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A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

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

Zidovudine

+ Aldesleukin
Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 18 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological responses which parallel those observed with IV dosing. Original design: To evaluate the short-term effects of combined administration of zidovudine (AZT) and increasing doses of recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get into the blood and how long they remain there (pharmacokinetics) will also be studied at each dose as well as the effect on HIV. Since AZT has no effect on cells that contain inactive virus (latently infected cells) and these cells may act as viral reservoirs, that a second agent that can destroy these infected cells would be useful in combination with AZT. The different activities of AZT and IL-2, as well as the non-overlapping nature of their mechanisms of action and toxicity, increase the theoretical benefits of combining AZT, a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of latently infected cells. Since AZT has no effect on cells that contain inactive virus (latently infected cells) and these cells may act as viral reservoirs, that a second agent that can destroy these infected cells would be useful in combination with AZT. The different activities of AZT and IL-2, as well as the non-overlapping nature of their mechanisms of action and toxicity, increase the theoretical benefits of combining AZT, a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of latently infected cells. Five patients who have already received and tolerated oral AZT for at least 8 weeks continue their AZT treatment and at the same time receive IL-2 on a schedule of 5 days on the drug, 2 days off the drug. The IL-2 is administered by 30-minute intravenous (IV) infusion according to this schedule for 4 weeks. The first week of IL-2 treatment is on an inpatient basis and the remaining 3 weeks are on an outpatient basis. Toxicity is monitored every week. Maximum tolerated dose (MTD) is defined as the maximum dose at which 3 out of 5 patients experience Grade 3 or above toxicity during the course of IL-2 administration. A second cohort of five patients will receive IV IL-2. If the MTD is not reached, five additional patients will receive IV IL-2. All five patients in a given cohort must complete a full 4-week course of IL-2 before subsequent patients are entered at the next higher dose level. After IV dosing is completed at these three levels, additional 5-patient cohorts receive subcutaneous (SC) IL-2 according to the same schedule. Each patient is restricted to one dosage group. Patients are treated and followed for a total of 24 weeks. Patients receive ibuprofen for fever and chills.

Título OficialInterleukin-2 Augmentation of Specific Anti-HIV Immune Responses: Phase I Trial of the Combination of 3'-Azido-3'-Deoxythymidine (Zidovudine) and Recombinant Interleukin-2 in Patients With Asymptomatic HIV Infection Associated With Lymphadenopathy (Walter Reed Stage II) 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 4 de noviembre de 2021
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 30 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.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Todos los involucrados en el estudio saben qué tratamiento se está administrando. Esto se utiliza cuando no es posible o necesario ocultar los detalles del tratamiento a los participantes o investigadores.

Otras formas de enmascarar la información
Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Doble ciego
: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

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.
A partir de 18 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: Allowed: * Necessary topical agents, including nystatin or clotrimazole, as well as acyclovir. Patients on medications without which the patient would be placed at significant risk (seizures, diabetic control, respiratory embarrassment) may continue only at the discretion of the study pharmacologist. Patients must have: * Asymptomatic HIV infection associated with lymphadenopathy. * Walter Reed Stage II disease, with positive antibody to HIV confirmed by Western blot test. Exclusion Criteria Co-existing Condition: Patients will be excluded from the study for the following: * Development of a disease requiring a drug which might potentiate toxicity of the study drugs or a drug likely to have antiretroviral effect. * Active opportunistic infection. * Major organ allograft. * Significant cardiac or pulmonary disease or central nervous system (CNS) lesions. Concurrent Medication: Excluded: * Ongoing therapy for an opportunistic infection. * Beta-blockers. * Antihypertensive medication other than diuretics. * All nonessential medication including pain medications. Patients without interleukin 2 (IL-2) augmentable anti-HIV antibody-dependent cellular cytotoxicity (ADCC) or or cell-mediated cytotoxicity (CMC) in vitro are excluded. Prior Medication: Excluded within 12 weeks of study entry: * Other antiretroviral agents (patients with CD4 counts of 400 - 500 per mm3 who are receiving AZT may continue to receive it until study treatment is initiated). * Immunomodulators. * Corticosteroids. * Other experimental therapy. * Antineoplastic chemotherapy. Active drug or alcohol abuse.



Centros del Estudio

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Este estudio tiene una ubicación
Suspendido
Duke Univ. Med. Ctr. Adult CRSDurham, United StatesVer ubicación

Completado1 Centros de Estudio