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An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients

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

Ditiocarb sodium

Medicamento
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: 27 de octubre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine, in HIV-infected patients, the magnitude and duration of the biological effects of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of HIV infection. DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug. DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug. Two groups of patients, one group asymptomatic and the other with AIDS diagnosis, are enrolled in the study. All patients receive DTC intravenously once a week for two weeks. Drugs are given on days 1 and 8. Blood samples are drawn on days 1, 3, 5, 8, 10, and 12.

Título OficialAn Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 27 de octubre 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 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.

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 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 Patients must: * Have HIV infection. * Be asymptomatic (group 1) or have AIDS (group 2). * Be able to understand and follow instructions. Concurrent Medication: Allowed: GROUP 2: * Anti-HIV therapy. * Systemic prophylaxis or maintenance therapy for any AIDS-defining opportunistic infection excluding agents considered immunomodulators or immunosuppressants. * Topical nystatin. * Clotrimazole troches. * Acyclovir. * Dapsone. * Trimethoprim / sulfamethoxazole (T/S). * Fluconazole. * Ketoconazole. * Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: ALL PATIENTS: * Known hypersensitivity to disulfiram or diethyldithiocarbamate (DTC). * Transfusion dependence. GROUP 1 PATIENTS ONLY: * Oral candidiasis documented by morphology or by a response to antifungal therapy. * Oral hairy leukoplakia. * Occurrence of herpes zoster in a single dermatomal distribution. * Recurrent seborrheic dermatitis. * Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study. * Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days within 2 years of expected study entry. * Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval. * Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation. GROUP 2 PATIENTS ONLY: * Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. * Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry. Concurrent Medication: Excluded: ALL PATIENTS: * Recombinant erythropoietin. GROUP 1: * Antiretroviral medications. GROUP 2: * Immunomodulators or immunosuppressants. Concurrent Treatment: Excluded: * Requirement for blood transfusions more than once a month. Patients with the following prior conditions are excluded: GROUP 1 PATIENTS ONLY: * Oral candidiasis documented by morphology or by a response to antifungal therapy. * Oral hairy leukoplakia. * Occurrence of herpes zoster in a single dermatomal distribution. * Recurrent seborrheic dermatitis. * Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study. * Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30-day period within 2 years of expected study entry. * Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval. * Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation. GROUP 2 PATIENTS ONLY: * Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry. Prior Medication: Excluded: ALL PATIENTS: * Corticosteroids, cytotoxic agents, or immunomodulating agents within 30 days prior to study entry. * Chronic Antabuse (disulfiram) therapy. GROUP 1 ONLY: * Antiretrovial medications within 1 week prior to study entry. Prior Treatment: Excluded: * Transfusion within 7 days of study entry. * Radiation therapy within 30 days prior to study entry. Unable to refrain from the use of alcohol for the duration of the study.



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
Johns Hopkins Adult AIDS CRSBaltimore, United StatesVer ubicación

Completado1 Centros de Estudio