A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
23 de julio de 2018 actualizado por: Merck Sharp & Dohme LLC
A Phase II, Multicenter, Open-Label, Noncomparative Study of Raltegravir (MK-0518) in Two Oral Formulations in Combination With Other Antiretroviral Agents to Evaluate the Safety, Tolerability, and Antiretroviral Activity in HIV-1 Infected Russian Children and Adolescents
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and antiretroviral activity in treatment-naive or treatment-experienced Russian children and adolescents infected with human immunodeficiency virus-1 (HIV-1).
As raltegravir is indicated in combination with other antiretroviral therapies (ARTs) for the treatment of HIV-1 infection in pediatric patients in the United States (US), this study is designed to gain local treatment experience on the use
of raltegravir in the pediatric HIV-infected population in Russia.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
Fase
- Fase 2
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
2 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- HIV positive
- Weight of at least 7 kg
- HIV RNA ≥1000 copies/mL within 45 days before study treatment
- Participants of reproductive potential and sexually active agree to remain
abstinent or use (or have their partner use) an acceptable method of birth control throughout the study.
Exclusion Criteria:
- Females pregnant or breast-feeding, or expecting to conceive or donate eggs
during the study; males planning to impregnate or provide sperm donation
during the study
- Use of any non-antiretroviral (ART) investigational agents within one month before study treatment
- Current (active) diagnosis of acute hepatitis or chronic hepatitis other than stable chronic Hepatitis B and/or C
- Prior or current use of raltegravir
- Use of another experimental HIV-integrase inhibitor
- History or current evidence of any condition, therapy, laboratory
abnormality, or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study
- Requires or is anticipated to require any prohibited medications
- Use of immunosuppressive therapy within 30 days before beginning
raltegravir study treatment; short courses of corticosteroids are permitted.
- History of malignancy
- Current treatment for active tuberculosis infection
- Use of recreational or illicit drugs or a recent history (within the
last year) of drug or alcohol abuse or dependence
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Raltegravir Film-coated Tablet
Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
Otros nombres:
At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
|
|
Experimental: Raltegravir Chewable Tablet
Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
|
At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With at Least One Clinical Adverse Experience
Periodo de tiempo: Up to Week 26
|
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
|
Up to Week 26
|
|
Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience
Periodo de tiempo: Up to Week 24
|
A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
|
Up to Week 24
|
|
Percentage of Participants With at Least One Laboratory Adverse Experience
Periodo de tiempo: Up to Week 26
|
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
|
Up to Week 26
|
|
Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience
Periodo de tiempo: Up to Week 24
|
A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
|
Up to Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count
Periodo de tiempo: Baseline and Week 24
|
This outcome is a measure of immunological response to treatment
|
Baseline and Week 24
|
|
Change From Baseline in CD4 Cell Percentage
Periodo de tiempo: Baseline and Week 24
|
This outcome is a measure of immunological response to treatment
|
Baseline and Week 24
|
|
Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL
Periodo de tiempo: Week 24
|
This outcome is a measure of virological (anti-retroviral) response to treatment.
Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
|
Week 24
|
|
Percentage of Participants Achieving HIV RNA <40 Copies/mL
Periodo de tiempo: Week 24
|
This outcome is a measure of virological (anti-retroviral) response to treatment.
Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
|
Week 24
|
|
Percentage of Participants Achieving HIV RNA <200 Copies/mL
Periodo de tiempo: Week 24
|
This outcome is a measure of virological (anti-retroviral) response to treatment.
Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL
|
Week 24
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Actual)
16 de noviembre de 2012
Finalización primaria (Actual)
11 de diciembre de 2013
Finalización del estudio (Actual)
11 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
26 de octubre de 2012
Publicado por primera vez (Estimar)
30 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
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
- Inhibidores de la integrasa del VIH
- Inhibidores de la integrasa
- Raltegravir Potasio
- Agentes antirretrovirales
Otros números de identificación del estudio
- 0518-248
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Datos del estudio/Documentos
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. .