Randomized Phase IV Trial of Metronidazole Single Dose Versus 7 Day Dose for Treatment of Trichomonas Vaginalis Among HIV-infected Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 5
- 主要终点
- TV Culture Positive Result
研究概览
简要总结
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.
详细描述
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •HIV-positive
- •TV positive by either wet preparation or culture
- •ability to refrain from all alcohol use for 24 hours before and after taking oral metronidazole
- •willing to take metronidazole treatment
排除标准
- •incarcerated
- •previously enrolled
- •currently taking disulfiram
- •alcoholism or known liver damage
- •medical contraindications to metronidazole
- •treated with metronidazole within the previous 14 days
- •requires treatment for B.V. per Amsel's criteria
研究组 & 干预措施
Single dose
Metronidazole 2 gm single dose
干预措施: Metronidazole (Drug)
7 day dose
Metronidazole 500 mg dose x 7 days
干预措施: Metronidazole (Drug)
结局指标
主要结局
TV Culture Positive Result
时间窗: test-of-cure visit at 6-12 days post-treatment completion
At the participants' test of cure (TOC) visits they were screened for Trichomonas vaginalis using (InPouch) culture. Presence of parasite will yield a culture positive result.
次要结局
- TV Culture Positive Result(3 months post-enrollment)
研究者
Patricia Kissinger
Principal Investigator
Tulane University Health Sciences Center