-infected patients with co-infections of Hepatitis B or Hepatitis C	Medicin: Lopinavir/Ritonavir (Kaletra) 3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

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. maj 2001

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

26. februar 2010

Først indsendt, der opfyldte QC-kriterier

28. juni 2010

Først opslået (Skøn)

30. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. december 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2011

Sidst verificeret

1. november 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

KAL 1 HO

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 .

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Human Immunodeficiency Virus-Infection

Kliniske forsøg med Lopinavir/Ritonavir (Kaletra)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

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