Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
16 listopada 2011 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
33
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
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Berlin, Niemcy, 10243
- Site Reference ID/Investigator# 27575
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Berlin, Niemcy, 10961
- Site Reference ID/Investigator# 27592
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Dortmund, Niemcy, 44137
- Site Reference ID/Investigator# 27588
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Frankfurt, Niemcy, 60311
- Site Reference ID/Investigator# 27583
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Frankfurt, Niemcy, 60596
- Site Reference ID/Investigator# 27587
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Hamburg, Niemcy, 20099
- Site Reference ID/Investigator# 27607
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Krefeld, Niemcy, 47800
- Site Reference ID/Investigator# 5355
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Muenster, Niemcy, 48149
- Site Reference ID/Investigator# 27604
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 maja 2001
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2010
Ukończenie studiów (Rzeczywisty)
1 listopada 2010
Daty rejestracji na studia
Pierwszy przesłany
26 lutego 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 czerwca 2010
Pierwszy wysłany (Oszacować)
30 czerwca 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
19 grudnia 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 listopada 2011
Ostatnia weryfikacja
1 listopada 2011
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Pokarmowego
- Zakażenia wirusem RNA
- Choroby wirusowe
- Infekcje
- Infekcje przenoszone przez krew
- Choroby zakaźne
- Choroby przenoszone drogą płciową, wirusowe
- Choroby przenoszone drogą płciową
- Infekcje lentiwirusowe
- Zakażenia Retroviridae
- Choroby układu odpornościowego
- Choroby wątroby
- Powolne choroby wirusowe
- Zakażenia wirusem HIV
- Zapalenie wątroby
- Zespół nabytego niedoboru odporności
- Zespoły niedoboru odporności
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Środki przeciwwirusowe
- Inhibitory enzymów
- Agenci przeciw HIV
- Środki przeciwretrowirusowe
- Inhibitory proteazy
- Inhibitory cytochromu P-450 CYP3A
- Inhibitory enzymów cytochromu P-450
- Inhibitory proteazy HIV
- Inhibitory wirusowych proteaz
- Rytonawir
- Lopinawir
Inne numery identyfikacyjne badania
- KAL 1 HO
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .