A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection
Sitamaquine
Infecciones Transmitidas por la Sangre+19
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 45 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: Any medications not listed as excluded will be permitted on study. [ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.] Patients must have: Documented HIV infection. Documented PCP. On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg. Signed informed consent from parent or legal guardian for those patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to quinolines. If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study. Concurrent Medication: Excluded: Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine). Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites). Patients with the following prior conditions or symptoms are excluded: History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency. Prior Medication: Excluded: More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at 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 12 ubicaciones
Queens Med. Ctr.
Honolulu, United StatesUniv. of Hawaii at Manoa, Leahi Hosp.
Honolulu, United StatesNorthwestern University CRS
Chicago, United States