An Open-Labeled, Multiple Dose, Multicenter Study to Investigate the Safety, Tolerability, and Plasma Concentration Profile of L-735,524 Capsules in HIV-Seropositive Older Children and Adolescent Patients
Indinavir sulfate
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Patients receive MK-639 for 14 and one-third days. Repeat plasma samples are collected up to 8 hours following the first and last dose. Urine samples are collected on days 1 and 5.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 12 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.De 10 a 18 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 positivity. No active opportunistic infection within the past 30 days, other than superficial candidiasis of the oral cavity or vagina. Body surface area at least 1.0 sqm. Consent of parent or guardian. Prior Medication: Allowed: Aerosolized pentamidine. Topical antifungals. TMP / SMX. AZT. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant hepatic disease including HBsAg or hepatitis C positivity. Significant neurologic disease such as loss of intellectual ability, motor deficits, or seizure disorder. Significant cardiac disease including dysrhythmia or cardiomyopathy. Significant medical condition or laboratory abnormality that may pose additional risk to patient on study or confound the results. Has a social situation that may interfere with study participation. Concurrent Medication: Excluded: Oral contraceptives. Patients with the following prior conditions are excluded: History of serious allergic drug reactions. History of significant cardiac disease. Participation on another clinical trial within the past 4 weeks. Donated blood within the past 4 weeks. Prior Medication: Excluded within the past 4 weeks: Hematopoietic growth factors. Excluded within the past 2 weeks: Antiretroviral agent other than zidovudine. Oral contraceptives. Prophylaxis for opportunistic infections, other than aerosolized pentamidine, topical antifungals, and TMP/SMX. Any other medication unless approved by Merck clinical monitor. Current illicit drug use.
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 una ubicación