- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006154
A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With Acute/Early HIV Infection
The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients.
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz (EFV) in combination with two nucleoside analogues is effective at achieving maximal viral suppression. This provides an alternative treatment to that of the more toxic PI-containing regimen. This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues. A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug.
Patients are randomized to initiate antiretroviral therapy of a PI-based (stavudine/didanosine/ritonavir [RTV]/indinavir [IDV]) or nonPI-based (stavudine/didanosine/EFV) regimen. Within these treatment arms, they are stratified according to a positive or negative p24 antigen result. At Week 16, patients not achieving maximal viral suppression (lower than 50 copies/ml) have the option to add abacavir (ABC) or other drugs as intensification therapy. Those achieving virologic suppression (less than 50 copies/ml) are randomized either to receive IL-2 or not. At study entry, and after 12 months, tissue samples of CSF, lymph node, and genital secretions are obtained, with permission. Patients have physical exams, women of child-bearing potential have pregnancy tests, and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed. Compensation for time and transportation is given.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá
- Viridae Clinical Sciences / University of British Columbia
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-
Quebec
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Montreal, Quebec, Canadá
- Centre Hospitalier de la Universite de Montreal (CHUM)
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Montreal, Quebec, Canadá
- Centre de traitment d'immunodeficience
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Montreal, Quebec, Canadá
- Institut Thoracique de Montreal
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
Patients may be eligible for this study if they:
- Have been infected recently with HIV. This will be determined by certain lab tests.
- Are 18 years of age or older.
- Are able to swallow a large number of pills.
- Are willing to use barrier methods of birth control (such as condoms) during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Abuse drugs or alcohol.
- Have any condition that, in the opinion of the investigator, could impair their ability to participate in the study.
- Are breast-feeding or pregnant.
- Have received any prior anti-HIV drugs. (However, use of anti-HIV drugs to try to prevent infection more than 6 months prior to study entry is allowed.)
Plan de estudios
¿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 |
---|---|
Experimental: A
Patients will receive combination antiretroviral therapy with a protease inhibitor
|
400 mg tablets equaling 1600 mg daily
Otros nombres:
100 mg liquid capsules equaling 400 mg daily
Otros nombres:
300 mg capsules equaling 600 mg daily.
Administration based on individual results after 16 weeks.
Otros nombres:
250-400 mg E.coated tablets equaling 250 or 400 mg daily
Otros nombres:
Subcutaneous injection equaling 15 x 10^6 IU daily dose.
Administration based on individual results after 16 weeks and randomization.
Otros nombres:
|
Comparador activo: B
Patients will receive combination antiretroviral therapy without a protease inhibitor
|
300 mg capsules equaling 600 mg daily.
Administration based on individual results after 16 weeks.
Otros nombres:
250-400 mg E.coated tablets equaling 250 or 400 mg daily
Otros nombres:
Subcutaneous injection equaling 15 x 10^6 IU daily dose.
Administration based on individual results after 16 weeks and randomization.
Otros nombres:
200 mg capsules equaling 600 mg daily
Otros nombres:
30-40 mg capsules equaling 60 or 80 mg daily
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance
Periodo de tiempo: Throughout study
|
Throughout study
|
Immunologic: A. Evaluation of CD4, CD8, CD45RA, CD45RO phenotypes and defined activation markers B. Evaluation of the diversity and persistence of the T cell repertoire (CD4+, CD8+) in the circulation and lymphoid tissues
Periodo de tiempo: Throughout study
|
Throughout study
|
Immunologic: C. Functional CD4+ cellular assays (class II MHC tetramers) D. Thymic regeneration as studied by the exclusion circle assay E. Evolution of Western blot banding patterns F. Evolution of anti-HIV neutralizing antibody levels
Periodo de tiempo: Throughout study
|
Throughout study
|
Clinical: A. Minor opportunistic infections or AIDS-defining conditions B. Death C. Clinical or laboratory adverse events D. Evaluation of adherence to therapy E. Evaluation of lipodystrophy
Periodo de tiempo: Throughout study
|
Throughout study
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Rafick-Pierre Sekaly
- Investigador principal: Brian Conway
Fechas de registro del estudio
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 (Estimar)
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
- Procesos Patológicos
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones transmitidas por la sangre
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Atributos de la enfermedad
- Enfermedades de virus lentos
- Infecciones por VIH
- Infecciones
- Enfermedades contagiosas
- Síndrome de inmunodeficiencia adquirida
- 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
- Antimetabolitos
- Agentes antineoplásicos
- Inhibidores de la proteasa
- Inhibidores del citocromo P-450 CYP3A
- Inhibidores de enzimas del citocromo P-450
- Inductores de enzimas de citocromo P-450
- Inductores de citocromo P-450 CYP3A
- Inhibidores de la proteasa del VIH
- Inhibidores de la proteasa viral
- Inductores de citocromo P-450 CYP2B6
- Inhibidores del citocromo P-450 CYP2C9
- Inhibidores del citocromo P-450 CYP2C19
- Aldesleukin
- Ritonavir
- Estavudina
- Indinavir
- Didanosina
- Efavirenz
- Abacavir
Otros números de identificación del estudio
- AI-07-001
- CTN #124
- 11530 (Identificador de registro: DAIDS-ES)
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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