Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients (SPARTAN)
2 de febrero de 2015 actualizado por: Bristol-Myers Squibb
An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Allocation: Randomized nonstratified
Intervention model: Parallel versus comparator
Tipo de estudio
Intervencionista
Inscripción (Actual)
132
Fase
- Fase 4
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
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Bochum, Alemania, 44791
- Local Institution
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Frankfurt, Alemania, 60590
- Local Institution
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Frankfurt Am Main, Alemania, 60311
- Local Institution
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Hamburg, Alemania, 20246
- Local Institution
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Munich, Alemania, 80336
- Local Institution
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Alicante, España, 03010
- Local Institution
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Barcelona, España, 08036
- Local Institution
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Madrid, España, 28006
- Local Institution
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Madrid, España, 28007
- Local Institution
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Madrid, España, 28046
- Local Institution
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Madrid, España, 28805
- Local Institution
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72207
- Health For Life Clinic Pllc
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California
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Palm Springs, California, Estados Unidos, 92264
- Eisenhower Medical Center
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San Francisco, California, Estados Unidos, 94109
- Metropolis Medical Pc
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Florida
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Daytona Beach, Florida, Estados Unidos, 32117
- Consultive Medicine
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Orlando, Florida, Estados Unidos, 32805
- Orange County Health Dept.
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West Palm Beach, Florida, Estados Unidos, 33401
- Triple O Medical Services, P.A.
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01105
- The Research Institute
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New York
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Rochester, New York, Estados Unidos, 14607
- Aids Care
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Lyons Cedex 04, Francia, 69317
- Local Institution
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Orleans Cedex 2, Francia, 45067
- Local Institution
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Paris, Francia, 75020
- Local Institution
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Paris Cedex 14, Francia, 75679
- Local Institution
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Strasbourg Cedex, Francia, 67091
- Local Institution
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Cedex 12
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Paris, Cedex 12, Francia, 75551
- Local Institution
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Genova, Italia, 16128
- Local Institution
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Genova, Italia, 16132
- Local Institution
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Milano, Italia, 20127
- Local Institution
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Milano, Italia, 20142
- Local Institution
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Roma, Italia, 00149
- Local Institution
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Warszawa, Polonia, 01-201
- Local Institution
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Wroclaw, Polonia, 50-136
- Local Institution
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Brighton, Reino Unido, BN2 1ES
- Local Institution
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London, Reino Unido, E9 6SR
- Local Institution
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London, Reino Unido, NW3 2QG
- Local Institution
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Sheffield, Reino Unido, S10 2RX
- Local Institution
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Greater London
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London, Greater London, Reino Unido, SW10 9EL
- Local Institution
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M8 5RB
- Local Institution
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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
Descripción
Key Inclusion Criteria
- Current treatment regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus any third agent for at least 3 months immediately prior to screening
- Virologic suppression (HIV-1 RNA <50 c/mL) for at least 3 months immediately prior to screening
- Virologic suppression (HIV-1 RNA <40 c/mL) using the Abbott m2000rt® polymerase chain reaction assay during screening period
- Treatment-related safety and/or tolerability issues to a regimen consisting of 2 NRTIs plus any third agent
Key Exclusion Criteria
- History of switch in highly active antiretroviral therapy due to virologic failure
- History of genotypic resistance to any component of the study regimen (atazanavir, raltegravir, tenofovir/emtricitabine)
- History of exposure to atazanavir/ritonavir or raltegravir prior to entering the study
- Experiencing safety and/or tolerability issues to tenofovir/emtricitabine or raltegravir
- Switch of any component of HIV antiretroviral medication regimen in the last 3 months immediately prior to or during the screening period
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
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Capsules, Oral, 300mg, Once daily, 48 weeks
Otros nombres:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Otros nombres:
Tablets, Oral, 400 mg, Twice daily, 48 weeks
Otros nombres:
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Otro: Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine |
Capsules, Oral, 300mg, Once daily, 48 weeks
Otros nombres:
Tablets, Oral, 100 mg, Once daily, 48 weeks
Otros nombres:
Tablets, Oral, 300/200 mg, Once daily, 48 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Periodo de tiempo: From Day 1 to Week 24
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HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay.
Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients.
Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders.
Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation.
Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures.
RNA=ribonucleic acid; HIV=human immunodeficiency virus.
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From Day 1 to Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Periodo de tiempo: From Day 1 to Week 48
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Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit.
Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
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From Day 1 to Week 48
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Number of Participants With Virologic Rebound at Weeks 24 and 48
Periodo de tiempo: Day 1 to Weeks 28 and 48
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Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
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Day 1 to Weeks 28 and 48
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Periodo de tiempo: Day 1 to Week 24
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Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
pts=patients
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Day 1 to Week 24
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Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Periodo de tiempo: Day 1 to Week 48
|
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL).
Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing.
Genotypic substitutions at baseline were summarized for virologic rebound.
The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database.
Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
pts=patients
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Day 1 to Week 48
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Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs
Periodo de tiempo: Day 1 to Week 48
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Related=having certain, probable, possible, or unknown relationship to study drug.
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Day 1 to Week 48
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Mean Changes in Fasting Lipid Levels From Baseline to Week 48
Periodo de tiempo: From Baseline to Week 48
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LD=low-density lipoprotein; HDL=high-density lipoprotein.
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From Baseline to Week 48
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Bristol-Mayers Squibb, Bristol-Mayers Squibb
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.
Enlaces Útiles
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 octubre de 2011
Finalización primaria (Actual)
1 de septiembre de 2013
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
8 de abril de 2011
Publicado por primera vez (Estimar)
11 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
2 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de la transcriptasa inversa
- Inhibidores de la síntesis de ácidos nucleicos
- 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 integrasa del VIH
- Inhibidores de la integrasa
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Tenofovir
- Emtricitabina
- Raltegravir Potasio
- Ritonavir
- Sulfato de atazanavir
Otros números de identificación del estudio
- AI424-402
- 2009-017032-41 (Número EudraCT)
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. .