NCT00002134已完成不适用
A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis
Roche Global Development42 个研究点 分布在 1 个国家目标入组 450 人开始时间: 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
- 入组人数
- 450
- 试验地点
- 42
研究概览
简要总结
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
详细描述
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Topical drugs and ophthalmics.
- •Patients must have:
- •Unilateral CMV retinitis.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
- •Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
- •Acute retinal necrosis or any other intraocular condition that might preclude study completion.
- •Ocular condition requiring immediate surgery.
- •Unable to have long-term IV catheter placement.
- •Concurrent Medication:
- •Vidarabine.
- •Amantadine hydrochloride.
- •Cytarabine.
- •FIAC or FIAU.
- •Idoxuridine.
- •Ribavirin.
- •Valacyclovir.
- •Foscarnet.
- •CMV hyperimmune globulin.
- •Soluble CD
- •Trichosanthin.
- •Imipenem-cilastatin.
- •Isoprinosine.
- •Levamisole.
- •Interferon.
- •Other investigational drugs.
- •Patients with the following prior conditions are excluded:
- •History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
- •History of hypersensitivity to acyclovir or ganciclovir.
- •Prior Medication:
- •Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
- •Prior intravitreal ganciclovir implant.
- •More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
- •Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).
研究者
研究点 (42)
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