A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
Saquinavir
+ Zidovudine
+ Zalcitabine
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 3000 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 18 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: Allowed: Erythropoietin and G-CSF. Concurrent Treatment: Allowed: Local skin radiotherapy. Patients must have: HIV infection. CD4 count 50 - 350 cells/mm3. No prior antiretroviral therapy OR less than 16 weeks of prior AZT. No acute serious opportunistic infections requiring immediate treatment. No unexplained fever persisting for 14 days within 90 days prior to study entry. No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. Life expectancy of at least 80 weeks. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Malabsorption. Severe chronic diarrhea. Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). Any grade 3 or worse toxicity. Inability to comply with study requirements. Concurrent Medication: Excluded: Other investigational agents. Antineoplastic agents. Biologic response modifiers (including interferons). Foscarnet. Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: Acute therapy for opportunistic infection within 14 days prior to study entry. Prior HIV proteinase inhibitor.
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 26 ubicaciones
UCD Med Ctr
Sacramento, United StatesDavies Med Ctr
San Francisco, United StatesMount Zion Med Ctr / UCSF
San Francisco, United States