A 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
Colección de datos
Enfermedades Transmisibles+12
+ Enfermedades Urogenitales
+ Síndrome de Inmunodeficiencia Adquirida
Estudio de Tratamiento
Resumen
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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 654 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 13 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
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
Memorial Sloan-Kettering Cancer Ctr.
New York, United StatesUniv. of Rochester ACTG CRS
Rochester, United StatesUnc Aids Crs
Chapel Hill, United States