- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02354209
Targeted Clinical Strategies and Low Level Viraemia (LLV) in Boosted Protease Inhibitor Therapy
Targeted Clinical Strategies and Low Abundance HIV Viraemia in Boosted-PI Therapy: an Observational Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Phase of Study: Non-Drug Study
Objectives:
Primary To investigate the causes of low level viraemia (LLV) in HIV-infected individuals with no PI resistance associated mutations (RAMs) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to their ARV regimens containing a boosted protease inhibitor.
*in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Secondary To observe the evolution in virologic and immunologic responses following routine clinical intervention in HIV-infected individuals with no primary protease inhibitor mutations (IAS, USA) on conventional genotyping who have a detectable plasma HIV viral load (pVL) and report >95% adherence* to antiretroviral regimens containing a boosted protease inhibitor.
- in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Study Design: A multi-centre, non-drug, observational cohort study.
Methodology: HIV-infected individuals attending three selected HIV clinics at the Chelsea and Westminster Hospital, St Mary's Hospital and Guy's and St Thomas' Hospital over the duration of the study will be identified at weekly viral resistance meetings and routine clinic appointments if they demonstrate the following HIV pVL criteria:
- An HIV pVL of 41-2000 copies/ml (c/ml) on two consecutive tests after being <40 c/ml on at least two occasions on a bPI-containing regimen
- An HIV pVL of 41-2000 c/ml on two consecutive tests having never achieved <40 c/ml on a bPI-containing regimen after more than six months of treatment.
Eligible patients will be provided with a patient information sheet and a written consent form. Following consent:
- Virologic and immunologic assessments will be collected from the clinical records available
- Viral resistance test (VRT) (using VircoTYPE HIV-1 Virtual PhenotypeTM-LM for conventional genotyping and Ilumina MiSeq as next generation sequencing, NGS for minority species testing) will be performed on the first detectable HIV pVL(>40 c/mL) found in clinic and at 3 to 6 and 12 months later, if HIV pVL is still >40 c/mL.
Planned Sample Size: 120 to 240 samples over the one-year study period, with each centre providing 40 to 80 samples.
Summary of Eligibility Criteria: HIV-infected individuals with no primary protease inhibitor mutations (IAS, USA) on standard VRTs who have a detectable pVL and report >95% adherence* ARV regimens containing a boosted protease inhibitor with HIV VL criteria as detailed above. Individuals who have a detectable HIV VL after stopping ARV or having an 8-item Morisky score of above 2 (or <95% reported adherence will not be eligible.
*in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level.
Number of Study Centres: Three
Duration of Study: One year from study approval. Samples for resistance testing will be collected over the duration of the study.
Criteria for Evaluation:
- Emergence of new primary protease inhibitor mutations (IAS, USA) using NGS will be described.
- Comparison of respective parameters (HIV VL and CD4 count) between different clinical interventions. The latter will not be dictated by the protocol but will be conducted as routine clinical practice.
Primary Endpoint:
Development of primary protease inhibitor mutations (IAS, USA) on NGS in HIV-infected patients with primary protease inhibitor mutations (IAS, USA) on standard VRTs who demonstrate LLV on ARV regimens containing a bPI.
Secondary Endpoints:
- Proportion of patients achieving an undetectable HIV VL following an intervention during periods of LLV on ARV regimens containing a bPI
- Evolution of CD4 cell count following an intervention during periods of LLV on ARV regimens containing a bPI.
Note: This is a non-drug study and no interventions will be dictated by this protocol.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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London, Reino Unido, W2 1NY
- St Mary's Hospital
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London, Reino Unido, SE1 7EH
- St Thomas Hospital
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London, Reino Unido, SW10 9NH
- St Stephen's Centre
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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:
A subject will be eligible for inclusion in the study if ALL of the following criteria apply:
- Chronic HIV-1 infection (adult male, female or transgender)
- Age >18 years
- Current HIV clinic attendee at the Chelsea and Westminster Hospital, St Mary's Hospital, and Guy's and St Thomas' Hospital [defined as at least 1 attended clinic visit since January 2010]
- Receiving a boosted protease inhibitor-containing antiretroviral regimen (bPI ARV)
- HIV plasma viral load (pVL) of 41-2000 copies/ml (c/ml) on two consecutive tests after being <40 c/ml on at least two occasions on a bPI-containing regimen OR HIV pVL of 41-2000 c/ml on two consecutive tests having never achieved <40 c/ml on a bPI containing regimen after more than six months of treatment.
Exclusion Criteria:
A subject will NOT be eligible for inclusion in this clinical trial if the following criteria apply:
- Demonstrable detectable HIV VL after stopping ARV
8-item Morisky score of 2 or more or documented poor adherence to combination ARV. (<95% adherence*)
- in case the questionnaire cannot be performed, clinical documentation of adherence will be used for interpretation of adherence level
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Otro
Cohortes e Intervenciones
Grupo / Cohorte |
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HIV-1 patients receiving bPI ARV
Non interventional study. Interventions will be clinically directed rather than by protocol. The following procedures will be carried out:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Change in primary protease inhibitor mutations on the HIV genome as defined by IAS-USA drug resistance mutations list.
Periodo de tiempo: Change between baseline and 12 months after first detectble viral load
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Change between baseline and 12 months after first detectble viral load
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Proportion of patients achieving an undetectable HIV VL following an intervention following LLV on ARV regimens containing a bPI
Periodo de tiempo: 12 months after first detectable VL on bPI
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12 months after first detectable VL on bPI
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Change in cell count following an intervention during periods of LLV on ARV regimens containing a bPI
Periodo de tiempo: Change in CD4 cell count from baseline to 1 year
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Change in CD4 cell count from baseline to 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marta Boffito, Chelsea & Westminster Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SSAT 057
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