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A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)

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Qué se está evaluando

AS-101

Medicamento
Quiénes están siendo reclutados

HIV Infections

De 18 a 60 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS related complex. Also to determine the effect of various doses of AS-101 on immune functions and the occurrence of infections in these patients. AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions. AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions. Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks. The first group of 6 patients receives a dose that did not cause toxic effects in a preliminary study. If no adverse effects occur, the next 6 patients receive a higher dose level and so on, until an optimum dose has been reached. The investigators will determine the optimum dose based on the type and severity of adverse effects experienced by the patients on the study and by the effect of the drug on the immune function of the patient and its effect on the HIV infection. Samples of blood and urine are taken periodically during the study and skin tests are performed 3 times to aid in the evaluation of AS-101. Patients receive standard treatment for any infections that develop during the study.

Título OficialA Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC) 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 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.
De 18 a 60 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: * Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. * Ketoconazole. * Standard outpatient therapy for infections developing during the trial. * Oral acyclovir for up to 7 days. Patients must have: * Antibody to HIV by ELISA. * AIDS or AIDS related complex (ARC). * T4 cell count \< 400 cells/mm3 on 2 determinations at least 72 hours apart. Prior Medication: Allowed: * Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. * Ketoconazole. * Oral acyclovir for up to 7 days. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Active opportunistic infection or malignancy requiring concurrent treatment. * Serious medical problems, such as diabetes, renal disease, ASHD, or hypertension, which would complicate interpretation of treatment results. * Transfusion requirements exceeding 2 transfusions per month in order to achieve hemoglobin \> 9 g/dl. Concurrent Medication: Excluded: * Treatment for active opportunistic infection or malignancy. * Systemic antiviral preparations. * Immunosuppressive agents. * Immunostimulation therapy. * Specific therapy for Kaposi's sarcoma or other malignancies. Concurrent Treatment: Excluded: * More than 2 units of red blood cell transfusions per month in order to achieve hemoglobin \> 8 g/dl. Patients unlikely or unable, for reasons such as distance from the hospital or psychological considerations, to comply with the requirements of the protocol, especially in regard to regular attendance for treatment, are excluded. Prior Medication: Excluded: * Systemic antiviral preparations. * Isoprinosine. * Excluded with 1 month of study entry: * Immunosuppressive agents. * Immunomodulators. Prior Treatment: Excluded: * Immunostimulation therapy, such as BCG vaccine. Active drug or alcohol 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
Mount Sinai Med CtrNew York, United StatesVer ubicación

Completado1 Centros de Estudio