Double-Blind, Randomized, Phase II Study of Ro 31-8959 Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Ro 31-8959 Plus AZT Plus ddC
Saquinavir
+ Zidovudine
+ Zalcitabine
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
PRIMARY: To determine the efficacy and toxicity of three treatment regimens: saquinavir mesylate (Ro 31-8959) plus zidovudine (AZT) vs. AZT plus zalcitabine (dideoxycytidine; ddC) vs. Ro 31-8959 plus AZT plus ddC. SECONDARY: To investigate the pharmacokinetics and effects on various clinical parameters of the three regimens.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 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 Prior Medication: Required: At least 4 months total of AZT at some point in the past, alone or in combination with other antiretroviral therapy. Patients must have: HIV seropositivity. Diagnosis of AIDS, ARC, PGL, or asymptomatic infection. CD4 count > 50 to <= 300 cells/mm3. Life expectancy of at least 6 months. Prior AZT therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Acute serious opportunistic infections requiring immediate treatment, including (but not limited to) tuberculosis, CMV, cryptococcal meningitis, disseminated MAC, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia. Known intolerance to Ro 31-8959, AZT, or ddC. Symptoms suggestive of pancreatitis. Moderate or severe peripheral neuropathy as evidenced by discomfort from numbness, tingling, burning or pain of the extremities or any related symptoms that are accompanied by an objective finding. Visceral Kaposi's sarcoma. Lymphoma that will require therapy within the next 6 months. Transfusion dependence. Concurrent Medication: Excluded: Investigational or antineoplastic agents. Concurrent Treatment: Excluded: Radiotherapy (other than local skin radiotherapy). Transfusions. Prior Medication: Excluded: Any antiretroviral agent (other than AZT) or immunomodulatory therapy within 14 days prior to study entry. Prior treatment with an 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 10 ubicaciones
Univ of Alabama at Birmingham
Birmingham, United StatesAbrir Univ of Alabama at Birmingham en Google MapsStanford Univ Med Ctr
Stanford, United StatesUniv of Colorado Health Sciences Ctr
Denver, United StatesNorthwestern Univ Med School
Chicago, United States