Impacts of HIV Treatment Regimens on Archived Drug Resistance
Impact of Antiretroviral Therapy (ART) Switch on Archived HIV-1 Drug Resistance in Virally Suppressed Patients: A Prospective Cohort Study
Descripción general del estudio
Estado
Descripción detallada
Aim/objectives: With the aim of determining the impact of antiretroviral regimen and switch on archived HIV-1 drug resistance mutation (DRM), the study's objectives are, to: (a) estimate the prevalence of DRM in virally suppressed HIV infection; (b) assess changes in archived resistance before and after switch; and (c) identify predictors of archived DRM after regimen switch.
Design: A prospective observational study
Setting: All HIV specialist clinic services in Hong Kong
Methods: Adults living with HIV infection on antiretroviral therapy (ART) with full viral suppression who are planned for regimen switch would be recruited. Controls are patients with and without low level viraemia (LLV) not planned for switch, matched by antiretroviral regimen. Blood samples would be collected before switch, shortly and then 2-3 years after switch. Nanopore sequencing would be performed to identify DRM present in HIV-1 proviral DNA. Transcription of relevant clinical record data would be made to contribute to statistical and phylogenetic analyses
Main outcome measures: Change in DRM frequency between baseline and followups at (a) short term and long term; (b) occurrence of virological failure and time to failure; (c) difference in DRM frequency between presence and absence of LLV, and switched and non-switched patients.
Anticipated outcome: The study results would determine if archived resistance clearance would change following ART switch, identify factors associated with persistence of archived resistance, and inform management on the application of proviral DNA testing in clinical practice.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shui Shan Lee, MD
- Número de teléfono: +852 22528812
- Correo electrónico: sslee@cuhk.edu.hk
Copia de seguridad de contactos de estudio
- Nombre: Ngai Sze Wong, PhD
- Número de teléfono: +852 22528862
- Correo electrónico: candy_wong@cuhk.edu.hk
Ubicaciones de estudio
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Hong Kong
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Hong Kong, Hong Kong, Porcelana, 0000
- Reclutamiento
- S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
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Contacto:
- Shui Shan Lee, MD
- Número de teléfono: +852 22528812
- Correo electrónico: sslee@cuhk.edu.hk
-
Contacto:
- Ngai Sze Wong, PhD
- Número de teléfono: +852 22528862
- Correo electrónico: candy_wong@cuhk.edu.hk
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients living with HIV who are (a) aged 18 or above, (b) on antiretroviral therapy, (c) has viral load <20 copies/mL at 2 time points for ≥6 months, (d) planning regimen switch.
- Patients for inclusion in the control group meet the same criteria (a) but they are not planned for switch. Controls include patients with low level viremia (LLV) as defined as ≥2 consecutive viral load level between 21 and 200 copies/mL in the preceding 2 years.
Exclusion Criteria:
- Patients living with HIV who (a) are pregnant, (b) have virologic failure, (c) are suffering from concurrent opportunistic infections, (d) are prisoners , (e) are unable to give consent, and (f) have mental illnesses.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Patients on ART planning for regimen switch
virally suppressed with viral undetectable at 2 consecutive timepoints prior to enrolment
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Patients on ART not for regimen switch
with and without low level viraemia prior to enrolment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportional difference of drug resistance mutation at short term after regimen switch
Periodo de tiempo: from enrolment to 3-6 months
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Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and short term (3-6 months) after regimen switch
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from enrolment to 3-6 months
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Proportional difference of drug resistance mutation at long term after regimen switch
Periodo de tiempo: From enrolment to 2-3 years after regimen switch
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Percentage difference between the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing at baseline and long term (2-3 years) after regimen switch
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From enrolment to 2-3 years after regimen switch
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of drug resistance mutation
Periodo de tiempo: at enrolment
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Percentage of patients on antiretroviral therapy with drug resistance mutation (DRM) detected by proviral DNA testing at baseline
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at enrolment
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Proportional Difference of drug resistance mutation prevalence between patients with and without by low level viremia
Periodo de tiempo: at enrolment
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Percentage difference in the prevalence of drug resistance mutation (DRM) detected by proviral DNA testing between the presence and absence of low level viremia at baseline
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at enrolment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of virologic failure
Periodo de tiempo: From enrolment to 2-3 years
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Prevalence of virologic failure in patients on antiretroviral therapy at 2-3 years after enrolment
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From enrolment to 2-3 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shui Shan Lee, MD, S.H. Ho Research Centre for Infectious Diseases, The Chinese University of Hong Kong
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Infecciones por VIH
Otros números de identificación del estudio
- HK HIV archived DRM
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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