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A Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection

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Qué se está evaluando

Zidovudine

Medicamento
Quiénes están siendo reclutados

AIDS Dementia Complex

+ HIV Infections
A partir de 12 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To test whether zidovudine (AZT) is useful as a treatment for the neurologic syndrome called AIDS dementia complex. To determine how long AZT takes to reach cerebral spinal fluid (CSF), how long, and at what concentration it is found there. HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex. HIV infection can result in impairment in the function of the brain and spinal cord, leading to disturbances in the ability to think clearly and in strength and coordination. This disorder, which has been called the AIDS dementia complex, may be due to a direct effect of HIV on the nervous system. It is known that AZT does get into the brain to some extent, where it may reduce growth of HIV. It is hoped that AZT will stabilize or improve the symptoms of the AIDS dementia complex. The study is done in 2 stages. In Stage 1, patients are randomized to receive placebo or 1 of 2 doses of AZT. Stage 1 lasts for 4 months. In Stage 2, patients who were initially treated with placebo are randomized again and all patients receive AZT. Stage 2 lasts an additional 12 months, during which time there are periodic medical and neurologic evaluations. Before beginning treatment, all patients have a lumbar puncture and a computerized tomographic (CT) scan of the brain. The lumbar puncture is repeated twice during and once at the end of Stage 1; the CT scan is also repeated at the end of Stage 1. Patients receiving AZT in either stage 1 or Stage 2 are seen by their physicians every week for the first 4 weeks and every other week thereafter for the first 4 months of receiving the drug. After 4 months, patients are seen by their physicians at 4 to 12 week intervals.

Título OficialA Multicenter Placebo-Controlled Double-Blind Trial to Evaluate Azidothymidine (AZT) Treatment of the AIDS Dementia Complex and Central Nervous System (CNS) Human Immunodeficiency Virus (HIV) Infection 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 3 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 315 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
Ni los participantes ni los investigadores saben quién está recibiendo qué tratamiento. Esta es la forma más rigurosa de reducir el sesgo, asegurando que las expectativas no influyan en los resultados.

Otras formas de enmascarar la información
Abierto
: Todos saben qué tratamiento se está administrando.

Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

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 12 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
AIDS Dementia Complex
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Aspirin, in modest doses. * Ibuprofen, in modest doses. * Maintenance antibiotic therapy posttherapy for an AIDS-defining opportunistic infection. Concurrent Treatment: Allowed: * Blood transfusion if cardiovascular status is compromised. Exclusion Criteria * Active substance abuse. Co-existing Condition: Patients with the following conditions will be excluded: * Concurrent or previous central nervous system infections or neoplasms. * Active AIDS-defining opportunistic infection. * Severe premorbid psychiatric illness. * Confounding neurological disease. * Concurrent neoplasms. Concurrent Medication: Excluded: * Maintenance methadone or naltrexone. * Acetaminophen. * Mood- or central nervous system-altering drugs. * Zidovudine for Pneumocystis carinii pneumonia (PCP). * Acyclovir. * Rifampin or derivatives. * Drugs with antiretroviral activity. * Experimental agents. The following patients will be excluded from the study: * Patients requiring ongoing therapy for an AIDS-defining opportunistic infection. * Patients with a history of Mycobacterium avium intracellulare infection. * Patients with a history of Pneumocystis carinii pneumonia infection. * Patients with a daily temperature of 38 degrees C or more for 1 month. Prior Medication: Excluded: * Zidovudine (AZT). * Excluded within 14 days of study entry: * Systemic anti-infectives. * Excluded within 30 days of study entry: * Immunomodulators and biologic response modifiers. * Any investigational agent. * Cytotoxic chemotherapy for Kaposi's sarcoma. Prior Treatment: Excluded: * Radiation therapy. Patients must demonstrate the following clinical and laboratory findings: * No currently active AIDS-defining opportunistic infections. * One negative blood culture for Mycobacterium avium intracellulare within 4-6 weeks prior to study entry. * Constitutionally well without persistent fever. * Less than 25 Kaposi's sarcoma lesions and less than 10 new lesions during the 30 days prior to study entry. Patients may have stable or indolently progressive mucocutaneous Kaposi's sarcoma. * Characteristic clinical symptoms and signs of AIDS dementia complex. * Abnormalities on 2 or more of 7 neuropsychological motor tests in the Neurological Screening Battery. * Estimated premorbid IQ equal to or greater than 70 (+ or - 5), which is consistent with completion of sixth grade.



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 21 ubicaciones
Suspendido
UCLA CARE CtrLos Angeles, United StatesVer ubicación
Suspendido
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspendido
Stanford Univ School of MedicineStanford, United States
Suspendido
Univ of Miami School of MedicineMiami, United States

Completado21 Centros de Estudio