NCT00002315已完成3 期
A Double-Blind, Multicenter Study Comparing Oral 882C87 With Oral Acyclovir for Treatment of Localized Herpes Zoster in Immunocompromised Patients
Glaxo Wellcome50 个研究点 分布在 1 个国家目标入组 400 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 50
研究概览
简要总结
To determine the efficacy of oral 882C87 compared with oral acyclovir in the treatment of localized herpes zoster in immunocompromised patients. To assess the safety and tolerance of oral 882C87 in immunocompromised patients.
详细描述
Patients are randomized to receive either 882C87 or acyclovir with corresponding placebos for 14 days, with two hundred patients in each of the two groups. They are stratified by presence or absence of HIV infection. Patients undergo 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Acute localized herpes zoster or rash present less than 72 hours, verified by clinical diagnosis.
- •Immunocompromised condition primarily as a result of documented HIV infection, malignancy, chemotherapy or radiation therapy, solid organ or bone marrow transplant, or chronic immunosuppressive therapy.
- •Life expectancy of at least 6 months.
- •Ability to cooperate with the requirements of the study.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Evidence of cutaneous or visceral dissemination (more than 20 discrete lesions outside adjacent dermatomes).
- •Acute, life-threatening condition.
- •Significant malabsorption syndrome or other gastrointestinal dysfunction that may severely reduce drug absorption.
- •Intolerance of oral medication.
- •Concurrent Medication:
- •Tricyclic antidepressants or anti-epileptics.
- •Topical applications to the zoster lesions that would obscure evaluation.
- •Fluorouracil and flucytosine.
- •Systemic therapy with agents with antiherpetic activity (from 2 weeks prior to first dose to day 28 of study).
- •Probenecid or other drugs likely to affect elimination of study drugs (from 2 days prior to first dose to day 14 of the study).
- •Capsaicin (Zostrix).
- •Warfarin (Coumadin) during 14 days of treatment.
- •Patients with the following prior conditions are excluded:
- •History of intolerance, hypersensitivity, or severe drug reaction to acyclovir.
- •Prior Medication:
- •Systemic therapy with agents with antiherpetic activity (including interferon) within the past 2 weeks.
- •Probenecid or other drugs likely to affect the elimination of 882C87 or acyclovir within the past 48 hours.
- •Drugs likely to interact with 882C87 (e.g., fluorouracil or flucytosine) within the past 7 days.
- •Zoster immune globulin or zoster immune plasma within the previous month. History of alcohol or drug abuse within the previous 6 months or current methadone therapy.
研究者
研究点 (50)
Loading locations...
相似试验
终止
3 期
Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell TransplantationAllogeneic Stem Cell TransplantationNCT01185223Pierrel Research Europe GmbH212
已完成
不适用
A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected PatientsHerpes SimplexHIV InfectionsNCT00002084Glaxo Wellcome
已完成
不适用
A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected PatientsHerpes SimplexHIV InfectionsNCT00002000Glaxo Wellcome
尚未招募
1 期
The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting ConditionsHealthy VolunteerNCT06228430International Bio service40
进行中（未招募）
3 期
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant RecipientsCMVKidney Transplant ComplicationsNCT06001320Virginia Commonwealth University60