Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
16 de noviembre de 2011 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
33
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Berlin, Alemania, 10243
- Site Reference ID/Investigator# 27575
-
Berlin, Alemania, 10961
- Site Reference ID/Investigator# 27592
-
Dortmund, Alemania, 44137
- Site Reference ID/Investigator# 27588
-
Frankfurt, Alemania, 60311
- Site Reference ID/Investigator# 27583
-
Frankfurt, Alemania, 60596
- Site Reference ID/Investigator# 27587
-
Hamburg, Alemania, 20099
- Site Reference ID/Investigator# 27607
-
Krefeld, Alemania, 47800
- Site Reference ID/Investigator# 5355
-
Muenster, Alemania, 48149
- Site Reference ID/Investigator# 27604
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2001
Finalización primaria (Actual)
1 de noviembre de 2010
Finalización del estudio (Actual)
1 de noviembre de 2010
Fechas de registro del estudio
Enviado por primera vez
26 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
28 de junio de 2010
Publicado por primera vez (Estimar)
30 de junio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de diciembre de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
16 de noviembre de 2011
Última verificación
1 de noviembre de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Enfermedades del sistema inmunológico
- Enfermedades del HIGADO
- Enfermedades de virus lentos
- Infecciones por VIH
- Hepatitis
- Síndrome de inmunodeficiencia adquirida
- Síndromes de deficiencia inmunológica
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Agentes Anti-VIH
- Agentes antirretrovirales
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Ritonavir
- Lopinavir
Otros números de identificación del estudio
- KAL 1 HO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .