Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 62
研究概览
简要总结
To evaluate the safety of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent Herpes Simplex Virus (HSV) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with AIDS.
详细描述
This trial is a double-blind, multicenter, placebo-controlled clinical trial. Participants are randomized to topical 15% SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. At presentation, patients are stratified by total lesion area within each treatment group. SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.
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:
- •AIDS, according to the CDC criteria.
- •Documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (HSV) types 1 or 2 infection in the active phase.
- •Duration of current episode of recurrent HSV lesions of 3 days or less.
- •Ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms and conditions are excluded:
- •Active internal anal or rectal herpes.
- •Inability to comply with protocol.
- •Impaired renal function.
- •Patients with the following prior conditions are excluded:
- •Prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen.
- •Uncompensated hepatic, cardiac, or renal failure within 1 month of the study.
- •History of hypersensitivity to acyclovir.
- •Previous enrollment in this study.
- •1. Treatment with another medication (topical, oral, or intravenous) with known anti-HSV activity within the past 5 days.
- •Systemic immunomodulatory therapy within 30 days prior to study.
- •Previous treatment with SP-
- •Unchanged antiretroviral therapy for the 2 weeks prior to study.