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A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past

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

Zidovudine

+ Zalcitabine
+ Didanosine
Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 13 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
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

To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs. Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs. Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.

Título OficialA Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy 
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 654 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.
A partir de 13 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: * PCP prophylaxis. Allowed: * Erythropoietin. * Prophylaxis for MAI or fungal infections. * Antibiotics. * Over-the-counter, alternative, or regularly prescribed drugs. * Steroids, if for \< 21 days. Concurrent Treatment: Allowed: * Radiation therapy for cutaneous Kaposi's sarcoma. Patients must have: * HIV infection. * CD4 count \<= 50 cells/mm3. * Prior nucleoside monotherapy for at least 6 months. * Life expectancy of at least 6 months. Prior Medication: Required: * Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Severe peripheral neuropathy. * Psychological or emotional problems sufficient to prevent study compliance. Concurrent Medication: Excluded: * Systemic chemotherapy for malignancy. * Acute or induction therapy for opportunistic infection. Patients with the following prior conditions are excluded: * History of acute or chronic pancreatitis. * Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions. Prior Medication: Excluded: * Non-study nucleosides or biologic response modifiers within 7 days prior to study entry. * Acute therapy for opportunistic process within 14 days prior to study entry. * Acute systemic therapy for other medical conditions within 14 days prior to study entry.



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 37 ubicaciones
Suspendido
USC CRSLos Angeles, United StatesVer ubicación
Suspendido
Stanford CRSPalo Alto, United States
Suspendido
Ucsd, Avrc CrsSan Diego, United States
Suspendido
Ucsf Aids CrsSan Francisco, United States

Completado37 Centros de Estudio