NCT00002025已完成不适用
Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Exclusion Criteria
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
- •Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
- •Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
- •Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
- •Hypersensitivity to acyclovir or ganciclovir.
- •Receiving antimetabolite treatment that cannot be discontinued.
- •Concurrent Medication:
- •Antimetabolites.
- •Alkylating agents.
- •Nucleoside analogs (topical ophthalmics are permitted).
- •Interferon.
- •Foscarnet.
- •Cytokines.
- •Patients with the following are excluded:
- •Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
- •Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
- •Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
- •Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
- •Hypersensitivity to acyclovir or ganciclovir.
- •Receiving antimetabolite treatment that cannot be discontinued.
- •Patients must qualify as follows:
- •Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.
- •Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.
- •Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.
排除标准
- 未提供
研究者
研究点 (1)
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