Completado

Evaluation of Patients Who Have Not Had Success With Zidovudine

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Zidovudine

+ Didanosine
Medicamento
Quiénes están siendo reclutados

HIV Infections

A partir de 12 años
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional

Resumen

Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate measures of viral load and short term clinical and laboratory markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the different therapy arms. High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors. One hundred-twenty patients who have been receiving AZT for at least 1 year are randomized to 1) continue with AZT, 2) switch to treatment with didanosine at 1 of 2 doses, or 3) receive both AZT and ddI. Treatment is given for 16 weeks, with a possible extension to 32 weeks. Patients are followed at weeks 2, 4, 8, 12, and 16. For analysis purposes only, patients are stratified according to degree of susceptibility of HIV isolates to AZT.

Título OficialA Study to Evaluate the Short-Term Clinical and Virologic Significance of Zidovudine Resistance 
Patrocinador PrincipalNational Institute of Allergy and Infectious Diseases (NIAID)
Última actualización: 1 de noviembre de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 120 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 12 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
HIV Infections
Criterios

Inclusion Criteria Concurrent Medication: Allowed: * Chemoprophylaxis against Pneumocystis carinii pneumonia (PCP), Mycobacterium tuberculosis, or Herpes simplex virus, or against other opportunistic infections as indicated. * Corticosteroids for no longer than 21 days (only as part of PCP therapy). * Erythropoietin and G-CSF. Patients must have: * Documented HIV-seropositivity. * CD4 count 100 - 300 cells/mm3. * Prior continuous AZT dose = or \> 300 mg/day for 1 year or longer. Prior Medication: Required: * AZT for at least 1 year prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: * Medical contraindication or is considered noncompliant in the opinion of the investigator. * Peripheral neuropathy = or \> grade 2. Concurrent Medication: Excluded: * Anti-HIV agents other than study drugs. * Biologic response modifiers (other than erythropoietin or G-CSF). * Systemic cytotoxic chemotherapy. * Regularly prescribed medications (such as antipyretics, analgesics, allergy medications) that are associated with an increased risk of pancreatitis, peripheral neuropathy, or bone marrow suppression. Concurrent Treatment: Excluded: * Radiation therapy. Patients with the following prior conditions are excluded: * History of acute or chronic pancreatitis, gout, or uric acid nephropathy. Prior Medication: Excluded: * Other antiretrovirals besides AZT. * ddI or ddC for more than 30 days within the past year or any time within 3 months prior to study entry. * Acute therapy for an infection or other medical illness within 14 days prior to study entry.



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 18 ubicaciones
Suspendido
Univ of Alabama at BirminghamBirmingham, United StatesVer ubicación
Suspendido
San Francisco Gen HospSan Francisco, United States
Suspendido
Santa Clara Valley Med Ctr / AIDS Community Rsch ConsortiumSan Jose, United States
Suspendido
San Mateo AIDS Program / Stanford UnivStanford, United States

Completado18 Centros de Estudio