NCT00002330已完成不适用
A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS
Roche Global Development68 个研究点 分布在 2 个国家目标入组 280 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
- 280
- 试验地点
- 68
研究概览
简要总结
To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.
详细描述
Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.
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 and ophthalmic nucleoside analogues.
- •Patients must have:
- •HIV positive.
- •No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
- •Currently stable retinitis.
- •Prior Medication:
- •Foscarnet prior to the 4 weeks of intravenous induction therapy.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Persistent or clinically significant diarrhea, nausea, or abdominal pain.
- •Severe odynophagia.
- •Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
- •Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
- •Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
- •Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.
- •Concurrent Medication:
- •Acyclovir sodium (Zovirax) by any route other than topical.
- •Valacyclovir.
- •Brovavir.
- •Vidarabine.
- •Amantadine hydrochloride.
- •Cytarabine.
- •Idoxuridine.
- •Ribavirin.
- •Interferon.
- •Foscarnet (non-nucleoside pyrophosphate analogue).
- •CMV hyperimmune globulin.
- •Soluble CD
- •Trichosanthin (Compound Q).
- •Imipenem-cilastatin.
- •Isoprinosine.
- •Levamisole.
- •Other investigational drugs.
- •Patients with the following prior condition are excluded:
- •History of hypersensitivity to acyclovir or ganciclovir.
- •Prior Medication:
- •More than three induction regimens with intravenous anti-CMV therapy.
- •Any prior oral ganciclovir.
研究者
研究点 (68)
Loading locations...
相似试验
已完成
不适用
A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDSCytomegalovirus RetinitisHIV InfectionsNCT00002257Hoffmann-La Roche150
已完成
3 期
A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVOMacular EdemaCentral Retinal Vein OcclusionNCT00567697Aleris Helse32
已完成
2 期
CMV Retinitis Retreatment TrialCytomegalovirus RetinitisHIV InfectionsNCT00000766National Institute of Allergy and Infectious Diseases (NIAID)300
已完成
3 期
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)Acquired Immunodeficiency SyndromeCytomegalovirus RetinitisHIV InfectionsNCT00000134Johns Hopkins Bloomberg School of Public Health279
撤回
3 期
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)Age Related Macular DegenerationNCT00557791OPKO Health, Inc.