- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00000949
A Study to Evaluate the Effects of Giving Proleukin (rIL-2) to HIV-Positive Patients With CD4 Counts Greater Than 300 Cells/mm3
A Randomized, Open-Label, Study of the Impact of Two Doses of Subcutaneous Recombinant IL-2 (Proleukin) on Viral Burden and CD4+ Cell Count in Patients With HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm3
The purpose of this study is to examine how rIL-2 affects HIV-positive patients with CD4 counts over 300 cells/mm3 who are on anti-HIV drug therapy. The drug rIL-2 has been shown to increase CD4 cell counts, which help the body fight off HIV.
There is strong evidence that rIL-2 increases CD4 cell counts (cells of the immune system that fight infection). This study examines the effect of 2 different amounts of rIL-2 on CD4 cell count and the amount of HIV in the blood (viral burden).
Descripción general del estudio
Descripción detallada
There is substantial evidence that rIL-2 increases CD4+ cell count. Whether or not rIL-2 delays progression to AIDS and extends survival is currently unknown, such clinical benefits of rIL-2 can only be established in a large, long-term, randomized trial. This study examines the effect of two different rIL-2 doses on HIV viral burden and CD4+ cell count and provides additional information on optimal dosing, safety, and antiviral activity of rIL-2.
Patients are randomized to receive one of two subcutaneous (sc) doses of recombinant rIL-2 or no rIL-2. Those patients who take rIL-2 initially receive three courses of treatment. For this study, a course is defined as eight calendar weeks, including the five-day period of sc rIL-2 administration. Additional courses are given (no more frequently than every 6 weeks) in order to maintain a CD4+ count of at least twice its baseline level or at least 1,000 cells/mm3. Follow-up will continue for all patients until a common closing date of 12 months following enrollment of the last patient.
Tipo de estudio
Inscripción
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94110
- Community Consortium / UCSF
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Colorado
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Denver, Colorado, Estados Unidos, 80204
- Denver CPCRA / Denver Public Hlth
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- Washington Reg AIDS Prog / Dept of Infect Dis
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- AIDS Research Consortium of Atlanta
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Illinois
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Chicago, Illinois, Estados Unidos, 60657
- AIDS Research Alliance - Chicago
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hosp
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State Univ - WSU/DMC / Univ Hlth Ctr
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Southern New Jersey AIDS Clinical Trials
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Newark, New Jersey, Estados Unidos, 07103
- North Jersey Community Research Initiative
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
- Partners in Research / New Mexico
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New York
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New York, New York, Estados Unidos, 10037
- Harlem AIDS Treatment Grp / Harlem Hosp Ctr
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- The Research and Education Group
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Philadelphia FIGHT
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Virginia
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Richmond, Virginia, Estados Unidos, 23298
- Richmond AIDS Consortium / Div of Infect Diseases
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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
You may be eligible for this study if you:
- Are HIV-positive.
- Agree to practice abstinence or use effective birth control methods during the study.
- Are on anti-HIV therapy and have a CD4 count of at least 300 cells/mm3.
- Are at least 18 years old.
Exclusion Criteria
You will not be eligible for this study if you:
- Have a history of progressive diseases.
- Have a history of severe autoimmune/inflammatory disease.
- Have Crohn's disease.
- Are taking antiseizure medications or certain other medications.
- Are receiving chemotherapy.
- Are pregnant or breast-feeding.
- Have ever received rIL-2.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Investigadores
- Silla de estudio: Donald I. Abrams
- Silla de estudio: Norman Markowitz
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- CPCRA 059
- 11615 (Identificador de registro: DAIDS ES Registry ID)
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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