- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00207142
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study) (INDUMA)
7 de enero de 2010 actualizado por: Bristol-Myers Squibb
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
252
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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Dusseldorf, Alemania
- Local Institution
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Hannover, Alemania
- Local Institution
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Stuttgart, Alemania
- Local Institution
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Ulm, Alemania
- Local Institution
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Barcelona, España
- Local Institution
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Madrid, España
- Local Institution
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Valencia, España
- Local Institution
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Alicante
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Elche, Alicante, España
- Local Institution
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Tallinn, Estonia
- Local Institution
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Moscow, Federación Rusa
- Local Institution
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Smolensk, Federación Rusa
- Local Institution
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St. Petersburg, Federación Rusa
- Local Institution
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Le Kremlin Bicetre 94, Francia
- Local Institution
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Orleans, Francia
- Local Institution
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Paris, Francia
- Local Institution
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Paris Cedex 12, Francia
- Local Institution
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Paris Cedex 20, Francia
- Local Institution
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Suresnes, Francia
- Local Institution
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Dublin
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Dublin 3, Dublin, Irlanda
- Local Institution
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Dublin 8, Dublin, Irlanda
- Local Institution
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Brescia, Italia
- Local Institution
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Milano, Italia
- Local Institution
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Napoli, Italia
- Local Institution
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Padova, Italia
- Local Institution
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Riga, Letonia
- Local Institution
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Cascais, Portugal
- Local Institution
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Porto, Portugal
- Local Institution
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Avon
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Bristol, Avon, Reino Unido
- Local Institution
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Central
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Edinburgh, Central, Reino Unido
- Local Institution
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Greater London
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London, Greater London, Reino Unido
- 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
Inclusion Criteria:
- Treatment naive HIV-1 infected subjects ( < 10 days of treatment with any ARV).
- Subjects who have an HIV-1 RNA level ≥ 5000 c/mL at screening.
- Subjects who have a CD4 count ≥ 50 cells/mm3.
- Men and women, ages 18 years of age or older (or minimum age as determined by local regulatory or as legal requirements dictate).
- Both females of child-bearing potential and males must utilize effective barrier contraception. Other contraception in addition to barrier methods is permitted; refer to the Investigator Brochure for details regarding potential interactions with ATV and some oral contraceptives
Exclusion Criteria:
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- WOCBP using a prohibited contraceptive method. Caution is warranted with coadministration of oral contraceptives (ethinyl estradiol and norethindrone) - see Investigator Brochure for details
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
- Primary HIV infection
- Medical History and Concurrent Diseases
- Active alcohol or substance use sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis Physical and Laboratory Test Findings
- Screening laboratory values measured as follows:
- Grade IV glucose,
- Grade IV electrolytes,
- Grade IV transaminases,
- Grade IV hematology.
- Hypersensitivity to any component of the formulation of study drug
- Prior history of taking any ARV for more than 10 days
- Concomitant administration of tenofovir (TDF).
- Refer to Section 6.4.1 which details all prohibited therapies
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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Comparador activo: Switch
ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD)
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Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Otros nombres:
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Comparador activo: Continuation
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
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Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Otros nombres:
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Otro: Rescue
ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
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Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
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 <50 Copies/mL (c/mL) Through Week 48 of the Maintenance Phase
Periodo de tiempo: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
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Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA.
Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 50 c/mL, or last HIV-1 RNA ≥ 50 c/mL followed by discontinuation), or discontinuation before Week 48.
Denominator included all randomized participants.
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From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
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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 <400 c/mL Through Week 48 of the Maintenance Phase
Periodo de tiempo: From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
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Participants were considered successes unless they experienced treatment failure, or had missing Week 48 HIV-1 RNA.
Treatment failure: virologic rebound (ie, 2 consecutive on-treatment HIV-1 RNA ≥ 400 c/mL, or last HIV-1 RNA ≥ 400 c/mL followed by discontinuation), or discontinuation before Week 48.
Denominator included all randomized participants.
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From the end of Induction Phase (Week 26 to Week 30 of Induction Phase treatment) through Week 48 of Maintenance Phase
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Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥50 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Periodo de tiempo: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
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Treatment failure based on HIV-1 RNA ≥ 50 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason.
Time to treatment failure was analyzed using life tables.
Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
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Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
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Kaplan-Meier Cumulative Proportion for Treatment Failure (HIV-1 RNA ≥400 c/mL) at Different Time Points Through Week 48 of the Maintenance Phase
Periodo de tiempo: Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
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Treatment failure based on HIV-1 RNA ≥ 400 c/mL was defined as virologic rebound on or before Week 48 or discontinuation of study therapy before Week 48 for any reason.
Time to treatment failure was analyzed using life tables.
Measured Values shows the Kaplan-Meier cumulative proportion of participants without treatment failure up to the end of the respective interval.
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Weeks 6-8, Weeks 14-16, Weeks 22-24, Weeks 30-32, Weeks 38-40, Weeks 46-48
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Change From End of Induction Phase in CD4 Cell Count at Week 48 of Maintenance Phase
Periodo de tiempo: End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
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Change in CD4 Cell Count From End of Induction Phase at Week 48 of Maintenance Phase.
Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening.
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End of Induction Phase (Week 26 to Week 30 of Induction Phase treatment), Week 48 of Maintenance Phase
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Change From Baseline in CD4 Cell Count at Week 24 of Induction Phase
Periodo de tiempo: Baseline, Week 24 of Induction Phase
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Change From Baseline in CD4 Count at Week 24 of Induction Phase.
Change=Week 24 Induction Phase value - Baseline value; a decrease signifies worsening.
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Baseline, Week 24 of Induction Phase
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Change From Baseline in CD4 Cell Count at Week 48 of Rescue Phase
Periodo de tiempo: Baseline, Week 48 of Rescue Phase
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Change From Baseline in CD4 Count at Week 48 of Rescue Phase.
Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies worsening.
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Baseline, Week 48 of Rescue Phase
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Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase
Periodo de tiempo: Baseline, Week 24 of Induction Phase
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Change From Baseline in HIV-1 RNA at Week 24 of the Induction Phase.
Change=Week 24 Induction Phase value - Baseline value; a decrease signifies improvement.
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Baseline, Week 24 of Induction Phase
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Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase
Periodo de tiempo: \Baseline, Week 48 of Rescue Phase
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Change From Baseline in HIV-1 RNA at Week 48 of the Rescue Phase.
Change=Week 48 Rescue Phase value - Baseline value; a decrease signifies improvement.
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\Baseline, Week 48 of Rescue Phase
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Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥50 c/mL) Through the End of Rescue Phase
Periodo de tiempo: Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.
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Treatment outcome is based on the first reason of failure.
These analyses were performed using HIV-1 RNA of 50 c/mL to define suppression and virologic rebound.
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Through Week 48 of Rescue Phase. Measurements were included from the end of Induction Phase through the last dose of Rescue Phase study therapy plus 4 days.
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Treatment Outcomes Based on Viral Loads (HIV-1 RNA ≥400 c/mL) Through the End of Rescue Phase
Periodo de tiempo: Baseline, Week 48 of Rescue Phase
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Treatment outcome is based on the first reason of failure.
These analyses were performed using HIV-1 RNA of 400 c/mL to define suppression and virologic rebound.
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Baseline, Week 48 of Rescue Phase
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Time to Suppression (Confirmed HIV-1 RNA < 50 c/mL) During Treatment Phase
Periodo de tiempo: Week 16-18, Week 24-26, Week 38-40, Week 64-66
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Description: Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements < 50 c/mL.
Time to suppression was analyzed using life tables.
Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
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Week 16-18, Week 24-26, Week 38-40, Week 64-66
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Time to Suppression (Confirmed HIV-1 RNA < 400 c/mL) During Treatment Phase
Periodo de tiempo: Week 16-18, Week 24-26, Week 30-32
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Time to suppression was measured from the first dose of Induction Phase study therapy to the first of the 2 consecutive measurements <400 c/mL.
Time to suppression was analyzed using life tables.
Measured Values show the Kaplan-Meier cumulative number of treated participants without suppression up to the end of the respective interval.
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Week 16-18, Week 24-26, Week 30-32
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Summary of Adverse Events During Induction Phase
Periodo de tiempo: Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).
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Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation.
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
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Measurements are included through the earlier of the last dose of Induction Phase study therapy plus 30 days or the first dose of Maintenance/Rescue Phase therapy (ie, up until 26 to 31 weeks + 30 days).
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Summary of Adverse Events During Maintenance Phase
Periodo de tiempo: Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.
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Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation.
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
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Measurements are included from the end of Induction Phase (26 to 30 weeks after first dose) through the last dose of Maintenance Phase study therapy plus 30 days.
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Summary of Adverse Events During Rescue Phase
Periodo de tiempo: Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.
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Summary of Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation.
An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition.
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
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Measurements are included from the end of Induction Phase (26 to 30 weeks after the first dose therapy) through the last dose of Rescue Phase study therapy plus 30 days.
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Percent Change From End of Induction Phase in Fasting Lipids at Week 48 of Maintenance Phase
Periodo de tiempo: Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.
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Percent change in fasting lipids from end of Induction Phase to Week 48 of Maintenance Phase.Percent changes were calculated on the log scale and then back transformed to the original scale.Change=Week 48 maintenance Phase value - end of Induction Phase value; a decrease signifies worsening for HDL cholesterol and improvement for all other lipds.
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Measurements were included from the end of Induction Phase (Week 26 to Week 30 of Induction therapy) through Week 48 of Maintenance Phase.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 noviembre de 2005
Finalización primaria (Actual)
1 de agosto de 2007
Finalización del estudio (Actual)
1 de enero de 2008
Fechas de registro del estudio
Enviado por primera vez
16 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
20 de septiembre de 2005
Publicado por primera vez (Estimar)
21 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de enero de 2010
Última actualización enviada que cumplió con los criterios de control de calidad
7 de enero de 2010
Última verificación
1 de enero de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Infecciones por VIH
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- 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 proteasa del VIH
- Inhibidores de la proteasa viral
- Ritonavir
- Sulfato de atazanavir
Otros números de identificación del estudio
- AI424-136
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. .
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