A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Stavudine
Infecciones Transmitidas por la Sangre+16
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1997
Fecha en la que se inscribió al primer participante.In this open-label, multicenter, multinational study, ZDV is replaced with d4T in ZDV-containing regimens, or d4T is added to non-ZDV-containing regimens in 20 patients experiencing ADC. Patients are defined as having failed treatment if they progress by one ADC stage on the MSK (Memorial Sloan Kettering) rating scale on study (i.e., from Stage 1 to 2 or Stage 2 to 3). Patients are evaluated on a weekly basis until the dementia deterioration is confirmed to be caused by HIV-1. The effect of d4T-containing regimens is assessed for the following parameters: neurological status, survival, AIDS-defining conditions, CSF (cerebrospinal fluid) and plasma viral load, CSF and blood immunological markers, blood CD4 cell counts, and viral resistance. This study also assesses the pharmacokinetics of d4T in the CSF and in the blood.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 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 You may be eligible for this study if you: Are HIV-positive. Are at least 13 years old (need consent if under 18). Have AIDS Dementia Complex. Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study entry. Agree to use effective methods of birth control during the study. Are available for at least 16 weeks of study. Exclusion Criteria You will not be eligible for this study if you: Have ever taken d4T. Have a neurological (brain/spinal cord) disease, such as chronic seizures or head injury, or certain other conditions that would interfere with your ability to complete the study. Are pregnant or breast-feeding. Abuse alcohol or drugs. Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires treatment at the time of study enrollment. Have received certain medications. Cannot take medications by mouth. Have severe diarrhea for at least 7 days in a row within 30 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 5 ubicaciones
HIV Neurobehavioral Research Ctr
San Diego, United StatesAbrir HIV Neurobehavioral Research Ctr en Google MapsAIDS ReSEARCH Alliance
West Hollywood, United StatesMount Sinai Hosp
New York, United StatesNational Centre in HIV Epidemiology and Clinical Research
Sydney, Australia