A Randomized, Comparative Trial of Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus Dideoxycytidine (ddC) in HIV-Infected Patients
Zidovudine
+ Zalcitabine
+ Didanosine
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Studies have indicated that maintenance therapy with AZT over extended periods may be limited by dose-dependent toxicity, primarily myelosuppression, and by the emergence of drug-resistant HIV strains. It is anticipated that the combination of AZT with either ddI or ddC may promote higher antiviral efficacy, with acceptable toxicity and less likelihood of development of drug-resistant strains, than AZT alone. Approximately 1200 patients are randomized in a 2:1:1:2 ratio to one of the following four treatment arms: AZT plus ddI, AZT plus ddI placebo, AZT plus ddC placebo, and AZT plus ddC. Average follow-up is 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 1200 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 Required: Documented HIV infection OR working diagnosis of HIV OR evidence of idiopathic suppression with an AIDS-defining opportunistic infection or malignancy (except Kaposi's sarcoma). CD4+ cell count = or < 200/mm3 or = or < 15 percent of total lymphocyte count within previous 90 days OR history of AIDS-defining opportunistic infection. Current PCP prophylaxis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Symptoms of pancreatitis or peripheral neuropathy of grade 2 or worse. Requirement for acute therapy for any active AIDS-defining opportunistic infection or systemic chemotherapy for malignancy. Stage 2 or worse (moderate) AIDS Dementia Complex. Other disorders or conditions for which the study drugs are contraindicated or that may prevent adequate compliance with study therapy. Concurrent Medication: Excluded: Acute therapy for active AIDS-defining opportunistic infection. Systemic chemotherapy for malignancy. Antiretroviral therapy other than that provided by this study. Patients with the following prior conditions are excluded: History of pancreatitis or peripheral neuropathy of grade 2 or worse. History of intolerance to the study drugs at entry doses and/or frequencies. History of phenylketonuria.
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 16 ubicaciones
Community Consortium of San Francisco
San Francisco, United StatesAbrir Community Consortium of San Francisco en Google MapsDenver CPCRA / Denver Public Hlth
Denver, United StatesHill Health Corp
New Haven, United StatesWilmington Hosp / Med Ctr of Delaware
Wilmington, United States