- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01153269
Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
16. November 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
33
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Berlin, Deutschland, 10243
- Site Reference ID/Investigator# 27575
-
Berlin, Deutschland, 10961
- Site Reference ID/Investigator# 27592
-
Dortmund, Deutschland, 44137
- Site Reference ID/Investigator# 27588
-
Frankfurt, Deutschland, 60311
- Site Reference ID/Investigator# 27583
-
Frankfurt, Deutschland, 60596
- Site Reference ID/Investigator# 27587
-
Hamburg, Deutschland, 20099
- Site Reference ID/Investigator# 27607
-
Krefeld, Deutschland, 47800
- Site Reference ID/Investigator# 5355
-
Muenster, Deutschland, 48149
- Site Reference ID/Investigator# 27604
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
|
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2001
Primärer Abschluss (Tatsächlich)
1. November 2010
Studienabschluss (Tatsächlich)
1. November 2010
Studienanmeldedaten
Zuerst eingereicht
26. Februar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Juni 2010
Zuerst gepostet (Schätzen)
30. Juni 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
19. Dezember 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. November 2011
Zuletzt verifiziert
1. November 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Erkrankungen des Immunsystems
- Leberkrankheiten
- Langsame Viruserkrankungen
- HIV-Infektionen
- Hepatitis
- Erworbenes Immunschwächesyndrom
- Immunologische Mangelsyndrome
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Anti-HIV-Agenten
- Antiretrovirale Mittel
- Protease-Inhibitoren
- Cytochrom P-450 CYP3A-Inhibitoren
- Cytochrom-P-450-Enzym-Inhibitoren
- HIV-Protease-Inhibitoren
- Virale Protease-Inhibitoren
- Ritonavir
- Lopinavir
Andere Studien-ID-Nummern
- KAL 1 HO
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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