A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
Zidovudine
+ Didanosine
Infecciones Transmitidas por la Sangre+10
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 85 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 Patients must have: HIV-1 seropositivity. CD4 count >= 550 cells/mm3. Asymptomatic disease. No prior antiretroviral therapy. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical condition that precludes study compliance. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Biologic response modifiers including erythropoietin and G-CSF. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Systemic radiation therapy. Patients with the following prior conditions are excluded: History of grade 2 or worse peripheral neuropathy. History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: Prior antiretrovirals. Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.
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 22 ubicaciones
Univ of Alabama at Birmingham
Birmingham, United StatesAbrir Univ of Alabama at Birmingham en Google MapsSan Francisco Gen Hosp
San Francisco, United StatesUniv of Colorado Health Sciences Ctr
Denver, United StatesUniv of Miami School of Medicine
Miami, United States