NCT00002142已完成不适用
An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients 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
- 1
研究概览
简要总结
To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.
详细描述
Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Antiretroviral agents.
- •Oral trimethoprim/sulfamethoxazole.
- •Aerosolized pentamidine.
- •Fluconazole.
- •Rifabutin.
- •Filgrastim (G-CSF).
- •Itraconazole.
- •HIV vaccines.
- •Patients must have:
- •CMV retinitis, with severity as specified in the Disease Status field.
- •Life expectancy of at least 3 months.
- •Consent of parent or guardian if less than 18 years of age.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Known clinically significant allergy to probenecid.
- •Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- •Other active medical problems sufficient to hinder study compliance.
- •Concurrent Medication:
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Vidarabine.
- •Intravenous pentamidine.
- •CMV hyperimmune immunoglobulin.
- •Other nephrotoxic or potentially nephrotoxic agents.
- •Other investigational agents with anti-CMV activity.
- •Ganciclovir.
- •Intravenous or oral acyclovir (except following development of herpetic lesion).
- •Foscarnet.
- •Diuretics.
- •Prior Medication:
- •Excluded within 2 days prior to study entry:
- •Ganciclovir or foscarnet.
- •Excluded within one week prior to study entry:
- •Amphotericin B.
- •Aminoglycoside antibiotics.
- •Vidarabine.
- •Intravenous pentamidine.
- •CMV hyperimmune immunoglobulin.
- •Other nephrotoxic agents.
- •Other investigational agents with anti-CMV activity.
- •Excluded at any time:
- •Prior systemic or intravitreal HPMPC.
- •Drug or alcohol abuse that is considered sufficient to hinder study compliance.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3HIV InfectionsNCT00002161Gilead Sciences400
已完成
2 期
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDSCytomegalovirus RetinitisHIV InfectionsNCT00002437Gilead Sciences48
已完成
3 期
Safety Study of Tipranavir Co-administered With Low-dose Ritonavir (TPV/r) in Patients With Advanced HIV-1 Infection and Limited Treatment OptionsHIV InfectionsNCT00144287Boehringer Ingelheim255
已完成
不适用
Cidofovir as a Treatment for Herpes Simplex in Patients With AIDSHerpes SimplexHIV InfectionsNCT00002181Gilead Sciences
Unknown
2 期
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected ChildrenHIV InfectionsNCT00002219Gilead Sciences36