NCT00002034已完成不适用
A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 17
研究概览
简要总结
To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.
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 acyclovir.
- •Selected cytokines.
- •Allowed after the first 4 weeks of ganciclovir:
- •Zidovudine (AZT) at a reduced dose (500 mg/day) in patients who have tolerated ganciclovir without grade 3/4 hematological toxicity.
- •Other anti-retrovirals after consultation with the Syntex study monitor.
- •Patients must have the following:
- •AIDS and newly diagnosed Cytomegalovirus (CMV) retinitis.
- •An understanding of the nature of the study, agreement to its provisions, and willingness to sign the informed consent approved by the appropriate institutions review board, and Syntex.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions or symptoms are excluded:
- •Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk, or greater than 3000 microns from the fovea).
- •Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment.
- •Ocular conditions requiring immediate surgical correction (eg:
- •retinal tear or detachment).
- •Demonstrated hypersensitivity to acyclovir or ganciclovir.
- •Dementia, decreased mentation or other encephalopathic signs and symptoms which would interfere with the ability of the patient to comply with the protocol.
- •Concurrent Medication:
- •Antimetabolites.
- •Alkylating agents.
- •Nucleoside analogs (excluding selected anti-retroviral agents).
- •Imipenem-cilastatin.
- •Interferons.
- •Selected cytokines.
- •Acyclovir (except topical acyclovir).
- •Patients with the following are excluded:
- •Have only peripheral CMV retinitis (defined as a lesion outside the major temporal vascular arcades, greater than 1500 microns from the optic disk or greater than 3000 microns from the fovea).
- •Concomitant conditions or diseases described in Exclusion Co-Existing Conditions.
- •Prior Medication:
- •Excluded within 1 month of study entry:
- •Previous treatment with anti-cytomegalovirus therapy (e.g., ganciclovir, foscarnet or CMV hyperimmune globulin).
研究者
研究点 (17)
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