A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients
Glutamic acid hydrochloride
+ Ganciclovir
Infecciones Transmitidas por la Sangre+26
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug. All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amendment 3/4/95) days. A permanent venous catheter is implanted for the induction therapy. If clinically improved following induction, patients are then randomized to receive one of three doses of oral ganciclovir, given first without and then with oral glutamic acid hydrochloride, every 8 hours until they reach a steady state. PER AMENDMENT 3/14/95: After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken. Subjects will continue the dosing regimen they were assigned to (glutamic acid hydrochloride will be added if it resulted in at least 33% increased bioavailability) for up to 12 months or until relapse of CMV GI disease is documented. Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse. Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 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: Recommended: PCP prophylaxis. Allowed: Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study. Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry. Recombinant human erythropoietin. GM-CSF and G-CSF. Other medications necessary for patient's welfare, at the physician's discretion. Patients must have: HIV infection. Biopsy-proven cytomegalovirus (CMV) colitis. Life expectancy of at least 3 months. No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression. NOTE: Kaposi's sarcoma is permitted if patients are hematologically stable for at least 30 days prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other etiologies for diarrhea identified at study entry. PER AMENDMENT 3/14/95: For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment. Known hypersensitivity to study drugs. CMV retinitis. Concurrent Medication: Excluded: Acyclovir or probenecid (PER AMENDMENT 3/14/95). Immunomodulators. Biologic response modifiers (other than GM-CSF or G-CSF). Investigational agents, with the exception of treatment IND drugs. Antacids. H2 blockers. Proton pump inhibitors. Foscarnet during induction and pharmacokinetic part of study. Intravenous CMV retinitis maintenance therapy (including ganciclovir) during pharmacokinetic part of study. Nephrotoxic agents. Prior Medication: Excluded within 14 days prior to study entry: Immunomodulators. Biologic response modifiers (other than GM-CSF or G-CSF). Investigational agents, with the exception of treatment IND drugs.
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
Ucsf Aids Crs
San Francisco, United StatesWashington U CRS
St Louis, United StatesNY Univ. HIV/AIDS CRS
New York, United States