- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000909
A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy
A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Alone vs No Therapy in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3 Who Do Not Wish to Receive Treatment With Antiretroviral Therapy
The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood.
IL-2 (a protein found in the blood that helps boost the immune system) can result in increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection; however, some HIV patients do not wish to take antiretrovirals. This study asks if it is safe and effective to take IL-2 alone to treat HIV infection.
Descripción general del estudio
Descripción detallada
Previous studies have shown that interleukin-2, when given under the skin, results in CD4+ cell count increases, and may impact upon disease progression. A Phase III trial is the next step in the development of these efficacy trials. One question, however, has not been addressed in previous IL-2 studies: whether it is both safe and reasonable to allow prospective IL-2 recipients the autonomy of choosing whether or not to take antiretrovirals in addition to their cytokine therapy. This trial addresses that concern.
In this open-label study, 36 patients are randomized to 1 of 3 treatment groups of 12 patients each:
Group I: IL-2 every 12 hours for 5 days every 8 weeks. Group II: IL-2 every 12 hours for 5 days every 8 weeks (higher IL-2 dose). Group III: Control group receiving no therapy. Patients must complete a minimum of 3 8-week cycles of treatment. Twelve patients are randomized to each arm. Following study completion, Group I and II patients may elect to continue receiving IL-2 during follow-up or as part of an additional protocol based on the results of this study.
[AS PER AMENDMENT 2/12/99: Patients who have received study medication and/or routine protocol visits and procedures for at least 6 months with acceptable compliance are eligible for continued follow-up in an extension phase. The extension phase will continue for at least 1 year from the date when the last patient has been enrolled in the extension phase. Patients originally randomized to IL-2 may continue to receive IL-2 during the extension period, with IL-2 therapy guided on an individual basis. Patients originally randomized to no therapy may continue to receive no therapy during the extension phase.] [AS PER AMENDMENT 7/11/00: Patients demonstrating acceptable compliance with routine visits and procedures during the initial treatment phase and/or extension phase may participate in the long-term follow-up phase which requires follow-up visits at least every 4 months for approximately 5 years. Patients originally randomized to Group 1 or 2 may continue to receive IL-2, with IL-2 therapy guided on an individual basis, during the long-term follow-up phase. Patients originally randomized to Group 3 may continue to receive no therapy during the long-term follow-up phase.]
Tipo de estudio
Inscripción
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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London, Reino Unido
- Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS
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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:
- Are HIV-positive.
- Have had at least one CD4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry.
- Are at least 18 years old.
- Agree to abstinence or use of effective methods of birth control 1 month before and during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history of a potentially life-threatening autoimmune or inflammatory disease.
- Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
- Have a history of an AIDS-defining illness.
- Have a history of cancer, other than Kaposi's sarcoma.
- Have ever taken IL-2 or any antiretroviral medications.
- Are pregnant.
- Are taking certain medications, including anti-seizure medications.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Michael Youle
- Silla de estudio: Jorge Tavel
Fechas de registro del estudio
Fechas importantes del estudio
Finalización del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- 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
- Enfermedades de virus lentos
- Infecciones por VIH
- Infecciones
- Síndrome de inmunodeficiencia adquirida
- Agentes antiinfecciosos
- Agentes Antivirales
- Agentes Anti-VIH
- Agentes antirretrovirales
- Agentes antineoplásicos
- Aldesleukin
Otros números de identificación del estudio
- IRP 021D
- 10462 (Identificador de registro: DAIDS ES)
- IL-2 UK
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