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A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Allogeneic lymphocyte transfer

Procedimiento
Quiénes están siendo reclutados

HIV Infections

De 18 a 50 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To examine, in HIV-infected patients, the safety of allogeneic lymphocyte transfer (i.e., infusion of white blood cells taken from an HIV-negative parent, sibling, or adult offspring who has a compatible blood type). To measure the distribution and survival of allogeneic lymphocytes in the circulation of HIV-infected patients, and to determine whether their infusion results in enhanced immunity. To determine whether enhanced immunity is passively transferred or actively induced. There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy. There is evidence that periodic infusion of allogeneic lymphocytes obtained from the peripheral blood of HLA-matched HIV-1 seronegative siblings of patients with AIDS can, in some instances, restore the number of circulating CD4+ lymphocytes. However, more controlled studies are needed to better quantitate the immunologic reconstitution seen with this type of therapy. Lymphocytes obtained by leukapheresis from a healthy, HIV-negative parent, sibling, or adult offspring of the HIV-infected patient are infused at day 0 and at weeks 4 and 8. A small portion of the lymphocytes obtained at day 0 will be radiolabeled prior to infusion, and two total body scans will be performed. Patients also undergo two tonsillar biopsies. Patients are followed weekly for 16 weeks, then by telephone periodically for 3 years (at 1 year, 2 years, 2.5 years, and 3 years).

Título OficialA Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 24 de junio de 2005
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 12 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 18 a 50 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Required: * Stable antiretroviral therapy. Allowed: * Maintenance therapy for a controlled opportunistic infection. Patients must have: * HIV infection. * CD4 count 50-200 cells/mm3. * No ongoing major opportunistic infections. * Been on stable antiretroviral therapy for the past 2 months. * Tonsils present. * Life expectancy greater than 6 months. * An HLA-single haplotype matched, single haplotype mismatched parent, sibling, or adult offspring who is ABO, Rh compatible to serve as an HIV-negative lymphocyte donor. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Lymphoma or other malignancy requiring chemotherapy. * Bleeding disorder that would preclude a tonsillar biopsy. * Antibody on donor/recipient lymphocyte reactive antibody assay. Donors with the following symptoms or conditions are excluded: * Medical condition that would endanger health of donor or recipient. * Failure to meet established donor standards on blood screening tests. * CMV seropositivity if the patient (recipient) is CMV seronegative. * Pregnancy. Concurrent Medication: Excluded: * GM-CSF or G-CSF. * Any investigational drug. * Immunomodulators (such as interferon, steroids, topical corticosteroids, thalidomide, pentoxifylline, IL-2). * Nonsteroidal anti-inflammatory drugs. * Aspirin. Prior Treatment: Excluded: * Blood transfusion within the past 2 months. Required: * Stable antiretroviral therapy for at least 2 months prior to study entry. Active substance abuse.



Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.
Este estudio tiene una ubicación
Suspendido
Univ Hosp of Cleveland / Case Western Reserve UnivCleveland, United StatesVer ubicación

Completado1 Centros de Estudio