- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01339416
HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University
14 de marzo de 2014 actualizado por: ViiV Healthcare
Clinical Adverse Events In HIV-Infected Patients
Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.
Descripción general del estudio
Descripción detallada
All patients identified in the HIV registries will be included without any sampling
Tipo de estudio
De observación
Inscripción (Actual)
8202
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill
Descripción
Inclusion Criteria:
- HIV infection.
Exclusion Criteria:
- None.
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 |
|---|
|
HIV infected cohort
HIV infected patients in the HIV cohorts at the three participating hospitals
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence Rate of Malignancies
Periodo de tiempo: Up to Week 626
|
Incidence rate of malignancies was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.
AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer.
Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported.
Incidence rate was computed as the number of events per 100 person-years.
|
Up to Week 626
|
|
Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections
Periodo de tiempo: Up to Week 626
|
Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time.
Only the first diagnosis of each event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Opportunistic infections were those that occurred on immune-compromised participants.
AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.)
multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.
|
Up to Week 626
|
|
Incidence Rate of Myocardial Infarction
Periodo de tiempo: Up to Week 626
|
Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
|
Up to Week 626
|
|
Incidence Rate of Liver Failure
Periodo de tiempo: Up to Week 626
|
Incidence rate of liver failure was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
|
Up to Week 626
|
|
Incidence Rate of Viral Encephalitis
Periodo de tiempo: Up to Week 626
|
Incidence rate of viral encephalitis was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Viral encephalitis was defined as inflammation of the brain due to virus.
|
Up to Week 626
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence Rate of Rhabdomyolysis
Periodo de tiempo: Up to Week 626
|
Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time.
Only first diagnosis of the event per participant was included.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
Rhabdomyolysis was a condition of muscle fibers breakdown.
|
Up to Week 626
|
|
Incidence Rate of Death
Periodo de tiempo: Up to Week 626
|
Incidence rate of death was calculated as the number of events divided by person-time.
Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.
All-cause mortality was used for the analyses.
|
Up to Week 626
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 marzo de 2009
Finalización primaria (Actual)
1 de mayo de 2013
Finalización del estudio (Actual)
1 de mayo de 2013
Fechas de registro del estudio
Enviado por primera vez
16 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
19 de abril de 2011
Publicado por primera vez (Estimar)
20 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
21 de abril de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
14 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- A4001106
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. .