Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a prospective, nonrandomized, open-label, single arm, cohort study of pathologically confirmed HIV-associated KS patients initiating chemotherapy in Malawi. The primary objective of this study is to estimate the complete response rate (CR by ACTG criteria) at 48 weeks. This will be done both overall and by chemotherapy (BV or not BV) treatment group. Secondary objectives are to estimate PFS and OS for both overall and by chemotherapy treatment group. Exploratory objectives include the investigation of: select clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS; the histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients; KSHV strains in tumor biopsies, PBMC and plasma, and KSHV gene expression characteristics between KS that develops on and off ART.
The investigators plan to accrue 200 HIV-associated KS patients at a rate of approximately 50 patients per year. Approximately half of the patients will receive BV chemotherapy treatment. An important factor for this study's size is that it will be comparable to or exceed the size of other important KS cohort studies, which have demonstrated significant differences in outcomes based on gender or baseline KSHV DNA levels.
The investigators want to show that there are definable biologic and clinical subsets within the HIV-associated KS population, and that identifying these subsets will have direct relevance to more effective treatment strategies for these patients.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lilongwe, Malaui
- UNC Project
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Lilongwe, Malaui
- UNC Project, Lighthouse Trust
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Histologically confirmed KS initiating chemotherapy at Lighthouse Trust or the Kamuzu Central Hospital (KCH) Cancer Clinic
- HIV positive (confirmed at any time point prior by local standard of care assay) on or off ART
- Age ≥18 years
- Residence <200 kilometers from KCH
- Able to understand and comply with study procedures for the entire length of the study
- Subject able to understand and provide written consent in English or Chichewa Informed consent reviewed and signed by patient
Exclusion Criteria:
- Failure to meet inclusion criteria listed above.
- Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
- KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group.
Periodo de tiempo: 48 weeks
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the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria
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48 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group
Periodo de tiempo: 48 weeks
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PFS which will be defined as the time from treatment initiation until disease progression or death
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48 weeks
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Estimate OS in HIV-associated KS patients overall and by BV treatment group
Periodo de tiempo: 48 weeks
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To estimate OS in HIV-associated KS patients overall and by BV treatment group
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48 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS
Periodo de tiempo: 48 weeks
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The prevalence and nature of lymphoproliferative diseases among HIV-associated KS patients
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48 weeks
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The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients
Periodo de tiempo: 48 weeks
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KSHV gene expression characteristics for HIV-associated KS that develops on and off antiretroviral therapy (ART)
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48 weeks
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The kind of KSHV strains in tumor biopsies, PBMC and plasma
Periodo de tiempo: 48 weeks
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Viral genome features of HIV-associated KS
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48 weeks
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The KSHV gene expression characteristics between KS that develops on and off ART
Periodo de tiempo: 48 weeks
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To describe KSHV gene expression characteristics between KS that develops on and off ART
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48 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dirk Dittmer, UNC-CH
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LCCC 1424
Plan de datos de participantes individuales (IPD)
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