A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA
Colección de datos
Enfermedades Transmisibles+10
+ Enfermedades Urogenitales
+ Infecciones Transmitidas por la Sangre
Estudio de Tratamiento
Resumen
Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration. Initially, all patients receive AZT alone. After detection of a 215 mutation in plasma RNA, patients are randomized to one of three treatment arms: AZT alone, AZT plus ddI, or AZT/ddI plus nevirapine. Patients are followed every 8 weeks and receive treatment for up to 4 years. AS PER AMENDMENT 5/9/96: All AZT monotherapy options have been eliminated. Patients will be randomized to either Arm II or Arm III, regardless of their codon 215 status. All patients who were randomized to Arm I following a mutation at codon 215 will be rerandomized to Arm II or Arm III. All patients who were randomized to either Arm II or Arm III following a mutation at codon 215 will remain on their initial randomized assignment.
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 Concurrent Medication: Allowed: * Chemoprophylaxis for Pneumocystis carinii pneumonia. * Antibiotics, antifungals, and antiviral medications, as clinically indicated. * Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider. Concurrent Treatment: Allowed: * Limited localized radiation therapy to the skin. Prior Medication: Required: * AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry. Patients must have: * Asymptomatic HIV infection. * CD4 count 300-600 cells/mm3. * No plasma/serum PCR for codon 215 mutation at screening. * Prior AZT monotherapy. NOTE: * All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged. AS PER AMENDMENT 04/03/95: * DOD female patients must have a negative pregnancy test within 48 hours prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Symptomatic grade 2 or worse peripheral neuropathy. * Unable to swallow capsules and tablets. * Other medical condition that contraindicates study participation. Concurrent Medication: Excluded: * Systemic cytotoxic chemotherapy. * Biologic response modifiers (such as interferon, ampligen, or PEG-IL2). * Anti-HIV agents other than study drugs. * Other investigational agents. * Foscarnet unless clinically indicated for unresponsive herpes virus infection. * Chronic antacid or H-2 blocker use. * Rifampin or rifamycin class agents. * Antibiotics containing clavulanic acid. Concurrent Treatment: Excluded: * Radiation therapy other than limited localized therapy to skin. Patients with the following prior condition are excluded: * History of pancreatitis. Prior Medication: Excluded: * Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT. * Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening. Prior Treatment: Excluded: * Blood transfusion within the preceding 2 weeks. Illicit drug or alcohol abuse.
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 59 ubicaciones
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, United StatesSanta Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, United StatesSan Mateo AIDS Program / Stanford Univ
Stanford, United States