Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 54
研究概览
简要总结
OBJECTIVES:
I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth.
II. Determine the neurologic outcome in these patients when treated with this regimen.
III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients.
IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen.
V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients.
VI. Determine the safety of this regimen in these patients.
详细描述
PROTOCOL OUTLINE:
This is a randomized, double blind, placebo controlled, multicenter study.
All patients undergo a lumbar puncture and then receive acyclovir IV every 8 hours on Days 1-14. On Day 12, patients may undergo a lumbar puncture (at discretion of investigator). Whole blood is obtained for herpes simplex virus PCR analysis. Upon completion of intravenous therapy, patients with a negative CSF PCR are randomized to one of two treatment arms.
Arm I: Patients receive oral acyclovir three times daily for 6 months.
Arm II: Patients receive placebo three times daily for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 0 Years 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Infants diagnosed with herpes simplex virus infection limited to skin, eyes, and mouth; HSV-1 or HSV-2 isolated from cutaneous lesions, conjunctivae, or oropharynx (presence of skin lesions not required); normal CSF indices: WBC less than 22/mm3 and protein less than 115 mg/dL for term infants OR WBC less than 25/mm3 and protein less than 220 mg/dL for preterm infants; no evidence of CNS involvement by CT with contrast, MRI with gadolinium, or head ultrasound; no visceral dissemination (normal liver function tests, normal chest x-ray, etc.); negative CSF PCR result
- •Birth weight at least 800 grams
- •-Prior/Concurrent Therapy--
- •No concurrent nursing from a mother who is receiving acyclovir, valacyclovir, or famciclovir for longer than 120 hours or 5 days; no prior prophylactic acyclovir for risk of herpes simplex virus infection
- •-Patient Characteristics--
- •Renal: Creatinine no greater than 1.5 mg/dL
- •Cardiovascular: No prior grade 3 or 4 intraventricular hemorrhage
- •Other: No infants known to be born to HIV-positive women
排除标准
- 未提供