NCT00002432已完成不适用
An Open Study of Foscarnet Treatment of CMV-Retinitis in AIDS Patients
Astra USA2 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of foscarnet maintenance therapy for treatment of AIDS patients experiencing CMV retinitis.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior Medication:
- •Ganciclovir (DHPG).
排除标准
- •Co-existing Condition:
- •Patients with the following are excluded:
- •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
- •Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
- •Known allergy to foscarnet.
- •Concurrent Medication:
- •Nephrotoxic drugs.
- •Acyclovir.
- •Patients with the following are excluded:
- •Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
- •Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
- •Known allergy to foscarnet.
- •Prior Medication:
- •Excluded within 7 days of study entry:
- •Immunomodulators.
- •Biologic response modifiers.
- •Investigational agents (other than ganciclovir).
- •Patients with AIDS as defined by the CDC, with manifest first episode cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.
- •Patients must be able to give informed consent.
- •Patients who enter the study because of ganciclovir toxicity will have received ganciclovir therapy which resulted in either absolute neutrophil count falling to < 750 cells/mm3 or platelet count falling to < 50000 platelets/mm3 on two separate occasions during either:
- •A ganciclovir induction regimen of 7.5 mg (or more)/kg/day in divided doses.
- •A maintenance regimen of 5 mg (or more)/kg/day as a single daily dose.
- •Patients who enter the study because of ganciclovir treatment failure will meet one of the following criteria:
- •CMV retinitis progression has occurred either 1) at the end of a 10 - 21 day induction course of ganciclovir (7.5 - 10 mg/kg/day in divided doses) or 2) during the first 28 days of maintenance ganciclovir therapy (5 mg (or more)/kg/day, at least 5 days/week) where maintenance therapy began within 1 week of completing induction therapy.
研究者
研究点 (2)
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